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Short-incubation Levulan Photodynamic Therapy Versus Vehicle for Face/Scalp Actinic Keratosis (AK)

A Phase II Study of Photodynamic Therapy With LEVULAN® Topical Solution + Blue Light Versus LEVULAN® Topical Solution Vehicle + Blue Light Using Spot and Broad Area Application and Incubation Times of 1, 2 and 3 Hours for the Treatment of Multiple Actinic Keratoses on the Face or Scalp

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01475955
Enrollment
235
Registered
2011-11-22
Start date
2011-12-31
Completion date
2012-11-30
Last updated
2016-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Actinic Keratosis

Brief summary

The purpose of this study is to determine if Levulan Photodynamic Therapy (PDT) is safe and effective in the treatment of actinic keratosis when applied to broad areas on the face and scalp for 1, 2 and 3 hours.

Interventions

DRUGBroad Area ALA 1-hour incubation

20% ALA, broad area, 1 hour incubation

DRUGBroad Area ALA 2 hour incubation

20% ALA broad area 2-hour incubation

DRUGbroad area ALA 3-hour incubation

20% ALA broad area 3 hour incubation

DRUGSpot ALA 2 hour incubation

20% ALA spot 2 hour incubation

DRUGVehicle PDT

Levulan Kerastick containing vehicle ingredients only.VEH group will be randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH will be considered a single treatment group.

DEVICEBlue Light Treatment

10 J/cm2 blue light delivered at 10 mW/cm2

Sponsors

DUSA Pharmaceuticals, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 6-20 Grade 1/2 AKs on the face or scalp * a history of AK therapy within the treatment area at least twice in the two years prior to study entry

Exclusion criteria

* Pregnancy * Grade 3 AKs or atypical AKs (e.g., AK \> 1 cm2 in size) within the Treatment Area * lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the Treatment Area * plans to be exposed to artificial tanning devices or excessive sunlight during the trial * Subject is immunosuppressed * unsuccessful outcome from previous ALA-PDT therapy * history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis * skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy * skin pathology or condition that could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy * any condition which would make it unsafe for the subject to participate in this research study * currently enrolled in an investigational drug or device study * has received an investigational drug or been treated with an investigational device within 30 days prior to the initiation of treatment * known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol) * Subject has; * an active herpes simplex infection OR * a history of 2 or more outbreaks within the past 12 months, in the Treatment Area * use of the following topical preparations on the extremities to be treated: * Keratolytics including urea (greater than 5%), alpha hydroxyacids \[e.g.glycolic acid, lactic acid, etc. greater than 5%\], salicylic acid (greater than 2%) within 2 days of initiation of treatment. * Cryotherapy within 2 weeks of initiation of treatment * Retinoids, including tazarotene, adapalene, tretinoin, retinol, within 4 weeks of initiation of treatment. * Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, imiquimod or other topical treatments for AK within 8 weeks of initiation of treatment. * Two or more ALA PDT treatments in the past 6 months * use of systemic retinoid therapy within 6 months of initiation of treatment.

Design outcomes

Primary

MeasureTime frameDescription
Complete Clearance RateWeek 12The proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area

Secondary

MeasureTime frameDescription
Partial Clearance RateBaseline, Week 4proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.
AK Clearance RateBaseline, Week 4AK Clearance Rate (AKCR) for a subject is defined as: 100% x \[1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)\]
Subject Satisfaction ScoreWeek 240 = no improvement or worsening (not satisfied at all) 1. = slight improvement (slightly satisfied) 2. = moderate improvement (moderately satisfied) 3. = excellent improvement (very satisfied)
Hyperpigmentation at BaselineBaselineHYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Hyperpigmentation at Visit 224-48 Hours after PDT #1HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Hyperpigmentation at Visit 3Week 2HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Hyperpigmentation at Visit 4Week 4HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Hyperpigmentation at Visit 5Week 8HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Hyperpigmentation at Visit 6Week 12HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Hyperpigmentation at Visit 7Week 24HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Hypopigmentation at BaselineBaselineHYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Hypopigmentation at Visit 224-48 Hours after PDT #1HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Hypopigmentation at Visit 3Week 2HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Hypopigmentation at Visit 4Week 4HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Hypopigmentation at Visit 5Week 8HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Hypopigmentation at Visit 6Week 12HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Hypopigmentation at Visit 7Week 24HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Erythema at BaselineBaselineErythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Erythema Post-Light Treatment5 minutes after PDT #1Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Edema Post PDT #25 minutes post PDT #2EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Erythema at Visit 224-48 hours after PDT #1Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Erythema at Visit 3Week 2Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Erythema at Visit 4Week 4Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Erythema at Visit 5 (Pre-drug)Week 8 pre-drugErythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Erythema at Visit 5 (Post-light)Week 8 5 minutes post light treatmentErythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Erythema at Visit 6Week 12Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Erythema at Visit 7Week 24Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Edema at BaselineBaselineEDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Edema Post-Light Treatment5 minutes after PDT #1EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Edema at Visit 224-48 hours post PDT#1EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Edema at Visit 3Week 2EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Edema at Visit 4Week 4EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Edema at Visit 5 (Pre-drug)Week 8 pre-drugEDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Edema at Week 12Week 12EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Edema at Week 24Week 24EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Stinging/Burning at BaselineBaselineSTINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.
Stinging/Burning During Light TreatmentDuring PDT #1 (most intense sensation)STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.
Stinging/Burning Post Light-Treatment5 minutes post PDT #1STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.
Stinging/Burning at Visit 224-48 hours post PDT #1STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.
Stinging/Burning at Visit 3Week 2STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.
Stinging/Burning at Visit 4Week 4STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.
Stinging/Burning at Visit 5 (Pre-drug)Week 8 prior to drugSTINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.
Stinging/Burning at Visit 5 During PDT#2during PDT #2STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.
Stinging/Burning at Visit 5 Post PDT#25 minutes post PDT #2STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.
Stinging/Burning at Visit 6Week 12STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.
Stinging/Burning at Visit 7Week 24STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.
Scaling and Dryness at BaselineBaselineSCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Scaling and Dryness at Visit 224-48 hours after PDT #1SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Scaling and Dryness at Visit 3Week 2SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Scaling and Dryness at Visit 4Week 4SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Scaling and Dryness at Visit 5Week 8SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Scaling and Dryness at Visit 6Week 12SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Scaling and Dryness at Visit 7Week 24SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Complete Clearance RateWeek 4The proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area
Oozing/Vesiculation/Crusting at Visit 224-48 hours after PDT #1OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Oozing/Vesiculation/Crusting at Visit 3Week 2OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Oozing/Vesiculation/Crusting at Visit 4Week 4OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Oozing/Vesiculation/Crusting at Visit 5Week 8OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Oozing/Vesiculation/Crusting at Visit 6Week 12OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Oozing/Vesiculation/Crusting at Visit 7Week 24OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Oozing/Vesiculation/Crusting at BaselineBaselineOOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above

Countries

United States

Participant flow

Participants by arm

ArmCount
Broad Area ALA 1-hour + BLUE Light Treatment
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation prior to BLUE light treatment at Visit 1 and Visit 5
48
Broad Area ALA 2-hour + BLUE Light Treatment
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation prior to BLUE light treatment at Visit 1 and Visit 5
48
Broad Area ALA 3-hour + BLUE Light Treatment
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation prior to BLUE light treatment at Visit 1 and Visit 5
47
Spot ALA 2-hour + BLUE Light Treatment
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation prior to BLUE light treatment at Visit 1 and Visit 5
46
Vehicle (VEH) + BLUE Light Treatment
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visit 1 and Visit 5. Subjects receiving VEH were considered a single treatment group. Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
46
Total235

Baseline characteristics

CharacteristicBroad Area ALA 1-hour + BLUE Light TreatmentBroad Area ALA 2-hour + BLUE Light TreatmentBroad Area ALA 3-hour + BLUE Light TreatmentSpot ALA 2-hour + BLUE Light TreatmentVehicle (VEH) + BLUE Light TreatmentTotal
Age, Continuous66.3 years
STANDARD_DEVIATION 7
67.1 years
STANDARD_DEVIATION 9.4
66.4 years
STANDARD_DEVIATION 10.6
69.5 years
STANDARD_DEVIATION 9.7
68.4 years
STANDARD_DEVIATION 9.4
67.5 years
STANDARD_DEVIATION 9.3
Region of Enrollment
United States
48 participants48 participants47 participants46 participants46 participants235 participants
Sex: Female, Male
Female
3 Participants5 Participants7 Participants2 Participants6 Participants23 Participants
Sex: Female, Male
Male
45 Participants43 Participants40 Participants44 Participants40 Participants212 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —— / —
other
Total, other adverse events
0 / 481 / 481 / 474 / 464 / 46
serious
Total, serious adverse events
5 / 481 / 483 / 472 / 462 / 46

Outcome results

Primary

Complete Clearance Rate

The proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area

Time frame: Week 12

Population: Intent to Treat (ITT) with last observation carried forward (LOCF) to impute missing data

ArmMeasureValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentComplete Clearance Rate14 participants
Broad Area ALA 2-hour + BLUE Light TreatmentComplete Clearance Rate7 participants
Broad Area ALA 3-hour + BLUE Light TreatmentComplete Clearance Rate13 participants
Spot ALA 2-hour + BLUE Light TreatmentComplete Clearance Rate8 participants
Vehicle + BLUE Light TreatmentComplete Clearance Rate1 participants
Comparison: Pearson chi-squarep-value: 0.0041Chi-squared
Secondary

AK Clearance Rate

AK Clearance Rate (AKCR) for a subject is defined as: 100% x \[1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)\]

Time frame: Baseline, Week 4

ArmMeasureValue (MEDIAN)Dispersion
Broad Area ALA 1-hour + BLUE Light TreatmentAK Clearance Rate40 percent clearanceStandard Deviation 41.8
Broad Area ALA 2-hour + BLUE Light TreatmentAK Clearance Rate58.4 percent clearanceStandard Deviation 34.8
Broad Area ALA 3-hour + BLUE Light TreatmentAK Clearance Rate54.5 percent clearanceStandard Deviation 30.4
Spot ALA 2-hour + BLUE Light TreatmentAK Clearance Rate56.3 percent clearanceStandard Deviation 54.3
Vehicle + BLUE Light TreatmentAK Clearance Rate0.0 percent clearanceStandard Deviation 28.7
Secondary

AK Clearance Rate

AK Clearance Rate (AKCR) for a subject is defined as: 100% x \[1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)\]

Time frame: Baseline, Week 8

ArmMeasureValue (MEDIAN)Dispersion
Broad Area ALA 1-hour + BLUE Light TreatmentAK Clearance Rate35.7 percent clearanceStandard Deviation 42
Broad Area ALA 2-hour + BLUE Light TreatmentAK Clearance Rate52.5 percent clearanceStandard Deviation 37.2
Broad Area ALA 3-hour + BLUE Light TreatmentAK Clearance Rate57.1 percent clearanceStandard Deviation 37
Spot ALA 2-hour + BLUE Light TreatmentAK Clearance Rate57.1 percent clearanceStandard Deviation 43.8
Vehicle + BLUE Light TreatmentAK Clearance Rate5.7 percent clearanceStandard Deviation 33.5
Secondary

AK Clearance Rate

AK Clearance Rate (AKCR) for a subject is defined as: 100% x \[1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)\]

Time frame: Baseline, Week 12

ArmMeasureValue (MEDIAN)Dispersion
Broad Area ALA 1-hour + BLUE Light TreatmentAK Clearance Rate71.4 percent clearanceStandard Deviation 34.8
Broad Area ALA 2-hour + BLUE Light TreatmentAK Clearance Rate73.6 percent clearanceStandard Deviation 31.1
Broad Area ALA 3-hour + BLUE Light TreatmentAK Clearance Rate78.6 percent clearanceStandard Deviation 30.5
Spot ALA 2-hour + BLUE Light TreatmentAK Clearance Rate68.3 percent clearanceStandard Deviation 39.4
Vehicle + BLUE Light TreatmentAK Clearance Rate7.1 percent clearanceStandard Deviation 44.3
Secondary

AK Clearance Rate

AK Clearance Rate (AKCR) for a subject is defined as: 100% x \[1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)\]

Time frame: Baseline, Week 24

ArmMeasureValue (MEDIAN)Dispersion
Broad Area ALA 1-hour + BLUE Light TreatmentAK Clearance Rate66.7 percent clearanceStandard Deviation 43.4
Broad Area ALA 2-hour + BLUE Light TreatmentAK Clearance Rate64.9 percent clearanceStandard Deviation 36.3
Broad Area ALA 3-hour + BLUE Light TreatmentAK Clearance Rate75.0 percent clearanceStandard Deviation 46.3
Spot ALA 2-hour + BLUE Light TreatmentAK Clearance Rate63.4 percent clearanceStandard Deviation 44.3
Vehicle + BLUE Light TreatmentAK Clearance Rate14.3 percent clearanceStandard Deviation 44
Secondary

Complete Clearance Rate

The proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area

Time frame: Week 8

ArmMeasureValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentComplete Clearance Rate3 participants
Broad Area ALA 2-hour + BLUE Light TreatmentComplete Clearance Rate7 participants
Broad Area ALA 3-hour + BLUE Light TreatmentComplete Clearance Rate8 participants
Spot ALA 2-hour + BLUE Light TreatmentComplete Clearance Rate4 participants
Vehicle + BLUE Light TreatmentComplete Clearance Rate0 participants
Secondary

Complete Clearance Rate

the proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area

Time frame: Week 24

ArmMeasureValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentComplete Clearance Rate11 participants
Broad Area ALA 2-hour + BLUE Light TreatmentComplete Clearance Rate3 participants
Broad Area ALA 3-hour + BLUE Light TreatmentComplete Clearance Rate12 participants
Spot ALA 2-hour + BLUE Light TreatmentComplete Clearance Rate2 participants
Vehicle + BLUE Light TreatmentComplete Clearance Rate1 participants
Secondary

Complete Clearance Rate

The proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area

Time frame: Week 4

Population: ITT LOCF

ArmMeasureValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentComplete Clearance Rate5 participants
Broad Area ALA 2-hour + BLUE Light TreatmentComplete Clearance Rate8 participants
Broad Area ALA 3-hour + BLUE Light TreatmentComplete Clearance Rate5 participants
Spot ALA 2-hour + BLUE Light TreatmentComplete Clearance Rate4 participants
Vehicle + BLUE Light TreatmentComplete Clearance Rate0 participants
Secondary

Edema at Baseline

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area

Time frame: Baseline

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentEdema at BaselineGrade 3 - Moderate0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentEdema at BaselineGrade 0 - None0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentEdema at BaselineGrade 4 - Severe0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentEdema at BaselineGrade 1 - Minimal0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentEdema at BaselineGrade 2 - Mild0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema at BaselineGrade 3 - Moderate0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema at BaselineGrade 2 - Mild0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema at BaselineGrade 1 - Minimal0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema at BaselineGrade 4 - Severe0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema at BaselineGrade 0 - None0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema at BaselineGrade 2 - Mild0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema at BaselineGrade 0 - None1 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema at BaselineGrade 1 - Minimal0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema at BaselineGrade 3 - Moderate0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema at BaselineGrade 4 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema at BaselineGrade 4 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema at BaselineGrade 0 - None0 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema at BaselineGrade 3 - Moderate0 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema at BaselineGrade 2 - Mild0 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema at BaselineGrade 1 - Minimal0 participants
Vehicle + BLUE Light TreatmentEdema at BaselineGrade 2 - Mild0 participants
Vehicle + BLUE Light TreatmentEdema at BaselineGrade 3 - Moderate0 participants
Vehicle + BLUE Light TreatmentEdema at BaselineGrade 0 - None0 participants
Vehicle + BLUE Light TreatmentEdema at BaselineGrade 4 - Severe0 participants
Vehicle + BLUE Light TreatmentEdema at BaselineGrade 1 - Minimal0 participants
Secondary

Edema at Visit 2

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area

Time frame: 24-48 hours post PDT#1

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentEdema at Visit 2Grade 3 - Moderate2 participants
Broad Area ALA 1-hour + BLUE Light TreatmentEdema at Visit 2Grade 0 - None32 participants
Broad Area ALA 1-hour + BLUE Light TreatmentEdema at Visit 2Grade 4 - Severe0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentEdema at Visit 2Grade 1 - Minimal8 participants
Broad Area ALA 1-hour + BLUE Light TreatmentEdema at Visit 2Grade 2 - Mild5 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema at Visit 2Grade 3 - Moderate3 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema at Visit 2Grade 2 - Mild3 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema at Visit 2Grade 1 - Minimal10 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema at Visit 2Grade 4 - Severe1 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema at Visit 2Grade 0 - None31 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema at Visit 2Grade 2 - Mild6 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema at Visit 2Grade 0 - None26 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema at Visit 2Grade 1 - Minimal10 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema at Visit 2Grade 3 - Moderate4 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema at Visit 2Grade 4 - Severe1 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema at Visit 2Grade 4 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema at Visit 2Grade 0 - None27 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema at Visit 2Grade 3 - Moderate2 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema at Visit 2Grade 2 - Mild4 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema at Visit 2Grade 1 - Minimal13 participants
Vehicle + BLUE Light TreatmentEdema at Visit 2Grade 2 - Mild0 participants
Vehicle + BLUE Light TreatmentEdema at Visit 2Grade 3 - Moderate0 participants
Vehicle + BLUE Light TreatmentEdema at Visit 2Grade 0 - None44 participants
Vehicle + BLUE Light TreatmentEdema at Visit 2Grade 4 - Severe0 participants
Vehicle + BLUE Light TreatmentEdema at Visit 2Grade 1 - Minimal2 participants
Secondary

Edema at Visit 3

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area

Time frame: Week 2

Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentEdema at Visit 3Grade 2 - Mild0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentEdema at Visit 3Grade 1 - Minimal1 participants
Broad Area ALA 1-hour + BLUE Light TreatmentEdema at Visit 3Grade 0 - None46 participants
Broad Area ALA 1-hour + BLUE Light TreatmentEdema at Visit 3Grade 4 - Severe0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentEdema at Visit 3Grade 3 - Moderate0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema at Visit 3Grade 4 - Severe0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema at Visit 3Grade 0 - None44 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema at Visit 3Grade 1 - Minimal2 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema at Visit 3Grade 2 - Mild2 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema at Visit 3Grade 3 - Moderate0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema at Visit 3Grade 4 - Severe0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema at Visit 3Grade 1 - Minimal1 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema at Visit 3Grade 2 - Mild4 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema at Visit 3Grade 3 - Moderate0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema at Visit 3Grade 0 - None42 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema at Visit 3Grade 3 - Moderate0 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema at Visit 3Grade 1 - Minimal2 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema at Visit 3Grade 4 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema at Visit 3Grade 0 - None44 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema at Visit 3Grade 2 - Mild0 participants
Vehicle + BLUE Light TreatmentEdema at Visit 3Grade 4 - Severe0 participants
Vehicle + BLUE Light TreatmentEdema at Visit 3Grade 0 - None44 participants
Vehicle + BLUE Light TreatmentEdema at Visit 3Grade 2 - Mild0 participants
Vehicle + BLUE Light TreatmentEdema at Visit 3Grade 1 - Minimal1 participants
Vehicle + BLUE Light TreatmentEdema at Visit 3Grade 3 - Moderate0 participants
Secondary

Edema at Visit 4

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area

Time frame: Week 4

Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentEdema at Visit 4Grade 3 - Moderate0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentEdema at Visit 4Grade 0 - None46 participants
Broad Area ALA 1-hour + BLUE Light TreatmentEdema at Visit 4Grade 4 - Severe0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentEdema at Visit 4Grade 1 - Minimal1 participants
Broad Area ALA 1-hour + BLUE Light TreatmentEdema at Visit 4Grade 2 - Mild0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema at Visit 4Grade 3 - Moderate0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema at Visit 4Grade 2 - Mild0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema at Visit 4Grade 1 - Minimal1 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema at Visit 4Grade 4 - Severe0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema at Visit 4Grade 0 - None47 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema at Visit 4Grade 2 - Mild0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema at Visit 4Grade 0 - None46 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema at Visit 4Grade 1 - Minimal0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema at Visit 4Grade 3 - Moderate0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema at Visit 4Grade 4 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema at Visit 4Grade 4 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema at Visit 4Grade 0 - None46 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema at Visit 4Grade 3 - Moderate0 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema at Visit 4Grade 2 - Mild0 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema at Visit 4Grade 1 - Minimal0 participants
Vehicle + BLUE Light TreatmentEdema at Visit 4Grade 2 - Mild0 participants
Vehicle + BLUE Light TreatmentEdema at Visit 4Grade 3 - Moderate0 participants
Vehicle + BLUE Light TreatmentEdema at Visit 4Grade 0 - None45 participants
Vehicle + BLUE Light TreatmentEdema at Visit 4Grade 4 - Severe0 participants
Vehicle + BLUE Light TreatmentEdema at Visit 4Grade 1 - Minimal0 participants
Secondary

Edema at Visit 5 (Pre-drug)

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area

Time frame: Week 8 pre-drug

Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentEdema at Visit 5 (Pre-drug)Grade 3 - Moderate0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentEdema at Visit 5 (Pre-drug)Grade 0 - None47 participants
Broad Area ALA 1-hour + BLUE Light TreatmentEdema at Visit 5 (Pre-drug)Grade 4 - Severe0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentEdema at Visit 5 (Pre-drug)Grade 1 - Minimal0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentEdema at Visit 5 (Pre-drug)Grade 2 - Mild0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema at Visit 5 (Pre-drug)Grade 3 - Moderate0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema at Visit 5 (Pre-drug)Grade 2 - Mild0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema at Visit 5 (Pre-drug)Grade 1 - Minimal0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema at Visit 5 (Pre-drug)Grade 4 - Severe0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema at Visit 5 (Pre-drug)Grade 0 - None48 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema at Visit 5 (Pre-drug)Grade 2 - Mild0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema at Visit 5 (Pre-drug)Grade 0 - None45 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema at Visit 5 (Pre-drug)Grade 1 - Minimal0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema at Visit 5 (Pre-drug)Grade 3 - Moderate0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema at Visit 5 (Pre-drug)Grade 4 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema at Visit 5 (Pre-drug)Grade 4 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema at Visit 5 (Pre-drug)Grade 0 - None46 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema at Visit 5 (Pre-drug)Grade 3 - Moderate0 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema at Visit 5 (Pre-drug)Grade 2 - Mild0 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema at Visit 5 (Pre-drug)Grade 1 - Minimal0 participants
Vehicle + BLUE Light TreatmentEdema at Visit 5 (Pre-drug)Grade 2 - Mild0 participants
Vehicle + BLUE Light TreatmentEdema at Visit 5 (Pre-drug)Grade 3 - Moderate0 participants
Vehicle + BLUE Light TreatmentEdema at Visit 5 (Pre-drug)Grade 0 - None44 participants
Vehicle + BLUE Light TreatmentEdema at Visit 5 (Pre-drug)Grade 4 - Severe0 participants
Vehicle + BLUE Light TreatmentEdema at Visit 5 (Pre-drug)Grade 1 - Minimal0 participants
Secondary

Edema at Week 12

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area

Time frame: Week 12

Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentEdema at Week 12Grade 3 - Moderate0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentEdema at Week 12Grade 0 - None47 participants
Broad Area ALA 1-hour + BLUE Light TreatmentEdema at Week 12Grade 4 - Severe0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentEdema at Week 12Grade 1 - Minimal0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentEdema at Week 12Grade 2 - Mild0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema at Week 12Grade 3 - Moderate0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema at Week 12Grade 2 - Mild0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema at Week 12Grade 1 - Minimal0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema at Week 12Grade 4 - Severe0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema at Week 12Grade 0 - None48 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema at Week 12Grade 2 - Mild0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema at Week 12Grade 0 - None43 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema at Week 12Grade 1 - Minimal1 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema at Week 12Grade 3 - Moderate0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema at Week 12Grade 4 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema at Week 12Grade 4 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema at Week 12Grade 0 - None46 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema at Week 12Grade 3 - Moderate0 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema at Week 12Grade 2 - Mild0 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema at Week 12Grade 1 - Minimal0 participants
Vehicle + BLUE Light TreatmentEdema at Week 12Grade 2 - Mild0 participants
Vehicle + BLUE Light TreatmentEdema at Week 12Grade 3 - Moderate0 participants
Vehicle + BLUE Light TreatmentEdema at Week 12Grade 0 - None44 participants
Vehicle + BLUE Light TreatmentEdema at Week 12Grade 4 - Severe0 participants
Vehicle + BLUE Light TreatmentEdema at Week 12Grade 1 - Minimal0 participants
Secondary

Edema at Week 24

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area

Time frame: Week 24

Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentEdema at Week 24Grade 3 - Moderate0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentEdema at Week 24Grade 0 - None47 participants
Broad Area ALA 1-hour + BLUE Light TreatmentEdema at Week 24Grade 4 - Severe0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentEdema at Week 24Grade 1 - Minimal0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentEdema at Week 24Grade 2 - Mild0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema at Week 24Grade 3 - Moderate0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema at Week 24Grade 2 - Mild0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema at Week 24Grade 1 - Minimal0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema at Week 24Grade 4 - Severe0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema at Week 24Grade 0 - None48 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema at Week 24Grade 2 - Mild0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema at Week 24Grade 0 - None43 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema at Week 24Grade 1 - Minimal1 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema at Week 24Grade 3 - Moderate0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema at Week 24Grade 4 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema at Week 24Grade 4 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema at Week 24Grade 0 - None45 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema at Week 24Grade 3 - Moderate0 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema at Week 24Grade 2 - Mild0 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema at Week 24Grade 1 - Minimal1 participants
Vehicle + BLUE Light TreatmentEdema at Week 24Grade 2 - Mild0 participants
Vehicle + BLUE Light TreatmentEdema at Week 24Grade 3 - Moderate0 participants
Vehicle + BLUE Light TreatmentEdema at Week 24Grade 0 - None45 participants
Vehicle + BLUE Light TreatmentEdema at Week 24Grade 4 - Severe0 participants
Vehicle + BLUE Light TreatmentEdema at Week 24Grade 1 - Minimal1 participants
Secondary

Edema Post-Light Treatment

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area

Time frame: 5 minutes after PDT #1

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentEdema Post-Light TreatmentGrade 3 - Moderate0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentEdema Post-Light TreatmentGrade 0 - None37 participants
Broad Area ALA 1-hour + BLUE Light TreatmentEdema Post-Light TreatmentGrade 4 - Severe0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentEdema Post-Light TreatmentGrade 1 - Minimal8 participants
Broad Area ALA 1-hour + BLUE Light TreatmentEdema Post-Light TreatmentGrade 2 - Mild2 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema Post-Light TreatmentGrade 3 - Moderate1 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema Post-Light TreatmentGrade 2 - Mild7 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema Post-Light TreatmentGrade 1 - Minimal12 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema Post-Light TreatmentGrade 4 - Severe0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema Post-Light TreatmentGrade 0 - None28 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema Post-Light TreatmentGrade 2 - Mild3 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema Post-Light TreatmentGrade 0 - None27 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema Post-Light TreatmentGrade 1 - Minimal11 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema Post-Light TreatmentGrade 3 - Moderate6 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema Post-Light TreatmentGrade 4 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema Post-Light TreatmentGrade 4 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema Post-Light TreatmentGrade 0 - None33 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema Post-Light TreatmentGrade 3 - Moderate0 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema Post-Light TreatmentGrade 2 - Mild3 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema Post-Light TreatmentGrade 1 - Minimal10 participants
Vehicle + BLUE Light TreatmentEdema Post-Light TreatmentGrade 2 - Mild0 participants
Vehicle + BLUE Light TreatmentEdema Post-Light TreatmentGrade 3 - Moderate0 participants
Vehicle + BLUE Light TreatmentEdema Post-Light TreatmentGrade 0 - None44 participants
Vehicle + BLUE Light TreatmentEdema Post-Light TreatmentGrade 4 - Severe0 participants
Vehicle + BLUE Light TreatmentEdema Post-Light TreatmentGrade 1 - Minimal2 participants
Secondary

Edema Post PDT #2

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area

Time frame: 5 minutes post PDT #2

Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentEdema Post PDT #2Grade 3 - Moderate1 participants
Broad Area ALA 1-hour + BLUE Light TreatmentEdema Post PDT #2Grade 0 - None32 participants
Broad Area ALA 1-hour + BLUE Light TreatmentEdema Post PDT #2Grade 4 - Severe0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentEdema Post PDT #2Grade 1 - Minimal6 participants
Broad Area ALA 1-hour + BLUE Light TreatmentEdema Post PDT #2Grade 2 - Mild2 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema Post PDT #2Grade 3 - Moderate1 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema Post PDT #2Grade 2 - Mild4 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema Post PDT #2Grade 1 - Minimal12 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema Post PDT #2Grade 4 - Severe0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentEdema Post PDT #2Grade 0 - None20 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema Post PDT #2Grade 2 - Mild3 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema Post PDT #2Grade 0 - None18 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema Post PDT #2Grade 1 - Minimal7 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema Post PDT #2Grade 3 - Moderate3 participants
Broad Area ALA 3-hour + BLUE Light TreatmentEdema Post PDT #2Grade 4 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema Post PDT #2Grade 4 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema Post PDT #2Grade 0 - None26 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema Post PDT #2Grade 3 - Moderate0 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema Post PDT #2Grade 2 - Mild4 participants
Spot ALA 2-hour + BLUE Light TreatmentEdema Post PDT #2Grade 1 - Minimal11 participants
Vehicle + BLUE Light TreatmentEdema Post PDT #2Grade 2 - Mild0 participants
Vehicle + BLUE Light TreatmentEdema Post PDT #2Grade 3 - Moderate0 participants
Vehicle + BLUE Light TreatmentEdema Post PDT #2Grade 0 - None43 participants
Vehicle + BLUE Light TreatmentEdema Post PDT #2Grade 4 - Severe0 participants
Vehicle + BLUE Light TreatmentEdema Post PDT #2Grade 1 - Minimal1 participants
Secondary

Erythema at Baseline

Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema

Time frame: Baseline

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentErythema at BaselineGrade 0 - None14 participants
Broad Area ALA 1-hour + BLUE Light TreatmentErythema at BaselineGrade 1 - Minimal23 participants
Broad Area ALA 1-hour + BLUE Light TreatmentErythema at BaselineGrade 2 Mild10 participants
Broad Area ALA 1-hour + BLUE Light TreatmentErythema at BaselineGrade 3 - Moderate0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema at BaselineGrade 0 - None10 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema at BaselineGrade 3 - Moderate0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema at BaselineGrade 1 - Minimal23 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema at BaselineGrade 2 Mild15 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema at BaselineGrade 3 - Moderate0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema at BaselineGrade 1 - Minimal24 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema at BaselineGrade 2 Mild8 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema at BaselineGrade 0 - None15 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema at BaselineGrade 0 - None19 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema at BaselineGrade 1 - Minimal19 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema at BaselineGrade 3 - Moderate0 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema at BaselineGrade 2 Mild8 participants
Vehicle + BLUE Light TreatmentErythema at BaselineGrade 3 - Moderate2 participants
Vehicle + BLUE Light TreatmentErythema at BaselineGrade 2 Mild11 participants
Vehicle + BLUE Light TreatmentErythema at BaselineGrade 1 - Minimal18 participants
Vehicle + BLUE Light TreatmentErythema at BaselineGrade 0 - None15 participants
Secondary

Erythema at Visit 2

Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema

Time frame: 24-48 hours after PDT #1

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentErythema at Visit 2Grade 0 - None2 participants
Broad Area ALA 1-hour + BLUE Light TreatmentErythema at Visit 2Grade 3 - Moderate25 participants
Broad Area ALA 1-hour + BLUE Light TreatmentErythema at Visit 2Grade 1 - Minimal8 participants
Broad Area ALA 1-hour + BLUE Light TreatmentErythema at Visit 2Grade 2 Mild10 participants
Broad Area ALA 1-hour + BLUE Light TreatmentErythema at Visit 2Grade 4 - Severe2 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema at Visit 2Grade 2 Mild14 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema at Visit 2Grade 3 - Moderate23 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema at Visit 2Grade 0 - None0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema at Visit 2Grade 4 - Severe8 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema at Visit 2Grade 1 - Minimal3 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema at Visit 2Grade 0 - None1 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema at Visit 2Grade 2 Mild12 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema at Visit 2Grade 1 - Minimal4 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema at Visit 2Grade 4 - Severe12 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema at Visit 2Grade 3 - Moderate18 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema at Visit 2Grade 2 Mild9 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema at Visit 2Grade 0 - None0 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema at Visit 2Grade 1 - Minimal11 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema at Visit 2Grade 3 - Moderate24 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema at Visit 2Grade 4 - Severe2 participants
Vehicle + BLUE Light TreatmentErythema at Visit 2Grade 1 - Minimal17 participants
Vehicle + BLUE Light TreatmentErythema at Visit 2Grade 0 - None13 participants
Vehicle + BLUE Light TreatmentErythema at Visit 2Grade 2 Mild14 participants
Vehicle + BLUE Light TreatmentErythema at Visit 2Grade 4 - Severe0 participants
Vehicle + BLUE Light TreatmentErythema at Visit 2Grade 3 - Moderate2 participants
Secondary

Erythema at Visit 3

Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema

Time frame: Week 2

Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentErythema at Visit 3Grade 3 - Moderate1 participants
Broad Area ALA 1-hour + BLUE Light TreatmentErythema at Visit 3Grade 0 - None11 participants
Broad Area ALA 1-hour + BLUE Light TreatmentErythema at Visit 3Grade 4 - Severe0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentErythema at Visit 3Grade 1 - Minimal22 participants
Broad Area ALA 1-hour + BLUE Light TreatmentErythema at Visit 3Grade 2 Mild13 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema at Visit 3Grade 3 - Moderate2 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema at Visit 3Grade 2 Mild18 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema at Visit 3Grade 1 - Minimal23 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema at Visit 3Grade 4 - Severe0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema at Visit 3Grade 0 - None5 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema at Visit 3Grade 2 Mild14 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema at Visit 3Grade 0 - None11 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema at Visit 3Grade 1 - Minimal19 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema at Visit 3Grade 3 - Moderate3 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema at Visit 3Grade 4 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema at Visit 3Grade 4 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema at Visit 3Grade 0 - None14 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema at Visit 3Grade 3 - Moderate0 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema at Visit 3Grade 2 Mild6 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema at Visit 3Grade 1 - Minimal26 participants
Vehicle + BLUE Light TreatmentErythema at Visit 3Grade 2 Mild8 participants
Vehicle + BLUE Light TreatmentErythema at Visit 3Grade 3 - Moderate1 participants
Vehicle + BLUE Light TreatmentErythema at Visit 3Grade 0 - None15 participants
Vehicle + BLUE Light TreatmentErythema at Visit 3Grade 4 - Severe0 participants
Vehicle + BLUE Light TreatmentErythema at Visit 3Grade 1 - Minimal21 participants
Secondary

Erythema at Visit 4

Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema

Time frame: Week 4

Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentErythema at Visit 4Grade 3 - Moderate0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentErythema at Visit 4Grade 0 - None12 participants
Broad Area ALA 1-hour + BLUE Light TreatmentErythema at Visit 4Grade 4 - Severe0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentErythema at Visit 4Grade 1 - Minimal27 participants
Broad Area ALA 1-hour + BLUE Light TreatmentErythema at Visit 4Grade 2 Mild8 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema at Visit 4Grade 3 - Moderate0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema at Visit 4Grade 2 Mild13 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema at Visit 4Grade 1 - Minimal22 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema at Visit 4Grade 4 - Severe0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema at Visit 4Grade 0 - None13 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema at Visit 4Grade 2 Mild9 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema at Visit 4Grade 0 - None16 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema at Visit 4Grade 1 - Minimal20 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema at Visit 4Grade 3 - Moderate1 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema at Visit 4Grade 4 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema at Visit 4Grade 4 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema at Visit 4Grade 0 - None12 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema at Visit 4Grade 3 - Moderate1 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema at Visit 4Grade 2 Mild7 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema at Visit 4Grade 1 - Minimal26 participants
Vehicle + BLUE Light TreatmentErythema at Visit 4Grade 2 Mild12 participants
Vehicle + BLUE Light TreatmentErythema at Visit 4Grade 3 - Moderate1 participants
Vehicle + BLUE Light TreatmentErythema at Visit 4Grade 0 - None14 participants
Vehicle + BLUE Light TreatmentErythema at Visit 4Grade 4 - Severe0 participants
Vehicle + BLUE Light TreatmentErythema at Visit 4Grade 1 - Minimal18 participants
Secondary

Erythema at Visit 5 (Post-light)

Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema

Time frame: Week 8 5 minutes post light treatment

Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentErythema at Visit 5 (Post-light)Grade 3 - Moderate12 participants
Broad Area ALA 1-hour + BLUE Light TreatmentErythema at Visit 5 (Post-light)Grade 0 - None1 participants
Broad Area ALA 1-hour + BLUE Light TreatmentErythema at Visit 5 (Post-light)Grade 4 - Severe1 participants
Broad Area ALA 1-hour + BLUE Light TreatmentErythema at Visit 5 (Post-light)Grade 1 - Minimal8 participants
Broad Area ALA 1-hour + BLUE Light TreatmentErythema at Visit 5 (Post-light)Grade 2 Mild19 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema at Visit 5 (Post-light)Grade 3 - Moderate19 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema at Visit 5 (Post-light)Grade 2 Mild10 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema at Visit 5 (Post-light)Grade 0 - None0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema at Visit 5 (Post-light)Grade 1 - Minimal5 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema at Visit 5 (Post-light)Grade 4 - Severe3 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema at Visit 5 (Post-light)Grade 2 Mild7 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema at Visit 5 (Post-light)Grade 0 - None1 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema at Visit 5 (Post-light)Grade 1 - Minimal7 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema at Visit 5 (Post-light)Grade 3 - Moderate16 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema at Visit 5 (Post-light)Grade 4 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema at Visit 5 (Post-light)Grade 4 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema at Visit 5 (Post-light)Grade 0 - None0 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema at Visit 5 (Post-light)Grade 3 - Moderate13 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema at Visit 5 (Post-light)Grade 2 Mild19 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema at Visit 5 (Post-light)Grade 1 - Minimal9 participants
Vehicle + BLUE Light TreatmentErythema at Visit 5 (Post-light)Grade 2 Mild7 participants
Vehicle + BLUE Light TreatmentErythema at Visit 5 (Post-light)Grade 3 - Moderate5 participants
Vehicle + BLUE Light TreatmentErythema at Visit 5 (Post-light)Grade 0 - None4 participants
Vehicle + BLUE Light TreatmentErythema at Visit 5 (Post-light)Grade 4 - Severe0 participants
Vehicle + BLUE Light TreatmentErythema at Visit 5 (Post-light)Grade 1 - Minimal28 participants
Secondary

Erythema at Visit 5 (Pre-drug)

Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema

Time frame: Week 8 pre-drug

Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentErythema at Visit 5 (Pre-drug)Grade 3 - Moderate0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentErythema at Visit 5 (Pre-drug)Grade 0 - None13 participants
Broad Area ALA 1-hour + BLUE Light TreatmentErythema at Visit 5 (Pre-drug)Grade 4 - Severe0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentErythema at Visit 5 (Pre-drug)Grade 1 - Minimal25 participants
Broad Area ALA 1-hour + BLUE Light TreatmentErythema at Visit 5 (Pre-drug)Grade 2 Mild9 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema at Visit 5 (Pre-drug)Grade 3 - Moderate0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema at Visit 5 (Pre-drug)Grade 2 Mild16 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema at Visit 5 (Pre-drug)Grade 1 - Minimal17 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema at Visit 5 (Pre-drug)Grade 4 - Severe0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema at Visit 5 (Pre-drug)Grade 0 - None15 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema at Visit 5 (Pre-drug)Grade 2 Mild5 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema at Visit 5 (Pre-drug)Grade 0 - None17 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema at Visit 5 (Pre-drug)Grade 1 - Minimal22 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema at Visit 5 (Pre-drug)Grade 3 - Moderate1 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema at Visit 5 (Pre-drug)Grade 4 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema at Visit 5 (Pre-drug)Grade 4 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema at Visit 5 (Pre-drug)Grade 0 - None21 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema at Visit 5 (Pre-drug)Grade 3 - Moderate0 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema at Visit 5 (Pre-drug)Grade 2 Mild6 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema at Visit 5 (Pre-drug)Grade 1 - Minimal19 participants
Vehicle + BLUE Light TreatmentErythema at Visit 5 (Pre-drug)Grade 2 Mild10 participants
Vehicle + BLUE Light TreatmentErythema at Visit 5 (Pre-drug)Grade 3 - Moderate2 participants
Vehicle + BLUE Light TreatmentErythema at Visit 5 (Pre-drug)Grade 0 - None12 participants
Vehicle + BLUE Light TreatmentErythema at Visit 5 (Pre-drug)Grade 4 - Severe0 participants
Vehicle + BLUE Light TreatmentErythema at Visit 5 (Pre-drug)Grade 1 - Minimal20 participants
Secondary

Erythema at Visit 6

Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema

Time frame: Week 12

Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentErythema at Visit 6Grade 3 - Moderate0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentErythema at Visit 6Grade 0 - None16 participants
Broad Area ALA 1-hour + BLUE Light TreatmentErythema at Visit 6Grade 4 - Severe0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentErythema at Visit 6Grade 1 - Minimal24 participants
Broad Area ALA 1-hour + BLUE Light TreatmentErythema at Visit 6Grade 2 Mild7 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema at Visit 6Grade 3 - Moderate0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema at Visit 6Grade 2 Mild10 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema at Visit 6Grade 1 - Minimal23 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema at Visit 6Grade 4 - Severe0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema at Visit 6Grade 0 - None15 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema at Visit 6Grade 2 Mild7 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema at Visit 6Grade 0 - None18 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema at Visit 6Grade 1 - Minimal19 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema at Visit 6Grade 3 - Moderate0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema at Visit 6Grade 4 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema at Visit 6Grade 4 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema at Visit 6Grade 0 - None22 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema at Visit 6Grade 3 - Moderate1 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema at Visit 6Grade 2 Mild4 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema at Visit 6Grade 1 - Minimal19 participants
Vehicle + BLUE Light TreatmentErythema at Visit 6Grade 2 Mild8 participants
Vehicle + BLUE Light TreatmentErythema at Visit 6Grade 3 - Moderate1 participants
Vehicle + BLUE Light TreatmentErythema at Visit 6Grade 0 - None17 participants
Vehicle + BLUE Light TreatmentErythema at Visit 6Grade 4 - Severe0 participants
Vehicle + BLUE Light TreatmentErythema at Visit 6Grade 1 - Minimal18 participants
Secondary

Erythema at Visit 7

Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema

Time frame: Week 24

Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentErythema at Visit 7Grade 3 - Moderate1 participants
Broad Area ALA 1-hour + BLUE Light TreatmentErythema at Visit 7Grade 0 - None20 participants
Broad Area ALA 1-hour + BLUE Light TreatmentErythema at Visit 7Grade 4 - Severe0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentErythema at Visit 7Grade 1 - Minimal19 participants
Broad Area ALA 1-hour + BLUE Light TreatmentErythema at Visit 7Grade 2 Mild7 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema at Visit 7Grade 3 - Moderate0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema at Visit 7Grade 2 Mild12 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema at Visit 7Grade 1 - Minimal20 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema at Visit 7Grade 4 - Severe0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema at Visit 7Grade 0 - None16 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema at Visit 7Grade 2 Mild5 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema at Visit 7Grade 0 - None19 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema at Visit 7Grade 1 - Minimal20 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema at Visit 7Grade 3 - Moderate0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema at Visit 7Grade 4 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema at Visit 7Grade 4 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema at Visit 7Grade 0 - None27 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema at Visit 7Grade 3 - Moderate0 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema at Visit 7Grade 2 Mild4 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema at Visit 7Grade 1 - Minimal15 participants
Vehicle + BLUE Light TreatmentErythema at Visit 7Grade 2 Mild7 participants
Vehicle + BLUE Light TreatmentErythema at Visit 7Grade 3 - Moderate2 participants
Vehicle + BLUE Light TreatmentErythema at Visit 7Grade 0 - None21 participants
Vehicle + BLUE Light TreatmentErythema at Visit 7Grade 4 - Severe0 participants
Vehicle + BLUE Light TreatmentErythema at Visit 7Grade 1 - Minimal16 participants
Secondary

Erythema Post-Light Treatment

Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema

Time frame: 5 minutes after PDT #1

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentErythema Post-Light TreatmentGrade 3 - Moderate16 participants
Broad Area ALA 1-hour + BLUE Light TreatmentErythema Post-Light TreatmentGrade 0 - None2 participants
Broad Area ALA 1-hour + BLUE Light TreatmentErythema Post-Light TreatmentGrade 4 - Severe2 participants
Broad Area ALA 1-hour + BLUE Light TreatmentErythema Post-Light TreatmentGrade 1 - Minimal8 participants
Broad Area ALA 1-hour + BLUE Light TreatmentErythema Post-Light TreatmentGrade 2 Mild19 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema Post-Light TreatmentGrade 3 - Moderate26 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema Post-Light TreatmentGrade 2 Mild16 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema Post-Light TreatmentGrade 1 - Minimal4 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema Post-Light TreatmentGrade 4 - Severe2 participants
Broad Area ALA 2-hour + BLUE Light TreatmentErythema Post-Light TreatmentGrade 0 - None0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema Post-Light TreatmentGrade 2 Mild13 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema Post-Light TreatmentGrade 0 - None0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema Post-Light TreatmentGrade 1 - Minimal5 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema Post-Light TreatmentGrade 3 - Moderate22 participants
Broad Area ALA 3-hour + BLUE Light TreatmentErythema Post-Light TreatmentGrade 4 - Severe7 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema Post-Light TreatmentGrade 4 - Severe1 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema Post-Light TreatmentGrade 0 - None0 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema Post-Light TreatmentGrade 3 - Moderate18 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema Post-Light TreatmentGrade 2 Mild18 participants
Spot ALA 2-hour + BLUE Light TreatmentErythema Post-Light TreatmentGrade 1 - Minimal9 participants
Vehicle + BLUE Light TreatmentErythema Post-Light TreatmentGrade 2 Mild14 participants
Vehicle + BLUE Light TreatmentErythema Post-Light TreatmentGrade 3 - Moderate3 participants
Vehicle + BLUE Light TreatmentErythema Post-Light TreatmentGrade 0 - None4 participants
Vehicle + BLUE Light TreatmentErythema Post-Light TreatmentGrade 4 - Severe0 participants
Vehicle + BLUE Light TreatmentErythema Post-Light TreatmentGrade 1 - Minimal25 participants
Secondary

Hyperpigmentation at Baseline

HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas

Time frame: Baseline

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentHyperpigmentation at BaselineGrade 0 - None12 participants
Broad Area ALA 1-hour + BLUE Light TreatmentHyperpigmentation at BaselineGrade 1 - Light23 participants
Broad Area ALA 1-hour + BLUE Light TreatmentHyperpigmentation at BaselineGrade 2 - Moderate/small12 participants
Broad Area ALA 1-hour + BLUE Light TreatmentHyperpigmentation at BaselineGrade 3 - Moderate/moderate0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHyperpigmentation at BaselineGrade 0 - None8 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHyperpigmentation at BaselineGrade 3 - Moderate/moderate2 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHyperpigmentation at BaselineGrade 1 - Light24 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHyperpigmentation at BaselineGrade 2 - Moderate/small14 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHyperpigmentation at BaselineGrade 3 - Moderate/moderate1 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHyperpigmentation at BaselineGrade 1 - Light23 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHyperpigmentation at BaselineGrade 2 - Moderate/small6 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHyperpigmentation at BaselineGrade 0 - None17 participants
Spot ALA 2-hour + BLUE Light TreatmentHyperpigmentation at BaselineGrade 0 - None14 participants
Spot ALA 2-hour + BLUE Light TreatmentHyperpigmentation at BaselineGrade 1 - Light21 participants
Spot ALA 2-hour + BLUE Light TreatmentHyperpigmentation at BaselineGrade 3 - Moderate/moderate2 participants
Spot ALA 2-hour + BLUE Light TreatmentHyperpigmentation at BaselineGrade 2 - Moderate/small9 participants
Vehicle + BLUE Light TreatmentHyperpigmentation at BaselineGrade 3 - Moderate/moderate1 participants
Vehicle + BLUE Light TreatmentHyperpigmentation at BaselineGrade 2 - Moderate/small7 participants
Vehicle + BLUE Light TreatmentHyperpigmentation at BaselineGrade 1 - Light27 participants
Vehicle + BLUE Light TreatmentHyperpigmentation at BaselineGrade 0 - None11 participants
Secondary

Hyperpigmentation at Visit 2

HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas

Time frame: 24-48 Hours after PDT #1

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentHyperpigmentation at Visit 2Grade 0 - None17 participants
Broad Area ALA 1-hour + BLUE Light TreatmentHyperpigmentation at Visit 2Grade 1 - Light19 participants
Broad Area ALA 1-hour + BLUE Light TreatmentHyperpigmentation at Visit 2Grade 2 - Moderate/small9 participants
Broad Area ALA 1-hour + BLUE Light TreatmentHyperpigmentation at Visit 2Grade 3 - Moderate/moderate2 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 2Grade 0 - None12 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 2Grade 3 - Moderate/moderate1 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 2Grade 1 - Light24 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 2Grade 2 - Moderate/small11 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHyperpigmentation at Visit 2Grade 3 - Moderate/moderate1 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHyperpigmentation at Visit 2Grade 1 - Light23 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHyperpigmentation at Visit 2Grade 2 - Moderate/small5 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHyperpigmentation at Visit 2Grade 0 - None18 participants
Spot ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 2Grade 0 - None15 participants
Spot ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 2Grade 1 - Light19 participants
Spot ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 2Grade 3 - Moderate/moderate1 participants
Spot ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 2Grade 2 - Moderate/small11 participants
Vehicle + BLUE Light TreatmentHyperpigmentation at Visit 2Grade 3 - Moderate/moderate1 participants
Vehicle + BLUE Light TreatmentHyperpigmentation at Visit 2Grade 2 - Moderate/small4 participants
Vehicle + BLUE Light TreatmentHyperpigmentation at Visit 2Grade 1 - Light25 participants
Vehicle + BLUE Light TreatmentHyperpigmentation at Visit 2Grade 0 - None16 participants
Secondary

Hyperpigmentation at Visit 3

HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas

Time frame: Week 2

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentHyperpigmentation at Visit 3Grade 0 - None16 participants
Broad Area ALA 1-hour + BLUE Light TreatmentHyperpigmentation at Visit 3Grade 1 - Light18 participants
Broad Area ALA 1-hour + BLUE Light TreatmentHyperpigmentation at Visit 3Grade 2 - Moderate/small12 participants
Broad Area ALA 1-hour + BLUE Light TreatmentHyperpigmentation at Visit 3Grade 3 - Moderate/moderate1 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 3Grade 0 - None10 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 3Grade 3 - Moderate/moderate1 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 3Grade 1 - Light27 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 3Grade 2 - Moderate/small10 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHyperpigmentation at Visit 3Grade 3 - Moderate/moderate1 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHyperpigmentation at Visit 3Grade 1 - Light21 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHyperpigmentation at Visit 3Grade 2 - Moderate/small5 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHyperpigmentation at Visit 3Grade 0 - None20 participants
Spot ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 3Grade 0 - None16 participants
Spot ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 3Grade 1 - Light23 participants
Spot ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 3Grade 3 - Moderate/moderate0 participants
Spot ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 3Grade 2 - Moderate/small7 participants
Vehicle + BLUE Light TreatmentHyperpigmentation at Visit 3Grade 3 - Moderate/moderate2 participants
Vehicle + BLUE Light TreatmentHyperpigmentation at Visit 3Grade 2 - Moderate/small4 participants
Vehicle + BLUE Light TreatmentHyperpigmentation at Visit 3Grade 1 - Light24 participants
Vehicle + BLUE Light TreatmentHyperpigmentation at Visit 3Grade 0 - None15 participants
Secondary

Hyperpigmentation at Visit 4

HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas

Time frame: Week 4

Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentHyperpigmentation at Visit 4Grade 0 - None16 participants
Broad Area ALA 1-hour + BLUE Light TreatmentHyperpigmentation at Visit 4Grade 1 - Light21 participants
Broad Area ALA 1-hour + BLUE Light TreatmentHyperpigmentation at Visit 4Grade 2 - Moderate/small10 participants
Broad Area ALA 1-hour + BLUE Light TreatmentHyperpigmentation at Visit 4Grade 3 - Moderate/moderate0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 4Grade 0 - None11 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 4Grade 3 - Moderate/moderate1 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 4Grade 1 - Light25 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 4Grade 2 - Moderate/small11 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHyperpigmentation at Visit 4Grade 3 - Moderate/moderate3 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHyperpigmentation at Visit 4Grade 1 - Light15 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHyperpigmentation at Visit 4Grade 2 - Moderate/small6 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHyperpigmentation at Visit 4Grade 0 - None22 participants
Spot ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 4Grade 0 - None16 participants
Spot ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 4Grade 1 - Light21 participants
Spot ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 4Grade 3 - Moderate/moderate0 participants
Spot ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 4Grade 2 - Moderate/small9 participants
Vehicle + BLUE Light TreatmentHyperpigmentation at Visit 4Grade 3 - Moderate/moderate1 participants
Vehicle + BLUE Light TreatmentHyperpigmentation at Visit 4Grade 2 - Moderate/small7 participants
Vehicle + BLUE Light TreatmentHyperpigmentation at Visit 4Grade 1 - Light25 participants
Vehicle + BLUE Light TreatmentHyperpigmentation at Visit 4Grade 0 - None12 participants
Secondary

Hyperpigmentation at Visit 5

HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas

Time frame: Week 8

Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentHyperpigmentation at Visit 5Grade 0 - None16 participants
Broad Area ALA 1-hour + BLUE Light TreatmentHyperpigmentation at Visit 5Grade 1 - Light19 participants
Broad Area ALA 1-hour + BLUE Light TreatmentHyperpigmentation at Visit 5Grade 2 - Moderate/small12 participants
Broad Area ALA 1-hour + BLUE Light TreatmentHyperpigmentation at Visit 5Grade 3 - Moderate/moderate0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 5Grade 0 - None11 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 5Grade 3 - Moderate/moderate1 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 5Grade 1 - Light26 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 5Grade 2 - Moderate/small10 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHyperpigmentation at Visit 5Grade 3 - Moderate/moderate1 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHyperpigmentation at Visit 5Grade 1 - Light20 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHyperpigmentation at Visit 5Grade 2 - Moderate/small7 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHyperpigmentation at Visit 5Grade 0 - None17 participants
Spot ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 5Grade 0 - None14 participants
Spot ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 5Grade 1 - Light23 participants
Spot ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 5Grade 3 - Moderate/moderate1 participants
Spot ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 5Grade 2 - Moderate/small8 participants
Vehicle + BLUE Light TreatmentHyperpigmentation at Visit 5Grade 3 - Moderate/moderate2 participants
Vehicle + BLUE Light TreatmentHyperpigmentation at Visit 5Grade 2 - Moderate/small6 participants
Vehicle + BLUE Light TreatmentHyperpigmentation at Visit 5Grade 1 - Light25 participants
Vehicle + BLUE Light TreatmentHyperpigmentation at Visit 5Grade 0 - None11 participants
Secondary

Hyperpigmentation at Visit 6

HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas

Time frame: Week 12

Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentHyperpigmentation at Visit 6Grade 0 - None17 participants
Broad Area ALA 1-hour + BLUE Light TreatmentHyperpigmentation at Visit 6Grade 1 - Light18 participants
Broad Area ALA 1-hour + BLUE Light TreatmentHyperpigmentation at Visit 6Grade 2 - Moderate/small11 participants
Broad Area ALA 1-hour + BLUE Light TreatmentHyperpigmentation at Visit 6Grade 3 - Moderate/moderate1 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 6Grade 0 - None9 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 6Grade 3 - Moderate/moderate2 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 6Grade 1 - Light29 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 6Grade 2 - Moderate/small8 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHyperpigmentation at Visit 6Grade 3 - Moderate/moderate1 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHyperpigmentation at Visit 6Grade 1 - Light16 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHyperpigmentation at Visit 6Grade 2 - Moderate/small9 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHyperpigmentation at Visit 6Grade 0 - None18 participants
Spot ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 6Grade 0 - None17 participants
Spot ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 6Grade 1 - Light20 participants
Spot ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 6Grade 3 - Moderate/moderate1 participants
Spot ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 6Grade 2 - Moderate/small8 participants
Vehicle + BLUE Light TreatmentHyperpigmentation at Visit 6Grade 3 - Moderate/moderate1 participants
Vehicle + BLUE Light TreatmentHyperpigmentation at Visit 6Grade 2 - Moderate/small8 participants
Vehicle + BLUE Light TreatmentHyperpigmentation at Visit 6Grade 1 - Light24 participants
Vehicle + BLUE Light TreatmentHyperpigmentation at Visit 6Grade 0 - None11 participants
Secondary

Hyperpigmentation at Visit 7

HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas

Time frame: Week 24

Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentHyperpigmentation at Visit 7Grade 3 - Moderate/moderate0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentHyperpigmentation at Visit 7Grade 1 - Light23 participants
Broad Area ALA 1-hour + BLUE Light TreatmentHyperpigmentation at Visit 7Grade 0 - None16 participants
Broad Area ALA 1-hour + BLUE Light TreatmentHyperpigmentation at Visit 7Grade 4 - Marked1 participants
Broad Area ALA 1-hour + BLUE Light TreatmentHyperpigmentation at Visit 7Grade 2 - Moderate/small7 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 7Grade 2 - Moderate/small10 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 7Grade 3 - Moderate/moderate2 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 7Grade 1 - Light27 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 7Grade 0 - None9 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 7Grade 4 - Marked0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHyperpigmentation at Visit 7Grade 0 - None20 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHyperpigmentation at Visit 7Grade 1 - Light19 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHyperpigmentation at Visit 7Grade 2 - Moderate/small4 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHyperpigmentation at Visit 7Grade 3 - Moderate/moderate1 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHyperpigmentation at Visit 7Grade 4 - Marked0 participants
Spot ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 7Grade 2 - Moderate/small6 participants
Spot ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 7Grade 0 - None18 participants
Spot ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 7Grade 1 - Light21 participants
Spot ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 7Grade 3 - Moderate/moderate1 participants
Spot ALA 2-hour + BLUE Light TreatmentHyperpigmentation at Visit 7Grade 4 - Marked0 participants
Vehicle + BLUE Light TreatmentHyperpigmentation at Visit 7Grade 1 - Light25 participants
Vehicle + BLUE Light TreatmentHyperpigmentation at Visit 7Grade 0 - None13 participants
Vehicle + BLUE Light TreatmentHyperpigmentation at Visit 7Grade 2 - Moderate/small7 participants
Vehicle + BLUE Light TreatmentHyperpigmentation at Visit 7Grade 4 - Marked0 participants
Vehicle + BLUE Light TreatmentHyperpigmentation at Visit 7Grade 3 - Moderate/moderate1 participants
Secondary

Hypopigmentation at Baseline

HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas

Time frame: Baseline

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentHypopigmentation at BaselineGrade 0 - None21 participants
Broad Area ALA 1-hour + BLUE Light TreatmentHypopigmentation at BaselineGrade 2 - Moderate/small5 participants
Broad Area ALA 1-hour + BLUE Light TreatmentHypopigmentation at BaselineGrade 1 - Light21 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHypopigmentation at BaselineGrade 1 - Light25 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHypopigmentation at BaselineGrade 0 - None20 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHypopigmentation at BaselineGrade 2 - Moderate/small3 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHypopigmentation at BaselineGrade 1 - Light16 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHypopigmentation at BaselineGrade 0 - None30 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHypopigmentation at BaselineGrade 2 - Moderate/small1 participants
Spot ALA 2-hour + BLUE Light TreatmentHypopigmentation at BaselineGrade 0 - None22 participants
Spot ALA 2-hour + BLUE Light TreatmentHypopigmentation at BaselineGrade 2 - Moderate/small1 participants
Spot ALA 2-hour + BLUE Light TreatmentHypopigmentation at BaselineGrade 1 - Light23 participants
Vehicle + BLUE Light TreatmentHypopigmentation at BaselineGrade 1 - Light24 participants
Vehicle + BLUE Light TreatmentHypopigmentation at BaselineGrade 0 - None18 participants
Vehicle + BLUE Light TreatmentHypopigmentation at BaselineGrade 2 - Moderate/small4 participants
Secondary

Hypopigmentation at Visit 2

HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas

Time frame: 24-48 Hours after PDT #1

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentHypopigmentation at Visit 2Grade 0 - None25 participants
Broad Area ALA 1-hour + BLUE Light TreatmentHypopigmentation at Visit 2Grade 2 - Moderate/small6 participants
Broad Area ALA 1-hour + BLUE Light TreatmentHypopigmentation at Visit 2Grade 1 - Light16 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHypopigmentation at Visit 2Grade 1 - Light20 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHypopigmentation at Visit 2Grade 0 - None24 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHypopigmentation at Visit 2Grade 2 - Moderate/small4 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHypopigmentation at Visit 2Grade 1 - Light14 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHypopigmentation at Visit 2Grade 0 - None31 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHypopigmentation at Visit 2Grade 2 - Moderate/small2 participants
Spot ALA 2-hour + BLUE Light TreatmentHypopigmentation at Visit 2Grade 0 - None23 participants
Spot ALA 2-hour + BLUE Light TreatmentHypopigmentation at Visit 2Grade 2 - Moderate/small1 participants
Spot ALA 2-hour + BLUE Light TreatmentHypopigmentation at Visit 2Grade 1 - Light22 participants
Vehicle + BLUE Light TreatmentHypopigmentation at Visit 2Grade 1 - Light20 participants
Vehicle + BLUE Light TreatmentHypopigmentation at Visit 2Grade 0 - None23 participants
Vehicle + BLUE Light TreatmentHypopigmentation at Visit 2Grade 2 - Moderate/small3 participants
Secondary

Hypopigmentation at Visit 3

HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas

Time frame: Week 2

Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentHypopigmentation at Visit 3Grade 0 - None25 participants
Broad Area ALA 1-hour + BLUE Light TreatmentHypopigmentation at Visit 3Grade 2 - Moderate/small5 participants
Broad Area ALA 1-hour + BLUE Light TreatmentHypopigmentation at Visit 3Grade 1 - Light17 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHypopigmentation at Visit 3Grade 1 - Light22 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHypopigmentation at Visit 3Grade 0 - None23 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHypopigmentation at Visit 3Grade 2 - Moderate/small3 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHypopigmentation at Visit 3Grade 1 - Light14 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHypopigmentation at Visit 3Grade 0 - None31 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHypopigmentation at Visit 3Grade 2 - Moderate/small2 participants
Spot ALA 2-hour + BLUE Light TreatmentHypopigmentation at Visit 3Grade 1 - Light24 participants
Spot ALA 2-hour + BLUE Light TreatmentHypopigmentation at Visit 3Grade 0 - None21 participants
Spot ALA 2-hour + BLUE Light TreatmentHypopigmentation at Visit 3Grade 2 - Moderate/small1 participants
Vehicle + BLUE Light TreatmentHypopigmentation at Visit 3Grade 0 - None20 participants
Vehicle + BLUE Light TreatmentHypopigmentation at Visit 3Grade 2 - Moderate/small4 participants
Vehicle + BLUE Light TreatmentHypopigmentation at Visit 3Grade 1 - Light21 participants
Secondary

Hypopigmentation at Visit 4

HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas

Time frame: Week 4

Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentHypopigmentation at Visit 4Grade - None25 participants
Broad Area ALA 1-hour + BLUE Light TreatmentHypopigmentation at Visit 4Grade 1 - Light17 participants
Broad Area ALA 1-hour + BLUE Light TreatmentHypopigmentation at Visit 4Grade 2 - Moderate/small5 participants
Broad Area ALA 1-hour + BLUE Light TreatmentHypopigmentation at Visit 4Grade 3 - Moderate/moderate0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHypopigmentation at Visit 4Grade - None20 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHypopigmentation at Visit 4Grade 3 - Moderate/moderate0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHypopigmentation at Visit 4Grade 1 - Light21 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHypopigmentation at Visit 4Grade 2 - Moderate/small1 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHypopigmentation at Visit 4Grade 3 - Moderate/moderate1 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHypopigmentation at Visit 4Grade 1 - Light16 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHypopigmentation at Visit 4Grade 2 - Moderate/small0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHypopigmentation at Visit 4Grade - None29 participants
Spot ALA 2-hour + BLUE Light TreatmentHypopigmentation at Visit 4Grade - None19 participants
Spot ALA 2-hour + BLUE Light TreatmentHypopigmentation at Visit 4Grade 1 - Light26 participants
Spot ALA 2-hour + BLUE Light TreatmentHypopigmentation at Visit 4Grade 3 - Moderate/moderate0 participants
Spot ALA 2-hour + BLUE Light TreatmentHypopigmentation at Visit 4Grade 2 - Moderate/small1 participants
Vehicle + BLUE Light TreatmentHypopigmentation at Visit 4Grade 3 - Moderate/moderate0 participants
Vehicle + BLUE Light TreatmentHypopigmentation at Visit 4Grade 2 - Moderate/small4 participants
Vehicle + BLUE Light TreatmentHypopigmentation at Visit 4Grade 1 - Light22 participants
Vehicle + BLUE Light TreatmentHypopigmentation at Visit 4Grade - None19 participants
Secondary

Hypopigmentation at Visit 5

HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas

Time frame: Week 8

Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentHypopigmentation at Visit 5Grade 0 - None23 participants
Broad Area ALA 1-hour + BLUE Light TreatmentHypopigmentation at Visit 5Grade 2 - Moderate/small3 participants
Broad Area ALA 1-hour + BLUE Light TreatmentHypopigmentation at Visit 5Grade 1 - Light21 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHypopigmentation at Visit 5Grade 1 - Light26 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHypopigmentation at Visit 5Grade 0 - None19 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHypopigmentation at Visit 5Grade 2 - Moderate/small3 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHypopigmentation at Visit 5Grade 1 - Light17 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHypopigmentation at Visit 5Grade 0 - None28 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHypopigmentation at Visit 5Grade 2 - Moderate/small0 participants
Spot ALA 2-hour + BLUE Light TreatmentHypopigmentation at Visit 5Grade 0 - None17 participants
Spot ALA 2-hour + BLUE Light TreatmentHypopigmentation at Visit 5Grade 2 - Moderate/small4 participants
Spot ALA 2-hour + BLUE Light TreatmentHypopigmentation at Visit 5Grade 1 - Light25 participants
Vehicle + BLUE Light TreatmentHypopigmentation at Visit 5Grade 1 - Light23 participants
Vehicle + BLUE Light TreatmentHypopigmentation at Visit 5Grade 0 - None18 participants
Vehicle + BLUE Light TreatmentHypopigmentation at Visit 5Grade 2 - Moderate/small3 participants
Secondary

Hypopigmentation at Visit 6

HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas

Time frame: Week 12

Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentHypopigmentation at Visit 6Grade 0 - None23 participants
Broad Area ALA 1-hour + BLUE Light TreatmentHypopigmentation at Visit 6Grade 1 - Light21 participants
Broad Area ALA 1-hour + BLUE Light TreatmentHypopigmentation at Visit 6Grade 2 - Moderate/small3 participants
Broad Area ALA 1-hour + BLUE Light TreatmentHypopigmentation at Visit 6Grade 3 - Moderate/moderate0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHypopigmentation at Visit 6Grade 0 - None20 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHypopigmentation at Visit 6Grade 3 - Moderate/moderate0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHypopigmentation at Visit 6Grade 1 - Light26 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHypopigmentation at Visit 6Grade 2 - Moderate/small2 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHypopigmentation at Visit 6Grade 3 - Moderate/moderate0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHypopigmentation at Visit 6Grade 1 - Light18 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHypopigmentation at Visit 6Grade 2 - Moderate/small0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHypopigmentation at Visit 6Grade 0 - None26 participants
Spot ALA 2-hour + BLUE Light TreatmentHypopigmentation at Visit 6Grade 0 - None19 participants
Spot ALA 2-hour + BLUE Light TreatmentHypopigmentation at Visit 6Grade 1 - Light20 participants
Spot ALA 2-hour + BLUE Light TreatmentHypopigmentation at Visit 6Grade 3 - Moderate/moderate1 participants
Spot ALA 2-hour + BLUE Light TreatmentHypopigmentation at Visit 6Grade 2 - Moderate/small6 participants
Vehicle + BLUE Light TreatmentHypopigmentation at Visit 6Grade 3 - Moderate/moderate0 participants
Vehicle + BLUE Light TreatmentHypopigmentation at Visit 6Grade 2 - Moderate/small3 participants
Vehicle + BLUE Light TreatmentHypopigmentation at Visit 6Grade 1 - Light26 participants
Vehicle + BLUE Light TreatmentHypopigmentation at Visit 6Grade 0 - None15 participants
Secondary

Hypopigmentation at Visit 7

HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas

Time frame: Week 24

Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentHypopigmentation at Visit 7Grade 1 - Light22 participants
Broad Area ALA 1-hour + BLUE Light TreatmentHypopigmentation at Visit 7Grade 0 - None22 participants
Broad Area ALA 1-hour + BLUE Light TreatmentHypopigmentation at Visit 7Grade 2 - Moderate/small3 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHypopigmentation at Visit 7Grade 2 - Moderate/small3 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHypopigmentation at Visit 7Grade 0 - None18 participants
Broad Area ALA 2-hour + BLUE Light TreatmentHypopigmentation at Visit 7Grade 1 - Light27 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHypopigmentation at Visit 7Grade 0 - None28 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHypopigmentation at Visit 7Grade 1 - Light15 participants
Broad Area ALA 3-hour + BLUE Light TreatmentHypopigmentation at Visit 7Grade 2 - Moderate/small1 participants
Spot ALA 2-hour + BLUE Light TreatmentHypopigmentation at Visit 7Grade 1 - Light24 participants
Spot ALA 2-hour + BLUE Light TreatmentHypopigmentation at Visit 7Grade 0 - None20 participants
Spot ALA 2-hour + BLUE Light TreatmentHypopigmentation at Visit 7Grade 2 - Moderate/small2 participants
Vehicle + BLUE Light TreatmentHypopigmentation at Visit 7Grade 0 - None17 participants
Vehicle + BLUE Light TreatmentHypopigmentation at Visit 7Grade 2 - Moderate/small4 participants
Vehicle + BLUE Light TreatmentHypopigmentation at Visit 7Grade 1 - Light25 participants
Secondary

Oozing/Vesiculation/Crusting at Baseline

OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above

Time frame: Baseline

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at BaselineGrade 3 - Moderate0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at BaselineGrade 2 - Mild1 participants
Broad Area ALA 1-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at BaselineGrade 0 - None45 participants
Broad Area ALA 1-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at BaselineGrade 1 - Minimal1 participants
Broad Area ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at BaselineGrade 0 - None47 participants
Broad Area ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at BaselineGrade 2 - Mild1 participants
Broad Area ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at BaselineGrade 3 - Moderate0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at BaselineGrade 1 - Minimal0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at BaselineGrade 3 - Moderate0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at BaselineGrade 2 - Mild0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at BaselineGrade 1 - Minimal1 participants
Broad Area ALA 3-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at BaselineGrade 0 - None46 participants
Spot ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at BaselineGrade 3 - Moderate0 participants
Spot ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at BaselineGrade 0 - None43 participants
Spot ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at BaselineGrade 2 - Mild0 participants
Spot ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at BaselineGrade 1 - Minimal3 participants
Vehicle + BLUE Light TreatmentOozing/Vesiculation/Crusting at BaselineGrade 2 - Mild1 participants
Vehicle + BLUE Light TreatmentOozing/Vesiculation/Crusting at BaselineGrade 3 - Moderate0 participants
Vehicle + BLUE Light TreatmentOozing/Vesiculation/Crusting at BaselineGrade 1 - Minimal1 participants
Vehicle + BLUE Light TreatmentOozing/Vesiculation/Crusting at BaselineGrade 0 - None44 participants
Secondary

Oozing/Vesiculation/Crusting at Visit 2

OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above

Time frame: 24-48 hours after PDT #1

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 2Grade 3 - Moderate0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 2Grade 0 - None43 participants
Broad Area ALA 1-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 2Grade 4 - Severe0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 2Grade 1 - Minimal2 participants
Broad Area ALA 1-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 2Grade 2 - Mild2 participants
Broad Area ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 2Grade 3 - Moderate1 participants
Broad Area ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 2Grade 2 - Mild4 participants
Broad Area ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 2Grade 1 - Minimal4 participants
Broad Area ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 2Grade 4 - Severe0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 2Grade 0 - None39 participants
Broad Area ALA 3-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 2Grade 2 - Mild4 participants
Broad Area ALA 3-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 2Grade 0 - None34 participants
Broad Area ALA 3-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 2Grade 1 - Minimal5 participants
Broad Area ALA 3-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 2Grade 3 - Moderate4 participants
Broad Area ALA 3-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 2Grade 4 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 2Grade 4 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 2Grade 0 - None34 participants
Spot ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 2Grade 3 - Moderate1 participants
Spot ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 2Grade 2 - Mild2 participants
Spot ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 2Grade 1 - Minimal9 participants
Vehicle + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 2Grade 2 - Mild1 participants
Vehicle + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 2Grade 3 - Moderate0 participants
Vehicle + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 2Grade 0 - None43 participants
Vehicle + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 2Grade 4 - Severe0 participants
Vehicle + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 2Grade 1 - Minimal2 participants
Secondary

Oozing/Vesiculation/Crusting at Visit 3

OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above

Time frame: Week 2

Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 3Grade 0 - None45 participants
Broad Area ALA 1-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 3Grade 1 - Minimal1 participants
Broad Area ALA 1-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 3Grade 2 - Mild1 participants
Broad Area ALA 1-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 3Grade 3 - Moderate0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 3Grade 0 - None42 participants
Broad Area ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 3Grade 3 - Moderate0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 3Grade 1 - Minimal5 participants
Broad Area ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 3Grade 2 - Mild1 participants
Broad Area ALA 3-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 3Grade 3 - Moderate0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 3Grade 1 - Minimal1 participants
Broad Area ALA 3-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 3Grade 2 - Mild1 participants
Broad Area ALA 3-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 3Grade 0 - None45 participants
Spot ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 3Grade 0 - None45 participants
Spot ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 3Grade 1 - Minimal0 participants
Spot ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 3Grade 3 - Moderate0 participants
Spot ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 3Grade 2 - Mild1 participants
Vehicle + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 3Grade 3 - Moderate0 participants
Vehicle + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 3Grade 2 - Mild0 participants
Vehicle + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 3Grade 1 - Minimal0 participants
Vehicle + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 3Grade 0 - None45 participants
Secondary

Oozing/Vesiculation/Crusting at Visit 4

OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above

Time frame: Week 4

Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 4Grade 0 - None46 participants
Broad Area ALA 1-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 4Grade 1 - Minimal1 participants
Broad Area ALA 1-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 4Grade 2 - Mild0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 4Grade 3 - Moderate0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 4Grade 0 - None45 participants
Broad Area ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 4Grade 3 - Moderate0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 4Grade 1 - Minimal3 participants
Broad Area ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 4Grade 2 - Mild0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 4Grade 3 - Moderate0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 4Grade 1 - Minimal0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 4Grade 2 - Mild0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 4Grade 0 - None46 participants
Spot ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 4Grade 0 - None46 participants
Spot ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 4Grade 1 - Minimal0 participants
Spot ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 4Grade 3 - Moderate0 participants
Spot ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 4Grade 2 - Mild0 participants
Vehicle + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 4Grade 3 - Moderate0 participants
Vehicle + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 4Grade 2 - Mild0 participants
Vehicle + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 4Grade 1 - Minimal0 participants
Vehicle + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 4Grade 0 - None45 participants
Secondary

Oozing/Vesiculation/Crusting at Visit 5

OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above

Time frame: Week 8

Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 5Grade 2 - Mild0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 5Grade 0 - None47 participants
Broad Area ALA 1-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 5Grade 1 - Minimal0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 5Grade 3 - Moderate0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 5Grade 1 - Minimal1 participants
Broad Area ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 5Grade 0 - None47 participants
Broad Area ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 5Grade 2 - Mild0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 5Grade 3 - Moderate0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 5Grade 0 - None45 participants
Broad Area ALA 3-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 5Grade 3 - Moderate0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 5Grade 1 - Minimal0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 5Grade 2 - Mild0 participants
Spot ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 5Grade 0 - None44 participants
Spot ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 5Grade 3 - Moderate0 participants
Spot ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 5Grade 2 - Mild0 participants
Spot ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 5Grade 1 - Minimal2 participants
Vehicle + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 5Grade 3 - Moderate1 participants
Vehicle + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 5Grade 0 - None42 participants
Vehicle + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 5Grade 1 - Minimal1 participants
Vehicle + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 5Grade 2 - Mild0 participants
Secondary

Oozing/Vesiculation/Crusting at Visit 6

OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above

Time frame: Week 12

Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 6Grade 0 - None46 participants
Broad Area ALA 1-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 6Grade 1 - Minimal1 participants
Broad Area ALA 1-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 6Grade 3 - Moderate0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 6Grade 2 - Mild0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 6Grade 2 - Mild0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 6Grade 0 - None48 participants
Broad Area ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 6Grade 1 - Minimal0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 6Grade 3 - Moderate0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 6Grade 3 - Moderate0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 6Grade 2 - Mild0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 6Grade 0 - None44 participants
Broad Area ALA 3-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 6Grade 1 - Minimal0 participants
Spot ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 6Grade 0 - None46 participants
Spot ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 6Grade 1 - Minimal0 participants
Spot ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 6Grade 2 - Mild0 participants
Spot ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 6Grade 3 - Moderate0 participants
Vehicle + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 6Grade 1 - Minimal0 participants
Vehicle + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 6Grade 0 - None44 participants
Vehicle + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 6Grade 3 - Moderate0 participants
Vehicle + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 6Grade 2 - Mild0 participants
Secondary

Oozing/Vesiculation/Crusting at Visit 7

OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above

Time frame: Week 24

Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 7Grade 0 - None47 participants
Broad Area ALA 1-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 7Grade 1 - Minimal0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 7Grade 2 - Mild0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 7Grade 3 - Moderate0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 7Grade 0 - None48 participants
Broad Area ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 7Grade 3 - Moderate0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 7Grade 1 - Minimal0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 7Grade 2 - Mild0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 7Grade 3 - Moderate0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 7Grade 1 - Minimal0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 7Grade 2 - Mild0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 7Grade 0 - None44 participants
Spot ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 7Grade 0 - None45 participants
Spot ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 7Grade 1 - Minimal1 participants
Spot ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 7Grade 3 - Moderate0 participants
Spot ALA 2-hour + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 7Grade 2 - Mild0 participants
Vehicle + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 7Grade 3 - Moderate0 participants
Vehicle + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 7Grade 2 - Mild0 participants
Vehicle + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 7Grade 1 - Minimal0 participants
Vehicle + BLUE Light TreatmentOozing/Vesiculation/Crusting at Visit 7Grade 0 - None46 participants
Secondary

Partial Clearance Rate

proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.

Time frame: Baseline, Week 12

ArmMeasureValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentPartial Clearance Rate23 participants
Broad Area ALA 2-hour + BLUE Light TreatmentPartial Clearance Rate24 participants
Broad Area ALA 3-hour + BLUE Light TreatmentPartial Clearance Rate25 participants
Spot ALA 2-hour + BLUE Light TreatmentPartial Clearance Rate20 participants
Vehicle + BLUE Light TreatmentPartial Clearance Rate5 participants
Secondary

Partial Clearance Rate

proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.

Time frame: Baseline, Week 4

ArmMeasureValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentPartial Clearance Rate12 participants
Broad Area ALA 2-hour + BLUE Light TreatmentPartial Clearance Rate16 participants
Broad Area ALA 3-hour + BLUE Light TreatmentPartial Clearance Rate14 participants
Spot ALA 2-hour + BLUE Light TreatmentPartial Clearance Rate12 participants
Vehicle + BLUE Light TreatmentPartial Clearance Rate2 participants
Secondary

Partial Clearance Rate

proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.

Time frame: Baseline Week 24

ArmMeasureValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentPartial Clearance Rate18 participants
Broad Area ALA 2-hour + BLUE Light TreatmentPartial Clearance Rate19 participants
Broad Area ALA 3-hour + BLUE Light TreatmentPartial Clearance Rate24 participants
Spot ALA 2-hour + BLUE Light TreatmentPartial Clearance Rate17 participants
Vehicle + BLUE Light TreatmentPartial Clearance Rate3 participants
Secondary

Partial Clearance Rate

proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.

Time frame: Baseline, Week 8

ArmMeasureValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentPartial Clearance Rate10 participants
Broad Area ALA 2-hour + BLUE Light TreatmentPartial Clearance Rate13 participants
Broad Area ALA 3-hour + BLUE Light TreatmentPartial Clearance Rate15 participants
Spot ALA 2-hour + BLUE Light TreatmentPartial Clearance Rate13 participants
Vehicle + BLUE Light TreatmentPartial Clearance Rate1 participants
Secondary

Scaling and Dryness at Baseline

SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling

Time frame: Baseline

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentScaling and Dryness at BaselineGrade 3 - Moderate0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentScaling and Dryness at BaselineGrade 0 - None25 participants
Broad Area ALA 1-hour + BLUE Light TreatmentScaling and Dryness at BaselineGrade 1 - Minimal16 participants
Broad Area ALA 1-hour + BLUE Light TreatmentScaling and Dryness at BaselineGrade 2 - Mild6 participants
Broad Area ALA 1-hour + BLUE Light TreatmentScaling and Dryness at BaselineGrade 4 - Severe0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentScaling and Dryness at BaselineGrade 2 - Mild5 participants
Broad Area ALA 2-hour + BLUE Light TreatmentScaling and Dryness at BaselineGrade 1 - Minimal19 participants
Broad Area ALA 2-hour + BLUE Light TreatmentScaling and Dryness at BaselineGrade 4 - Severe0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentScaling and Dryness at BaselineGrade 0 - None24 participants
Broad Area ALA 2-hour + BLUE Light TreatmentScaling and Dryness at BaselineGrade 3 - Moderate0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentScaling and Dryness at BaselineGrade 0 - None26 participants
Broad Area ALA 3-hour + BLUE Light TreatmentScaling and Dryness at BaselineGrade 2 - Mild4 participants
Broad Area ALA 3-hour + BLUE Light TreatmentScaling and Dryness at BaselineGrade 4 - Severe0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentScaling and Dryness at BaselineGrade 1 - Minimal17 participants
Broad Area ALA 3-hour + BLUE Light TreatmentScaling and Dryness at BaselineGrade 3 - Moderate0 participants
Spot ALA 2-hour + BLUE Light TreatmentScaling and Dryness at BaselineGrade 1 - Minimal15 participants
Spot ALA 2-hour + BLUE Light TreatmentScaling and Dryness at BaselineGrade 0 - None29 participants
Spot ALA 2-hour + BLUE Light TreatmentScaling and Dryness at BaselineGrade 2 - Mild2 participants
Spot ALA 2-hour + BLUE Light TreatmentScaling and Dryness at BaselineGrade 3 - Moderate0 participants
Spot ALA 2-hour + BLUE Light TreatmentScaling and Dryness at BaselineGrade 4 - Severe0 participants
Vehicle + BLUE Light TreatmentScaling and Dryness at BaselineGrade 2 - Mild6 participants
Vehicle + BLUE Light TreatmentScaling and Dryness at BaselineGrade 1 - Minimal21 participants
Vehicle + BLUE Light TreatmentScaling and Dryness at BaselineGrade 0 - None16 participants
Vehicle + BLUE Light TreatmentScaling and Dryness at BaselineGrade 4 - Severe0 participants
Vehicle + BLUE Light TreatmentScaling and Dryness at BaselineGrade 3 - Moderate3 participants
Secondary

Scaling and Dryness at Visit 2

SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling

Time frame: 24-48 hours after PDT #1

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentScaling and Dryness at Visit 2Grade 3 - Moderate5 participants
Broad Area ALA 1-hour + BLUE Light TreatmentScaling and Dryness at Visit 2Grade 0 - None19 participants
Broad Area ALA 1-hour + BLUE Light TreatmentScaling and Dryness at Visit 2Grade 4 - Severe0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentScaling and Dryness at Visit 2Grade 1 - Minimal13 participants
Broad Area ALA 1-hour + BLUE Light TreatmentScaling and Dryness at Visit 2Grade 2 - Mild10 participants
Broad Area ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 2Grade 3 - Moderate4 participants
Broad Area ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 2Grade 2 - Mild8 participants
Broad Area ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 2Grade 1 - Minimal16 participants
Broad Area ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 2Grade 4 - Severe0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 2Grade 0 - None20 participants
Broad Area ALA 3-hour + BLUE Light TreatmentScaling and Dryness at Visit 2Grade 2 - Mild4 participants
Broad Area ALA 3-hour + BLUE Light TreatmentScaling and Dryness at Visit 2Grade 0 - None22 participants
Broad Area ALA 3-hour + BLUE Light TreatmentScaling and Dryness at Visit 2Grade 1 - Minimal15 participants
Broad Area ALA 3-hour + BLUE Light TreatmentScaling and Dryness at Visit 2Grade 3 - Moderate5 participants
Broad Area ALA 3-hour + BLUE Light TreatmentScaling and Dryness at Visit 2Grade 4 - Severe1 participants
Spot ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 2Grade 4 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 2Grade 0 - None17 participants
Spot ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 2Grade 3 - Moderate0 participants
Spot ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 2Grade 2 - Mild6 participants
Spot ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 2Grade 1 - Minimal23 participants
Vehicle + BLUE Light TreatmentScaling and Dryness at Visit 2Grade 2 - Mild6 participants
Vehicle + BLUE Light TreatmentScaling and Dryness at Visit 2Grade 3 - Moderate0 participants
Vehicle + BLUE Light TreatmentScaling and Dryness at Visit 2Grade 0 - None18 participants
Vehicle + BLUE Light TreatmentScaling and Dryness at Visit 2Grade 4 - Severe0 participants
Vehicle + BLUE Light TreatmentScaling and Dryness at Visit 2Grade 1 - Minimal22 participants
Secondary

Scaling and Dryness at Visit 3

SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling

Time frame: Week 2

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentScaling and Dryness at Visit 3Grade 3 - Moderate1 participants
Broad Area ALA 1-hour + BLUE Light TreatmentScaling and Dryness at Visit 3Grade 0 - None22 participants
Broad Area ALA 1-hour + BLUE Light TreatmentScaling and Dryness at Visit 3Grade 4 - Severe0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentScaling and Dryness at Visit 3Grade 1 - Minimal17 participants
Broad Area ALA 1-hour + BLUE Light TreatmentScaling and Dryness at Visit 3Grade 2 - Mild7 participants
Broad Area ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 3Grade 3 - Moderate3 participants
Broad Area ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 3Grade 2 - Mild8 participants
Broad Area ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 3Grade 1 - Minimal15 participants
Broad Area ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 3Grade 4 - Severe1 participants
Broad Area ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 3Grade 0 - None21 participants
Broad Area ALA 3-hour + BLUE Light TreatmentScaling and Dryness at Visit 3Grade 2 - Mild8 participants
Broad Area ALA 3-hour + BLUE Light TreatmentScaling and Dryness at Visit 3Grade 0 - None20 participants
Broad Area ALA 3-hour + BLUE Light TreatmentScaling and Dryness at Visit 3Grade 1 - Minimal16 participants
Broad Area ALA 3-hour + BLUE Light TreatmentScaling and Dryness at Visit 3Grade 3 - Moderate3 participants
Broad Area ALA 3-hour + BLUE Light TreatmentScaling and Dryness at Visit 3Grade 4 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 3Grade 4 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 3Grade 0 - None27 participants
Spot ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 3Grade 3 - Moderate0 participants
Spot ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 3Grade 2 - Mild3 participants
Spot ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 3Grade 1 - Minimal16 participants
Vehicle + BLUE Light TreatmentScaling and Dryness at Visit 3Grade 2 - Mild6 participants
Vehicle + BLUE Light TreatmentScaling and Dryness at Visit 3Grade 3 - Moderate0 participants
Vehicle + BLUE Light TreatmentScaling and Dryness at Visit 3Grade 0 - None19 participants
Vehicle + BLUE Light TreatmentScaling and Dryness at Visit 3Grade 4 - Severe0 participants
Vehicle + BLUE Light TreatmentScaling and Dryness at Visit 3Grade 1 - Minimal20 participants
Secondary

Scaling and Dryness at Visit 4

SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling

Time frame: Week 4

Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentScaling and Dryness at Visit 4Grade 3 - Moderate1 participants
Broad Area ALA 1-hour + BLUE Light TreatmentScaling and Dryness at Visit 4Grade 0 - None24 participants
Broad Area ALA 1-hour + BLUE Light TreatmentScaling and Dryness at Visit 4Grade 4 - Severe0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentScaling and Dryness at Visit 4Grade 1 - Minimal19 participants
Broad Area ALA 1-hour + BLUE Light TreatmentScaling and Dryness at Visit 4Grade 2 - Mild3 participants
Broad Area ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 4Grade 3 - Moderate0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 4Grade 2 - Mild6 participants
Broad Area ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 4Grade 1 - Minimal18 participants
Broad Area ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 4Grade 4 - Severe0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 4Grade 0 - None24 participants
Broad Area ALA 3-hour + BLUE Light TreatmentScaling and Dryness at Visit 4Grade 2 - Mild1 participants
Broad Area ALA 3-hour + BLUE Light TreatmentScaling and Dryness at Visit 4Grade 0 - None27 participants
Broad Area ALA 3-hour + BLUE Light TreatmentScaling and Dryness at Visit 4Grade 1 - Minimal17 participants
Broad Area ALA 3-hour + BLUE Light TreatmentScaling and Dryness at Visit 4Grade 3 - Moderate1 participants
Broad Area ALA 3-hour + BLUE Light TreatmentScaling and Dryness at Visit 4Grade 4 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 4Grade 4 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 4Grade 0 - None28 participants
Spot ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 4Grade 3 - Moderate0 participants
Spot ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 4Grade 2 - Mild4 participants
Spot ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 4Grade 1 - Minimal14 participants
Vehicle + BLUE Light TreatmentScaling and Dryness at Visit 4Grade 2 - Mild4 participants
Vehicle + BLUE Light TreatmentScaling and Dryness at Visit 4Grade 3 - Moderate1 participants
Vehicle + BLUE Light TreatmentScaling and Dryness at Visit 4Grade 0 - None18 participants
Vehicle + BLUE Light TreatmentScaling and Dryness at Visit 4Grade 4 - Severe0 participants
Vehicle + BLUE Light TreatmentScaling and Dryness at Visit 4Grade 1 - Minimal22 participants
Secondary

Scaling and Dryness at Visit 5

SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling

Time frame: Week 8

Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentScaling and Dryness at Visit 5Grade 4 - Severe0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentScaling and Dryness at Visit 5Grade 1 - Minimal21 participants
Broad Area ALA 1-hour + BLUE Light TreatmentScaling and Dryness at Visit 5Grade 3 - Moderate0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentScaling and Dryness at Visit 5Grade 2 - Mild3 participants
Broad Area ALA 1-hour + BLUE Light TreatmentScaling and Dryness at Visit 5Grade 0 - None23 participants
Broad Area ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 5Grade 1 - Minimal16 participants
Broad Area ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 5Grade 3 - Moderate0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 5Grade 0 - None30 participants
Broad Area ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 5Grade 4 - Severe0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 5Grade 2 - Mild2 participants
Broad Area ALA 3-hour + BLUE Light TreatmentScaling and Dryness at Visit 5Grade 2 - Mild3 participants
Broad Area ALA 3-hour + BLUE Light TreatmentScaling and Dryness at Visit 5Grade 3 - Moderate0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentScaling and Dryness at Visit 5Grade 4 - Severe0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentScaling and Dryness at Visit 5Grade 1 - Minimal11 participants
Broad Area ALA 3-hour + BLUE Light TreatmentScaling and Dryness at Visit 5Grade 0 - None31 participants
Spot ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 5Grade 4 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 5Grade 0 - None31 participants
Spot ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 5Grade 1 - Minimal13 participants
Spot ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 5Grade 2 - Mild2 participants
Spot ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 5Grade 3 - Moderate0 participants
Vehicle + BLUE Light TreatmentScaling and Dryness at Visit 5Grade 3 - Moderate0 participants
Vehicle + BLUE Light TreatmentScaling and Dryness at Visit 5Grade 2 - Mild9 participants
Vehicle + BLUE Light TreatmentScaling and Dryness at Visit 5Grade 1 - Minimal18 participants
Vehicle + BLUE Light TreatmentScaling and Dryness at Visit 5Grade 0 - None17 participants
Vehicle + BLUE Light TreatmentScaling and Dryness at Visit 5Grade 4 - Severe0 participants
Secondary

Scaling and Dryness at Visit 6

SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling

Time frame: Week 12

Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentScaling and Dryness at Visit 6Grade 3 - Moderate0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentScaling and Dryness at Visit 6Grade 0 - None32 participants
Broad Area ALA 1-hour + BLUE Light TreatmentScaling and Dryness at Visit 6Grade 4 - Severe0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentScaling and Dryness at Visit 6Grade 1 - Minimal13 participants
Broad Area ALA 1-hour + BLUE Light TreatmentScaling and Dryness at Visit 6Grade 2 - Mild2 participants
Broad Area ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 6Grade 3 - Moderate0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 6Grade 2 - Mild2 participants
Broad Area ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 6Grade 1 - Minimal12 participants
Broad Area ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 6Grade 4 - Severe0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 6Grade 0 - None34 participants
Broad Area ALA 3-hour + BLUE Light TreatmentScaling and Dryness at Visit 6Grade 2 - Mild0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentScaling and Dryness at Visit 6Grade 0 - None30 participants
Broad Area ALA 3-hour + BLUE Light TreatmentScaling and Dryness at Visit 6Grade 1 - Minimal13 participants
Broad Area ALA 3-hour + BLUE Light TreatmentScaling and Dryness at Visit 6Grade 3 - Moderate1 participants
Broad Area ALA 3-hour + BLUE Light TreatmentScaling and Dryness at Visit 6Grade 4 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 6Grade 4 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 6Grade 0 - None33 participants
Spot ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 6Grade 3 - Moderate0 participants
Spot ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 6Grade 2 - Mild2 participants
Spot ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 6Grade 1 - Minimal11 participants
Vehicle + BLUE Light TreatmentScaling and Dryness at Visit 6Grade 2 - Mild4 participants
Vehicle + BLUE Light TreatmentScaling and Dryness at Visit 6Grade 3 - Moderate0 participants
Vehicle + BLUE Light TreatmentScaling and Dryness at Visit 6Grade 0 - None23 participants
Vehicle + BLUE Light TreatmentScaling and Dryness at Visit 6Grade 4 - Severe0 participants
Vehicle + BLUE Light TreatmentScaling and Dryness at Visit 6Grade 1 - Minimal17 participants
Secondary

Scaling and Dryness at Visit 7

SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling

Time frame: Week 24

Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentScaling and Dryness at Visit 7Grade 3 - Moderate0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentScaling and Dryness at Visit 7Grade 0 - None31 participants
Broad Area ALA 1-hour + BLUE Light TreatmentScaling and Dryness at Visit 7Grade 4 - Severe0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentScaling and Dryness at Visit 7Grade 1 - Minimal13 participants
Broad Area ALA 1-hour + BLUE Light TreatmentScaling and Dryness at Visit 7Grade 2 - Mild3 participants
Broad Area ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 7Grade 3 - Moderate0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 7Grade 2 - Mild0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 7Grade 1 - Minimal22 participants
Broad Area ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 7Grade 4 - Severe0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 7Grade 0 - None26 participants
Broad Area ALA 3-hour + BLUE Light TreatmentScaling and Dryness at Visit 7Grade 2 - Mild1 participants
Broad Area ALA 3-hour + BLUE Light TreatmentScaling and Dryness at Visit 7Grade 0 - None32 participants
Broad Area ALA 3-hour + BLUE Light TreatmentScaling and Dryness at Visit 7Grade 1 - Minimal11 participants
Broad Area ALA 3-hour + BLUE Light TreatmentScaling and Dryness at Visit 7Grade 3 - Moderate0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentScaling and Dryness at Visit 7Grade 4 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 7Grade 4 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 7Grade 0 - None37 participants
Spot ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 7Grade 3 - Moderate0 participants
Spot ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 7Grade 2 - Mild1 participants
Spot ALA 2-hour + BLUE Light TreatmentScaling and Dryness at Visit 7Grade 1 - Minimal8 participants
Vehicle + BLUE Light TreatmentScaling and Dryness at Visit 7Grade 2 - Mild5 participants
Vehicle + BLUE Light TreatmentScaling and Dryness at Visit 7Grade 3 - Moderate1 participants
Vehicle + BLUE Light TreatmentScaling and Dryness at Visit 7Grade 0 - None28 participants
Vehicle + BLUE Light TreatmentScaling and Dryness at Visit 7Grade 4 - Severe0 participants
Vehicle + BLUE Light TreatmentScaling and Dryness at Visit 7Grade 1 - Minimal12 participants
Secondary

Stinging/Burning at Baseline

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.

Time frame: Baseline

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning at BaselineGrade 0 - None47 participants
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning at BaselineGrade 1 - MInimal0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning at BaselineGrade 2 - Moderate0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning at BaselineGrade 3 - Severe0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning at BaselineGrade 0 - None48 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning at BaselineGrade 3 - Severe0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning at BaselineGrade 1 - MInimal0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning at BaselineGrade 2 - Moderate0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning at BaselineGrade 3 - Severe0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning at BaselineGrade 1 - MInimal0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning at BaselineGrade 2 - Moderate0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning at BaselineGrade 0 - None47 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning at BaselineGrade 0 - None46 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning at BaselineGrade 1 - MInimal0 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning at BaselineGrade 3 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning at BaselineGrade 2 - Moderate0 participants
Vehicle + BLUE Light TreatmentStinging/Burning at BaselineGrade 3 - Severe0 participants
Vehicle + BLUE Light TreatmentStinging/Burning at BaselineGrade 2 - Moderate0 participants
Vehicle + BLUE Light TreatmentStinging/Burning at BaselineGrade 1 - MInimal2 participants
Vehicle + BLUE Light TreatmentStinging/Burning at BaselineGrade 0 - None44 participants
Secondary

Stinging/Burning at Visit 2

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.

Time frame: 24-48 hours post PDT #1

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning at Visit 2Grade 0 - None25 participants
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning at Visit 2Grade 1 - MInimal18 participants
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning at Visit 2Grade 2 - Moderate4 participants
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning at Visit 2Grade 3 - Severe0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 2Grade 0 - None23 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 2Grade 3 - Severe1 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 2Grade 1 - MInimal20 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 2Grade 2 - Moderate4 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning at Visit 2Grade 3 - Severe3 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning at Visit 2Grade 1 - MInimal17 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning at Visit 2Grade 2 - Moderate7 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning at Visit 2Grade 0 - None20 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 2Grade 0 - None35 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 2Grade 1 - MInimal10 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 2Grade 3 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 2Grade 2 - Moderate1 participants
Vehicle + BLUE Light TreatmentStinging/Burning at Visit 2Grade 3 - Severe0 participants
Vehicle + BLUE Light TreatmentStinging/Burning at Visit 2Grade 2 - Moderate1 participants
Vehicle + BLUE Light TreatmentStinging/Burning at Visit 2Grade 1 - MInimal4 participants
Vehicle + BLUE Light TreatmentStinging/Burning at Visit 2Grade 0 - None41 participants
Secondary

Stinging/Burning at Visit 3

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.

Time frame: Week 2

Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning at Visit 3Grade 0 - None46 participants
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning at Visit 3Grade 1 - MInimal1 participants
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning at Visit 3Grade 2 - Moderate0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning at Visit 3Grade 3 - Severe0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 3Grade 0 - None45 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 3Grade 3 - Severe0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 3Grade 1 - MInimal3 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 3Grade 2 - Moderate0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning at Visit 3Grade 3 - Severe0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning at Visit 3Grade 1 - MInimal2 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning at Visit 3Grade 2 - Moderate1 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning at Visit 3Grade 0 - None44 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 3Grade 0 - None46 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 3Grade 1 - MInimal0 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 3Grade 3 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 3Grade 2 - Moderate0 participants
Vehicle + BLUE Light TreatmentStinging/Burning at Visit 3Grade 3 - Severe0 participants
Vehicle + BLUE Light TreatmentStinging/Burning at Visit 3Grade 2 - Moderate0 participants
Vehicle + BLUE Light TreatmentStinging/Burning at Visit 3Grade 1 - MInimal0 participants
Vehicle + BLUE Light TreatmentStinging/Burning at Visit 3Grade 0 - None45 participants
Secondary

Stinging/Burning at Visit 4

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.

Time frame: Week 4

Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning at Visit 4Grade 0 - None45 participants
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning at Visit 4Grade 1 - MInimal2 participants
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning at Visit 4Grade 2 - Moderate0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning at Visit 4Grade 3 - Severe0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 4Grade 0 - None47 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 4Grade 3 - Severe0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 4Grade 1 - MInimal1 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 4Grade 2 - Moderate0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning at Visit 4Grade 3 - Severe0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning at Visit 4Grade 1 - MInimal0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning at Visit 4Grade 2 - Moderate0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning at Visit 4Grade 0 - None46 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 4Grade 0 - None46 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 4Grade 1 - MInimal0 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 4Grade 3 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 4Grade 2 - Moderate0 participants
Vehicle + BLUE Light TreatmentStinging/Burning at Visit 4Grade 3 - Severe0 participants
Vehicle + BLUE Light TreatmentStinging/Burning at Visit 4Grade 2 - Moderate1 participants
Vehicle + BLUE Light TreatmentStinging/Burning at Visit 4Grade 1 - MInimal0 participants
Vehicle + BLUE Light TreatmentStinging/Burning at Visit 4Grade 0 - None44 participants
Secondary

Stinging/Burning at Visit 5 During PDT#2

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.

Time frame: during PDT #2

Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning at Visit 5 During PDT#2Grade 0 - None4 participants
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning at Visit 5 During PDT#2Grade 1 - MInimal20 participants
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning at Visit 5 During PDT#2Grade 2 - Moderate15 participants
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning at Visit 5 During PDT#2Grade 3 - Severe2 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 5 During PDT#2Grade 0 - None1 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 5 During PDT#2Grade 3 - Severe5 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 5 During PDT#2Grade 1 - MInimal11 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 5 During PDT#2Grade 2 - Moderate20 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning at Visit 5 During PDT#2Grade 3 - Severe8 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning at Visit 5 During PDT#2Grade 1 - MInimal7 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning at Visit 5 During PDT#2Grade 2 - Moderate16 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning at Visit 5 During PDT#2Grade 0 - None0 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 5 During PDT#2Grade 0 - None4 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 5 During PDT#2Grade 1 - MInimal23 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 5 During PDT#2Grade 3 - Severe1 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 5 During PDT#2Grade 2 - Moderate13 participants
Vehicle + BLUE Light TreatmentStinging/Burning at Visit 5 During PDT#2Grade 3 - Severe0 participants
Vehicle + BLUE Light TreatmentStinging/Burning at Visit 5 During PDT#2Grade 2 - Moderate0 participants
Vehicle + BLUE Light TreatmentStinging/Burning at Visit 5 During PDT#2Grade 1 - MInimal16 participants
Vehicle + BLUE Light TreatmentStinging/Burning at Visit 5 During PDT#2Grade 0 - None28 participants
Secondary

Stinging/Burning at Visit 5 Post PDT#2

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.

Time frame: 5 minutes post PDT #2

Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning at Visit 5 Post PDT#2Grade 0 - None7 participants
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning at Visit 5 Post PDT#2Grade 1 - MInimal26 participants
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning at Visit 5 Post PDT#2Grade 2 - Moderate8 participants
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning at Visit 5 Post PDT#2Grade 3 - Severe0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 5 Post PDT#2Grade 0 - None2 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 5 Post PDT#2Grade 3 - Severe2 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 5 Post PDT#2Grade 1 - MInimal18 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 5 Post PDT#2Grade 2 - Moderate15 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning at Visit 5 Post PDT#2Grade 3 - Severe4 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning at Visit 5 Post PDT#2Grade 1 - MInimal14 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning at Visit 5 Post PDT#2Grade 2 - Moderate11 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning at Visit 5 Post PDT#2Grade 0 - None2 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 5 Post PDT#2Grade 0 - None10 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 5 Post PDT#2Grade 1 - MInimal22 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 5 Post PDT#2Grade 3 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 5 Post PDT#2Grade 2 - Moderate9 participants
Vehicle + BLUE Light TreatmentStinging/Burning at Visit 5 Post PDT#2Grade 3 - Severe0 participants
Vehicle + BLUE Light TreatmentStinging/Burning at Visit 5 Post PDT#2Grade 2 - Moderate0 participants
Vehicle + BLUE Light TreatmentStinging/Burning at Visit 5 Post PDT#2Grade 1 - MInimal9 participants
Vehicle + BLUE Light TreatmentStinging/Burning at Visit 5 Post PDT#2Grade 0 - None35 participants
Secondary

Stinging/Burning at Visit 5 (Pre-drug)

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.

Time frame: Week 8 prior to drug

Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning at Visit 5 (Pre-drug)Grade 0 - None47 participants
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning at Visit 5 (Pre-drug)Grade 1 - MInimal0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning at Visit 5 (Pre-drug)Grade 2 - Moderate0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning at Visit 5 (Pre-drug)Grade 3 - Severe0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 5 (Pre-drug)Grade 0 - None48 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 5 (Pre-drug)Grade 3 - Severe0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 5 (Pre-drug)Grade 1 - MInimal0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 5 (Pre-drug)Grade 2 - Moderate0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning at Visit 5 (Pre-drug)Grade 3 - Severe0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning at Visit 5 (Pre-drug)Grade 1 - MInimal0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning at Visit 5 (Pre-drug)Grade 2 - Moderate0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning at Visit 5 (Pre-drug)Grade 0 - None45 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 5 (Pre-drug)Grade 0 - None45 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 5 (Pre-drug)Grade 1 - MInimal1 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 5 (Pre-drug)Grade 3 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 5 (Pre-drug)Grade 2 - Moderate0 participants
Vehicle + BLUE Light TreatmentStinging/Burning at Visit 5 (Pre-drug)Grade 3 - Severe0 participants
Vehicle + BLUE Light TreatmentStinging/Burning at Visit 5 (Pre-drug)Grade 2 - Moderate0 participants
Vehicle + BLUE Light TreatmentStinging/Burning at Visit 5 (Pre-drug)Grade 1 - MInimal2 participants
Vehicle + BLUE Light TreatmentStinging/Burning at Visit 5 (Pre-drug)Grade 0 - None42 participants
Secondary

Stinging/Burning at Visit 6

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.

Time frame: Week 12

Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning at Visit 6Grade 0 - None47 participants
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning at Visit 6Grade 3 - Severe0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning at Visit 6Grade 2 - Moderate0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning at Visit 6Grade 1 - MInimal0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 6Grade 3 - Severe0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 6Grade 1 - MInimal0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 6Grade 0 - None48 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 6Grade 2 - Moderate0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning at Visit 6Grade 2 - Moderate0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning at Visit 6Grade 3 - Severe0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning at Visit 6Grade 0 - None44 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning at Visit 6Grade 1 - MInimal0 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 6Grade 0 - None44 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 6Grade 1 - MInimal2 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 6Grade 2 - Moderate0 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 6Grade 3 - Severe0 participants
Vehicle + BLUE Light TreatmentStinging/Burning at Visit 6Grade 3 - Severe0 participants
Vehicle + BLUE Light TreatmentStinging/Burning at Visit 6Grade 0 - None43 participants
Vehicle + BLUE Light TreatmentStinging/Burning at Visit 6Grade 1 - MInimal1 participants
Vehicle + BLUE Light TreatmentStinging/Burning at Visit 6Grade 2 - Moderate0 participants
Secondary

Stinging/Burning at Visit 7

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.

Time frame: Week 24

Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning at Visit 7Grade 0 - None47 participants
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning at Visit 7Grade 1 - MInimal0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning at Visit 7Grade 2 - Moderate0 participants
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning at Visit 7Grade 3 - Severe0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 7Grade 0 - None48 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 7Grade 3 - Severe0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 7Grade 1 - MInimal0 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 7Grade 2 - Moderate0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning at Visit 7Grade 3 - Severe0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning at Visit 7Grade 1 - MInimal0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning at Visit 7Grade 2 - Moderate0 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning at Visit 7Grade 0 - None44 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 7Grade 0 - None45 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 7Grade 1 - MInimal1 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 7Grade 3 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning at Visit 7Grade 2 - Moderate0 participants
Vehicle + BLUE Light TreatmentStinging/Burning at Visit 7Grade 3 - Severe0 participants
Vehicle + BLUE Light TreatmentStinging/Burning at Visit 7Grade 2 - Moderate0 participants
Vehicle + BLUE Light TreatmentStinging/Burning at Visit 7Grade 1 - MInimal0 participants
Vehicle + BLUE Light TreatmentStinging/Burning at Visit 7Grade 0 - None46 participants
Secondary

Stinging/Burning During Light Treatment

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.

Time frame: During PDT #1 (most intense sensation)

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning During Light TreatmentGrade 0 - None2 participants
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning During Light TreatmentGrade 1 - MInimal15 participants
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning During Light TreatmentGrade 2 - Moderate23 participants
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning During Light TreatmentGrade 3 - Severe7 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning During Light TreatmentGrade 0 - None1 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning During Light TreatmentGrade 3 - Severe9 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning During Light TreatmentGrade 1 - MInimal9 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning During Light TreatmentGrade 2 - Moderate29 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning During Light TreatmentGrade 3 - Severe15 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning During Light TreatmentGrade 1 - MInimal10 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning During Light TreatmentGrade 2 - Moderate22 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning During Light TreatmentGrade 0 - None0 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning During Light TreatmentGrade 0 - None3 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning During Light TreatmentGrade 1 - MInimal16 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning During Light TreatmentGrade 3 - Severe8 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning During Light TreatmentGrade 2 - Moderate19 participants
Vehicle + BLUE Light TreatmentStinging/Burning During Light TreatmentGrade 3 - Severe0 participants
Vehicle + BLUE Light TreatmentStinging/Burning During Light TreatmentGrade 2 - Moderate6 participants
Vehicle + BLUE Light TreatmentStinging/Burning During Light TreatmentGrade 1 - MInimal11 participants
Vehicle + BLUE Light TreatmentStinging/Burning During Light TreatmentGrade 0 - None35 participants
Secondary

Stinging/Burning Post Light-Treatment

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.

Time frame: 5 minutes post PDT #1

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning Post Light-TreatmentGrade 0 - None8 participants
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning Post Light-TreatmentGrade 1 - MInimal29 participants
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning Post Light-TreatmentGrade 2 - Moderate8 participants
Broad Area ALA 1-hour + BLUE Light TreatmentStinging/Burning Post Light-TreatmentGrade 3 - Severe2 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning Post Light-TreatmentGrade 0 - None5 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning Post Light-TreatmentGrade 3 - Severe1 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning Post Light-TreatmentGrade 1 - MInimal17 participants
Broad Area ALA 2-hour + BLUE Light TreatmentStinging/Burning Post Light-TreatmentGrade 2 - Moderate25 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning Post Light-TreatmentGrade 3 - Severe8 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning Post Light-TreatmentGrade 1 - MInimal19 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning Post Light-TreatmentGrade 2 - Moderate19 participants
Broad Area ALA 3-hour + BLUE Light TreatmentStinging/Burning Post Light-TreatmentGrade 0 - None1 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning Post Light-TreatmentGrade 0 - None8 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning Post Light-TreatmentGrade 1 - MInimal25 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning Post Light-TreatmentGrade 3 - Severe0 participants
Spot ALA 2-hour + BLUE Light TreatmentStinging/Burning Post Light-TreatmentGrade 2 - Moderate13 participants
Vehicle + BLUE Light TreatmentStinging/Burning Post Light-TreatmentGrade 3 - Severe0 participants
Vehicle + BLUE Light TreatmentStinging/Burning Post Light-TreatmentGrade 2 - Moderate0 participants
Vehicle + BLUE Light TreatmentStinging/Burning Post Light-TreatmentGrade 1 - MInimal6 participants
Vehicle + BLUE Light TreatmentStinging/Burning Post Light-TreatmentGrade 0 - None40 participants
Secondary

Subject Satisfaction Score

0 = no improvement or worsening (not satisfied at all) 1. = slight improvement (slightly satisfied) 2. = moderate improvement (moderately satisfied) 3. = excellent improvement (very satisfied)

Time frame: Week 24

ArmMeasureGroupValue (NUMBER)
Broad Area ALA 1-hour + BLUE Light TreatmentSubject Satisfaction Score3 = excellent improvement (very satisfied)20 participants
Broad Area ALA 1-hour + BLUE Light TreatmentSubject Satisfaction Score2 = moderate improvement (moderately satisfied)14 participants
Broad Area ALA 1-hour + BLUE Light TreatmentSubject Satisfaction Score1 = slight improvement (slightly satisfied)6 participants
Broad Area ALA 1-hour + BLUE Light TreatmentSubject Satisfaction Score0 = no improvement or worsening (not satisfied at7 participants
Broad Area ALA 2-hour + BLUE Light TreatmentSubject Satisfaction Score3 = excellent improvement (very satisfied)21 participants
Broad Area ALA 2-hour + BLUE Light TreatmentSubject Satisfaction Score0 = no improvement or worsening (not satisfied at2 participants
Broad Area ALA 2-hour + BLUE Light TreatmentSubject Satisfaction Score2 = moderate improvement (moderately satisfied)16 participants
Broad Area ALA 2-hour + BLUE Light TreatmentSubject Satisfaction Score1 = slight improvement (slightly satisfied)9 participants
Broad Area ALA 3-hour + BLUE Light TreatmentSubject Satisfaction Score0 = no improvement or worsening (not satisfied at4 participants
Broad Area ALA 3-hour + BLUE Light TreatmentSubject Satisfaction Score2 = moderate improvement (moderately satisfied)19 participants
Broad Area ALA 3-hour + BLUE Light TreatmentSubject Satisfaction Score1 = slight improvement (slightly satisfied)1 participants
Broad Area ALA 3-hour + BLUE Light TreatmentSubject Satisfaction Score3 = excellent improvement (very satisfied)20 participants
Spot ALA 2-hour + BLUE Light TreatmentSubject Satisfaction Score3 = excellent improvement (very satisfied)20 participants
Spot ALA 2-hour + BLUE Light TreatmentSubject Satisfaction Score2 = moderate improvement (moderately satisfied)17 participants
Spot ALA 2-hour + BLUE Light TreatmentSubject Satisfaction Score0 = no improvement or worsening (not satisfied at7 participants
Spot ALA 2-hour + BLUE Light TreatmentSubject Satisfaction Score1 = slight improvement (slightly satisfied)2 participants
Vehicle + BLUE Light TreatmentSubject Satisfaction Score0 = no improvement or worsening (not satisfied at24 participants
Vehicle + BLUE Light TreatmentSubject Satisfaction Score1 = slight improvement (slightly satisfied)6 participants
Vehicle + BLUE Light TreatmentSubject Satisfaction Score2 = moderate improvement (moderately satisfied)9 participants
Vehicle + BLUE Light TreatmentSubject Satisfaction Score3 = excellent improvement (very satisfied)7 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026