Levulan PDT Versus Vehicle for Extremity Actinic Keratoses (AK)

A Phase II Study of Photodynamic Therapy (PDT)With LEVULAN® Topical Solution + Blue Light Versus LEVULAN® Topical Solution Vehicle + Blue Light for the Treatment of Actinic Keratoses on the Upper Extremities

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01458587

Enrollment

Registered

2011-10-25

Start date

2011-11-30

Completion date

2012-07-31

Last updated

2013-03-14

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

Conditions

Keratosis, Actinic

Keywords

Actinic keratosis

Brief summary

The purpose of this study is to determine if Levulan PDT is safe and effective in the treatment of actinic keratoses on the upper arms and hands.

Interventions

DRUGAminolevulinic Acid PDT (ALA)

20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light

DRUGVehicle PDT (VEH)

Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light

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

Inclusion criteria

* At least 4 Grade 1/2 AKs on each upper extremity

Exclusion criteria

* Pregnancy * history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis * lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the Treatment Area * skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy * Subject is immunosuppressed * unsuccessful outcome from previous ALA-PDT therapy * 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) * 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

Measure	Time frame	Description
Lesion Clearance Rate	Week 12	Clearance rate for all lesions

Secondary

Measure	Time frame	Description
Complete Clearance Rate	Week 8	proportion of subjects with a count of zero lesions in the treatment area
Partial Clearance Rate	Baseline and Week 8	proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.
Subject Satisfaction Score	Week 12	Subject satisfaction score 1. = Excellent (very satisfied) 2. = Good (moderately satisfied) 3. = Fair (slightly satisfied) 4. = Poor (not satisfied at all)
Hyperpigmentation at Baseline	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
Hyperpigmentation at Visit 3	2 weeks after PDT #1	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
Hyperpigmentation at Visit 4	8 weeks after PDT #1	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
Hyperpigmentation at Visit 5	12 weeks after PDT #1	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
Hypopigmentation at Baseline	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
Hypopigmentation at Visit 3	2 Weeks after PDT #1	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
Hypopigmentation at Visit 4	8 Weeks after PDT #1	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
Hypopigmentation at Visit 5	12 Weeks after PDT #1	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
Erythema at Baseline	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
Erythema Post-Light Treatment	5 Minutes after PDT #1	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
Erythema at Visit 3	2 Weeks after PDT #1	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
Erythema at Visit 4	8 Weeks after PDT #1	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
Erythema at Visit 5	12 Weeks after PDT #1	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
Edema at Baseline	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
Lesion Clearance Rate	Week 8	—
Edema at Visit 3	2 Weeks after PDT #1	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
Edema at Visit 4	8 Weeks after PDT #1	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
Edema at Visit 5	12 Weeks after PDT #1	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
Stinging/Burning at Baseline	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
Stinging/Burning During Light Treatment	During PDT #1	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
Stinging/Burning Post Light Treatment	5 minutes after PDT #1	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
Stinging/Burning at Visit 3	2 Weeks after PDT #1	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
Stinging/Burning at Visit 4	8 Weeks after PDT #1	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
Stinging/Burning at Visit 5	12 Weeks after PDT #1	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
Scaling and Dryness at Baseline	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
Scaling and Dryness at Visit 3	2 Weeks Post PDT #1	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
Scaling and Dryness at Visit 4	8 Weeks Post PDT #1	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
Scaling and Dryness at Visit 5	12 Weeks Post PDT #1	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
OOZING/VESICULATION/CRUSTING at Baseline	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
OOZING/VESICULATION/CRUSTING at Visit 3	Week 2 after PDT #1	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
OOZING/VESICULATION/CRUSTING at Visit 4	8 Weeks after PDT #1	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
OOZING/VESICULATION/CRUSTING at Visit 5	12 Weeks after PDT #1	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
Edema Post-Light Treatment	5 Minutes after PDT #1	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

Countries

United States

Participant flow

Recruitment details

Recruitment period was from 28November2011 - 4April2012 at 3 medical clinics in the U.S.

Participants by arm

Arm	Count
Aminolevulinic Acid ALA applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period.	35
Vehicle Vehicle applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period.	35
Total	70

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Withdrawal by Subject	1	0

Baseline characteristics

Characteristic	Vehicle	Total	Aminolevulinic Acid
Age Continuous	65.6 years STANDARD_DEVIATION 9.3	63.8 years STANDARD_DEVIATION 9.72	62.1 years STANDARD_DEVIATION 9.96
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants	70 Participants	35 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	35 Participants	70 Participants	35 Participants
Region of Enrollment United States	35 participants	70 participants	35 participants
Sex: Female, Male Female	12 Participants	25 Participants	13 Participants
Sex: Female, Male Male	23 Participants	45 Participants	22 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	17 / 35	5 / 35
serious Total, serious adverse events	0 / 35	0 / 35

Outcome results

Primary

Lesion Clearance Rate

Clearance rate for all lesions

Time frame: Week 12

Population: ITT analysis with LOCF

Arm	Measure	Value (MEDIAN)	Dispersion
ALA+OCC	Lesion Clearance Rate	88.7 percentage of lesions cleared	Standard Deviation 25.1
ALA-OCC	Lesion Clearance Rate	70.0 percentage of lesions cleared	Standard Deviation 31.1
VEH+OCC	Lesion Clearance Rate	16.7 percentage of lesions cleared	Standard Deviation 27.6
VEH-OCC	Lesion Clearance Rate	5.6 percentage of lesions cleared	Standard Deviation 26.8

Secondary

Complete Clearance Rate

proportion of subjects with a count of zero lesions in the treatment area

Time frame: Week 12

Population: ITT LOCF

Arm	Measure	Value (NUMBER)
ALA+OCC	Complete Clearance Rate	12 arms 100% cleared
ALA-OCC	Complete Clearance Rate	7 arms 100% cleared
VEH+OCC	Complete Clearance Rate	0 arms 100% cleared
VEH-OCC	Complete Clearance Rate	1 arms 100% cleared

Secondary

Complete Clearance Rate

proportion of subjects with a count of zero lesions in the treatment area

Time frame: Week 8

Population: ITT LOCF

Arm	Measure	Value (NUMBER)
ALA+OCC	Complete Clearance Rate	8 arms 100% cleared
ALA-OCC	Complete Clearance Rate	4 arms 100% cleared
VEH+OCC	Complete Clearance Rate	0 arms 100% cleared
VEH-OCC	Complete Clearance Rate	0 arms 100% cleared

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

Population: ITT

Arm	Measure	Group	Value (NUMBER)
ALA+OCC	Edema at Baseline	Grade 2 (mild)	0 participants
ALA+OCC	Edema at Baseline	Grade 1 (minimal)	0 participants
ALA+OCC	Edema at Baseline	Grade 0 (none)	35 participants
ALA-OCC	Edema at Baseline	Grade 2 (mild)	0 participants
ALA-OCC	Edema at Baseline	Grade 0 (none)	35 participants
ALA-OCC	Edema at Baseline	Grade 1 (minimal)	0 participants
VEH+OCC	Edema at Baseline	Grade 0 (none)	35 participants
VEH+OCC	Edema at Baseline	Grade 2 (mild)	0 participants
VEH+OCC	Edema at Baseline	Grade 1 (minimal)	0 participants
VEH-OCC	Edema at Baseline	Grade 1 (minimal)	0 participants
VEH-OCC	Edema at Baseline	Grade 2 (mild)	0 participants
VEH-OCC	Edema at Baseline	Grade 0 (none)	35 participants

Secondary

Edema at Visit 3

Time frame: 2 Weeks after PDT #1

Population: ITT

Arm	Measure	Group	Value (NUMBER)
ALA+OCC	Edema at Visit 3	Grade 0 (none)	27 participants
ALA+OCC	Edema at Visit 3	Grade 2 (mild)	3 participants
ALA+OCC	Edema at Visit 3	Grade 1 (minimal)	5 participants
ALA-OCC	Edema at Visit 3	Grade 0 (none)	34 participants
ALA-OCC	Edema at Visit 3	Grade 2 (mild)	0 participants
ALA-OCC	Edema at Visit 3	Grade 1 (minimal)	1 participants
VEH+OCC	Edema at Visit 3	Grade 1 (minimal)	0 participants
VEH+OCC	Edema at Visit 3	Grade 0 (none)	35 participants
VEH+OCC	Edema at Visit 3	Grade 2 (mild)	0 participants
VEH-OCC	Edema at Visit 3	Grade 0 (none)	35 participants
VEH-OCC	Edema at Visit 3	Grade 2 (mild)	0 participants
VEH-OCC	Edema at Visit 3	Grade 1 (minimal)	0 participants

Secondary

Edema at Visit 4

Time frame: 8 Weeks after PDT #1

Population: ITT

Arm	Measure	Group	Value (NUMBER)
ALA+OCC	Edema at Visit 4	Grade 2 (mild)	0 participants
ALA+OCC	Edema at Visit 4	Grade 0 (none)	35 participants
ALA+OCC	Edema at Visit 4	Grade 1 (minimal)	0 participants
ALA-OCC	Edema at Visit 4	Grade 1 (minimal)	0 participants
ALA-OCC	Edema at Visit 4	Grade 0 (none)	35 participants
ALA-OCC	Edema at Visit 4	Grade 2 (mild)	0 participants
VEH+OCC	Edema at Visit 4	Grade 2 (mild)	0 participants
VEH+OCC	Edema at Visit 4	Grade 0 (none)	34 participants
VEH+OCC	Edema at Visit 4	Grade 1 (minimal)	0 participants
VEH-OCC	Edema at Visit 4	Grade 1 (minimal)	0 participants
VEH-OCC	Edema at Visit 4	Grade 0 (none)	34 participants
VEH-OCC	Edema at Visit 4	Grade 2 (mild)	0 participants

Secondary

Edema at Visit 5

Time frame: 12 Weeks after PDT #1

Population: ITT

Arm	Measure	Group	Value (NUMBER)
ALA+OCC	Edema at Visit 5	Grade 1 (minimal)	0 participants
ALA+OCC	Edema at Visit 5	Grade 0 (none)	33 participants
ALA+OCC	Edema at Visit 5	Grade 2 (mild)	0 participants
ALA-OCC	Edema at Visit 5	Grade 0 (none)	33 participants
ALA-OCC	Edema at Visit 5	Grade 1 (minimal)	0 participants
ALA-OCC	Edema at Visit 5	Grade 2 (mild)	0 participants
VEH+OCC	Edema at Visit 5	Grade 1 (minimal)	0 participants
VEH+OCC	Edema at Visit 5	Grade 0 (none)	35 participants
VEH+OCC	Edema at Visit 5	Grade 2 (mild)	0 participants
VEH-OCC	Edema at Visit 5	Grade 0 (none)	35 participants
VEH-OCC	Edema at Visit 5	Grade 2 (mild)	0 participants
VEH-OCC	Edema at Visit 5	Grade 1 (minimal)	0 participants

Secondary

Edema Post-Light Treatment

Time frame: 5 Minutes after PDT #1

Population: ITT

Arm	Measure	Group	Value (NUMBER)
ALA+OCC	Edema Post-Light Treatment	Grade 2 (mild)	2 participants
ALA+OCC	Edema Post-Light Treatment	Grade 1 (minimal)	5 participants
ALA+OCC	Edema Post-Light Treatment	Grade 0 (none)	28 participants
ALA-OCC	Edema Post-Light Treatment	Grade 2 (mild)	0 participants
ALA-OCC	Edema Post-Light Treatment	Grade 1 (minimal)	2 participants
ALA-OCC	Edema Post-Light Treatment	Grade 0 (none)	33 participants
VEH+OCC	Edema Post-Light Treatment	Grade 0 (none)	34 participants
VEH+OCC	Edema Post-Light Treatment	Grade 1 (minimal)	1 participants
VEH+OCC	Edema Post-Light Treatment	Grade 2 (mild)	0 participants
VEH-OCC	Edema Post-Light Treatment	Grade 2 (mild)	0 participants
VEH-OCC	Edema Post-Light Treatment	Grade 1 (minimal)	1 participants
VEH-OCC	Edema Post-Light Treatment	Grade 0 (none)	34 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

Population: ITT

Arm	Measure	Group	Value (NUMBER)
ALA+OCC	Erythema at Baseline	Grade 1 (minimal)	16 participants
ALA+OCC	Erythema at Baseline	Grade 0 (none)	10 participants
ALA+OCC	Erythema at Baseline	Grade 2 (mild)	8 participants
ALA+OCC	Erythema at Baseline	Grade 4 (severe)	0 participants
ALA+OCC	Erythema at Baseline	Grade 3 (moderate)	1 participants
ALA-OCC	Erythema at Baseline	Grade 2 (mild)	9 participants
ALA-OCC	Erythema at Baseline	Grade 4 (severe)	0 participants
ALA-OCC	Erythema at Baseline	Grade 0 (none)	10 participants
ALA-OCC	Erythema at Baseline	Grade 1 (minimal)	16 participants
ALA-OCC	Erythema at Baseline	Grade 3 (moderate)	0 participants
VEH+OCC	Erythema at Baseline	Grade 3 (moderate)	1 participants
VEH+OCC	Erythema at Baseline	Grade 1 (minimal)	13 participants
VEH+OCC	Erythema at Baseline	Grade 2 (mild)	9 participants
VEH+OCC	Erythema at Baseline	Grade 0 (none)	12 participants
VEH+OCC	Erythema at Baseline	Grade 4 (severe)	0 participants
VEH-OCC	Erythema at Baseline	Grade 2 (mild)	10 participants
VEH-OCC	Erythema at Baseline	Grade 3 (moderate)	1 participants
VEH-OCC	Erythema at Baseline	Grade 1 (minimal)	12 participants
VEH-OCC	Erythema at Baseline	Grade 0 (none)	12 participants
VEH-OCC	Erythema at Baseline	Grade 4 (severe)	0 participants

Secondary

Erythema at Visit 3

Time frame: 2 Weeks after PDT #1

Population: ITT

Arm	Measure	Group	Value (NUMBER)
ALA+OCC	Erythema at Visit 3	Grade 1 (minimal)	8 participants
ALA+OCC	Erythema at Visit 3	Grade 3 (moderate)	12 participants
ALA+OCC	Erythema at Visit 3	Grade 4 (severe)	1 participants
ALA+OCC	Erythema at Visit 3	Grade 0 (none)	0 participants
ALA+OCC	Erythema at Visit 3	Grade 2 (mild)	14 participants
ALA-OCC	Erythema at Visit 3	Grade 0 (none)	4 participants
ALA-OCC	Erythema at Visit 3	Grade 1 (minimal)	14 participants
ALA-OCC	Erythema at Visit 3	Grade 4 (severe)	0 participants
ALA-OCC	Erythema at Visit 3	Grade 3 (moderate)	2 participants
ALA-OCC	Erythema at Visit 3	Grade 2 (mild)	15 participants
VEH+OCC	Erythema at Visit 3	Grade 0 (none)	10 participants
VEH+OCC	Erythema at Visit 3	Grade 3 (moderate)	1 participants
VEH+OCC	Erythema at Visit 3	Grade 4 (severe)	0 participants
VEH+OCC	Erythema at Visit 3	Grade 1 (minimal)	15 participants
VEH+OCC	Erythema at Visit 3	Grade 2 (mild)	9 participants
VEH-OCC	Erythema at Visit 3	Grade 0 (none)	10 participants
VEH-OCC	Erythema at Visit 3	Grade 4 (severe)	0 participants
VEH-OCC	Erythema at Visit 3	Grade 3 (moderate)	1 participants
VEH-OCC	Erythema at Visit 3	Grade 2 (mild)	10 participants
VEH-OCC	Erythema at Visit 3	Grade 1 (minimal)	14 participants

Secondary

Erythema at Visit 4

Time frame: 8 Weeks after PDT #1

Population: ITT

Arm	Measure	Group	Value (NUMBER)
ALA+OCC	Erythema at Visit 4	Grade 3 (moderate)	2 participants
ALA+OCC	Erythema at Visit 4	Grade 1 (minimal)	17 participants
ALA+OCC	Erythema at Visit 4	Grade 0 (none)	7 participants
ALA+OCC	Erythema at Visit 4	Grade 2 (mild)	9 participants
ALA+OCC	Erythema at Visit 4	Grade 4 (severe)	0 participants
ALA-OCC	Erythema at Visit 4	Grade 2 (mild)	9 participants
ALA-OCC	Erythema at Visit 4	Grade 0 (none)	6 participants
ALA-OCC	Erythema at Visit 4	Grade 3 (moderate)	0 participants
ALA-OCC	Erythema at Visit 4	Grade 1 (minimal)	20 participants
ALA-OCC	Erythema at Visit 4	Grade 4 (severe)	0 participants
VEH+OCC	Erythema at Visit 4	Grade 3 (moderate)	1 participants
VEH+OCC	Erythema at Visit 4	Grade 4 (severe)	0 participants
VEH+OCC	Erythema at Visit 4	Grade 1 (minimal)	16 participants
VEH+OCC	Erythema at Visit 4	Grade 2 (mild)	7 participants
VEH+OCC	Erythema at Visit 4	Grade 0 (none)	10 participants
VEH-OCC	Erythema at Visit 4	Grade 4 (severe)	0 participants
VEH-OCC	Erythema at Visit 4	Grade 1 (minimal)	15 participants
VEH-OCC	Erythema at Visit 4	Grade 2 (mild)	7 participants
VEH-OCC	Erythema at Visit 4	Grade 3 (moderate)	1 participants
VEH-OCC	Erythema at Visit 4	Grade 0 (none)	11 participants

Secondary

Erythema at Visit 5

Time frame: 12 Weeks after PDT #1

Population: ITT

Arm	Measure	Group	Value (NUMBER)
ALA+OCC	Erythema at Visit 5	Grade 3 (moderate)	1 participants
ALA+OCC	Erythema at Visit 5	Grade 1 (minimal)	7 participants
ALA+OCC	Erythema at Visit 5	Grade 4 (severe)	0 participants
ALA+OCC	Erythema at Visit 5	Grade 2 (mild)	16 participants
ALA+OCC	Erythema at Visit 5	Grade 0 (none)	9 participants
ALA-OCC	Erythema at Visit 5	Grade 2 (mild)	14 participants
ALA-OCC	Erythema at Visit 5	Grade 3 (moderate)	0 participants
ALA-OCC	Erythema at Visit 5	Grade 4 (severe)	0 participants
ALA-OCC	Erythema at Visit 5	Grade 1 (minimal)	12 participants
ALA-OCC	Erythema at Visit 5	Grade 0 (none)	7 participants
VEH+OCC	Erythema at Visit 5	Grade 2 (mild)	10 participants
VEH+OCC	Erythema at Visit 5	Grade 0 (none)	11 participants
VEH+OCC	Erythema at Visit 5	Grade 1 (minimal)	14 participants
VEH+OCC	Erythema at Visit 5	Grade 3 (moderate)	0 participants
VEH+OCC	Erythema at Visit 5	Grade 4 (severe)	0 participants
VEH-OCC	Erythema at Visit 5	Grade 3 (moderate)	0 participants
VEH-OCC	Erythema at Visit 5	Grade 1 (minimal)	14 participants
VEH-OCC	Erythema at Visit 5	Grade 0 (none)	12 participants
VEH-OCC	Erythema at Visit 5	Grade 2 (mild)	9 participants
VEH-OCC	Erythema at Visit 5	Grade 4 (severe)	0 participants

Secondary

Erythema Post-Light Treatment

Time frame: 5 Minutes after PDT #1

Population: ITT

Arm	Measure	Group	Value (NUMBER)
ALA+OCC	Erythema Post-Light Treatment	Grade 0 (none)	0 participants
ALA+OCC	Erythema Post-Light Treatment	Grade 2 (mild)	7 participants
ALA+OCC	Erythema Post-Light Treatment	Grade 4 (severe)	7 participants
ALA+OCC	Erythema Post-Light Treatment	Grade 1 (minimal)	0 participants
ALA+OCC	Erythema Post-Light Treatment	Grade 3 (moderate)	21 participants
ALA-OCC	Erythema Post-Light Treatment	Grade 3 (moderate)	10 participants
ALA-OCC	Erythema Post-Light Treatment	Grade 4 (severe)	2 participants
ALA-OCC	Erythema Post-Light Treatment	Grade 2 (mild)	19 participants
ALA-OCC	Erythema Post-Light Treatment	Grade 0 (none)	0 participants
ALA-OCC	Erythema Post-Light Treatment	Grade 1 (minimal)	4 participants
VEH+OCC	Erythema Post-Light Treatment	Grade 1 (minimal)	11 participants
VEH+OCC	Erythema Post-Light Treatment	Grade 2 (mild)	17 participants
VEH+OCC	Erythema Post-Light Treatment	Grade 0 (none)	4 participants
VEH+OCC	Erythema Post-Light Treatment	Grade 3 (moderate)	3 participants
VEH+OCC	Erythema Post-Light Treatment	Grade 4 (severe)	0 participants
VEH-OCC	Erythema Post-Light Treatment	Grade 4 (severe)	0 participants
VEH-OCC	Erythema Post-Light Treatment	Grade 3 (moderate)	3 participants
VEH-OCC	Erythema Post-Light Treatment	Grade 1 (minimal)	15 participants
VEH-OCC	Erythema Post-Light Treatment	Grade 2 (mild)	13 participants
VEH-OCC	Erythema Post-Light Treatment	Grade 0 (none)	4 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

Population: ITT

Arm	Measure	Group	Value (NUMBER)
ALA+OCC	Hyperpigmentation at Baseline	Grade 0 (none)	5 participants
ALA+OCC	Hyperpigmentation at Baseline	Grade 1 (light)	20 participants
ALA+OCC	Hyperpigmentation at Baseline	Grade 2 (moderate - small)	9 participants
ALA+OCC	Hyperpigmentation at Baseline	Grade 3 (moderate - moderate)	1 participants
ALA-OCC	Hyperpigmentation at Baseline	Grade 1 (light)	19 participants
ALA-OCC	Hyperpigmentation at Baseline	Grade 2 (moderate - small)	10 participants
ALA-OCC	Hyperpigmentation at Baseline	Grade 3 (moderate - moderate)	1 participants
ALA-OCC	Hyperpigmentation at Baseline	Grade 0 (none)	5 participants
VEH+OCC	Hyperpigmentation at Baseline	Grade 2 (moderate - small)	8 participants
VEH+OCC	Hyperpigmentation at Baseline	Grade 1 (light)	23 participants
VEH+OCC	Hyperpigmentation at Baseline	Grade 3 (moderate - moderate)	3 participants
VEH+OCC	Hyperpigmentation at Baseline	Grade 0 (none)	1 participants
VEH-OCC	Hyperpigmentation at Baseline	Grade 3 (moderate - moderate)	3 participants
VEH-OCC	Hyperpigmentation at Baseline	Grade 1 (light)	23 participants
VEH-OCC	Hyperpigmentation at Baseline	Grade 0 (none)	1 participants
VEH-OCC	Hyperpigmentation at Baseline	Grade 2 (moderate - small)	8 participants

Secondary

Hyperpigmentation at Visit 3

Time frame: 2 weeks after PDT #1

Population: ITT

Arm	Measure	Group	Value (NUMBER)
ALA+OCC	Hyperpigmentation at Visit 3	Grade 0 (none)	4 participants
ALA+OCC	Hyperpigmentation at Visit 3	Grade 1 (light)	19 participants
ALA+OCC	Hyperpigmentation at Visit 3	Grade 2 (moderate - small)	9 participants
ALA+OCC	Hyperpigmentation at Visit 3	Grade 3 (moderate - moderate)	2 participants
ALA-OCC	Hyperpigmentation at Visit 3	Grade 1 (light)	20 participants
ALA-OCC	Hyperpigmentation at Visit 3	Grade 2 (moderate - small)	10 participants
ALA-OCC	Hyperpigmentation at Visit 3	Grade 3 (moderate - moderate)	1 participants
ALA-OCC	Hyperpigmentation at Visit 3	Grade 0 (none)	4 participants
VEH+OCC	Hyperpigmentation at Visit 3	Grade 2 (moderate - small)	10 participants
VEH+OCC	Hyperpigmentation at Visit 3	Grade 1 (light)	21 participants
VEH+OCC	Hyperpigmentation at Visit 3	Grade 3 (moderate - moderate)	3 participants
VEH+OCC	Hyperpigmentation at Visit 3	Grade 0 (none)	1 participants
VEH-OCC	Hyperpigmentation at Visit 3	Grade 3 (moderate - moderate)	3 participants
VEH-OCC	Hyperpigmentation at Visit 3	Grade 1 (light)	21 participants
VEH-OCC	Hyperpigmentation at Visit 3	Grade 0 (none)	1 participants
VEH-OCC	Hyperpigmentation at Visit 3	Grade 2 (moderate - small)	10 participants

Secondary

Hyperpigmentation at Visit 4

Time frame: 8 weeks after PDT #1

Population: ITT

Arm	Measure	Group	Value (NUMBER)
ALA+OCC	Hyperpigmentation at Visit 4	Grade 0 (none)	2 participants
ALA+OCC	Hyperpigmentation at Visit 4	Grade 1 (light)	24 participants
ALA+OCC	Hyperpigmentation at Visit 4	Grade 2 (moderate - small)	8 participants
ALA+OCC	Hyperpigmentation at Visit 4	Grade 3 (moderate - moderate)	1 participants
ALA-OCC	Hyperpigmentation at Visit 4	Grade 1 (light)	21 participants
ALA-OCC	Hyperpigmentation at Visit 4	Grade 2 (moderate - small)	11 participants
ALA-OCC	Hyperpigmentation at Visit 4	Grade 3 (moderate - moderate)	1 participants
ALA-OCC	Hyperpigmentation at Visit 4	Grade 0 (none)	2 participants
VEH+OCC	Hyperpigmentation at Visit 4	Grade 2 (moderate - small)	11 participants
VEH+OCC	Hyperpigmentation at Visit 4	Grade 1 (light)	19 participants
VEH+OCC	Hyperpigmentation at Visit 4	Grade 3 (moderate - moderate)	4 participants
VEH+OCC	Hyperpigmentation at Visit 4	Grade 0 (none)	0 participants
VEH-OCC	Hyperpigmentation at Visit 4	Grade 3 (moderate - moderate)	4 participants
VEH-OCC	Hyperpigmentation at Visit 4	Grade 1 (light)	17 participants
VEH-OCC	Hyperpigmentation at Visit 4	Grade 0 (none)	0 participants
VEH-OCC	Hyperpigmentation at Visit 4	Grade 2 (moderate - small)	13 participants

Secondary

Hyperpigmentation at Visit 5

Time frame: 12 weeks after PDT #1

Population: ITT

Arm	Measure	Group	Value (NUMBER)
ALA+OCC	Hyperpigmentation at Visit 5	Grade 0 (none)	2 participants
ALA+OCC	Hyperpigmentation at Visit 5	Grade 1 (light)	25 participants
ALA+OCC	Hyperpigmentation at Visit 5	Grade 2 (moderate - small)	6 participants
ALA+OCC	Hyperpigmentation at Visit 5	Grade 3 (moderate - moderate)	0 participants
ALA-OCC	Hyperpigmentation at Visit 5	Grade 1 (light)	23 participants
ALA-OCC	Hyperpigmentation at Visit 5	Grade 2 (moderate - small)	8 participants
ALA-OCC	Hyperpigmentation at Visit 5	Grade 3 (moderate - moderate)	0 participants
ALA-OCC	Hyperpigmentation at Visit 5	Grade 0 (none)	2 participants
VEH+OCC	Hyperpigmentation at Visit 5	Grade 2 (moderate - small)	11 participants
VEH+OCC	Hyperpigmentation at Visit 5	Grade 1 (light)	20 participants
VEH+OCC	Hyperpigmentation at Visit 5	Grade 3 (moderate - moderate)	4 participants
VEH+OCC	Hyperpigmentation at Visit 5	Grade 0 (none)	0 participants
VEH-OCC	Hyperpigmentation at Visit 5	Grade 3 (moderate - moderate)	4 participants
VEH-OCC	Hyperpigmentation at Visit 5	Grade 1 (light)	20 participants
VEH-OCC	Hyperpigmentation at Visit 5	Grade 0 (none)	0 participants
VEH-OCC	Hyperpigmentation at Visit 5	Grade 2 (moderate - small)	11 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

Time frame: Baseline

Population: ITT

Arm	Measure	Group	Value (NUMBER)
ALA+OCC	Hypopigmentation at Baseline	Grade 0 (none)	9 participants
ALA+OCC	Hypopigmentation at Baseline	Grade 1 (light)	21 participants
ALA+OCC	Hypopigmentation at Baseline	Grade 2 (moderate - small)	5 participants
ALA+OCC	Hypopigmentation at Baseline	Grade 3 (moderate - moderate)	0 participants
ALA-OCC	Hypopigmentation at Baseline	Grade 3 (moderate - moderate)	0 participants
ALA-OCC	Hypopigmentation at Baseline	Grade 2 (moderate - small)	5 participants
ALA-OCC	Hypopigmentation at Baseline	Grade 1 (light)	21 participants
ALA-OCC	Hypopigmentation at Baseline	Grade 0 (none)	9 participants
VEH+OCC	Hypopigmentation at Baseline	Grade 2 (moderate - small)	2 participants
VEH+OCC	Hypopigmentation at Baseline	Grade 3 (moderate - moderate)	1 participants
VEH+OCC	Hypopigmentation at Baseline	Grade 1 (light)	24 participants
VEH+OCC	Hypopigmentation at Baseline	Grade 0 (none)	8 participants
VEH-OCC	Hypopigmentation at Baseline	Grade 3 (moderate - moderate)	1 participants
VEH-OCC	Hypopigmentation at Baseline	Grade 0 (none)	8 participants
VEH-OCC	Hypopigmentation at Baseline	Grade 1 (light)	24 participants
VEH-OCC	Hypopigmentation at Baseline	Grade 2 (moderate - small)	2 participants

Secondary

Hypopigmentation at Visit 3

Time frame: 2 Weeks after PDT #1

Population: ITT

Arm	Measure	Group	Value (NUMBER)
ALA+OCC	Hypopigmentation at Visit 3	Grade 2 (moderate - small)	4 participants
ALA+OCC	Hypopigmentation at Visit 3	Grade 1 (light)	20 participants
ALA+OCC	Hypopigmentation at Visit 3	Grade 0 (none)	10 participants
ALA+OCC	Hypopigmentation at Visit 3	Grade 3 (moderate - moderate)	0 participants
ALA-OCC	Hypopigmentation at Visit 3	Grade 1 (light)	20 participants
ALA-OCC	Hypopigmentation at Visit 3	Grade 0 (none)	10 participants
ALA-OCC	Hypopigmentation at Visit 3	Grade 2 (moderate - small)	5 participants
ALA-OCC	Hypopigmentation at Visit 3	Grade 3 (moderate - moderate)	0 participants
VEH+OCC	Hypopigmentation at Visit 3	Grade 3 (moderate - moderate)	1 participants
VEH+OCC	Hypopigmentation at Visit 3	Grade 0 (none)	7 participants
VEH+OCC	Hypopigmentation at Visit 3	Grade 1 (light)	26 participants
VEH+OCC	Hypopigmentation at Visit 3	Grade 2 (moderate - small)	1 participants
VEH-OCC	Hypopigmentation at Visit 3	Grade 1 (light)	26 participants
VEH-OCC	Hypopigmentation at Visit 3	Grade 3 (moderate - moderate)	1 participants
VEH-OCC	Hypopigmentation at Visit 3	Grade 2 (moderate - small)	1 participants
VEH-OCC	Hypopigmentation at Visit 3	Grade 0 (none)	7 participants

Secondary

Hypopigmentation at Visit 4

Time frame: 8 Weeks after PDT #1

Population: ITT

Arm	Measure	Group	Value (NUMBER)
ALA+OCC	Hypopigmentation at Visit 4	Grade 0 (none)	13 participants
ALA+OCC	Hypopigmentation at Visit 4	Grade 1 (light)	18 participants
ALA+OCC	Hypopigmentation at Visit 4	Grade 2 (moderate - small)	3 participants
ALA+OCC	Hypopigmentation at Visit 4	Grade 3 (moderate - moderate)	1 participants
ALA-OCC	Hypopigmentation at Visit 4	Grade 1 (light)	21 participants
ALA-OCC	Hypopigmentation at Visit 4	Grade 2 (moderate - small)	4 participants
ALA-OCC	Hypopigmentation at Visit 4	Grade 3 (moderate - moderate)	0 participants
ALA-OCC	Hypopigmentation at Visit 4	Grade 0 (none)	10 participants
VEH+OCC	Hypopigmentation at Visit 4	Grade 2 (moderate - small)	1 participants
VEH+OCC	Hypopigmentation at Visit 4	Grade 1 (light)	23 participants
VEH+OCC	Hypopigmentation at Visit 4	Grade 3 (moderate - moderate)	1 participants
VEH+OCC	Hypopigmentation at Visit 4	Grade 0 (none)	9 participants
VEH-OCC	Hypopigmentation at Visit 4	Grade 3 (moderate - moderate)	1 participants
VEH-OCC	Hypopigmentation at Visit 4	Grade 1 (light)	23 participants
VEH-OCC	Hypopigmentation at Visit 4	Grade 0 (none)	9 participants
VEH-OCC	Hypopigmentation at Visit 4	Grade 2 (moderate - small)	1 participants

Secondary

Hypopigmentation at Visit 5

Time frame: 12 Weeks after PDT #1

Population: ITT

Arm	Measure	Group	Value (NUMBER)
ALA+OCC	Hypopigmentation at Visit 5	Grade 0 (none)	10 participants
ALA+OCC	Hypopigmentation at Visit 5	Grade 1 (light)	22 participants
ALA+OCC	Hypopigmentation at Visit 5	Grade 3 (moderate - moderate)	0 participants
ALA+OCC	Hypopigmentation at Visit 5	Grade 2 (moderate - small)	1 participants
ALA-OCC	Hypopigmentation at Visit 5	Grade 0 (none)	8 participants
ALA-OCC	Hypopigmentation at Visit 5	Grade 3 (moderate - moderate)	0 participants
ALA-OCC	Hypopigmentation at Visit 5	Grade 1 (light)	24 participants
ALA-OCC	Hypopigmentation at Visit 5	Grade 2 (moderate - small)	1 participants
VEH+OCC	Hypopigmentation at Visit 5	Grade 0 (none)	12 participants
VEH+OCC	Hypopigmentation at Visit 5	Grade 2 (moderate - small)	1 participants
VEH+OCC	Hypopigmentation at Visit 5	Grade 3 (moderate - moderate)	1 participants
VEH+OCC	Hypopigmentation at Visit 5	Grade 1 (light)	21 participants
VEH-OCC	Hypopigmentation at Visit 5	Grade 3 (moderate - moderate)	1 participants
VEH-OCC	Hypopigmentation at Visit 5	Grade 0 (none)	11 participants
VEH-OCC	Hypopigmentation at Visit 5	Grade 1 (light)	22 participants
VEH-OCC	Hypopigmentation at Visit 5	Grade 2 (moderate - small)	1 participants

Secondary

Lesion Clearance Rate

Time frame: Week 8

Population: ITT LOCF

Arm	Measure	Value (MEDIAN)	Dispersion
ALA+OCC	Lesion Clearance Rate	75.0 percentage of lesions cleared	Standard Deviation 34.6
ALA-OCC	Lesion Clearance Rate	47.4 percentage of lesions cleared	Standard Deviation 30.7
VEH+OCC	Lesion Clearance Rate	3.3 percentage of lesions cleared	Standard Deviation 28.7
VEH-OCC	Lesion Clearance Rate	6.3 percentage of lesions cleared	Standard Deviation 25.8

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

Population: ITT observed

Arm	Measure	Group	Value (NUMBER)
ALA+OCC	OOZING/VESICULATION/CRUSTING at Baseline	Grade 0 (none)	35 participants
ALA+OCC	OOZING/VESICULATION/CRUSTING at Baseline	Grade 4 (severe)	0 participants
ALA+OCC	OOZING/VESICULATION/CRUSTING at Baseline	Grade 1 (minimal)	0 participants
ALA+OCC	OOZING/VESICULATION/CRUSTING at Baseline	Grade 2 (mild)	0 participants
ALA+OCC	OOZING/VESICULATION/CRUSTING at Baseline	Grade 3 (moderate)	0 participants
ALA-OCC	OOZING/VESICULATION/CRUSTING at Baseline	Grade 4 (severe)	0 participants
ALA-OCC	OOZING/VESICULATION/CRUSTING at Baseline	Grade 0 (none)	35 participants
ALA-OCC	OOZING/VESICULATION/CRUSTING at Baseline	Grade 2 (mild)	0 participants
ALA-OCC	OOZING/VESICULATION/CRUSTING at Baseline	Grade 3 (moderate)	0 participants
ALA-OCC	OOZING/VESICULATION/CRUSTING at Baseline	Grade 1 (minimal)	0 participants
VEH+OCC	OOZING/VESICULATION/CRUSTING at Baseline	Grade 3 (moderate)	0 participants
VEH+OCC	OOZING/VESICULATION/CRUSTING at Baseline	Grade 0 (none)	35 participants
VEH+OCC	OOZING/VESICULATION/CRUSTING at Baseline	Grade 1 (minimal)	0 participants
VEH+OCC	OOZING/VESICULATION/CRUSTING at Baseline	Grade 4 (severe)	0 participants
VEH+OCC	OOZING/VESICULATION/CRUSTING at Baseline	Grade 2 (mild)	0 participants
VEH-OCC	OOZING/VESICULATION/CRUSTING at Baseline	Grade 4 (severe)	0 participants
VEH-OCC	OOZING/VESICULATION/CRUSTING at Baseline	Grade 0 (none)	35 participants
VEH-OCC	OOZING/VESICULATION/CRUSTING at Baseline	Grade 3 (moderate)	0 participants
VEH-OCC	OOZING/VESICULATION/CRUSTING at Baseline	Grade 2 (mild)	0 participants
VEH-OCC	OOZING/VESICULATION/CRUSTING at Baseline	Grade 1 (minimal)	0 participants

Secondary

OOZING/VESICULATION/CRUSTING at Visit 3

Time frame: Week 2 after PDT #1

Population: ITT observed

Arm	Measure	Group	Value (NUMBER)
ALA+OCC	OOZING/VESICULATION/CRUSTING at Visit 3	Grade 1 (minimal)	1 participants
ALA+OCC	OOZING/VESICULATION/CRUSTING at Visit 3	Grade 3 (moderate)	1 participants
ALA+OCC	OOZING/VESICULATION/CRUSTING at Visit 3	Grade 2 (mild)	0 participants
ALA+OCC	OOZING/VESICULATION/CRUSTING at Visit 3	0	0 participants
ALA+OCC	OOZING/VESICULATION/CRUSTING at Visit 3	Grade 0 (none)	33 participants
ALA-OCC	OOZING/VESICULATION/CRUSTING at Visit 3	Grade 0 (none)	34 participants
ALA-OCC	OOZING/VESICULATION/CRUSTING at Visit 3	Grade 1 (minimal)	0 participants
ALA-OCC	OOZING/VESICULATION/CRUSTING at Visit 3	0	0 participants
ALA-OCC	OOZING/VESICULATION/CRUSTING at Visit 3	Grade 2 (mild)	1 participants
ALA-OCC	OOZING/VESICULATION/CRUSTING at Visit 3	Grade 3 (moderate)	0 participants
VEH+OCC	OOZING/VESICULATION/CRUSTING at Visit 3	Grade 1 (minimal)	1 participants
VEH+OCC	OOZING/VESICULATION/CRUSTING at Visit 3	Grade 3 (moderate)	0 participants
VEH+OCC	OOZING/VESICULATION/CRUSTING at Visit 3	0	0 participants
VEH+OCC	OOZING/VESICULATION/CRUSTING at Visit 3	Grade 2 (mild)	0 participants
VEH+OCC	OOZING/VESICULATION/CRUSTING at Visit 3	Grade 0 (none)	34 participants
VEH-OCC	OOZING/VESICULATION/CRUSTING at Visit 3	Grade 2 (mild)	0 participants
VEH-OCC	OOZING/VESICULATION/CRUSTING at Visit 3	Grade 0 (none)	34 participants
VEH-OCC	OOZING/VESICULATION/CRUSTING at Visit 3	Grade 1 (minimal)	1 participants
VEH-OCC	OOZING/VESICULATION/CRUSTING at Visit 3	0	0 participants
VEH-OCC	OOZING/VESICULATION/CRUSTING at Visit 3	Grade 3 (moderate)	0 participants

Secondary

OOZING/VESICULATION/CRUSTING at Visit 4

Time frame: 8 Weeks after PDT #1

Population: ITT observed

Arm	Measure	Group	Value (NUMBER)
ALA+OCC	OOZING/VESICULATION/CRUSTING at Visit 4	Grade 0 (none)	35 participants
ALA+OCC	OOZING/VESICULATION/CRUSTING at Visit 4	Grade 1 (minimal)	0 participants
ALA+OCC	OOZING/VESICULATION/CRUSTING at Visit 4	Grade 2 (mild)	0 participants
ALA+OCC	OOZING/VESICULATION/CRUSTING at Visit 4	Grade 3 (moderate)	0 participants
ALA+OCC	OOZING/VESICULATION/CRUSTING at Visit 4	0	0 participants
ALA-OCC	OOZING/VESICULATION/CRUSTING at Visit 4	Grade 0 (none)	35 participants
ALA-OCC	OOZING/VESICULATION/CRUSTING at Visit 4	Grade 2 (mild)	0 participants
ALA-OCC	OOZING/VESICULATION/CRUSTING at Visit 4	Grade 3 (moderate)	0 participants
ALA-OCC	OOZING/VESICULATION/CRUSTING at Visit 4	0	0 participants
ALA-OCC	OOZING/VESICULATION/CRUSTING at Visit 4	Grade 1 (minimal)	0 participants
VEH+OCC	OOZING/VESICULATION/CRUSTING at Visit 4	Grade 3 (moderate)	0 participants
VEH+OCC	OOZING/VESICULATION/CRUSTING at Visit 4	Grade 0 (none)	34 participants
VEH+OCC	OOZING/VESICULATION/CRUSTING at Visit 4	0	0 participants
VEH+OCC	OOZING/VESICULATION/CRUSTING at Visit 4	Grade 2 (mild)	0 participants
VEH+OCC	OOZING/VESICULATION/CRUSTING at Visit 4	Grade 1 (minimal)	0 participants
VEH-OCC	OOZING/VESICULATION/CRUSTING at Visit 4	Grade 3 (moderate)	0 participants
VEH-OCC	OOZING/VESICULATION/CRUSTING at Visit 4	Grade 0 (none)	34 participants
VEH-OCC	OOZING/VESICULATION/CRUSTING at Visit 4	0	0 participants
VEH-OCC	OOZING/VESICULATION/CRUSTING at Visit 4	Grade 1 (minimal)	0 participants
VEH-OCC	OOZING/VESICULATION/CRUSTING at Visit 4	Grade 2 (mild)	0 participants

Secondary

OOZING/VESICULATION/CRUSTING at Visit 5

Time frame: 12 Weeks after PDT #1

Population: ITT observed

Arm	Measure	Group	Value (NUMBER)
ALA+OCC	OOZING/VESICULATION/CRUSTING at Visit 5	Grade 0 (none)	33 participants
ALA+OCC	OOZING/VESICULATION/CRUSTING at Visit 5	Grade 1 (minimal)	0 participants
ALA+OCC	OOZING/VESICULATION/CRUSTING at Visit 5	0	0 participants
ALA+OCC	OOZING/VESICULATION/CRUSTING at Visit 5	Grade 3 (moderate)	0 participants
ALA+OCC	OOZING/VESICULATION/CRUSTING at Visit 5	Grade 2 (mild)	0 participants
ALA-OCC	OOZING/VESICULATION/CRUSTING at Visit 5	Grade 3 (moderate)	0 participants
ALA-OCC	OOZING/VESICULATION/CRUSTING at Visit 5	0	0 participants
ALA-OCC	OOZING/VESICULATION/CRUSTING at Visit 5	Grade 1 (minimal)	1 participants
ALA-OCC	OOZING/VESICULATION/CRUSTING at Visit 5	Grade 0 (none)	32 participants
ALA-OCC	OOZING/VESICULATION/CRUSTING at Visit 5	Grade 2 (mild)	0 participants
VEH+OCC	OOZING/VESICULATION/CRUSTING at Visit 5	0	0 participants
VEH+OCC	OOZING/VESICULATION/CRUSTING at Visit 5	Grade 3 (moderate)	0 participants
VEH+OCC	OOZING/VESICULATION/CRUSTING at Visit 5	Grade 2 (mild)	0 participants
VEH+OCC	OOZING/VESICULATION/CRUSTING at Visit 5	Grade 0 (none)	35 participants
VEH+OCC	OOZING/VESICULATION/CRUSTING at Visit 5	Grade 1 (minimal)	0 participants
VEH-OCC	OOZING/VESICULATION/CRUSTING at Visit 5	Grade 3 (moderate)	0 participants
VEH-OCC	OOZING/VESICULATION/CRUSTING at Visit 5	0	0 participants
VEH-OCC	OOZING/VESICULATION/CRUSTING at Visit 5	Grade 0 (none)	35 participants
VEH-OCC	OOZING/VESICULATION/CRUSTING at Visit 5	Grade 1 (minimal)	0 participants
VEH-OCC	OOZING/VESICULATION/CRUSTING at Visit 5	Grade 2 (mild)	0 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 and Week 8

Population: ITT LOCF

Arm	Measure	Value (NUMBER)
ALA+OCC	Partial Clearance Rate	18 arms >75% cleared
ALA-OCC	Partial Clearance Rate	5 arms >75% cleared
VEH+OCC	Partial Clearance Rate	1 arms >75% cleared
VEH-OCC	Partial Clearance Rate	2 arms >75% cleared

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 and Week 12

Population: ITT LOCF

Arm	Measure	Value (NUMBER)
ALA+OCC	Partial Clearance Rate	21 arms >75% cleared
ALA-OCC	Partial Clearance Rate	15 arms >75% cleared
VEH+OCC	Partial Clearance Rate	3 arms >75% cleared
VEH-OCC	Partial Clearance Rate	2 arms >75% cleared

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

Population: ITT observed

Arm	Measure	Group	Value (NUMBER)
ALA+OCC	Scaling and Dryness at Baseline	Grade 1 (minimal)	15 participants
ALA+OCC	Scaling and Dryness at Baseline	Grade 4 (severe)	0 participants
ALA+OCC	Scaling and Dryness at Baseline	Grade 3 (moderate)	2 participants
ALA+OCC	Scaling and Dryness at Baseline	Grade 0 (none)	16 participants
ALA+OCC	Scaling and Dryness at Baseline	Grade 2 (mild)	2 participants
ALA-OCC	Scaling and Dryness at Baseline	Grade 0 (none)	16 participants
ALA-OCC	Scaling and Dryness at Baseline	Grade 1 (minimal)	15 participants
ALA-OCC	Scaling and Dryness at Baseline	Grade 2 (mild)	2 participants
ALA-OCC	Scaling and Dryness at Baseline	Grade 3 (moderate)	2 participants
ALA-OCC	Scaling and Dryness at Baseline	Grade 4 (severe)	0 participants
VEH+OCC	Scaling and Dryness at Baseline	Grade 2 (mild)	4 participants
VEH+OCC	Scaling and Dryness at Baseline	Grade 4 (severe)	0 participants
VEH+OCC	Scaling and Dryness at Baseline	Grade 3 (moderate)	1 participants
VEH+OCC	Scaling and Dryness at Baseline	Grade 1 (minimal)	13 participants
VEH+OCC	Scaling and Dryness at Baseline	Grade 0 (none)	17 participants
VEH-OCC	Scaling and Dryness at Baseline	Grade 1 (minimal)	13 participants
VEH-OCC	Scaling and Dryness at Baseline	Grade 4 (severe)	0 participants
VEH-OCC	Scaling and Dryness at Baseline	Grade 3 (moderate)	1 participants
VEH-OCC	Scaling and Dryness at Baseline	Grade 0 (none)	17 participants
VEH-OCC	Scaling and Dryness at Baseline	Grade 2 (mild)	4 participants

Secondary

Scaling and Dryness at Visit 3

Time frame: 2 Weeks Post PDT #1

Population: ITT observed

Arm	Measure	Group	Value (NUMBER)
ALA+OCC	Scaling and Dryness at Visit 3	Grade 2 (mild)	5 participants
ALA+OCC	Scaling and Dryness at Visit 3	Grade 3 (moderate)	21 participants
ALA+OCC	Scaling and Dryness at Visit 3	Grade 0 (none)	3 participants
ALA+OCC	Scaling and Dryness at Visit 3	Grade 4 (severe)	1 participants
ALA+OCC	Scaling and Dryness at Visit 3	Grade 1 (minimal)	5 participants
ALA-OCC	Scaling and Dryness at Visit 3	Grade 0 (none)	5 participants
ALA-OCC	Scaling and Dryness at Visit 3	Grade 1 (minimal)	17 participants
ALA-OCC	Scaling and Dryness at Visit 3	Grade 4 (severe)	0 participants
ALA-OCC	Scaling and Dryness at Visit 3	Grade 3 (moderate)	3 participants
ALA-OCC	Scaling and Dryness at Visit 3	Grade 2 (mild)	10 participants
VEH+OCC	Scaling and Dryness at Visit 3	Grade 1 (minimal)	20 participants
VEH+OCC	Scaling and Dryness at Visit 3	Grade 3 (moderate)	2 participants
VEH+OCC	Scaling and Dryness at Visit 3	Grade 0 (none)	10 participants
VEH+OCC	Scaling and Dryness at Visit 3	Grade 2 (mild)	3 participants
VEH+OCC	Scaling and Dryness at Visit 3	Grade 4 (severe)	0 participants
VEH-OCC	Scaling and Dryness at Visit 3	Grade 3 (moderate)	2 participants
VEH-OCC	Scaling and Dryness at Visit 3	Grade 4 (severe)	0 participants
VEH-OCC	Scaling and Dryness at Visit 3	Grade 0 (none)	11 participants
VEH-OCC	Scaling and Dryness at Visit 3	Grade 1 (minimal)	19 participants
VEH-OCC	Scaling and Dryness at Visit 3	Grade 2 (mild)	3 participants

Secondary

Scaling and Dryness at Visit 4

Time frame: 8 Weeks Post PDT #1

Population: ITT observed

Arm	Measure	Group	Value (NUMBER)
ALA+OCC	Scaling and Dryness at Visit 4	Grade 3 (moderate)	1 participants
ALA+OCC	Scaling and Dryness at Visit 4	Grade 1 (minimal)	14 participants
ALA+OCC	Scaling and Dryness at Visit 4	Grade 4 (severe)	0 participants
ALA+OCC	Scaling and Dryness at Visit 4	Grade 2 (mild)	4 participants
ALA+OCC	Scaling and Dryness at Visit 4	Grade 0 (none)	16 participants
ALA-OCC	Scaling and Dryness at Visit 4	Grade 2 (mild)	5 participants
ALA-OCC	Scaling and Dryness at Visit 4	Grade 3 (moderate)	1 participants
ALA-OCC	Scaling and Dryness at Visit 4	Grade 4 (severe)	0 participants
ALA-OCC	Scaling and Dryness at Visit 4	Grade 1 (minimal)	12 participants
ALA-OCC	Scaling and Dryness at Visit 4	Grade 0 (none)	17 participants
VEH+OCC	Scaling and Dryness at Visit 4	Grade 2 (mild)	3 participants
VEH+OCC	Scaling and Dryness at Visit 4	Grade 0 (none)	14 participants
VEH+OCC	Scaling and Dryness at Visit 4	Grade 1 (minimal)	14 participants
VEH+OCC	Scaling and Dryness at Visit 4	Grade 3 (moderate)	3 participants
VEH+OCC	Scaling and Dryness at Visit 4	Grade 4 (severe)	0 participants
VEH-OCC	Scaling and Dryness at Visit 4	Grade 3 (moderate)	3 participants
VEH-OCC	Scaling and Dryness at Visit 4	Grade 1 (minimal)	14 participants
VEH-OCC	Scaling and Dryness at Visit 4	Grade 0 (none)	14 participants
VEH-OCC	Scaling and Dryness at Visit 4	Grade 2 (mild)	3 participants
VEH-OCC	Scaling and Dryness at Visit 4	Grade 4 (severe)	0 participants

Secondary

Scaling and Dryness at Visit 5

Time frame: 12 Weeks Post PDT #1

Population: ITT observed

Arm	Measure	Group	Value (NUMBER)
ALA+OCC	Scaling and Dryness at Visit 5	Grade 3 (moderate)	1 participants
ALA+OCC	Scaling and Dryness at Visit 5	Grade 0 (none)	18 participants
ALA+OCC	Scaling and Dryness at Visit 5	Grade 4 (severe)	0 participants
ALA+OCC	Scaling and Dryness at Visit 5	Grade 1 (minimal)	12 participants
ALA+OCC	Scaling and Dryness at Visit 5	Grade 2 (mild)	2 participants
ALA-OCC	Scaling and Dryness at Visit 5	Grade 1 (minimal)	13 participants
ALA-OCC	Scaling and Dryness at Visit 5	Grade 2 (mild)	2 participants
ALA-OCC	Scaling and Dryness at Visit 5	Grade 4 (severe)	0 participants
ALA-OCC	Scaling and Dryness at Visit 5	Grade 0 (none)	17 participants
ALA-OCC	Scaling and Dryness at Visit 5	Grade 3 (moderate)	1 participants
VEH+OCC	Scaling and Dryness at Visit 5	Grade 1 (minimal)	17 participants
VEH+OCC	Scaling and Dryness at Visit 5	Grade 3 (moderate)	1 participants
VEH+OCC	Scaling and Dryness at Visit 5	Grade 0 (none)	12 participants
VEH+OCC	Scaling and Dryness at Visit 5	Grade 2 (mild)	5 participants
VEH+OCC	Scaling and Dryness at Visit 5	Grade 4 (severe)	0 participants
VEH-OCC	Scaling and Dryness at Visit 5	Grade 1 (minimal)	17 participants
VEH-OCC	Scaling and Dryness at Visit 5	Grade 0 (none)	12 participants
VEH-OCC	Scaling and Dryness at Visit 5	Grade 3 (moderate)	1 participants
VEH-OCC	Scaling and Dryness at Visit 5	Grade 4 (severe)	0 participants
VEH-OCC	Scaling and Dryness at Visit 5	Grade 2 (mild)	5 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

Time frame: Baseline

Population: ITT, observed

Arm	Measure	Group	Value (NUMBER)
ALA+OCC	Stinging/Burning at Baseline	Grade 0 (none)	35 participants
ALA+OCC	Stinging/Burning at Baseline	Grade 1 (mild)	0 participants
ALA+OCC	Stinging/Burning at Baseline	Grade 2 (moderate)	0 participants
ALA+OCC	Stinging/Burning at Baseline	Grade 3 (severe)	0 participants
ALA-OCC	Stinging/Burning at Baseline	Grade 1 (mild)	0 participants
ALA-OCC	Stinging/Burning at Baseline	Grade 2 (moderate)	0 participants
ALA-OCC	Stinging/Burning at Baseline	Grade 3 (severe)	0 participants
ALA-OCC	Stinging/Burning at Baseline	Grade 0 (none)	35 participants
VEH+OCC	Stinging/Burning at Baseline	Grade 2 (moderate)	0 participants
VEH+OCC	Stinging/Burning at Baseline	Grade 1 (mild)	0 participants
VEH+OCC	Stinging/Burning at Baseline	Grade 3 (severe)	0 participants
VEH+OCC	Stinging/Burning at Baseline	Grade 0 (none)	35 participants
VEH-OCC	Stinging/Burning at Baseline	Grade 3 (severe)	0 participants
VEH-OCC	Stinging/Burning at Baseline	Grade 1 (mild)	0 participants
VEH-OCC	Stinging/Burning at Baseline	Grade 0 (none)	35 participants
VEH-OCC	Stinging/Burning at Baseline	Grade 2 (moderate)	0 participants

Secondary

Stinging/Burning at Visit 3

Time frame: 2 Weeks after PDT #1

Population: ITT, observed

Arm	Measure	Group	Value (NUMBER)
ALA+OCC	Stinging/Burning at Visit 3	Grade 1 (mild)	4 participants
ALA+OCC	Stinging/Burning at Visit 3	Grade 3 (severe)	0 participants
ALA+OCC	Stinging/Burning at Visit 3	Grade 0 (none)	31 participants
ALA+OCC	Stinging/Burning at Visit 3	Grade 2 (moderate)	0 participants
ALA-OCC	Stinging/Burning at Visit 3	Grade 3 (severe)	0 participants
ALA-OCC	Stinging/Burning at Visit 3	Grade 1 (mild)	0 participants
ALA-OCC	Stinging/Burning at Visit 3	Grade 2 (moderate)	0 participants
ALA-OCC	Stinging/Burning at Visit 3	Grade 0 (none)	35 participants
VEH+OCC	Stinging/Burning at Visit 3	Grade 1 (mild)	0 participants
VEH+OCC	Stinging/Burning at Visit 3	Grade 0 (none)	35 participants
VEH+OCC	Stinging/Burning at Visit 3	Grade 2 (moderate)	0 participants
VEH+OCC	Stinging/Burning at Visit 3	Grade 3 (severe)	0 participants
VEH-OCC	Stinging/Burning at Visit 3	Grade 3 (severe)	0 participants
VEH-OCC	Stinging/Burning at Visit 3	Grade 2 (moderate)	0 participants
VEH-OCC	Stinging/Burning at Visit 3	Grade 0 (none)	35 participants
VEH-OCC	Stinging/Burning at Visit 3	Grade 1 (mild)	0 participants

Secondary

Stinging/Burning at Visit 4

Time frame: 8 Weeks after PDT #1

Population: ITT, observed

Arm	Measure	Group	Value (NUMBER)
ALA+OCC	Stinging/Burning at Visit 4	Grade 1 (mild)	0 participants
ALA+OCC	Stinging/Burning at Visit 4	Grade 2 (moderate)	0 participants
ALA+OCC	Stinging/Burning at Visit 4	Grade 3 (severe)	0 participants
ALA+OCC	Stinging/Burning at Visit 4	Grade 0 (none)	35 participants
ALA-OCC	Stinging/Burning at Visit 4	Grade 0 (none)	35 participants
ALA-OCC	Stinging/Burning at Visit 4	Grade 3 (severe)	0 participants
ALA-OCC	Stinging/Burning at Visit 4	Grade 1 (mild)	0 participants
ALA-OCC	Stinging/Burning at Visit 4	Grade 2 (moderate)	0 participants
VEH+OCC	Stinging/Burning at Visit 4	Grade 0 (none)	34 participants
VEH+OCC	Stinging/Burning at Visit 4	Grade 1 (mild)	0 participants
VEH+OCC	Stinging/Burning at Visit 4	Grade 2 (moderate)	0 participants
VEH+OCC	Stinging/Burning at Visit 4	Grade 3 (severe)	0 participants
VEH-OCC	Stinging/Burning at Visit 4	Grade 3 (severe)	0 participants
VEH-OCC	Stinging/Burning at Visit 4	Grade 2 (moderate)	0 participants
VEH-OCC	Stinging/Burning at Visit 4	Grade 0 (none)	34 participants
VEH-OCC	Stinging/Burning at Visit 4	Grade 1 (mild)	0 participants

Secondary

Stinging/Burning at Visit 5

Time frame: 12 Weeks after PDT #1

Population: ITT, observed

Arm	Measure	Group	Value (NUMBER)
ALA+OCC	Stinging/Burning at Visit 5	Grade 2 (moderate)	0 participants
ALA+OCC	Stinging/Burning at Visit 5	Grade 1 (mild)	0 participants
ALA+OCC	Stinging/Burning at Visit 5	Grade 3 (severe)	0 participants
ALA+OCC	Stinging/Burning at Visit 5	Grade 0 (none)	33 participants
ALA-OCC	Stinging/Burning at Visit 5	Grade 0 (none)	33 participants
ALA-OCC	Stinging/Burning at Visit 5	Grade 1 (mild)	0 participants
ALA-OCC	Stinging/Burning at Visit 5	Grade 3 (severe)	0 participants
ALA-OCC	Stinging/Burning at Visit 5	Grade 2 (moderate)	0 participants
VEH+OCC	Stinging/Burning at Visit 5	Grade 3 (severe)	0 participants
VEH+OCC	Stinging/Burning at Visit 5	Grade 2 (moderate)	0 participants
VEH+OCC	Stinging/Burning at Visit 5	Grade 0 (none)	35 participants
VEH+OCC	Stinging/Burning at Visit 5	Grade 1 (mild)	0 participants
VEH-OCC	Stinging/Burning at Visit 5	Grade 3 (severe)	0 participants
VEH-OCC	Stinging/Burning at Visit 5	Grade 2 (moderate)	0 participants
VEH-OCC	Stinging/Burning at Visit 5	Grade 1 (mild)	0 participants
VEH-OCC	Stinging/Burning at Visit 5	Grade 0 (none)	35 participants

Secondary

Stinging/Burning During Light Treatment

Time frame: During PDT #1

Population: ITT, observed

Arm	Measure	Group	Value (NUMBER)
ALA+OCC	Stinging/Burning During Light Treatment	Grade 0 (none)	0 participants
ALA+OCC	Stinging/Burning During Light Treatment	Grade 3 (severe)	9 participants
ALA+OCC	Stinging/Burning During Light Treatment	Grade 1 (mild)	5 participants
ALA+OCC	Stinging/Burning During Light Treatment	Grade 2 (moderate)	21 participants
ALA-OCC	Stinging/Burning During Light Treatment	Grade 2 (moderate)	12 participants
ALA-OCC	Stinging/Burning During Light Treatment	Grade 3 (severe)	3 participants
ALA-OCC	Stinging/Burning During Light Treatment	Grade 0 (none)	0 participants
ALA-OCC	Stinging/Burning During Light Treatment	Grade 1 (mild)	20 participants
VEH+OCC	Stinging/Burning During Light Treatment	Grade 1 (mild)	6 participants
VEH+OCC	Stinging/Burning During Light Treatment	Grade 0 (none)	29 participants
VEH+OCC	Stinging/Burning During Light Treatment	Grade 3 (severe)	0 participants
VEH+OCC	Stinging/Burning During Light Treatment	Grade 2 (moderate)	0 participants
VEH-OCC	Stinging/Burning During Light Treatment	Grade 3 (severe)	0 participants
VEH-OCC	Stinging/Burning During Light Treatment	Grade 0 (none)	29 participants
VEH-OCC	Stinging/Burning During Light Treatment	Grade 1 (mild)	6 participants
VEH-OCC	Stinging/Burning During Light Treatment	Grade 2 (moderate)	0 participants

Secondary

Stinging/Burning Post Light Treatment

Time frame: 5 minutes after PDT #1

Population: ITT, observed

Arm	Measure	Group	Value (NUMBER)
ALA+OCC	Stinging/Burning Post Light Treatment	Grade 0 (none)	0 participants
ALA+OCC	Stinging/Burning Post Light Treatment	Grade 3 (severe)	7 participants
ALA+OCC	Stinging/Burning Post Light Treatment	Grade 1 (mild)	7 participants
ALA+OCC	Stinging/Burning Post Light Treatment	Grade 2 (moderate)	21 participants
ALA-OCC	Stinging/Burning Post Light Treatment	Grade 1 (mild)	22 participants
ALA-OCC	Stinging/Burning Post Light Treatment	Grade 0 (none)	2 participants
ALA-OCC	Stinging/Burning Post Light Treatment	Grade 2 (moderate)	10 participants
ALA-OCC	Stinging/Burning Post Light Treatment	Grade 3 (severe)	1 participants
VEH+OCC	Stinging/Burning Post Light Treatment	Grade 1 (mild)	5 participants
VEH+OCC	Stinging/Burning Post Light Treatment	Grade 2 (moderate)	0 participants
VEH+OCC	Stinging/Burning Post Light Treatment	Grade 0 (none)	30 participants
VEH+OCC	Stinging/Burning Post Light Treatment	Grade 3 (severe)	0 participants
VEH-OCC	Stinging/Burning Post Light Treatment	Grade 0 (none)	33 participants
VEH-OCC	Stinging/Burning Post Light Treatment	Grade 2 (moderate)	0 participants
VEH-OCC	Stinging/Burning Post Light Treatment	Grade 3 (severe)	0 participants
VEH-OCC	Stinging/Burning Post Light Treatment	Grade 1 (mild)	2 participants

Secondary

Subject Satisfaction Score

Subject satisfaction score 1. = Excellent (very satisfied) 2. = Good (moderately satisfied) 3. = Fair (slightly satisfied) 4. = Poor (not satisfied at all)

Time frame: Week 12

Population: ITT

Arm	Measure	Group	Value (NUMBER)
ALA+OCC	Subject Satisfaction Score	Very satisfied	13 participants
ALA+OCC	Subject Satisfaction Score	Moderately satisfied	16 participants
ALA+OCC	Subject Satisfaction Score	Slightly satisfied	3 participants
ALA+OCC	Subject Satisfaction Score	Not satisfied	3 participants
ALA-OCC	Subject Satisfaction Score	Moderately satisfied	14 participants
ALA-OCC	Subject Satisfaction Score	Slightly satisfied	8 participants
ALA-OCC	Subject Satisfaction Score	Not satisfied	6 participants
ALA-OCC	Subject Satisfaction Score	Very satisfied	7 participants
VEH+OCC	Subject Satisfaction Score	Slightly satisfied	7 participants
VEH+OCC	Subject Satisfaction Score	Moderately satisfied	5 participants
VEH+OCC	Subject Satisfaction Score	Not satisfied	20 participants
VEH+OCC	Subject Satisfaction Score	Very satisfied	3 participants
VEH-OCC	Subject Satisfaction Score	Not satisfied	20 participants
VEH-OCC	Subject Satisfaction Score	Moderately satisfied	5 participants
VEH-OCC	Subject Satisfaction Score	Very satisfied	1 participants
VEH-OCC	Subject Satisfaction Score	Slightly satisfied	9 participants

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

Levulan PDT Versus Vehicle for Extremity Actinic Keratoses (AK)

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Lesion Clearance Rate

Complete Clearance Rate

Complete Clearance Rate

Edema at Baseline

Edema at Visit 3

Edema at Visit 4

Edema at Visit 5

Edema Post-Light Treatment

Erythema at Baseline

Erythema at Visit 3

Erythema at Visit 4

Erythema at Visit 5

Erythema Post-Light Treatment

Hyperpigmentation at Baseline

Hyperpigmentation at Visit 3

Hyperpigmentation at Visit 4

Hyperpigmentation at Visit 5

Hypopigmentation at Baseline

Hypopigmentation at Visit 3

Hypopigmentation at Visit 4

Hypopigmentation at Visit 5

Lesion Clearance Rate

OOZING/VESICULATION/CRUSTING at Baseline

OOZING/VESICULATION/CRUSTING at Visit 3

OOZING/VESICULATION/CRUSTING at Visit 4

OOZING/VESICULATION/CRUSTING at Visit 5

Partial Clearance Rate

Partial Clearance Rate

Scaling and Dryness at Baseline

Scaling and Dryness at Visit 3

Scaling and Dryness at Visit 4

Scaling and Dryness at Visit 5

Stinging/Burning at Baseline

Stinging/Burning at Visit 3

Stinging/Burning at Visit 4

Stinging/Burning at Visit 5

Stinging/Burning During Light Treatment

Stinging/Burning Post Light Treatment

Subject Satisfaction Score