Actinic Keratosis
Conditions
Keywords
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 keratoses on the upper arms and hands
Interventions
20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
DEVICEBlue Light Photodynamic Therapy Illuminator (BLU-U)
10 J/cm2 blue light delivered at 10mW/cm2
Sponsors
DUSA Pharmaceuticals, Inc.
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
* Four to fifteen Grade 1/2 actinic keratosis lesions (AKs) on one upper extremity
Exclusion criteria
* Pregnancy * grade 3 and/or atypical \>1cm AKs within Treatment Area * 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 extremity 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, within 4 weeks of initiation of treatment. * Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, ingenol mebutate, imiquimod or other topical treatments for AK within 8 weeks of initiation of treatment. * use of systemic retinoid therapy within 6 months of initiation of treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Clearance Rate | Week 12 | proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AK Clearance Rate | Baseline and Week 12 | {1 - \[(number of AK lesions at follow-up)/(number of AK lesions at Baseline)\]} x 100 |
| Complete Clearance Rate | Week 8 | proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area |
| 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Stinging/Burning | 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 |
| Hyperpigmentation | 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 |
| Oozing/Vesiculation/Crusting | 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 |
| Scaling & Dryness | 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 |
| Hypopigmentation | 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 |
| Erythema | 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 |
| Edema | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ALA-PDT Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2 | 135 |
| Vehicle Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2 | 134 |
| Total | 269 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | subject moved out of state | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 4 |
Baseline characteristics
| Characteristic | Vehicle | Total | ALA-PDT |
|---|---|---|---|
| Age, Continuous | 67.6 years | 67.6 years | 67.6 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 3 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 131 Participants | 266 Participants | 135 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 | 134 Participants | 269 Participants | 135 Participants |
| Sex: Female, Male Female | 38 Participants | 81 Participants | 43 Participants |
| Sex: Female, Male Male | 96 Participants | 188 Participants | 92 Participants |
| Skin Type Type I | 16 participants | 33 participants | 17 participants |
| Skin Type Type II | 73 participants | 140 participants | 67 participants |
| Skin Type Type III | 32 participants | 69 participants | 37 participants |
| Skin Type Type IV | 13 participants | 27 participants | 14 participants |
| Skin Type Type V | 0 participants | 0 participants | 0 participants |
| Skin Type Type VI | 0 participants | 0 participants | 0 participants |
| Total Number AK Lesions (Grade 1/2) | 8.6 lesions per subject STANDARD_DEVIATION 3.4 | 8.5 lesions per subject STANDARD_DEVIATION 3.5 | 8.5 lesions per subject STANDARD_DEVIATION 3.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 135 | 6 / 134 |
| serious Total, serious adverse events | 5 / 135 | 2 / 134 |
Outcome results
Primary
Complete Clearance Rate
proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area
Time frame: Week 12
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ALA-PDT | Complete Clearance Rate | 42 participants |
| Vehicle | Complete Clearance Rate | 17 participants |
Comparison: A hierarchical procedure was used to control the level of significance. If the primary analysis was sig (p≤0.05), then AKCR at Week 12 were to be compared. If this analysis was significant, then the AKCR at Week 8 were to be compared. If this analysis was significant, then the CCR at Week 8 was to be compared.p-value: 0.0001Cochran-Mantel-Haenszel
Secondary
AK Clearance Rate
{1 - \[(number of AK lesions at follow-up)/(number of AK lesions at Baseline)\]} x 100
Time frame: Baseline and Week 8
Population: ITT using observed data only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ALA-PDT | AK Clearance Rate | 53.4 percentage of baseline lesions cleared | Standard Deviation 45 |
| Vehicle | AK Clearance Rate | 26.3 percentage of baseline lesions cleared | Standard Deviation 44.3 |
p-value: <0.0001Mixed Models Analysis
Secondary
AK Clearance Rate
{1 - \[(number of AK lesions at follow-up)/(number of AK lesions at Baseline)\]} x 100
Time frame: Baseline and Week 12
Population: ITT using observed data only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ALA-PDT | AK Clearance Rate | 69.1 percentage of baseline lesions cleared | Standard Deviation 37.4 |
| Vehicle | AK Clearance Rate | 29.9 percentage of baseline lesions cleared | Standard Deviation 51.5 |
p-value: <0.0001Mixed Models Analysis
Secondary
Complete Clearance Rate
proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area
Time frame: Week 8
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ALA-PDT | Complete Clearance Rate | 35 participants |
| Vehicle | Complete Clearance Rate | 12 participants |
p-value: 0.0001Cochran-Mantel-Haenszel
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-PDT | Subject Satisfaction Score | Very Satisfied | 71 participants |
| ALA-PDT | Subject Satisfaction Score | Slightly Satisfied | 12 participants |
| ALA-PDT | Subject Satisfaction Score | Not Satisfied | 4 participants |
| ALA-PDT | Subject Satisfaction Score | Moderately Satisfied | 47 participants |
| Vehicle | Subject Satisfaction Score | Not Satisfied | 48 participants |
| Vehicle | Subject Satisfaction Score | Very Satisfied | 29 participants |
| Vehicle | Subject Satisfaction Score | Moderately Satisfied | 26 participants |
| Vehicle | Subject Satisfaction Score | Slightly Satisfied | 28 participants |
Other Pre-specified
Edema
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-PDT | Edema | Grade 0 (none) | 133 participants |
| ALA-PDT | Edema | Grade 3 (moderate) | 0 participants |
| ALA-PDT | Edema | Grade 2 (mild) | 0 participants |
| ALA-PDT | Edema | Grade 4 (severe) | 0 participants |
| ALA-PDT | Edema | Grade 1 (minimal) | 2 participants |
| Vehicle | Edema | Grade 4 (severe) | 0 participants |
| Vehicle | Edema | Grade 0 (none) | 134 participants |
| Vehicle | Edema | Grade 1 (minimal) | 0 participants |
| Vehicle | Edema | Grade 2 (mild) | 0 participants |
| Vehicle | Edema | Grade 3 (moderate) | 0 participants |
Other Pre-specified
Edema
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: 8 Weeks after PDT #1
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Edema | Grade 1 (minimal) | 0 participants |
| ALA-PDT | Edema | Grade 3 (moderate) | 0 participants |
| ALA-PDT | Edema | Grade 2 (mild) | 1 participants |
| ALA-PDT | Edema | Grade 4 (severe) | 0 participants |
| ALA-PDT | Edema | Grade 0 (none) | 131 participants |
| Vehicle | Edema | Grade 4 (severe) | 0 participants |
| Vehicle | Edema | Grade 0 (none) | 128 participants |
| Vehicle | Edema | Grade 1 (minimal) | 0 participants |
| Vehicle | Edema | Grade 2 (mild) | 0 participants |
| Vehicle | Edema | Grade 3 (moderate) | 1 participants |
Other Pre-specified
Edema
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: 12 Weeks after PDT #1
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Edema | Grade 1 (minimal) | 0 participants |
| ALA-PDT | Edema | Grade 3 (moderate) | 0 participants |
| ALA-PDT | Edema | Grade 2 (mild) | 0 participants |
| ALA-PDT | Edema | Grade 4 (severe) | 0 participants |
| ALA-PDT | Edema | Grade 0 (none) | 132 participants |
| Vehicle | Edema | Grade 4 (severe) | 0 participants |
| Vehicle | Edema | Grade 0 (none) | 130 participants |
| Vehicle | Edema | Grade 1 (minimal) | 0 participants |
| Vehicle | Edema | Grade 2 (mild) | 0 participants |
| Vehicle | Edema | Grade 3 (moderate) | 0 participants |
Other Pre-specified
Edema
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: 4 Weeks after PDT #1
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Edema | Grade 1 (minimal) | 1 participants |
| ALA-PDT | Edema | Grade 3 (moderate) | 0 participants |
| ALA-PDT | Edema | Grade 0 (none) | 134 participants |
| ALA-PDT | Edema | Grade 4 (severe) | 0 participants |
| ALA-PDT | Edema | Grade 2 (mild) | 0 participants |
| Vehicle | Edema | Grade 4 (severe) | 0 participants |
| Vehicle | Edema | Grade 1 (minimal) | 0 participants |
| Vehicle | Edema | Grade 2 (mild) | 0 participants |
| Vehicle | Edema | Grade 3 (moderate) | 0 participants |
| Vehicle | Edema | Grade 0 (none) | 132 participants |
Other Pre-specified
Edema
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: 2 weeks after PDT #1
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Edema | Grade 1 (minimal) | 4 participants |
| ALA-PDT | Edema | Grade 3 (moderate) | 0 participants |
| ALA-PDT | Edema | Grade 2 (mild) | 0 participants |
| ALA-PDT | Edema | Grade 4 (severe) | 0 participants |
| ALA-PDT | Edema | Grade 0 (none) | 131 participants |
| Vehicle | Edema | Grade 4 (severe) | 0 participants |
| Vehicle | Edema | Grade 0 (none) | 134 participants |
| Vehicle | Edema | Grade 1 (minimal) | 0 participants |
| Vehicle | Edema | Grade 2 (mild) | 0 participants |
| Vehicle | Edema | Grade 3 (moderate) | 0 participants |
Other Pre-specified
Edema
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 after PDT #1
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Edema | Grade 1 (minimal) | 27 participants |
| ALA-PDT | Edema | Grade 3 (moderate) | 1 participants |
| ALA-PDT | Edema | Grade 2 (mild) | 18 participants |
| ALA-PDT | Edema | Grade 4 (severe) | 0 participants |
| ALA-PDT | Edema | Grade 0 (none) | 89 participants |
| Vehicle | Edema | Grade 4 (severe) | 0 participants |
| Vehicle | Edema | Grade 0 (none) | 133 participants |
| Vehicle | Edema | Grade 1 (minimal) | 0 participants |
| Vehicle | Edema | Grade 2 (mild) | 1 participants |
| Vehicle | Edema | Grade 3 (moderate) | 0 participants |
Other Pre-specified
Edema
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
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Edema | Grade 1 (minimal) | 30 participants |
| ALA-PDT | Edema | Grade 3 (moderate) | 3 participants |
| ALA-PDT | Edema | Grade 2 (mild) | 10 participants |
| ALA-PDT | Edema | Grade 4 (severe) | 0 participants |
| ALA-PDT | Edema | Grade 0 (none) | 92 participants |
| Vehicle | Edema | Grade 4 (severe) | 0 participants |
| Vehicle | Edema | Grade 0 (none) | 127 participants |
| Vehicle | Edema | Grade 1 (minimal) | 7 participants |
| Vehicle | Edema | Grade 2 (mild) | 0 participants |
| Vehicle | Edema | Grade 3 (moderate) | 0 participants |
Other Pre-specified
Erythema
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
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Erythema | Grade 1 (light) | 26 participants |
| ALA-PDT | Erythema | Grade 3 (moderate) | 52 participants |
| ALA-PDT | Erythema | Grade 2 (mild) | 43 participants |
| ALA-PDT | Erythema | Grade 4 (severe) | 2 participants |
| ALA-PDT | Erythema | Grade 0 (none) | 12 participants |
| Vehicle | Erythema | Grade 4 (severe) | 0 participants |
| Vehicle | Erythema | Grade 0 (none) | 57 participants |
| Vehicle | Erythema | Grade 1 (light) | 41 participants |
| Vehicle | Erythema | Grade 2 (mild) | 27 participants |
| Vehicle | Erythema | Grade 3 (moderate) | 9 participants |
Other Pre-specified
Erythema
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: 2 Weeks after PDT #1
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Erythema | Grade 1 (minimal) | 46 participants |
| ALA-PDT | Erythema | Grade 3 (moderate) | 10 participants |
| ALA-PDT | Erythema | Grade 2 (mild) | 51 participants |
| ALA-PDT | Erythema | Grade 4 (severe) | 0 participants |
| ALA-PDT | Erythema | Grade 0 (none) | 28 participants |
| Vehicle | Erythema | Grade 4 (severe) | 0 participants |
| Vehicle | Erythema | Grade 0 (none) | 61 participants |
| Vehicle | Erythema | Grade 1 (minimal) | 58 participants |
| Vehicle | Erythema | Grade 2 (mild) | 14 participants |
| Vehicle | Erythema | Grade 3 (moderate) | 1 participants |
Other Pre-specified
Erythema
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: 4 Weeks after PDT #1
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Erythema | Grade 1 (minimal) | 54 participants |
| ALA-PDT | Erythema | Grade 3 (moderate) | 3 participants |
| ALA-PDT | Erythema | Grade 2 (mild) | 24 participants |
| ALA-PDT | Erythema | Grade 4 (severe) | 0 participants |
| ALA-PDT | Erythema | Grade 0 (none) | 54 participants |
| Vehicle | Erythema | Grade 4 (severe) | 0 participants |
| Vehicle | Erythema | Grade 0 (none) | 72 participants |
| Vehicle | Erythema | Grade 1 (minimal) | 49 participants |
| Vehicle | Erythema | Grade 2 (mild) | 11 participants |
| Vehicle | Erythema | Grade 3 (moderate) | 0 participants |
Other Pre-specified
Erythema
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: 8 Weeks after PDT #1
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Erythema | Grade 1 (minimal) | 30 participants |
| ALA-PDT | Erythema | Grade 3 (moderate) | 5 participants |
| ALA-PDT | Erythema | Grade 2 (mild) | 18 participants |
| ALA-PDT | Erythema | Grade 4 (severe) | 0 participants |
| ALA-PDT | Erythema | Grade 0 (none) | 79 participants |
| Vehicle | Erythema | Grade 4 (severe) | 0 participants |
| Vehicle | Erythema | Grade 0 (none) | 81 participants |
| Vehicle | Erythema | Grade 1 (minimal) | 39 participants |
| Vehicle | Erythema | Grade 2 (mild) | 7 participants |
| Vehicle | Erythema | Grade 3 (moderate) | 2 participants |
Other Pre-specified
Erythema
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: 12 Weeks after PDT #1
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Erythema | Grade 1 (minimal) | 34 participants |
| ALA-PDT | Erythema | Grade 3 (moderate) | 3 participants |
| ALA-PDT | Erythema | Grade 2 (mild) | 15 participants |
| ALA-PDT | Erythema | Grade 4 (severe) | 0 participants |
| ALA-PDT | Erythema | Grade 0 (none) | 80 participants |
| Vehicle | Erythema | Grade 4 (severe) | 0 participants |
| Vehicle | Erythema | Grade 0 (none) | 85 participants |
| Vehicle | Erythema | Grade 1 (minimal) | 36 participants |
| Vehicle | Erythema | Grade 2 (mild) | 8 participants |
| Vehicle | Erythema | Grade 3 (moderate) | 1 participants |
Other Pre-specified
Erythema
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-PDT | Erythema | Grade 1 (minimal) | 38 participants |
| ALA-PDT | Erythema | Grade 3 (moderate) | 3 participants |
| ALA-PDT | Erythema | Grade 2 (mild) | 21 participants |
| ALA-PDT | Erythema | Grade 4 (severe) | 0 participants |
| ALA-PDT | Erythema | Grade 0 (none) | 73 participants |
| Vehicle | Erythema | Grade 4 (severe) | 0 participants |
| Vehicle | Erythema | Grade 0 (none) | 73 participants |
| Vehicle | Erythema | Grade 1 (minimal) | 39 participants |
| Vehicle | Erythema | Grade 2 (mild) | 19 participants |
| Vehicle | Erythema | Grade 3 (moderate) | 3 participants |
Other Pre-specified
Erythema
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
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Erythema | Grade 1 (minimal) | 16 participants |
| ALA-PDT | Erythema | Grade 3 (moderate) | 66 participants |
| ALA-PDT | Erythema | Grade 2 (mild) | 48 participants |
| ALA-PDT | Erythema | Grade 4 (severe) | 3 participants |
| ALA-PDT | Erythema | Grade 0 (none) | 2 participants |
| Vehicle | Erythema | Grade 4 (severe) | 0 participants |
| Vehicle | Erythema | Grade 0 (none) | 64 participants |
| Vehicle | Erythema | Grade 1 (minimal) | 43 participants |
| Vehicle | Erythema | Grade 2 (mild) | 23 participants |
| Vehicle | Erythema | Grade 3 (moderate) | 4 participants |
Other Pre-specified
Hyperpigmentation
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
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Hyperpigmentation | Grade 1 (light) | 49 participants |
| ALA-PDT | Hyperpigmentation | Grade 3 (moderate - moderate) | 11 participants |
| ALA-PDT | Hyperpigmentation | Grade 2 (moderate - small) | 28 participants |
| ALA-PDT | Hyperpigmentation | Grade 4 (marked) | 1 participants |
| ALA-PDT | Hyperpigmentation | Grade 0 (none) | 46 participants |
| Vehicle | Hyperpigmentation | Grade 4 (marked) | 2 participants |
| Vehicle | Hyperpigmentation | Grade 0 (none) | 58 participants |
| Vehicle | Hyperpigmentation | Grade 1 (light) | 34 participants |
| Vehicle | Hyperpigmentation | Grade 2 (moderate - small) | 30 participants |
| Vehicle | Hyperpigmentation | Grade 3 (moderate - moderate) | 10 participants |
Other Pre-specified
Hyperpigmentation
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-PDT | Hyperpigmentation | Grade 1 (light) | 51 participants |
| ALA-PDT | Hyperpigmentation | Grade 3 (moderate - moderate) | 10 participants |
| ALA-PDT | Hyperpigmentation | Grade 2 (moderate - small) | 27 participants |
| ALA-PDT | Hyperpigmentation | Grade 4 (marked) | 1 participants |
| ALA-PDT | Hyperpigmentation | Grade 0 (none) | 46 participants |
| Vehicle | Hyperpigmentation | Grade 4 (marked) | 2 participants |
| Vehicle | Hyperpigmentation | Grade 0 (none) | 53 participants |
| Vehicle | Hyperpigmentation | Grade 1 (light) | 34 participants |
| Vehicle | Hyperpigmentation | Grade 2 (moderate - small) | 35 participants |
| Vehicle | Hyperpigmentation | Grade 3 (moderate - moderate) | 10 participants |
Other Pre-specified
Hyperpigmentation
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: 2 Weeks after PDT #1
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Hyperpigmentation | Grade 0 (none) | 45 participants |
| ALA-PDT | Hyperpigmentation | Grade 3 (moderate - moderate) | 10 participants |
| ALA-PDT | Hyperpigmentation | Grade 2 (moderate - small) | 33 participants |
| ALA-PDT | Hyperpigmentation | Grade 4 (marked) | 1 participants |
| ALA-PDT | Hyperpigmentation | Grade 1 (light) | 46 participants |
| Vehicle | Hyperpigmentation | Grade 4 (marked) | 2 participants |
| Vehicle | Hyperpigmentation | Grade 0 (none) | 58 participants |
| Vehicle | Hyperpigmentation | Grade 1 (light) | 35 participants |
| Vehicle | Hyperpigmentation | Grade 2 (moderate - small) | 30 participants |
| Vehicle | Hyperpigmentation | Grade 3 (moderate - moderate) | 9 participants |
Other Pre-specified
Hyperpigmentation
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: 4 Weeks after PDT #1
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Hyperpigmentation | Grade 1 (light) | 44 participants |
| ALA-PDT | Hyperpigmentation | Grade 3 (moderate - moderate) | 9 participants |
| ALA-PDT | Hyperpigmentation | Grade 2 (moderate - small) | 30 participants |
| ALA-PDT | Hyperpigmentation | Grade 4 (marked) | 1 participants |
| ALA-PDT | Hyperpigmentation | Grade 0 (none) | 51 participants |
| Vehicle | Hyperpigmentation | Grade 4 (marked) | 2 participants |
| Vehicle | Hyperpigmentation | Grade 0 (none) | 56 participants |
| Vehicle | Hyperpigmentation | Grade 1 (light) | 37 participants |
| Vehicle | Hyperpigmentation | Grade 2 (moderate - small) | 28 participants |
| Vehicle | Hyperpigmentation | Grade 3 (moderate - moderate) | 9 participants |
Other Pre-specified
Hyperpigmentation
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: 8 Weeks after PDT #1
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Hyperpigmentation | Grade 1 (light) | 44 participants |
| ALA-PDT | Hyperpigmentation | Grade 3 (moderate - moderate) | 9 participants |
| ALA-PDT | Hyperpigmentation | Grade 2 (moderate - small) | 27 participants |
| ALA-PDT | Hyperpigmentation | Grade 4 (marked) | 1 participants |
| ALA-PDT | Hyperpigmentation | Grade 0 (none) | 51 participants |
| Vehicle | Hyperpigmentation | Grade 4 (marked) | 2 participants |
| Vehicle | Hyperpigmentation | Grade 0 (none) | 53 participants |
| Vehicle | Hyperpigmentation | Grade 1 (light) | 37 participants |
| Vehicle | Hyperpigmentation | Grade 2 (moderate - small) | 27 participants |
| Vehicle | Hyperpigmentation | Grade 3 (moderate - moderate) | 10 participants |
Other Pre-specified
Hyperpigmentation
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: 12 Weeks after PDT #1
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Hyperpigmentation | Grade 1 (light) | 42 participants |
| ALA-PDT | Hyperpigmentation | Grade 3 (moderate - moderate) | 8 participants |
| ALA-PDT | Hyperpigmentation | Grade 2 (moderate - small) | 29 participants |
| ALA-PDT | Hyperpigmentation | Grade 4 (marked) | 1 participants |
| ALA-PDT | Hyperpigmentation | Grade 0 (none) | 52 participants |
| Vehicle | Hyperpigmentation | Grade 4 (marked) | 2 participants |
| Vehicle | Hyperpigmentation | Grade 0 (none) | 49 participants |
| Vehicle | Hyperpigmentation | Grade 1 (light) | 43 participants |
| Vehicle | Hyperpigmentation | Grade 2 (moderate - small) | 26 participants |
| Vehicle | Hyperpigmentation | Grade 3 (moderate - moderate) | 10 participants |
Other Pre-specified
Hypopigmentation
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
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Hypopigmentation | Grade 3 (moderate - moderate) | 5 participants |
| ALA-PDT | Hypopigmentation | Grade 4 (marked) | 0 participants |
| ALA-PDT | Hypopigmentation | Grade 0 (none) | 76 participants |
| ALA-PDT | Hypopigmentation | Grade 1 (light) | 42 participants |
| ALA-PDT | Hypopigmentation | Grade 2 (moderate - small) | 12 participants |
| Vehicle | Hypopigmentation | Grade 2 (moderate - small) | 14 participants |
| Vehicle | Hypopigmentation | Grade 3 (moderate - moderate) | 4 participants |
| Vehicle | Hypopigmentation | Grade 1 (light) | 46 participants |
| Vehicle | Hypopigmentation | Grade 4 (marked) | 2 participants |
| Vehicle | Hypopigmentation | Grade 0 (none) | 68 participants |
Other Pre-specified
Hypopigmentation
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
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Hypopigmentation | Grade 1 (light) | 40 participants |
| ALA-PDT | Hypopigmentation | Grade 3 (moderate - moderate) | 4 participants |
| ALA-PDT | Hypopigmentation | Grade 2 (moderate - small) | 16 participants |
| ALA-PDT | Hypopigmentation | Grade 4 (marked) | 0 participants |
| ALA-PDT | Hypopigmentation | Grade 0 (none) | 75 participants |
| Vehicle | Hypopigmentation | Grade 4 (marked) | 2 participants |
| Vehicle | Hypopigmentation | Grade 0 (none) | 64 participants |
| Vehicle | Hypopigmentation | Grade 1 (light) | 47 participants |
| Vehicle | Hypopigmentation | Grade 2 (moderate - small) | 17 participants |
| Vehicle | Hypopigmentation | Grade 3 (moderate - moderate) | 4 participants |
Other Pre-specified
Hypopigmentation
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: 12 Weeks after PDT #1
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Hypopigmentation | Grade 1 (light) | 40 participants |
| ALA-PDT | Hypopigmentation | Grade 3 (moderate - moderate) | 3 participants |
| ALA-PDT | Hypopigmentation | Grade 2 (moderate - small) | 16 participants |
| ALA-PDT | Hypopigmentation | Grade 4 (marked) | 0 participants |
| ALA-PDT | Hypopigmentation | Grade 0 (none) | 73 participants |
| Vehicle | Hypopigmentation | Grade 4 (marked) | 2 participants |
| Vehicle | Hypopigmentation | Grade 0 (none) | 66 participants |
| Vehicle | Hypopigmentation | Grade 1 (light) | 45 participants |
| Vehicle | Hypopigmentation | Grade 2 (moderate - small) | 14 participants |
| Vehicle | Hypopigmentation | Grade 3 (moderate - moderate) | 3 participants |
Other Pre-specified
Hypopigmentation
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: 8 Weeks after PDT #1
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Hypopigmentation | Grade 2 (moderate - small) | 15 participants |
| ALA-PDT | Hypopigmentation | Grade 3 (moderate - moderate) | 3 participants |
| ALA-PDT | Hypopigmentation | Grade 0 (none) | 75 participants |
| ALA-PDT | Hypopigmentation | Grade 1 (light) | 39 participants |
| ALA-PDT | Hypopigmentation | Grade 4 (marked) | 0 participants |
| Vehicle | Hypopigmentation | Grade 4 (marked) | 2 participants |
| Vehicle | Hypopigmentation | Grade 2 (moderate - small) | 15 participants |
| Vehicle | Hypopigmentation | Grade 1 (light) | 45 participants |
| Vehicle | Hypopigmentation | Grade 3 (moderate - moderate) | 4 participants |
| Vehicle | Hypopigmentation | Grade 0 (none) | 63 participants |
Other Pre-specified
Hypopigmentation
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: 4 Weeks after PDT #1
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Hypopigmentation | Grade 1 (light) | 42 participants |
| ALA-PDT | Hypopigmentation | Grade 3 (moderate - moderate) | 4 participants |
| ALA-PDT | Hypopigmentation | Grade 2 (moderate - small) | 13 participants |
| ALA-PDT | Hypopigmentation | Grade 4 (marked) | 0 participants |
| ALA-PDT | Hypopigmentation | Grade 0 (none) | 76 participants |
| Vehicle | Hypopigmentation | Grade 4 (marked) | 2 participants |
| Vehicle | Hypopigmentation | Grade 0 (none) | 65 participants |
| Vehicle | Hypopigmentation | Grade 1 (light) | 47 participants |
| Vehicle | Hypopigmentation | Grade 2 (moderate - small) | 14 participants |
| Vehicle | Hypopigmentation | Grade 3 (moderate - moderate) | 4 participants |
Other Pre-specified
Hypopigmentation
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: 2 Weeks after PDT #1
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Hypopigmentation | Grade 1 (light) | 44 participants |
| ALA-PDT | Hypopigmentation | Grade 3 (moderate - moderate) | 4 participants |
| ALA-PDT | Hypopigmentation | Grade 2 (moderate - small) | 13 participants |
| ALA-PDT | Hypopigmentation | Grade 4 (marked) | 0 participants |
| ALA-PDT | Hypopigmentation | Grade 0 (none) | 74 participants |
| Vehicle | Hypopigmentation | Grade 4 (marked) | 2 participants |
| Vehicle | Hypopigmentation | Grade 0 (none) | 67 participants |
| Vehicle | Hypopigmentation | Grade 1 (light) | 47 participants |
| Vehicle | Hypopigmentation | Grade 2 (moderate - small) | 14 participants |
| Vehicle | Hypopigmentation | Grade 3 (moderate - moderate) | 4 participants |
Other Pre-specified
Oozing/Vesiculation/Crusting
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: 8 Weeks after PDT #1
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Oozing/Vesiculation/Crusting | Grade 1 (minimal) | 5 participants |
| ALA-PDT | Oozing/Vesiculation/Crusting | Grade 3 (moderate) | 0 participants |
| ALA-PDT | Oozing/Vesiculation/Crusting | Grade 2 (mild) | 2 participants |
| ALA-PDT | Oozing/Vesiculation/Crusting | Grade 4 (severe) | 0 participants |
| ALA-PDT | Oozing/Vesiculation/Crusting | Grade 0 (none) | 125 participants |
| Vehicle | Oozing/Vesiculation/Crusting | Grade 4 (severe) | 0 participants |
| Vehicle | Oozing/Vesiculation/Crusting | Grade 0 (none) | 124 participants |
| Vehicle | Oozing/Vesiculation/Crusting | Grade 1 (minimal) | 3 participants |
| Vehicle | Oozing/Vesiculation/Crusting | Grade 2 (mild) | 2 participants |
| Vehicle | Oozing/Vesiculation/Crusting | Grade 3 (moderate) | 0 participants |
Other Pre-specified
Oozing/Vesiculation/Crusting
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: 12 Weeks after PDT #1
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Oozing/Vesiculation/Crusting | Grade 1 (minimal) | 5 participants |
| ALA-PDT | Oozing/Vesiculation/Crusting | Grade 3 (moderate) | 1 participants |
| ALA-PDT | Oozing/Vesiculation/Crusting | Grade 2 (mild) | 3 participants |
| ALA-PDT | Oozing/Vesiculation/Crusting | Grade 4 (severe) | 0 participants |
| ALA-PDT | Oozing/Vesiculation/Crusting | Grade 0 (none) | 123 participants |
| Vehicle | Oozing/Vesiculation/Crusting | Grade 4 (severe) | 0 participants |
| Vehicle | Oozing/Vesiculation/Crusting | Grade 0 (none) | 125 participants |
| Vehicle | Oozing/Vesiculation/Crusting | Grade 1 (minimal) | 4 participants |
| Vehicle | Oozing/Vesiculation/Crusting | Grade 2 (mild) | 0 participants |
| Vehicle | Oozing/Vesiculation/Crusting | Grade 3 (moderate) | 1 participants |
Other Pre-specified
Oozing/Vesiculation/Crusting
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Oozing/Vesiculation/Crusting | Grade 1 (minimal) | 7 participants |
| ALA-PDT | Oozing/Vesiculation/Crusting | Grade 3 (moderate) | 0 participants |
| ALA-PDT | Oozing/Vesiculation/Crusting | Grade 2 (mild) | 0 participants |
| ALA-PDT | Oozing/Vesiculation/Crusting | Grade 4 (severe) | 0 participants |
| ALA-PDT | Oozing/Vesiculation/Crusting | Grade 0 (none) | 128 participants |
| Vehicle | Oozing/Vesiculation/Crusting | Grade 4 (severe) | 0 participants |
| Vehicle | Oozing/Vesiculation/Crusting | Grade 0 (none) | 129 participants |
| Vehicle | Oozing/Vesiculation/Crusting | Grade 1 (minimal) | 4 participants |
| Vehicle | Oozing/Vesiculation/Crusting | Grade 2 (mild) | 1 participants |
| Vehicle | Oozing/Vesiculation/Crusting | Grade 3 (moderate) | 0 participants |
Other Pre-specified
Oozing/Vesiculation/Crusting
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
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Oozing/Vesiculation/Crusting | Grade 1 (minimal) | 12 participants |
| ALA-PDT | Oozing/Vesiculation/Crusting | Grade 3 (moderate) | 2 participants |
| ALA-PDT | Oozing/Vesiculation/Crusting | Grade 2 (mild) | 5 participants |
| ALA-PDT | Oozing/Vesiculation/Crusting | Grade 4 (severe) | 0 participants |
| ALA-PDT | Oozing/Vesiculation/Crusting | Grade 0 (none) | 116 participants |
| Vehicle | Oozing/Vesiculation/Crusting | Grade 4 (severe) | 0 participants |
| Vehicle | Oozing/Vesiculation/Crusting | Grade 0 (none) | 127 participants |
| Vehicle | Oozing/Vesiculation/Crusting | Grade 1 (minimal) | 3 participants |
| Vehicle | Oozing/Vesiculation/Crusting | Grade 2 (mild) | 3 participants |
| Vehicle | Oozing/Vesiculation/Crusting | Grade 3 (moderate) | 1 participants |
Other Pre-specified
Oozing/Vesiculation/Crusting
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: 2 Weeks after PDT #1
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Oozing/Vesiculation/Crusting | Grade 1 (minimal) | 23 participants |
| ALA-PDT | Oozing/Vesiculation/Crusting | Grade 3 (moderate) | 4 participants |
| ALA-PDT | Oozing/Vesiculation/Crusting | Grade 2 (mild) | 16 participants |
| ALA-PDT | Oozing/Vesiculation/Crusting | Grade 4 (severe) | 0 participants |
| ALA-PDT | Oozing/Vesiculation/Crusting | Grade 0 (none) | 92 participants |
| Vehicle | Oozing/Vesiculation/Crusting | Grade 4 (severe) | 0 participants |
| Vehicle | Oozing/Vesiculation/Crusting | Grade 0 (none) | 129 participants |
| Vehicle | Oozing/Vesiculation/Crusting | Grade 1 (minimal) | 4 participants |
| Vehicle | Oozing/Vesiculation/Crusting | Grade 2 (mild) | 1 participants |
| Vehicle | Oozing/Vesiculation/Crusting | Grade 3 (moderate) | 0 participants |
Other Pre-specified
Oozing/Vesiculation/Crusting
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: 4 Weeks after PDT #1
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Oozing/Vesiculation/Crusting | Grade 1 (minimal) | 12 participants |
| ALA-PDT | Oozing/Vesiculation/Crusting | Grade 3 (moderate) | 0 participants |
| ALA-PDT | Oozing/Vesiculation/Crusting | Grade 2 (mild) | 2 participants |
| ALA-PDT | Oozing/Vesiculation/Crusting | Grade 4 (severe) | 0 participants |
| ALA-PDT | Oozing/Vesiculation/Crusting | Grade 0 (none) | 121 participants |
| Vehicle | Oozing/Vesiculation/Crusting | Grade 4 (severe) | 0 participants |
| Vehicle | Oozing/Vesiculation/Crusting | Grade 0 (none) | 129 participants |
| Vehicle | Oozing/Vesiculation/Crusting | Grade 1 (minimal) | 2 participants |
| Vehicle | Oozing/Vesiculation/Crusting | Grade 2 (mild) | 1 participants |
| Vehicle | Oozing/Vesiculation/Crusting | Grade 3 (moderate) | 0 participants |
Other Pre-specified
Scaling & Dryness
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: 4 Weeks after PDT #1
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Scaling & Dryness | Grade 1 (minimal) | 44 participants |
| ALA-PDT | Scaling & Dryness | Grade 3 (moderate) | 3 participants |
| ALA-PDT | Scaling & Dryness | Grade 2 (mild) | 15 participants |
| ALA-PDT | Scaling & Dryness | Grade 4 (severe) | 0 participants |
| ALA-PDT | Scaling & Dryness | Grade 0 (none) | 73 participants |
| Vehicle | Scaling & Dryness | Grade 4 (severe) | 0 participants |
| Vehicle | Scaling & Dryness | Grade 0 (none) | 83 participants |
| Vehicle | Scaling & Dryness | Grade 1 (minimal) | 38 participants |
| Vehicle | Scaling & Dryness | Grade 2 (mild) | 11 participants |
| Vehicle | Scaling & Dryness | Grade 3 (moderate) | 0 participants |
Other Pre-specified
Scaling & Dryness
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: 12 Weeks after PDT #1
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Scaling & Dryness | Grade 1 (minimal) | 33 participants |
| ALA-PDT | Scaling & Dryness | Grade 3 (moderate) | 5 participants |
| ALA-PDT | Scaling & Dryness | Grade 2 (mild) | 9 participants |
| ALA-PDT | Scaling & Dryness | Grade 4 (severe) | 0 participants |
| ALA-PDT | Scaling & Dryness | Grade 0 (none) | 85 participants |
| Vehicle | Scaling & Dryness | Grade 4 (severe) | 0 participants |
| Vehicle | Scaling & Dryness | Grade 0 (none) | 86 participants |
| Vehicle | Scaling & Dryness | Grade 1 (minimal) | 32 participants |
| Vehicle | Scaling & Dryness | Grade 2 (mild) | 10 participants |
| Vehicle | Scaling & Dryness | Grade 3 (moderate) | 2 participants |
Other Pre-specified
Scaling & Dryness
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Scaling & Dryness | Grade 1 (minimal) | 35 participants |
| ALA-PDT | Scaling & Dryness | Grade 3 (moderate) | 7 participants |
| ALA-PDT | Scaling & Dryness | Grade 2 (mild) | 10 participants |
| ALA-PDT | Scaling & Dryness | Grade 4 (severe) | 0 participants |
| ALA-PDT | Scaling & Dryness | Grade 0 (none) | 83 participants |
| Vehicle | Scaling & Dryness | Grade 4 (severe) | 0 participants |
| Vehicle | Scaling & Dryness | Grade 0 (none) | 78 participants |
| Vehicle | Scaling & Dryness | Grade 1 (minimal) | 41 participants |
| Vehicle | Scaling & Dryness | Grade 2 (mild) | 11 participants |
| Vehicle | Scaling & Dryness | Grade 3 (moderate) | 4 participants |
Other Pre-specified
Scaling & Dryness
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
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Scaling & Dryness | Grade 1 (minimal) | 30 participants |
| ALA-PDT | Scaling & Dryness | Grade 3 (moderate) | 4 participants |
| ALA-PDT | Scaling & Dryness | Grade 2 (mild) | 17 participants |
| ALA-PDT | Scaling & Dryness | Grade 4 (severe) | 0 participants |
| ALA-PDT | Scaling & Dryness | Grade 0 (none) | 84 participants |
| Vehicle | Scaling & Dryness | Grade 4 (severe) | 0 participants |
| Vehicle | Scaling & Dryness | Grade 0 (none) | 79 participants |
| Vehicle | Scaling & Dryness | Grade 1 (minimal) | 40 participants |
| Vehicle | Scaling & Dryness | Grade 2 (mild) | 10 participants |
| Vehicle | Scaling & Dryness | Grade 3 (moderate) | 5 participants |
Other Pre-specified
Scaling & Dryness
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: 2 Weeks after PDT #1
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Scaling & Dryness | Grade 1 (minimal) | 47 participants |
| ALA-PDT | Scaling & Dryness | Grade 3 (moderate) | 26 participants |
| ALA-PDT | Scaling & Dryness | Grade 2 (mild) | 29 participants |
| ALA-PDT | Scaling & Dryness | Grade 4 (severe) | 0 participants |
| ALA-PDT | Scaling & Dryness | Grade 0 (none) | 33 participants |
| Vehicle | Scaling & Dryness | Grade 4 (severe) | 0 participants |
| Vehicle | Scaling & Dryness | Grade 0 (none) | 81 participants |
| Vehicle | Scaling & Dryness | Grade 1 (minimal) | 38 participants |
| Vehicle | Scaling & Dryness | Grade 2 (mild) | 11 participants |
| Vehicle | Scaling & Dryness | Grade 3 (moderate) | 4 participants |
Other Pre-specified
Scaling & Dryness
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: 8 Weeks after PDT #1
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Scaling & Dryness | Grade 1 (minimal) | 35 participants |
| ALA-PDT | Scaling & Dryness | Grade 3 (moderate) | 3 participants |
| ALA-PDT | Scaling & Dryness | Grade 2 (mild) | 11 participants |
| ALA-PDT | Scaling & Dryness | Grade 4 (severe) | 0 participants |
| ALA-PDT | Scaling & Dryness | Grade 0 (none) | 83 participants |
| Vehicle | Scaling & Dryness | Grade 4 (severe) | 0 participants |
| Vehicle | Scaling & Dryness | Grade 0 (none) | 86 participants |
| Vehicle | Scaling & Dryness | Grade 1 (minimal) | 35 participants |
| Vehicle | Scaling & Dryness | Grade 2 (mild) | 5 participants |
| Vehicle | Scaling & Dryness | Grade 3 (moderate) | 3 participants |
Other Pre-specified
Stinging/Burning
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: 12 Weeks after PDT #1
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Stinging/Burning | Grade 2 (moderate) | 1 participants |
| ALA-PDT | Stinging/Burning | Grade 1 (mild) | 1 participants |
| ALA-PDT | Stinging/Burning | Grade 3 (severe) | 0 participants |
| ALA-PDT | Stinging/Burning | Grade 0 (none) | 130 participants |
| Vehicle | Stinging/Burning | Grade 3 (severe) | 0 participants |
| Vehicle | Stinging/Burning | Grade 1 (mild) | 0 participants |
| Vehicle | Stinging/Burning | Grade 2 (moderate) | 0 participants |
| Vehicle | Stinging/Burning | Grade 0 (none) | 130 participants |
Other Pre-specified
Stinging/Burning
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: During PDT #1
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Stinging/Burning | Grade 0 (none) | 10 participants |
| ALA-PDT | Stinging/Burning | Grade 1 (mild) | 39 participants |
| ALA-PDT | Stinging/Burning | Grade 2 (moderate) | 74 participants |
| ALA-PDT | Stinging/Burning | Grade 3 (severe) | 12 participants |
| Vehicle | Stinging/Burning | Grade 3 (severe) | 0 participants |
| Vehicle | Stinging/Burning | Grade 0 (none) | 111 participants |
| Vehicle | Stinging/Burning | Grade 2 (moderate) | 0 participants |
| Vehicle | Stinging/Burning | Grade 1 (mild) | 23 participants |
Other Pre-specified
Stinging/Burning
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: 5 minutes after PDT #1
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Stinging/Burning | Grade 0 (none) | 30 participants |
| ALA-PDT | Stinging/Burning | Grade 1 (mild) | 70 participants |
| ALA-PDT | Stinging/Burning | Grade 2 (moderate) | 35 participants |
| ALA-PDT | Stinging/Burning | Grade 3 (severe) | 0 participants |
| Vehicle | Stinging/Burning | Grade 3 (severe) | 0 participants |
| Vehicle | Stinging/Burning | Grade 0 (none) | 130 participants |
| Vehicle | Stinging/Burning | Grade 2 (moderate) | 0 participants |
| Vehicle | Stinging/Burning | Grade 1 (mild) | 4 participants |
Other Pre-specified
Stinging/Burning
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: 24-48 Hours after PDT #1
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Stinging/Burning | Grade 0 (none) | 107 participants |
| ALA-PDT | Stinging/Burning | Grade 1 (mild) | 23 participants |
| ALA-PDT | Stinging/Burning | Grade 2 (moderate) | 5 participants |
| ALA-PDT | Stinging/Burning | Grade 3 (severe) | 0 participants |
| Vehicle | Stinging/Burning | Grade 3 (severe) | 0 participants |
| Vehicle | Stinging/Burning | Grade 0 (none) | 132 participants |
| Vehicle | Stinging/Burning | Grade 2 (moderate) | 0 participants |
| Vehicle | Stinging/Burning | Grade 1 (mild) | 2 participants |
Other Pre-specified
Stinging/Burning
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: 2 Weeks after PDT #1
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Stinging/Burning | Grade 0 (none) | 131 ITT |
| ALA-PDT | Stinging/Burning | Grade 1 (mild) | 3 ITT |
| ALA-PDT | Stinging/Burning | Grade 2 (moderate) | 0 ITT |
| ALA-PDT | Stinging/Burning | Grade 3 (severe) | 1 ITT |
| Vehicle | Stinging/Burning | Grade 3 (severe) | 0 ITT |
| Vehicle | Stinging/Burning | Grade 0 (none) | 134 ITT |
| Vehicle | Stinging/Burning | Grade 2 (moderate) | 0 ITT |
| Vehicle | Stinging/Burning | Grade 1 (mild) | 0 ITT |
Other Pre-specified
Stinging/Burning
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: 4 Weeks after PDT #1
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Stinging/Burning | Grade 0 (none) | 132 participants |
| ALA-PDT | Stinging/Burning | Grade 1 (mild) | 2 participants |
| ALA-PDT | Stinging/Burning | Grade 2 (moderate) | 1 participants |
| ALA-PDT | Stinging/Burning | Grade 3 (severe) | 0 participants |
| Vehicle | Stinging/Burning | Grade 3 (severe) | 0 participants |
| Vehicle | Stinging/Burning | Grade 0 (none) | 132 participants |
| Vehicle | Stinging/Burning | Grade 2 (moderate) | 0 participants |
| Vehicle | Stinging/Burning | Grade 1 (mild) | 0 participants |
Other Pre-specified
Stinging/Burning
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: 8 Weeks after PDT #1
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Stinging/Burning | Grade 0 (none) | 130 participants |
| ALA-PDT | Stinging/Burning | Grade 1 (mild) | 2 participants |
| ALA-PDT | Stinging/Burning | Grade 2 (moderate) | 0 participants |
| ALA-PDT | Stinging/Burning | Grade 3 (severe) | 0 participants |
| Vehicle | Stinging/Burning | Grade 3 (severe) | 0 participants |
| Vehicle | Stinging/Burning | Grade 0 (none) | 129 participants |
| Vehicle | Stinging/Burning | Grade 2 (moderate) | 0 participants |
| Vehicle | Stinging/Burning | Grade 1 (mild) | 0 participants |
Other Pre-specified
Stinging/Burning
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA-PDT | Stinging/Burning | Grade 0 (none) | 134 participants |
| ALA-PDT | Stinging/Burning | Grade 1 (mild) | 1 participants |
| ALA-PDT | Stinging/Burning | Grade 2 (moderate) | 0 participants |
| ALA-PDT | Stinging/Burning | Grade 3 (severe) | 0 participants |
| Vehicle | Stinging/Burning | Grade 3 (severe) | 0 participants |
| Vehicle | Stinging/Burning | Grade 0 (none) | 133 participants |
| Vehicle | Stinging/Burning | Grade 2 (moderate) | 1 participants |
| Vehicle | Stinging/Burning | Grade 1 (mild) | 0 participants |