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 (AK) on the face, following treatment with liquid nitrogen cryotherapy.
Interventions
DRUGAminolevulinic Acid
20% ALA applied to face for one hour prior to 10 J/cm2 blue light
Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face one hour prior to 10 J/cm2 blue light
DEVICEBLU-U
10 J/cm2 blue light delivered at 10 mW/cm2
PROCEDURECryotherapy
Liquid nitrogen cryotherapy by standard of care method to all visible/palpable actinic keratosis (AK) lesions at screening.
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 AKs on the face * histologically confirmed presence of abnormal architecture and satellite atypical keratinocytes in the epidermis, in clinically normal tissue samples of photodamaged skin adjacent to AKs * at least one previously treated nonmelanoma skin cancer (NMSC) on the head and/or neck area within the past five years
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) * has an active herpes simplex infection OR a history of 2 or more outbreaks within the past 12 months, on the face * 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 * Retinoids, including tazarotene, adapalene, tretinoin, within 4 weeks * Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-fluorouracil (5-FU), diclofenac, ingenol mebutate, imiquimod or other topical treatments for AK within 8 weeks * use of systemic retinoid therapy within 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of AKs in Treatment Area | Week 52 | Count of observed lesions in the treatment area, which include lesions that recurred after on-study cryotherapy as well as newly occurring lesions. AK lesions in the treatment area at baseline (maximum of 2) were excluded for this endpoint. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects With 0 AKs | Week 4 | Normalized based on number of lesions present at Baseline |
| Subject Satisfaction Score | Week 52 | Subject satisfaction score 1. = Excellent (very satisfied) 2. = Good (moderately satisfied) 3. = Fair (slightly satisfied) 4. = Poor (not satisfied at all) Unknown |
| Recurrence Rate | Week 52 | Recurrence rate of all lesions that were complete responses following on-study cryotherapy (at Visit 3/Baseline). |
| Duration of Response | within 52 weeks after Baseline | Duration of response is the elapsed number of weeks from the Baseline visit until a lesion recurred or Week 52, whichever comes first |
Other
| Measure | Time frame | Description |
|---|---|---|
| Scaling & Dryness | Screening | 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 |
| Hyperpigmentation | Screening | 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 | Screening | 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 |
| Hypopigmentation | Screening | 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 | Screening | 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 | Screening | 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 | Screening | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ALA X2 Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | 53 |
| ALA X3 Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | 59 |
| VEH-PDT Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.
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: 10 J/cm2 blue light delivered at 10mW/cm2
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | 54 |
| Total | 166 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 3 | 1 |
Baseline characteristics
| Characteristic | ALA X2 | ALA X3 | VEH-PDT | Total |
|---|---|---|---|---|
| Age, Continuous | 67.9 years STANDARD_DEVIATION 9.65 | 66.7 years STANDARD_DEVIATION 9.35 | 65.8 years STANDARD_DEVIATION 9.5 | 66.8 years STANDARD_DEVIATION 9.48 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 52 Participants | 59 Participants | 53 Participants | 164 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 53 Participants | 59 Participants | 54 Participants | 166 Participants |
| Region of Enrollment United States | 53 Participants | 59 Participants | 54 Participants | 166 Participants |
| Sex: Female, Male Female | 10 Participants | 11 Participants | 10 Participants | 31 Participants |
| Sex: Female, Male Male | 43 Participants | 48 Participants | 44 Participants | 135 Participants |
| Skin Type Skin Type I - Burns easily, never tans | 6 Participants | 5 Participants | 2 Participants | 13 Participants |
| Skin Type Skin Type II - Burns easily, tans minimally | 29 Participants | 37 Participants | 35 Participants | 101 Participants |
| Skin Type Skin Type III - Burns moderately, tans gradually | 16 Participants | 12 Participants | 12 Participants | 40 Participants |
| Skin Type Skin Type IV - Burns minimally, tans well | 2 Participants | 4 Participants | 5 Participants | 11 Participants |
| Skin Type Skin Type V - Rarely burns, tans profusely | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 59 | 0 / 54 |
| other Total, other adverse events | 13 / 53 | 9 / 59 | 15 / 54 |
| serious Total, serious adverse events | 0 / 53 | 3 / 59 | 4 / 54 |
Outcome results
Primary
Total Number of AKs in Treatment Area
Count of observed lesions in the treatment area, which include lesions that recurred after on-study cryotherapy as well as newly occurring lesions. AK lesions in the treatment area at baseline (maximum of 2) were excluded for this endpoint.
Time frame: Week 52
Population: Analysis population consisted of observed data; ie. subjects remaining on-study at Week 52.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ALA X2 | Total Number of AKs in Treatment Area | 3.0 lesions | Standard Error 0.91 |
| ALA X3 | Total Number of AKs in Treatment Area | 2.1 lesions | Standard Error 0.84 |
| VEH-PDT | Total Number of AKs in Treatment Area | 4.7 lesions | Standard Error 0.86 |
p-value: 0.0166ANCOVA
Secondary
Duration of Response
Duration of response is the elapsed number of weeks from the Baseline visit until a lesion recurred or Week 52, whichever comes first
Time frame: within 52 weeks after Baseline
Population: Subjects who discontinued prior to Week 52 were excluded; analysis used observed data only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ALA X2 | Duration of Response | 35.9 weeks | Standard Deviation 20.4 |
| ALA X3 | Duration of Response | 33.3 weeks | Standard Deviation 19.7 |
| VEH-PDT | Duration of Response | 25.9 weeks | Standard Deviation 20.7 |
Secondary
Proportion of Subjects With 0 AKs
Normalized based on number of lesions present at Baseline
Time frame: Week 36
Population: Analysis population consisted of observed data only
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ALA X2 | Proportion of Subjects With 0 AKs | 15 Participants |
| ALA X3 | Proportion of Subjects With 0 AKs | 20 Participants |
| VEH-PDT | Proportion of Subjects With 0 AKs | 10 Participants |
Secondary
Proportion of Subjects With 0 AKs
Normalized based on number of lesions present at Baseline
Time frame: Week 52
Population: Analysis population consisted of observed data only
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ALA X2 | Proportion of Subjects With 0 AKs | 18 Participants |
| ALA X3 | Proportion of Subjects With 0 AKs | 21 Participants |
| VEH-PDT | Proportion of Subjects With 0 AKs | 10 Participants |
p-value: 0.0102Cochran-Mantel-Haenszel
p-value: 0.0089Cochran-Mantel-Haenszel
Secondary
Proportion of Subjects With 0 AKs
Normalized based on number of lesions present at Baseline
Time frame: Week 4
Population: Analysis population consisted of observed data; ie. subjects with data at Week 4.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ALA X2 | Proportion of Subjects With 0 AKs | 35 Participants |
| ALA X3 | Proportion of Subjects With 0 AKs | 35 Participants |
| VEH-PDT | Proportion of Subjects With 0 AKs | 27 Participants |
Secondary
Proportion of Subjects With 0 AKs
Normalized based on number of lesions present at Baseline
Time frame: Week 12
Population: Analysis population consisted of observed data; ie. subjects with data at Week 12.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ALA X2 | Proportion of Subjects With 0 AKs | 27 Participants |
| ALA X3 | Proportion of Subjects With 0 AKs | 35 Participants |
| VEH-PDT | Proportion of Subjects With 0 AKs | 22 Participants |
Secondary
Proportion of Subjects With 0 AKs
Normalized based on number of lesions present at Baseline
Time frame: Week 24
Population: Analysis population consisted of observed data only.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ALA X2 | Proportion of Subjects With 0 AKs | 30 Participants |
| ALA X3 | Proportion of Subjects With 0 AKs | 22 Participants |
| VEH-PDT | Proportion of Subjects With 0 AKs | 14 Participants |
Secondary
Recurrence Rate
Recurrence rate of all lesions that were complete responses following on-study cryotherapy (at Visit 3/Baseline).
Time frame: Week 52
Population: Analysis population consisted of observed data only
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| ALA X2 | Recurrence Rate | 34 number of lesions |
| ALA X3 | Recurrence Rate | 32 number of lesions |
| VEH-PDT | Recurrence Rate | 81 number of lesions |
p-value: 0.0004Cochran-Mantel-Haenszel
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) Unknown
Time frame: Week 52
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Subject Satisfaction Score | Not Satisfied | 2 Participants |
| ALA X2 | Subject Satisfaction Score | Slightly Satisfied | 7 Participants |
| ALA X2 | Subject Satisfaction Score | Very Satisfied | 27 Participants |
| ALA X2 | Subject Satisfaction Score | Moderately Satisfied | 15 Participants |
| ALA X2 | Subject Satisfaction Score | Unknown | 2 Participants |
| ALA X3 | Subject Satisfaction Score | Slightly Satisfied | 9 Participants |
| ALA X3 | Subject Satisfaction Score | Very Satisfied | 26 Participants |
| ALA X3 | Subject Satisfaction Score | Moderately Satisfied | 21 Participants |
| ALA X3 | Subject Satisfaction Score | Not Satisfied | 0 Participants |
| ALA X3 | Subject Satisfaction Score | Unknown | 3 Participants |
| VEH-PDT | Subject Satisfaction Score | Unknown | 1 Participants |
| VEH-PDT | Subject Satisfaction Score | Not Satisfied | 9 Participants |
| VEH-PDT | Subject Satisfaction Score | Very Satisfied | 16 Participants |
| VEH-PDT | Subject Satisfaction Score | Slightly Satisfied | 14 Participants |
| VEH-PDT | Subject Satisfaction Score | Moderately Satisfied | 14 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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Edema | Grade 3 | 0 Participants |
| ALA X2 | Edema | Grade 2 | 0 Participants |
| ALA X2 | Edema | Grade 0 | 53 Participants |
| ALA X2 | Edema | Grade 1 | 0 Participants |
| ALA X2 | Edema | Grade 4 | 0 Participants |
| ALA X3 | Edema | Grade 2 | 0 Participants |
| ALA X3 | Edema | Grade 0 | 59 Participants |
| ALA X3 | Edema | Grade 1 | 0 Participants |
| ALA X3 | Edema | Grade 3 | 0 Participants |
| ALA X3 | Edema | Grade 4 | 0 Participants |
| VEH-PDT | Edema | Grade 4 | 0 Participants |
| VEH-PDT | Edema | Grade 3 | 0 Participants |
| VEH-PDT | Edema | Grade 0 | 54 Participants |
| VEH-PDT | Edema | Grade 2 | 0 Participants |
| VEH-PDT | Edema | Grade 1 | 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: 36 Weeks after PDT #1
Population: Analysis population consisted of observed data only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Edema | Grade 3 | 0 Participants |
| ALA X2 | Edema | Grade 2 | 0 Participants |
| ALA X2 | Edema | Grade 0 | 49 Participants |
| ALA X2 | Edema | Grade 1 | 1 Participants |
| ALA X2 | Edema | Grade 4 | 0 Participants |
| ALA X3 | Edema | Grade 2 | 0 Participants |
| ALA X3 | Edema | Grade 0 | 55 Participants |
| ALA X3 | Edema | Grade 1 | 1 Participants |
| ALA X3 | Edema | Grade 3 | 0 Participants |
| ALA X3 | Edema | Grade 4 | 0 Participants |
| VEH-PDT | Edema | Grade 4 | 0 Participants |
| VEH-PDT | Edema | Grade 3 | 0 Participants |
| VEH-PDT | Edema | Grade 0 | 51 Participants |
| VEH-PDT | Edema | Grade 2 | 1 Participants |
| VEH-PDT | Edema | Grade 1 | 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: 52 Weeks after PDT #1
Population: Analysis population consisted of observed data only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Edema | Grade 3 | 0 Participants |
| ALA X2 | Edema | Grade 2 | 0 Participants |
| ALA X2 | Edema | Grade 0 | 50 Participants |
| ALA X2 | Edema | Grade 1 | 0 Participants |
| ALA X2 | Edema | Grade 4 | 0 Participants |
| ALA X3 | Edema | Grade 2 | 0 Participants |
| ALA X3 | Edema | Grade 0 | 56 Participants |
| ALA X3 | Edema | Grade 1 | 0 Participants |
| ALA X3 | Edema | Grade 3 | 0 Participants |
| ALA X3 | Edema | Grade 4 | 0 Participants |
| VEH-PDT | Edema | Grade 4 | 0 Participants |
| VEH-PDT | Edema | Grade 3 | 0 Participants |
| VEH-PDT | Edema | Grade 0 | 53 Participants |
| VEH-PDT | Edema | Grade 2 | 0 Participants |
| VEH-PDT | Edema | Grade 1 | 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: 12 Weeks after PDT #1
Population: Analysis population consisted of observed data only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Edema | Grade 3 | 0 Participants |
| ALA X2 | Edema | Grade 2 | 0 Participants |
| ALA X2 | Edema | Grade 0 | 51 Participants |
| ALA X2 | Edema | Grade 1 | 0 Participants |
| ALA X2 | Edema | Grade 4 | 0 Participants |
| ALA X3 | Edema | Grade 2 | 0 Participants |
| ALA X3 | Edema | Grade 0 | 57 Participants |
| ALA X3 | Edema | Grade 1 | 0 Participants |
| ALA X3 | Edema | Grade 3 | 0 Participants |
| ALA X3 | Edema | Grade 4 | 0 Participants |
| VEH-PDT | Edema | Grade 4 | 0 Participants |
| VEH-PDT | Edema | Grade 3 | 0 Participants |
| VEH-PDT | Edema | Grade 0 | 53 Participants |
| VEH-PDT | Edema | Grade 2 | 0 Participants |
| VEH-PDT | Edema | Grade 1 | 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: Analysis population consisted of observed data only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Edema | Grade 3 | 0 Participants |
| ALA X2 | Edema | Grade 2 | 0 Participants |
| ALA X2 | Edema | Grade 0 | 51 Participants |
| ALA X2 | Edema | Grade 1 | 0 Participants |
| ALA X2 | Edema | Grade 4 | 0 Participants |
| ALA X3 | Edema | Grade 2 | 1 Participants |
| ALA X3 | Edema | Grade 0 | 56 Participants |
| ALA X3 | Edema | Grade 1 | 0 Participants |
| ALA X3 | Edema | Grade 3 | 0 Participants |
| ALA X3 | Edema | Grade 4 | 0 Participants |
| VEH-PDT | Edema | Grade 4 | 0 Participants |
| VEH-PDT | Edema | Grade 3 | 0 Participants |
| VEH-PDT | Edema | Grade 0 | 53 Participants |
| VEH-PDT | Edema | Grade 2 | 0 Participants |
| VEH-PDT | Edema | Grade 1 | 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: 24-48 hours after PDT #1
Population: Analysis population consisted of observed data only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Edema | Grade 3 | 0 Participants |
| ALA X2 | Edema | Grade 4 | 0 Participants |
| ALA X2 | Edema | Grade 1 | 14 Participants |
| ALA X2 | Edema | Grade 0 | 33 Participants |
| ALA X2 | Edema | Grade 2 | 6 Participants |
| ALA X3 | Edema | Grade 3 | 0 Participants |
| ALA X3 | Edema | Grade 2 | 10 Participants |
| ALA X3 | Edema | Grade 0 | 31 Participants |
| ALA X3 | Edema | Grade 4 | 0 Participants |
| ALA X3 | Edema | Grade 1 | 16 Participants |
| VEH-PDT | Edema | Grade 4 | 0 Participants |
| VEH-PDT | Edema | Grade 1 | 0 Participants |
| VEH-PDT | Edema | Grade 0 | 53 Participants |
| VEH-PDT | Edema | Grade 2 | 0 Participants |
| VEH-PDT | Edema | Grade 3 | 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: Screening
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Edema | Grade 3 | 0 Participants |
| ALA X2 | Edema | Grade 2 | 0 Participants |
| ALA X2 | Edema | Grade 0 | 52 Participants |
| ALA X2 | Edema | Grade 1 | 1 Participants |
| ALA X2 | Edema | Grade 4 | 0 Participants |
| ALA X3 | Edema | Grade 2 | 0 Participants |
| ALA X3 | Edema | Grade 0 | 59 Participants |
| ALA X3 | Edema | Grade 1 | 0 Participants |
| ALA X3 | Edema | Grade 3 | 0 Participants |
| ALA X3 | Edema | Grade 4 | 0 Participants |
| VEH-PDT | Edema | Grade 4 | 0 Participants |
| VEH-PDT | Edema | Grade 3 | 0 Participants |
| VEH-PDT | Edema | Grade 0 | 54 Participants |
| VEH-PDT | Edema | Grade 2 | 0 Participants |
| VEH-PDT | Edema | Grade 1 | 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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Edema | Grade 1 | 6 Participants |
| ALA X2 | Edema | Grade 0 | 46 Participants |
| ALA X2 | Edema | Grade 2 | 1 Participants |
| ALA X2 | Edema | Grade 4 | 0 Participants |
| ALA X2 | Edema | Grade 3 | 0 Participants |
| ALA X3 | Edema | Grade 4 | 0 Participants |
| ALA X3 | Edema | Grade 0 | 44 Participants |
| ALA X3 | Edema | Grade 1 | 12 Participants |
| ALA X3 | Edema | Grade 2 | 2 Participants |
| ALA X3 | Edema | Grade 3 | 1 Participants |
| VEH-PDT | Edema | Grade 2 | 0 Participants |
| VEH-PDT | Edema | Grade 0 | 52 Participants |
| VEH-PDT | Edema | Grade 4 | 0 Participants |
| VEH-PDT | Edema | Grade 1 | 2 Participants |
| VEH-PDT | Edema | Grade 3 | 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 weeks after PDT #1
Population: Analysis population consisted of observed data only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Edema | Grade 4 | 0 Participants |
| ALA X2 | Edema | Grade 2 | 0 Participants |
| ALA X2 | Edema | Grade 1 | 0 Participants |
| ALA X2 | Edema | Grade 3 | 0 Participants |
| ALA X2 | Edema | Grade 0 | 51 Participants |
| ALA X3 | Edema | Grade 3 | 0 Participants |
| ALA X3 | Edema | Grade 4 | 0 Participants |
| ALA X3 | Edema | Grade 0 | 56 Participants |
| ALA X3 | Edema | Grade 1 | 0 Participants |
| ALA X3 | Edema | Grade 2 | 0 Participants |
| VEH-PDT | Edema | Grade 0 | 53 Participants |
| VEH-PDT | Edema | Grade 3 | 0 Participants |
| VEH-PDT | Edema | Grade 2 | 0 Participants |
| VEH-PDT | Edema | Grade 4 | 0 Participants |
| VEH-PDT | Edema | Grade 1 | 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: 52 Weeks after PDT #1
Population: Analysis population consisted of observed data only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Erythema | Grade 3 | 0 Participants |
| ALA X2 | Erythema | Grade 2 | 1 Participants |
| ALA X2 | Erythema | Grade 0 | 38 Participants |
| ALA X2 | Erythema | Grade 1 | 11 Participants |
| ALA X2 | Erythema | Grade 4 | 0 Participants |
| ALA X3 | Erythema | Grade 2 | 2 Participants |
| ALA X3 | Erythema | Grade 0 | 40 Participants |
| ALA X3 | Erythema | Grade 1 | 14 Participants |
| ALA X3 | Erythema | Grade 3 | 0 Participants |
| ALA X3 | Erythema | Grade 4 | 0 Participants |
| VEH-PDT | Erythema | Grade 4 | 0 Participants |
| VEH-PDT | Erythema | Grade 3 | 0 Participants |
| VEH-PDT | Erythema | Grade 0 | 37 Participants |
| VEH-PDT | Erythema | Grade 2 | 2 Participants |
| VEH-PDT | Erythema | Grade 1 | 14 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 Weeks after PDT #1
Population: Analysis population consisted of observed data only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Erythema | Grade 3 | 0 Participants |
| ALA X2 | Erythema | Grade 2 | 0 Participants |
| ALA X2 | Erythema | Grade 0 | 37 Participants |
| ALA X2 | Erythema | Grade 1 | 14 Participants |
| ALA X2 | Erythema | Grade 4 | 0 Participants |
| ALA X3 | Erythema | Grade 2 | 2 Participants |
| ALA X3 | Erythema | Grade 0 | 41 Participants |
| ALA X3 | Erythema | Grade 1 | 13 Participants |
| ALA X3 | Erythema | Grade 3 | 0 Participants |
| ALA X3 | Erythema | Grade 4 | 0 Participants |
| VEH-PDT | Erythema | Grade 4 | 0 Participants |
| VEH-PDT | Erythema | Grade 3 | 0 Participants |
| VEH-PDT | Erythema | Grade 0 | 31 Participants |
| VEH-PDT | Erythema | Grade 2 | 2 Participants |
| VEH-PDT | Erythema | Grade 1 | 20 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: Screening
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Erythema | Grade 1 | 16 Participants |
| ALA X2 | Erythema | Grade 0 | 31 Participants |
| ALA X2 | Erythema | Grade 2 | 6 Participants |
| ALA X2 | Erythema | Grade 4 | 0 Participants |
| ALA X2 | Erythema | Grade 3 | 0 Participants |
| ALA X3 | Erythema | Grade 4 | 0 Participants |
| ALA X3 | Erythema | Grade 0 | 41 Participants |
| ALA X3 | Erythema | Grade 1 | 13 Participants |
| ALA X3 | Erythema | Grade 2 | 4 Participants |
| ALA X3 | Erythema | Grade 3 | 1 Participants |
| VEH-PDT | Erythema | Grade 2 | 8 Participants |
| VEH-PDT | Erythema | Grade 0 | 33 Participants |
| VEH-PDT | Erythema | Grade 4 | 0 Participants |
| VEH-PDT | Erythema | Grade 1 | 13 Participants |
| VEH-PDT | Erythema | Grade 3 | 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: Baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Erythema | Grade 3 | 0 Participants |
| ALA X2 | Erythema | Grade 2 | 5 Participants |
| ALA X2 | Erythema | Grade 0 | 34 Participants |
| ALA X2 | Erythema | Grade 1 | 14 Participants |
| ALA X2 | Erythema | Grade 4 | 0 Participants |
| ALA X3 | Erythema | Grade 2 | 3 Participants |
| ALA X3 | Erythema | Grade 0 | 38 Participants |
| ALA X3 | Erythema | Grade 1 | 18 Participants |
| ALA X3 | Erythema | Grade 3 | 0 Participants |
| ALA X3 | Erythema | Grade 4 | 0 Participants |
| VEH-PDT | Erythema | Grade 4 | 0 Participants |
| VEH-PDT | Erythema | Grade 3 | 0 Participants |
| VEH-PDT | Erythema | Grade 0 | 33 Participants |
| VEH-PDT | Erythema | Grade 2 | 6 Participants |
| VEH-PDT | Erythema | Grade 1 | 15 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: Analysis population consisted of observed data only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Erythema | Grade 3 | 23 Participants |
| ALA X2 | Erythema | Grade 2 | 13 Participants |
| ALA X2 | Erythema | Grade 0 | 2 Participants |
| ALA X2 | Erythema | Grade 1 | 12 Participants |
| ALA X2 | Erythema | Grade 4 | 3 Participants |
| ALA X3 | Erythema | Grade 2 | 14 Participants |
| ALA X3 | Erythema | Grade 0 | 3 Participants |
| ALA X3 | Erythema | Grade 1 | 10 Participants |
| ALA X3 | Erythema | Grade 3 | 26 Participants |
| ALA X3 | Erythema | Grade 4 | 4 Participants |
| VEH-PDT | Erythema | Grade 4 | 0 Participants |
| VEH-PDT | Erythema | Grade 3 | 2 Participants |
| VEH-PDT | Erythema | Grade 0 | 22 Participants |
| VEH-PDT | Erythema | Grade 2 | 8 Participants |
| VEH-PDT | Erythema | Grade 1 | 21 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: Analysis population consisted of observed data only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Erythema | Grade 3 | 0 Participants |
| ALA X2 | Erythema | Grade 2 | 2 Participants |
| ALA X2 | Erythema | Grade 0 | 35 Participants |
| ALA X2 | Erythema | Grade 1 | 14 Participants |
| ALA X2 | Erythema | Grade 4 | 0 Participants |
| ALA X3 | Erythema | Grade 2 | 2 Participants |
| ALA X3 | Erythema | Grade 0 | 41 Participants |
| ALA X3 | Erythema | Grade 1 | 14 Participants |
| ALA X3 | Erythema | Grade 3 | 0 Participants |
| ALA X3 | Erythema | Grade 4 | 0 Participants |
| VEH-PDT | Erythema | Grade 4 | 0 Participants |
| VEH-PDT | Erythema | Grade 3 | 0 Participants |
| VEH-PDT | Erythema | Grade 0 | 34 Participants |
| VEH-PDT | Erythema | Grade 2 | 5 Participants |
| VEH-PDT | Erythema | Grade 1 | 15 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: Analysis population consisted of observed data only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Erythema | Grade 3 | 0 Participants |
| ALA X2 | Erythema | Grade 2 | 0 Participants |
| ALA X2 | Erythema | Grade 0 | 35 Participants |
| ALA X2 | Erythema | Grade 1 | 16 Participants |
| ALA X2 | Erythema | Grade 4 | 0 Participants |
| ALA X3 | Erythema | Grade 2 | 1 Participants |
| ALA X3 | Erythema | Grade 0 | 43 Participants |
| ALA X3 | Erythema | Grade 1 | 13 Participants |
| ALA X3 | Erythema | Grade 3 | 0 Participants |
| ALA X3 | Erythema | Grade 4 | 0 Participants |
| VEH-PDT | Erythema | Grade 4 | 0 Participants |
| VEH-PDT | Erythema | Grade 3 | 1 Participants |
| VEH-PDT | Erythema | Grade 0 | 36 Participants |
| VEH-PDT | Erythema | Grade 2 | 1 Participants |
| VEH-PDT | Erythema | Grade 1 | 15 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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Erythema | Grade 3 | 12 Participants |
| ALA X2 | Erythema | Grade 2 | 29 Participants |
| ALA X2 | Erythema | Grade 0 | 4 Participants |
| ALA X2 | Erythema | Grade 1 | 8 Participants |
| ALA X2 | Erythema | Grade 4 | 0 Participants |
| ALA X3 | Erythema | Grade 2 | 25 Participants |
| ALA X3 | Erythema | Grade 0 | 6 Participants |
| ALA X3 | Erythema | Grade 1 | 11 Participants |
| ALA X3 | Erythema | Grade 3 | 17 Participants |
| ALA X3 | Erythema | Grade 4 | 0 Participants |
| VEH-PDT | Erythema | Grade 4 | 0 Participants |
| VEH-PDT | Erythema | Grade 3 | 4 Participants |
| VEH-PDT | Erythema | Grade 0 | 11 Participants |
| VEH-PDT | Erythema | Grade 2 | 12 Participants |
| VEH-PDT | Erythema | Grade 1 | 27 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: 36 Weeks after PDT #1
Population: Analysis population consisted of observed data only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Erythema | Grade 3 | 0 Participants |
| ALA X2 | Erythema | Grade 2 | 0 Participants |
| ALA X2 | Erythema | Grade 0 | 37 Participants |
| ALA X2 | Erythema | Grade 1 | 13 Participants |
| ALA X2 | Erythema | Grade 4 | 0 Participants |
| ALA X3 | Erythema | Grade 2 | 1 Participants |
| ALA X3 | Erythema | Grade 0 | 36 Participants |
| ALA X3 | Erythema | Grade 1 | 19 Participants |
| ALA X3 | Erythema | Grade 3 | 0 Participants |
| ALA X3 | Erythema | Grade 4 | 0 Participants |
| VEH-PDT | Erythema | Grade 4 | 0 Participants |
| VEH-PDT | Erythema | Grade 3 | 0 Participants |
| VEH-PDT | Erythema | Grade 0 | 33 Participants |
| VEH-PDT | Erythema | Grade 2 | 2 Participants |
| VEH-PDT | Erythema | Grade 1 | 18 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: Analysis population consisted of observed data only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Hyperpigmentation | Grade 3 | 0 Participants |
| ALA X2 | Hyperpigmentation | Grade 2 | 8 Participants |
| ALA X2 | Hyperpigmentation | Grade 0 | 22 Participants |
| ALA X2 | Hyperpigmentation | Grade 1 | 21 Participants |
| ALA X2 | Hyperpigmentation | Grade 4 | 0 Participants |
| ALA X3 | Hyperpigmentation | Grade 2 | 5 Participants |
| ALA X3 | Hyperpigmentation | Grade 0 | 28 Participants |
| ALA X3 | Hyperpigmentation | Grade 1 | 22 Participants |
| ALA X3 | Hyperpigmentation | Grade 3 | 1 Participants |
| ALA X3 | Hyperpigmentation | Grade 4 | 1 Participants |
| VEH-PDT | Hyperpigmentation | Grade 4 | 0 Participants |
| VEH-PDT | Hyperpigmentation | Grade 3 | 1 Participants |
| VEH-PDT | Hyperpigmentation | Grade 0 | 23 Participants |
| VEH-PDT | Hyperpigmentation | Grade 2 | 6 Participants |
| VEH-PDT | Hyperpigmentation | Grade 1 | 23 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: Screening
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Hyperpigmentation | Grade 3 | 1 Participants |
| ALA X2 | Hyperpigmentation | Grade 2 | 13 Participants |
| ALA X2 | Hyperpigmentation | Grade 4 | 0 Participants |
| ALA X2 | Hyperpigmentation | Grade 0 | 22 Participants |
| ALA X2 | Hyperpigmentation | Grade 1 | 17 Participants |
| ALA X3 | Hyperpigmentation | Grade 1 | 23 Participants |
| ALA X3 | Hyperpigmentation | Grade 0 | 27 Participants |
| ALA X3 | Hyperpigmentation | Grade 2 | 5 Participants |
| ALA X3 | Hyperpigmentation | Grade 4 | 1 Participants |
| ALA X3 | Hyperpigmentation | Grade 3 | 3 Participants |
| VEH-PDT | Hyperpigmentation | Grade 4 | 0 Participants |
| VEH-PDT | Hyperpigmentation | Grade 3 | 1 Participants |
| VEH-PDT | Hyperpigmentation | Grade 0 | 25 Participants |
| VEH-PDT | Hyperpigmentation | Grade 1 | 20 Participants |
| VEH-PDT | Hyperpigmentation | Grade 2 | 8 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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Hyperpigmentation | Grade 3 | 1 Participants |
| ALA X2 | Hyperpigmentation | Grade 2 | 12 Participants |
| ALA X2 | Hyperpigmentation | Grade 0 | 23 Participants |
| ALA X2 | Hyperpigmentation | Grade 1 | 17 Participants |
| ALA X2 | Hyperpigmentation | Grade 4 | 0 Participants |
| ALA X3 | Hyperpigmentation | Grade 2 | 5 Participants |
| ALA X3 | Hyperpigmentation | Grade 0 | 26 Participants |
| ALA X3 | Hyperpigmentation | Grade 1 | 25 Participants |
| ALA X3 | Hyperpigmentation | Grade 3 | 2 Participants |
| ALA X3 | Hyperpigmentation | Grade 4 | 1 Participants |
| VEH-PDT | Hyperpigmentation | Grade 4 | 0 Participants |
| VEH-PDT | Hyperpigmentation | Grade 3 | 1 Participants |
| VEH-PDT | Hyperpigmentation | Grade 0 | 22 Participants |
| VEH-PDT | Hyperpigmentation | Grade 2 | 9 Participants |
| VEH-PDT | Hyperpigmentation | Grade 1 | 22 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 photodynamic therapy (PDT) #1
Population: Analysis population consisted of observed data only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Hyperpigmentation | Grade 3 | 3 Participants |
| ALA X2 | Hyperpigmentation | Grade 2 | 13 Participants |
| ALA X2 | Hyperpigmentation | Grade 0 | 23 Participants |
| ALA X2 | Hyperpigmentation | Grade 1 | 14 Participants |
| ALA X2 | Hyperpigmentation | Grade 4 | 0 Participants |
| ALA X3 | Hyperpigmentation | Grade 2 | 10 Participants |
| ALA X3 | Hyperpigmentation | Grade 0 | 22 Participants |
| ALA X3 | Hyperpigmentation | Grade 1 | 24 Participants |
| ALA X3 | Hyperpigmentation | Grade 3 | 0 Participants |
| ALA X3 | Hyperpigmentation | Grade 4 | 1 Participants |
| VEH-PDT | Hyperpigmentation | Grade 4 | 0 Participants |
| VEH-PDT | Hyperpigmentation | Grade 3 | 1 Participants |
| VEH-PDT | Hyperpigmentation | Grade 0 | 23 Participants |
| VEH-PDT | Hyperpigmentation | Grade 2 | 8 Participants |
| VEH-PDT | Hyperpigmentation | Grade 1 | 21 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: Analysis population consisted of observed data only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Hyperpigmentation | Grade 3 | 1 Participants |
| ALA X2 | Hyperpigmentation | Grade 2 | 8 Participants |
| ALA X2 | Hyperpigmentation | Grade 0 | 21 Participants |
| ALA X2 | Hyperpigmentation | Grade 1 | 21 Participants |
| ALA X2 | Hyperpigmentation | Grade 4 | 0 Participants |
| ALA X3 | Hyperpigmentation | Grade 2 | 4 Participants |
| ALA X3 | Hyperpigmentation | Grade 0 | 26 Participants |
| ALA X3 | Hyperpigmentation | Grade 1 | 25 Participants |
| ALA X3 | Hyperpigmentation | Grade 3 | 1 Participants |
| ALA X3 | Hyperpigmentation | Grade 4 | 1 Participants |
| VEH-PDT | Hyperpigmentation | Grade 4 | 0 Participants |
| VEH-PDT | Hyperpigmentation | Grade 3 | 1 Participants |
| VEH-PDT | Hyperpigmentation | Grade 0 | 23 Participants |
| VEH-PDT | Hyperpigmentation | Grade 2 | 7 Participants |
| VEH-PDT | Hyperpigmentation | Grade 1 | 23 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 Weeks after PDT #1
Population: Analysis population consisted of observed data only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Hyperpigmentation | Grade 3 | 0 Participants |
| ALA X2 | Hyperpigmentation | Grade 2 | 8 Participants |
| ALA X2 | Hyperpigmentation | Grade 0 | 25 Participants |
| ALA X2 | Hyperpigmentation | Grade 1 | 18 Participants |
| ALA X2 | Hyperpigmentation | Grade 4 | 0 Participants |
| ALA X3 | Hyperpigmentation | Grade 2 | 4 Participants |
| ALA X3 | Hyperpigmentation | Grade 0 | 26 Participants |
| ALA X3 | Hyperpigmentation | Grade 1 | 24 Participants |
| ALA X3 | Hyperpigmentation | Grade 3 | 1 Participants |
| ALA X3 | Hyperpigmentation | Grade 4 | 1 Participants |
| VEH-PDT | Hyperpigmentation | Grade 4 | 0 Participants |
| VEH-PDT | Hyperpigmentation | Grade 3 | 1 Participants |
| VEH-PDT | Hyperpigmentation | Grade 0 | 24 Participants |
| VEH-PDT | Hyperpigmentation | Grade 2 | 5 Participants |
| VEH-PDT | Hyperpigmentation | Grade 1 | 23 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: 36 Weeks after PDT #1
Population: Analysis population consisted of observed data only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Hyperpigmentation | Grade 3 | 0 Participants |
| ALA X2 | Hyperpigmentation | Grade 2 | 7 Participants |
| ALA X2 | Hyperpigmentation | Grade 0 | 24 Participants |
| ALA X2 | Hyperpigmentation | Grade 1 | 19 Participants |
| ALA X2 | Hyperpigmentation | Grade 4 | 0 Participants |
| ALA X3 | Hyperpigmentation | Grade 2 | 3 Participants |
| ALA X3 | Hyperpigmentation | Grade 0 | 25 Participants |
| ALA X3 | Hyperpigmentation | Grade 1 | 26 Participants |
| ALA X3 | Hyperpigmentation | Grade 3 | 1 Participants |
| ALA X3 | Hyperpigmentation | Grade 4 | 1 Participants |
| VEH-PDT | Hyperpigmentation | Grade 4 | 0 Participants |
| VEH-PDT | Hyperpigmentation | Grade 3 | 1 Participants |
| VEH-PDT | Hyperpigmentation | Grade 0 | 24 Participants |
| VEH-PDT | Hyperpigmentation | Grade 2 | 5 Participants |
| VEH-PDT | Hyperpigmentation | Grade 1 | 23 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: 52 Weeks after PDT #1
Population: Analysis population consisted of observed data only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Hyperpigmentation | Grade 3 | 0 Participants |
| ALA X2 | Hyperpigmentation | Grade 2 | 7 Participants |
| ALA X2 | Hyperpigmentation | Grade 0 | 22 Participants |
| ALA X2 | Hyperpigmentation | Grade 1 | 21 Participants |
| ALA X2 | Hyperpigmentation | Grade 4 | 0 Participants |
| ALA X3 | Hyperpigmentation | Grade 2 | 5 Participants |
| ALA X3 | Hyperpigmentation | Grade 0 | 24 Participants |
| ALA X3 | Hyperpigmentation | Grade 1 | 25 Participants |
| ALA X3 | Hyperpigmentation | Grade 3 | 1 Participants |
| ALA X3 | Hyperpigmentation | Grade 4 | 1 Participants |
| VEH-PDT | Hyperpigmentation | Grade 4 | 0 Participants |
| VEH-PDT | Hyperpigmentation | Grade 3 | 1 Participants |
| VEH-PDT | Hyperpigmentation | Grade 0 | 24 Participants |
| VEH-PDT | Hyperpigmentation | Grade 2 | 5 Participants |
| VEH-PDT | Hyperpigmentation | Grade 1 | 23 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
Time frame: Screening
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Hypopigmentation | Grade 3 | 0 Participants |
| ALA X2 | Hypopigmentation | Grade 2 | 2 Participants |
| ALA X2 | Hypopigmentation | Grade 0 | 35 Participants |
| ALA X2 | Hypopigmentation | Grade 1 | 16 Participants |
| ALA X2 | Hypopigmentation | Grade 4 | 0 Participants |
| ALA X3 | Hypopigmentation | Grade 2 | 2 Participants |
| ALA X3 | Hypopigmentation | Grade 0 | 40 Participants |
| ALA X3 | Hypopigmentation | Grade 1 | 17 Participants |
| ALA X3 | Hypopigmentation | Grade 3 | 0 Participants |
| ALA X3 | Hypopigmentation | Grade 4 | 0 Participants |
| VEH-PDT | Hypopigmentation | Grade 4 | 0 Participants |
| VEH-PDT | Hypopigmentation | Grade 3 | 0 Participants |
| VEH-PDT | Hypopigmentation | Grade 0 | 38 Participants |
| VEH-PDT | Hypopigmentation | Grade 2 | 2 Participants |
| VEH-PDT | Hypopigmentation | Grade 1 | 14 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
Time frame: 36 Weeks after PDT #1
Population: Analysis population consisted of observed data only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Hypopigmentation | Grade 3 | 0 Participants |
| ALA X2 | Hypopigmentation | Grade 2 | 1 Participants |
| ALA X2 | Hypopigmentation | Grade 0 | 31 Participants |
| ALA X2 | Hypopigmentation | Grade 1 | 18 Participants |
| ALA X2 | Hypopigmentation | Grade 4 | 0 Participants |
| ALA X3 | Hypopigmentation | Grade 2 | 1 Participants |
| ALA X3 | Hypopigmentation | Grade 0 | 38 Participants |
| ALA X3 | Hypopigmentation | Grade 1 | 16 Participants |
| ALA X3 | Hypopigmentation | Grade 3 | 1 Participants |
| ALA X3 | Hypopigmentation | Grade 4 | 0 Participants |
| VEH-PDT | Hypopigmentation | Grade 4 | 0 Participants |
| VEH-PDT | Hypopigmentation | Grade 3 | 0 Participants |
| VEH-PDT | Hypopigmentation | Grade 0 | 35 Participants |
| VEH-PDT | Hypopigmentation | Grade 2 | 1 Participants |
| VEH-PDT | Hypopigmentation | Grade 1 | 17 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
Time frame: 24 Weeks after PDT #1
Population: Analysis population consisted of observed data only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Hypopigmentation | Grade 3 | 0 Participants |
| ALA X2 | Hypopigmentation | Grade 2 | 2 Participants |
| ALA X2 | Hypopigmentation | Grade 0 | 33 Participants |
| ALA X2 | Hypopigmentation | Grade 1 | 16 Participants |
| ALA X2 | Hypopigmentation | Grade 4 | 0 Participants |
| ALA X3 | Hypopigmentation | Grade 2 | 1 Participants |
| ALA X3 | Hypopigmentation | Grade 0 | 39 Participants |
| ALA X3 | Hypopigmentation | Grade 1 | 15 Participants |
| ALA X3 | Hypopigmentation | Grade 3 | 1 Participants |
| ALA X3 | Hypopigmentation | Grade 4 | 0 Participants |
| VEH-PDT | Hypopigmentation | Grade 4 | 0 Participants |
| VEH-PDT | Hypopigmentation | Grade 3 | 0 Participants |
| VEH-PDT | Hypopigmentation | Grade 0 | 37 Participants |
| VEH-PDT | Hypopigmentation | Grade 2 | 1 Participants |
| VEH-PDT | Hypopigmentation | Grade 1 | 15 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
Time frame: 12 Weeks after PDT #1
Population: Analysis population consisted of observed data only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Hypopigmentation | Grade 3 | 0 Participants |
| ALA X2 | Hypopigmentation | Grade 2 | 4 Participants |
| ALA X2 | Hypopigmentation | Grade 0 | 33 Participants |
| ALA X2 | Hypopigmentation | Grade 1 | 14 Participants |
| ALA X2 | Hypopigmentation | Grade 4 | 0 Participants |
| ALA X3 | Hypopigmentation | Grade 2 | 1 Participants |
| ALA X3 | Hypopigmentation | Grade 0 | 40 Participants |
| ALA X3 | Hypopigmentation | Grade 1 | 15 Participants |
| ALA X3 | Hypopigmentation | Grade 3 | 1 Participants |
| ALA X3 | Hypopigmentation | Grade 4 | 0 Participants |
| VEH-PDT | Hypopigmentation | Grade 4 | 0 Participants |
| VEH-PDT | Hypopigmentation | Grade 3 | 0 Participants |
| VEH-PDT | Hypopigmentation | Grade 0 | 35 Participants |
| VEH-PDT | Hypopigmentation | Grade 2 | 1 Participants |
| VEH-PDT | Hypopigmentation | Grade 1 | 17 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
Time frame: 52 Weeks after PDT #1
Population: Analysis population consisted of observed data only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Hypopigmentation | Grade 3 | 0 Participants |
| ALA X2 | Hypopigmentation | Grade 2 | 2 Participants |
| ALA X2 | Hypopigmentation | Grade 0 | 26 Participants |
| ALA X2 | Hypopigmentation | Grade 1 | 22 Participants |
| ALA X2 | Hypopigmentation | Grade 4 | 0 Participants |
| ALA X3 | Hypopigmentation | Grade 2 | 1 Participants |
| ALA X3 | Hypopigmentation | Grade 0 | 35 Participants |
| ALA X3 | Hypopigmentation | Grade 1 | 19 Participants |
| ALA X3 | Hypopigmentation | Grade 3 | 1 Participants |
| ALA X3 | Hypopigmentation | Grade 4 | 0 Participants |
| VEH-PDT | Hypopigmentation | Grade 4 | 0 Participants |
| VEH-PDT | Hypopigmentation | Grade 3 | 0 Participants |
| VEH-PDT | Hypopigmentation | Grade 0 | 33 Participants |
| VEH-PDT | Hypopigmentation | Grade 2 | 1 Participants |
| VEH-PDT | Hypopigmentation | Grade 1 | 19 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
Time frame: 4 Weeks after PDT #1
Population: Analysis population consisted of observed data only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Hypopigmentation | Grade 3 | 0 Participants |
| ALA X2 | Hypopigmentation | Grade 2 | 3 Participants |
| ALA X2 | Hypopigmentation | Grade 0 | 34 Participants |
| ALA X2 | Hypopigmentation | Grade 1 | 14 Participants |
| ALA X2 | Hypopigmentation | Grade 4 | 0 Participants |
| ALA X3 | Hypopigmentation | Grade 2 | 2 Participants |
| ALA X3 | Hypopigmentation | Grade 0 | 38 Participants |
| ALA X3 | Hypopigmentation | Grade 1 | 17 Participants |
| ALA X3 | Hypopigmentation | Grade 3 | 0 Participants |
| ALA X3 | Hypopigmentation | Grade 4 | 0 Participants |
| VEH-PDT | Hypopigmentation | Grade 4 | 0 Participants |
| VEH-PDT | Hypopigmentation | Grade 3 | 0 Participants |
| VEH-PDT | Hypopigmentation | Grade 0 | 35 Participants |
| VEH-PDT | Hypopigmentation | Grade 2 | 2 Participants |
| VEH-PDT | Hypopigmentation | Grade 1 | 17 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
Time frame: 24-48 hours after PDT #1
Population: Analysis population consisted of observed data only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Hypopigmentation | Grade 3 | 1 Participants |
| ALA X2 | Hypopigmentation | Grade 2 | 4 Participants |
| ALA X2 | Hypopigmentation | Grade 0 | 34 Participants |
| ALA X2 | Hypopigmentation | Grade 1 | 14 Participants |
| ALA X2 | Hypopigmentation | Grade 4 | 0 Participants |
| ALA X3 | Hypopigmentation | Grade 2 | 2 Participants |
| ALA X3 | Hypopigmentation | Grade 0 | 35 Participants |
| ALA X3 | Hypopigmentation | Grade 1 | 19 Participants |
| ALA X3 | Hypopigmentation | Grade 3 | 1 Participants |
| ALA X3 | Hypopigmentation | Grade 4 | 0 Participants |
| VEH-PDT | Hypopigmentation | Grade 4 | 0 Participants |
| VEH-PDT | Hypopigmentation | Grade 3 | 0 Participants |
| VEH-PDT | Hypopigmentation | Grade 0 | 35 Participants |
| VEH-PDT | Hypopigmentation | Grade 2 | 2 Participants |
| VEH-PDT | Hypopigmentation | Grade 1 | 16 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
Time frame: Baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Hypopigmentation | Grade 3 | 0 Participants |
| ALA X2 | Hypopigmentation | Grade 2 | 2 Participants |
| ALA X2 | Hypopigmentation | Grade 0 | 37 Participants |
| ALA X2 | Hypopigmentation | Grade 1 | 14 Participants |
| ALA X2 | Hypopigmentation | Grade 4 | 0 Participants |
| ALA X3 | Hypopigmentation | Grade 2 | 2 Participants |
| ALA X3 | Hypopigmentation | Grade 0 | 38 Participants |
| ALA X3 | Hypopigmentation | Grade 1 | 19 Participants |
| ALA X3 | Hypopigmentation | Grade 3 | 0 Participants |
| ALA X3 | Hypopigmentation | Grade 4 | 0 Participants |
| VEH-PDT | Hypopigmentation | Grade 4 | 0 Participants |
| VEH-PDT | Hypopigmentation | Grade 3 | 0 Participants |
| VEH-PDT | Hypopigmentation | Grade 0 | 37 Participants |
| VEH-PDT | Hypopigmentation | Grade 2 | 3 Participants |
| VEH-PDT | Hypopigmentation | Grade 1 | 14 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: 52 Weeks after PDT #1
Population: Analysis population consisted of observed data only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Oozing/Vesiculation/Crusting | Grade 3 | 0 Participants |
| ALA X2 | Oozing/Vesiculation/Crusting | Grade 2 | 0 Participants |
| ALA X2 | Oozing/Vesiculation/Crusting | Grade 0 | 49 Participants |
| ALA X2 | Oozing/Vesiculation/Crusting | Grade 1 | 1 Participants |
| ALA X2 | Oozing/Vesiculation/Crusting | Grade 4 | 0 Participants |
| ALA X3 | Oozing/Vesiculation/Crusting | Grade 2 | 0 Participants |
| ALA X3 | Oozing/Vesiculation/Crusting | Grade 0 | 56 Participants |
| ALA X3 | Oozing/Vesiculation/Crusting | Grade 1 | 0 Participants |
| ALA X3 | Oozing/Vesiculation/Crusting | Grade 3 | 0 Participants |
| ALA X3 | Oozing/Vesiculation/Crusting | Grade 4 | 0 Participants |
| VEH-PDT | Oozing/Vesiculation/Crusting | Grade 4 | 0 Participants |
| VEH-PDT | Oozing/Vesiculation/Crusting | Grade 3 | 0 Participants |
| VEH-PDT | Oozing/Vesiculation/Crusting | Grade 0 | 53 Participants |
| VEH-PDT | Oozing/Vesiculation/Crusting | Grade 2 | 0 Participants |
| VEH-PDT | Oozing/Vesiculation/Crusting | Grade 1 | 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: Screening
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Oozing/Vesiculation/Crusting | Grade 3 | 0 Participants |
| ALA X2 | Oozing/Vesiculation/Crusting | Grade 2 | 0 Participants |
| ALA X2 | Oozing/Vesiculation/Crusting | Grade 0 | 53 Participants |
| ALA X2 | Oozing/Vesiculation/Crusting | Grade 1 | 0 Participants |
| ALA X2 | Oozing/Vesiculation/Crusting | Grade 4 | 0 Participants |
| ALA X3 | Oozing/Vesiculation/Crusting | Grade 2 | 0 Participants |
| ALA X3 | Oozing/Vesiculation/Crusting | Grade 0 | 58 Participants |
| ALA X3 | Oozing/Vesiculation/Crusting | Grade 1 | 1 Participants |
| ALA X3 | Oozing/Vesiculation/Crusting | Grade 3 | 0 Participants |
| ALA X3 | Oozing/Vesiculation/Crusting | Grade 4 | 0 Participants |
| VEH-PDT | Oozing/Vesiculation/Crusting | Grade 4 | 0 Participants |
| VEH-PDT | Oozing/Vesiculation/Crusting | Grade 3 | 0 Participants |
| VEH-PDT | Oozing/Vesiculation/Crusting | Grade 0 | 53 Participants |
| VEH-PDT | Oozing/Vesiculation/Crusting | Grade 2 | 0 Participants |
| VEH-PDT | Oozing/Vesiculation/Crusting | Grade 1 | 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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Oozing/Vesiculation/Crusting | Grade 3 | 0 Participants |
| ALA X2 | Oozing/Vesiculation/Crusting | Grade 2 | 0 Participants |
| ALA X2 | Oozing/Vesiculation/Crusting | Grade 0 | 49 Participants |
| ALA X2 | Oozing/Vesiculation/Crusting | Grade 1 | 4 Participants |
| ALA X2 | Oozing/Vesiculation/Crusting | Grade 4 | 0 Participants |
| ALA X3 | Oozing/Vesiculation/Crusting | Grade 2 | 0 Participants |
| ALA X3 | Oozing/Vesiculation/Crusting | Grade 0 | 58 Participants |
| ALA X3 | Oozing/Vesiculation/Crusting | Grade 1 | 1 Participants |
| ALA X3 | Oozing/Vesiculation/Crusting | Grade 3 | 0 Participants |
| ALA X3 | Oozing/Vesiculation/Crusting | Grade 4 | 0 Participants |
| VEH-PDT | Oozing/Vesiculation/Crusting | Grade 4 | 0 Participants |
| VEH-PDT | Oozing/Vesiculation/Crusting | Grade 3 | 0 Participants |
| VEH-PDT | Oozing/Vesiculation/Crusting | Grade 0 | 51 Participants |
| VEH-PDT | Oozing/Vesiculation/Crusting | Grade 2 | 1 Participants |
| VEH-PDT | Oozing/Vesiculation/Crusting | Grade 1 | 2 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: Analysis population consisted of observed data only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Oozing/Vesiculation/Crusting | Grade 3 | 0 Participants |
| ALA X2 | Oozing/Vesiculation/Crusting | Grade 2 | 0 Participants |
| ALA X2 | Oozing/Vesiculation/Crusting | Grade 0 | 50 Participants |
| ALA X2 | Oozing/Vesiculation/Crusting | Grade 1 | 3 Participants |
| ALA X2 | Oozing/Vesiculation/Crusting | Grade 4 | 0 Participants |
| ALA X3 | Oozing/Vesiculation/Crusting | Grade 2 | 0 Participants |
| ALA X3 | Oozing/Vesiculation/Crusting | Grade 0 | 53 Participants |
| ALA X3 | Oozing/Vesiculation/Crusting | Grade 1 | 3 Participants |
| ALA X3 | Oozing/Vesiculation/Crusting | Grade 3 | 1 Participants |
| ALA X3 | Oozing/Vesiculation/Crusting | Grade 4 | 0 Participants |
| VEH-PDT | Oozing/Vesiculation/Crusting | Grade 4 | 0 Participants |
| VEH-PDT | Oozing/Vesiculation/Crusting | Grade 3 | 0 Participants |
| VEH-PDT | Oozing/Vesiculation/Crusting | Grade 0 | 49 Participants |
| VEH-PDT | Oozing/Vesiculation/Crusting | Grade 2 | 1 Participants |
| VEH-PDT | Oozing/Vesiculation/Crusting | Grade 1 | 3 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: Analysis population consisted of observed data only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Oozing/Vesiculation/Crusting | Grade 3 | 0 Participants |
| ALA X2 | Oozing/Vesiculation/Crusting | Grade 2 | 0 Participants |
| ALA X2 | Oozing/Vesiculation/Crusting | Grade 0 | 50 Participants |
| ALA X2 | Oozing/Vesiculation/Crusting | Grade 1 | 1 Participants |
| ALA X2 | Oozing/Vesiculation/Crusting | Grade 4 | 0 Participants |
| ALA X3 | Oozing/Vesiculation/Crusting | Grade 2 | 0 Participants |
| ALA X3 | Oozing/Vesiculation/Crusting | Grade 0 | 56 Participants |
| ALA X3 | Oozing/Vesiculation/Crusting | Grade 1 | 1 Participants |
| ALA X3 | Oozing/Vesiculation/Crusting | Grade 3 | 0 Participants |
| ALA X3 | Oozing/Vesiculation/Crusting | Grade 4 | 0 Participants |
| VEH-PDT | Oozing/Vesiculation/Crusting | Grade 4 | 0 Participants |
| VEH-PDT | Oozing/Vesiculation/Crusting | Grade 3 | 0 Participants |
| VEH-PDT | Oozing/Vesiculation/Crusting | Grade 0 | 53 Participants |
| VEH-PDT | Oozing/Vesiculation/Crusting | Grade 2 | 0 Participants |
| VEH-PDT | Oozing/Vesiculation/Crusting | Grade 1 | 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: Analysis population consisted of observed data only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Oozing/Vesiculation/Crusting | Grade 3 | 0 Participants |
| ALA X2 | Oozing/Vesiculation/Crusting | Grade 2 | 0 Participants |
| ALA X2 | Oozing/Vesiculation/Crusting | Grade 0 | 51 Participants |
| ALA X2 | Oozing/Vesiculation/Crusting | Grade 1 | 0 Participants |
| ALA X2 | Oozing/Vesiculation/Crusting | Grade 4 | 0 Participants |
| ALA X3 | Oozing/Vesiculation/Crusting | Grade 2 | 0 Participants |
| ALA X3 | Oozing/Vesiculation/Crusting | Grade 0 | 56 Participants |
| ALA X3 | Oozing/Vesiculation/Crusting | Grade 1 | 1 Participants |
| ALA X3 | Oozing/Vesiculation/Crusting | Grade 3 | 0 Participants |
| ALA X3 | Oozing/Vesiculation/Crusting | Grade 4 | 0 Participants |
| VEH-PDT | Oozing/Vesiculation/Crusting | Grade 4 | 0 Participants |
| VEH-PDT | Oozing/Vesiculation/Crusting | Grade 3 | 0 Participants |
| VEH-PDT | Oozing/Vesiculation/Crusting | Grade 0 | 51 Participants |
| VEH-PDT | Oozing/Vesiculation/Crusting | Grade 2 | 1 Participants |
| VEH-PDT | Oozing/Vesiculation/Crusting | Grade 1 | 2 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 Weeks after PDT #1
Population: Analysis population consisted of observed data only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Oozing/Vesiculation/Crusting | Grade 3 | 0 Participants |
| ALA X2 | Oozing/Vesiculation/Crusting | Grade 2 | 0 Participants |
| ALA X2 | Oozing/Vesiculation/Crusting | Grade 0 | 50 Participants |
| ALA X2 | Oozing/Vesiculation/Crusting | Grade 1 | 1 Participants |
| ALA X2 | Oozing/Vesiculation/Crusting | Grade 4 | 0 Participants |
| ALA X3 | Oozing/Vesiculation/Crusting | Grade 2 | 0 Participants |
| ALA X3 | Oozing/Vesiculation/Crusting | Grade 0 | 56 Participants |
| ALA X3 | Oozing/Vesiculation/Crusting | Grade 1 | 0 Participants |
| ALA X3 | Oozing/Vesiculation/Crusting | Grade 3 | 0 Participants |
| ALA X3 | Oozing/Vesiculation/Crusting | Grade 4 | 0 Participants |
| VEH-PDT | Oozing/Vesiculation/Crusting | Grade 4 | 0 Participants |
| VEH-PDT | Oozing/Vesiculation/Crusting | Grade 3 | 0 Participants |
| VEH-PDT | Oozing/Vesiculation/Crusting | Grade 0 | 53 Participants |
| VEH-PDT | Oozing/Vesiculation/Crusting | Grade 2 | 0 Participants |
| VEH-PDT | Oozing/Vesiculation/Crusting | Grade 1 | 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: 36 Weeks after PDT #1
Population: Analysis population consisted of observed data only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Oozing/Vesiculation/Crusting | Grade 3 | 0 Participants |
| ALA X2 | Oozing/Vesiculation/Crusting | Grade 2 | 0 Participants |
| ALA X2 | Oozing/Vesiculation/Crusting | Grade 0 | 50 Participants |
| ALA X2 | Oozing/Vesiculation/Crusting | Grade 1 | 0 Participants |
| ALA X2 | Oozing/Vesiculation/Crusting | Grade 4 | 0 Participants |
| ALA X3 | Oozing/Vesiculation/Crusting | Grade 2 | 0 Participants |
| ALA X3 | Oozing/Vesiculation/Crusting | Grade 0 | 56 Participants |
| ALA X3 | Oozing/Vesiculation/Crusting | Grade 1 | 0 Participants |
| ALA X3 | Oozing/Vesiculation/Crusting | Grade 3 | 0 Participants |
| ALA X3 | Oozing/Vesiculation/Crusting | Grade 4 | 0 Participants |
| VEH-PDT | Oozing/Vesiculation/Crusting | Grade 4 | 0 Participants |
| VEH-PDT | Oozing/Vesiculation/Crusting | Grade 3 | 0 Participants |
| VEH-PDT | Oozing/Vesiculation/Crusting | Grade 0 | 52 Participants |
| VEH-PDT | Oozing/Vesiculation/Crusting | Grade 2 | 0 Participants |
| VEH-PDT | Oozing/Vesiculation/Crusting | Grade 1 | 1 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: Screening
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Scaling & Dryness | Grade 3 | 0 Participants |
| ALA X2 | Scaling & Dryness | Grade 2 | 4 Participants |
| ALA X2 | Scaling & Dryness | Grade 0 | 41 Participants |
| ALA X2 | Scaling & Dryness | Grade 1 | 8 Participants |
| ALA X2 | Scaling & Dryness | Grade 4 | 0 Participants |
| ALA X3 | Scaling & Dryness | Grade 2 | 4 Participants |
| ALA X3 | Scaling & Dryness | Grade 0 | 43 Participants |
| ALA X3 | Scaling & Dryness | Grade 1 | 11 Participants |
| ALA X3 | Scaling & Dryness | Grade 3 | 1 Participants |
| ALA X3 | Scaling & Dryness | Grade 4 | 0 Participants |
| VEH-PDT | Scaling & Dryness | Grade 4 | 0 Participants |
| VEH-PDT | Scaling & Dryness | Grade 3 | 0 Participants |
| VEH-PDT | Scaling & Dryness | Grade 0 | 40 Participants |
| VEH-PDT | Scaling & Dryness | Grade 2 | 3 Participants |
| VEH-PDT | Scaling & Dryness | Grade 1 | 11 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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Scaling & Dryness | Grade 3 | 1 Participants |
| ALA X2 | Scaling & Dryness | Grade 2 | 4 Participants |
| ALA X2 | Scaling & Dryness | Grade 0 | 38 Participants |
| ALA X2 | Scaling & Dryness | Grade 1 | 10 Participants |
| ALA X2 | Scaling & Dryness | Grade 4 | 0 Participants |
| ALA X3 | Scaling & Dryness | Grade 2 | 3 Participants |
| ALA X3 | Scaling & Dryness | Grade 0 | 44 Participants |
| ALA X3 | Scaling & Dryness | Grade 1 | 12 Participants |
| ALA X3 | Scaling & Dryness | Grade 3 | 0 Participants |
| ALA X3 | Scaling & Dryness | Grade 4 | 0 Participants |
| VEH-PDT | Scaling & Dryness | Grade 4 | 0 Participants |
| VEH-PDT | Scaling & Dryness | Grade 3 | 0 Participants |
| VEH-PDT | Scaling & Dryness | Grade 0 | 39 Participants |
| VEH-PDT | Scaling & Dryness | Grade 2 | 4 Participants |
| VEH-PDT | Scaling & Dryness | Grade 1 | 11 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: Analysis population consisted of observed data only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Scaling & Dryness | Grade 3 | 1 Participants |
| ALA X2 | Scaling & Dryness | Grade 2 | 4 Participants |
| ALA X2 | Scaling & Dryness | Grade 0 | 30 Participants |
| ALA X2 | Scaling & Dryness | Grade 1 | 18 Participants |
| ALA X2 | Scaling & Dryness | Grade 4 | 0 Participants |
| ALA X3 | Scaling & Dryness | Grade 2 | 7 Participants |
| ALA X3 | Scaling & Dryness | Grade 0 | 35 Participants |
| ALA X3 | Scaling & Dryness | Grade 1 | 14 Participants |
| ALA X3 | Scaling & Dryness | Grade 3 | 1 Participants |
| ALA X3 | Scaling & Dryness | Grade 4 | 0 Participants |
| VEH-PDT | Scaling & Dryness | Grade 4 | 0 Participants |
| VEH-PDT | Scaling & Dryness | Grade 3 | 0 Participants |
| VEH-PDT | Scaling & Dryness | Grade 0 | 38 Participants |
| VEH-PDT | Scaling & Dryness | Grade 2 | 2 Participants |
| VEH-PDT | Scaling & Dryness | Grade 1 | 13 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: Analysis population consisted of observed data only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Scaling & Dryness | Grade 3 | 0 Participants |
| ALA X2 | Scaling & Dryness | Grade 2 | 0 Participants |
| ALA X2 | Scaling & Dryness | Grade 0 | 41 Participants |
| ALA X2 | Scaling & Dryness | Grade 1 | 10 Participants |
| ALA X2 | Scaling & Dryness | Grade 4 | 0 Participants |
| ALA X3 | Scaling & Dryness | Grade 2 | 1 Participants |
| ALA X3 | Scaling & Dryness | Grade 0 | 46 Participants |
| ALA X3 | Scaling & Dryness | Grade 1 | 10 Participants |
| ALA X3 | Scaling & Dryness | Grade 3 | 0 Participants |
| ALA X3 | Scaling & Dryness | Grade 4 | 0 Participants |
| VEH-PDT | Scaling & Dryness | Grade 4 | 0 Participants |
| VEH-PDT | Scaling & Dryness | Grade 3 | 0 Participants |
| VEH-PDT | Scaling & Dryness | Grade 0 | 41 Participants |
| VEH-PDT | Scaling & Dryness | Grade 2 | 2 Participants |
| VEH-PDT | Scaling & Dryness | Grade 1 | 11 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: Analysis population consisted of observed data only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Scaling & Dryness | Grade 3 | 1 Participants |
| ALA X2 | Scaling & Dryness | Grade 2 | 0 Participants |
| ALA X2 | Scaling & Dryness | Grade 0 | 40 Participants |
| ALA X2 | Scaling & Dryness | Grade 1 | 10 Participants |
| ALA X2 | Scaling & Dryness | Grade 4 | 0 Participants |
| ALA X3 | Scaling & Dryness | Grade 2 | 2 Participants |
| ALA X3 | Scaling & Dryness | Grade 0 | 44 Participants |
| ALA X3 | Scaling & Dryness | Grade 1 | 11 Participants |
| ALA X3 | Scaling & Dryness | Grade 3 | 0 Participants |
| ALA X3 | Scaling & Dryness | Grade 4 | 0 Participants |
| VEH-PDT | Scaling & Dryness | Grade 4 | 0 Participants |
| VEH-PDT | Scaling & Dryness | Grade 3 | 1 Participants |
| VEH-PDT | Scaling & Dryness | Grade 0 | 43 Participants |
| VEH-PDT | Scaling & Dryness | Grade 2 | 2 Participants |
| VEH-PDT | Scaling & Dryness | Grade 1 | 7 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 Weeks after PDT #1
Population: Analysis population consisted of observed data only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Scaling & Dryness | Grade 3 | 0 Participants |
| ALA X2 | Scaling & Dryness | Grade 2 | 2 Participants |
| ALA X2 | Scaling & Dryness | Grade 0 | 43 Participants |
| ALA X2 | Scaling & Dryness | Grade 1 | 6 Participants |
| ALA X2 | Scaling & Dryness | Grade 4 | 0 Participants |
| ALA X3 | Scaling & Dryness | Grade 2 | 2 Participants |
| ALA X3 | Scaling & Dryness | Grade 0 | 46 Participants |
| ALA X3 | Scaling & Dryness | Grade 1 | 8 Participants |
| ALA X3 | Scaling & Dryness | Grade 3 | 0 Participants |
| ALA X3 | Scaling & Dryness | Grade 4 | 0 Participants |
| VEH-PDT | Scaling & Dryness | Grade 4 | 0 Participants |
| VEH-PDT | Scaling & Dryness | Grade 3 | 0 Participants |
| VEH-PDT | Scaling & Dryness | Grade 0 | 39 Participants |
| VEH-PDT | Scaling & Dryness | Grade 2 | 2 Participants |
| VEH-PDT | Scaling & Dryness | Grade 1 | 12 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: 36 Weeks after PDT #1
Population: Analysis population consisted of observed data only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Scaling & Dryness | Grade 3 | 0 Participants |
| ALA X2 | Scaling & Dryness | Grade 2 | 1 Participants |
| ALA X2 | Scaling & Dryness | Grade 0 | 38 Participants |
| ALA X2 | Scaling & Dryness | Grade 1 | 11 Participants |
| ALA X2 | Scaling & Dryness | Grade 4 | 0 Participants |
| ALA X3 | Scaling & Dryness | Grade 2 | 2 Participants |
| ALA X3 | Scaling & Dryness | Grade 0 | 46 Participants |
| ALA X3 | Scaling & Dryness | Grade 1 | 8 Participants |
| ALA X3 | Scaling & Dryness | Grade 3 | 0 Participants |
| ALA X3 | Scaling & Dryness | Grade 4 | 0 Participants |
| VEH-PDT | Scaling & Dryness | Grade 4 | 0 Participants |
| VEH-PDT | Scaling & Dryness | Grade 3 | 0 Participants |
| VEH-PDT | Scaling & Dryness | Grade 0 | 38 Participants |
| VEH-PDT | Scaling & Dryness | Grade 2 | 2 Participants |
| VEH-PDT | Scaling & Dryness | Grade 1 | 13 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: 52 Weeks after PDT #1
Population: Analysis population consisted of observed data only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Scaling & Dryness | Grade 3 | 0 Participants |
| ALA X2 | Scaling & Dryness | Grade 2 | 2 Participants |
| ALA X2 | Scaling & Dryness | Grade 0 | 42 Participants |
| ALA X2 | Scaling & Dryness | Grade 1 | 6 Participants |
| ALA X2 | Scaling & Dryness | Grade 4 | 0 Participants |
| ALA X3 | Scaling & Dryness | Grade 2 | 4 Participants |
| ALA X3 | Scaling & Dryness | Grade 0 | 42 Participants |
| ALA X3 | Scaling & Dryness | Grade 1 | 10 Participants |
| ALA X3 | Scaling & Dryness | Grade 3 | 0 Participants |
| ALA X3 | Scaling & Dryness | Grade 4 | 0 Participants |
| VEH-PDT | Scaling & Dryness | Grade 4 | 0 Participants |
| VEH-PDT | Scaling & Dryness | Grade 3 | 0 Participants |
| VEH-PDT | Scaling & Dryness | Grade 0 | 47 Participants |
| VEH-PDT | Scaling & Dryness | Grade 2 | 2 Participants |
| VEH-PDT | Scaling & Dryness | Grade 1 | 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: 5 minutes after PDT #1
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Stinging/Burning | Grade 0 | 11 Participants |
| ALA X2 | Stinging/Burning | Grade 1 | 33 Participants |
| ALA X2 | Stinging/Burning | Grade 2 | 9 Participants |
| ALA X2 | Stinging/Burning | Grade 3 | 0 Participants |
| ALA X3 | Stinging/Burning | Grade 3 | 0 Participants |
| ALA X3 | Stinging/Burning | Grade 0 | 11 Participants |
| ALA X3 | Stinging/Burning | Grade 2 | 11 Participants |
| ALA X3 | Stinging/Burning | Grade 1 | 37 Participants |
| VEH-PDT | Stinging/Burning | Grade 3 | 0 Participants |
| VEH-PDT | Stinging/Burning | Grade 1 | 8 Participants |
| VEH-PDT | Stinging/Burning | Grade 2 | 0 Participants |
| VEH-PDT | Stinging/Burning | Grade 0 | 46 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: 4 Weeks after PDT #1
Population: Analysis population consisted of observed data only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Stinging/Burning | Grade 0 | 51 Participants |
| ALA X2 | Stinging/Burning | Grade 1 | 0 Participants |
| ALA X2 | Stinging/Burning | Grade 2 | 0 Participants |
| ALA X2 | Stinging/Burning | Grade 3 | 0 Participants |
| ALA X3 | Stinging/Burning | Grade 3 | 0 Participants |
| ALA X3 | Stinging/Burning | Grade 0 | 57 Participants |
| ALA X3 | Stinging/Burning | Grade 2 | 0 Participants |
| ALA X3 | Stinging/Burning | Grade 1 | 0 Participants |
| VEH-PDT | Stinging/Burning | Grade 3 | 0 Participants |
| VEH-PDT | Stinging/Burning | Grade 1 | 0 Participants |
| VEH-PDT | Stinging/Burning | Grade 2 | 1 Participants |
| VEH-PDT | Stinging/Burning | Grade 0 | 53 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: Analysis population consisted of observed data only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Stinging/Burning | Grade 0 | 31 Participants |
| ALA X2 | Stinging/Burning | Grade 1 | 17 Participants |
| ALA X2 | Stinging/Burning | Grade 2 | 5 Participants |
| ALA X2 | Stinging/Burning | Grade 3 | 0 Participants |
| ALA X3 | Stinging/Burning | Grade 3 | 0 Participants |
| ALA X3 | Stinging/Burning | Grade 0 | 23 Participants |
| ALA X3 | Stinging/Burning | Grade 2 | 5 Participants |
| ALA X3 | Stinging/Burning | Grade 1 | 29 Participants |
| VEH-PDT | Stinging/Burning | Grade 3 | 0 Participants |
| VEH-PDT | Stinging/Burning | Grade 1 | 2 Participants |
| VEH-PDT | Stinging/Burning | Grade 2 | 0 Participants |
| VEH-PDT | Stinging/Burning | Grade 0 | 51 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: Analysis population consisted of observed data only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Stinging/Burning | Grade 0 | 51 Participants |
| ALA X2 | Stinging/Burning | Grade 1 | 0 Participants |
| ALA X2 | Stinging/Burning | Grade 2 | 0 Participants |
| ALA X2 | Stinging/Burning | Grade 3 | 0 Participants |
| ALA X3 | Stinging/Burning | Grade 3 | 0 Participants |
| ALA X3 | Stinging/Burning | Grade 0 | 57 Participants |
| ALA X3 | Stinging/Burning | Grade 2 | 0 Participants |
| ALA X3 | Stinging/Burning | Grade 1 | 0 Participants |
| VEH-PDT | Stinging/Burning | Grade 3 | 0 Participants |
| VEH-PDT | Stinging/Burning | Grade 1 | 1 Participants |
| VEH-PDT | Stinging/Burning | Grade 2 | 0 Participants |
| VEH-PDT | Stinging/Burning | Grade 0 | 52 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 Weeks after PDT #1
Population: Analysis population consisted of observed data only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Stinging/Burning | Grade 0 | 51 Participants |
| ALA X2 | Stinging/Burning | Grade 1 | 0 Participants |
| ALA X2 | Stinging/Burning | Grade 2 | 0 Participants |
| ALA X2 | Stinging/Burning | Grade 3 | 0 Participants |
| ALA X3 | Stinging/Burning | Grade 3 | 0 Participants |
| ALA X3 | Stinging/Burning | Grade 0 | 55 Participants |
| ALA X3 | Stinging/Burning | Grade 2 | 0 Participants |
| ALA X3 | Stinging/Burning | Grade 1 | 1 Participants |
| VEH-PDT | Stinging/Burning | Grade 3 | 0 Participants |
| VEH-PDT | Stinging/Burning | Grade 1 | 0 Participants |
| VEH-PDT | Stinging/Burning | Grade 2 | 0 Participants |
| VEH-PDT | Stinging/Burning | Grade 0 | 53 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: 36 Weeks after PDT #1
Population: Analysis population consisted of observed data only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Stinging/Burning | Grade 3 | 0 Participants |
| ALA X2 | Stinging/Burning | Grade 0 | 49 Participants |
| ALA X2 | Stinging/Burning | Grade 1 | 0 Participants |
| ALA X2 | Stinging/Burning | Grade 2 | 1 Participants |
| ALA X3 | Stinging/Burning | Grade 2 | 0 Participants |
| ALA X3 | Stinging/Burning | Grade 3 | 0 Participants |
| ALA X3 | Stinging/Burning | Grade 1 | 0 Participants |
| ALA X3 | Stinging/Burning | Grade 0 | 56 Participants |
| VEH-PDT | Stinging/Burning | Grade 2 | 0 Participants |
| VEH-PDT | Stinging/Burning | Grade 0 | 51 Participants |
| VEH-PDT | Stinging/Burning | Grade 1 | 2 Participants |
| VEH-PDT | Stinging/Burning | Grade 3 | 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: 52 Weeks after PDT #1
Population: Analysis population consisted of observed data only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Stinging/Burning | Grade 1 | 1 Participants |
| ALA X2 | Stinging/Burning | Grade 2 | 0 Participants |
| ALA X2 | Stinging/Burning | Grade 0 | 49 Participants |
| ALA X2 | Stinging/Burning | Grade 3 | 0 Participants |
| ALA X3 | Stinging/Burning | Grade 1 | 0 Participants |
| ALA X3 | Stinging/Burning | Grade 0 | 56 Participants |
| ALA X3 | Stinging/Burning | Grade 2 | 0 Participants |
| ALA X3 | Stinging/Burning | Grade 3 | 0 Participants |
| VEH-PDT | Stinging/Burning | Grade 2 | 1 Participants |
| VEH-PDT | Stinging/Burning | Grade 0 | 52 Participants |
| VEH-PDT | Stinging/Burning | Grade 1 | 0 Participants |
| VEH-PDT | Stinging/Burning | Grade 3 | 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: Screening
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Stinging/Burning | Grade 3 | 0 Participants |
| ALA X2 | Stinging/Burning | Grade 2 | 0 Participants |
| ALA X2 | Stinging/Burning | Grade 0 | 53 Participants |
| ALA X2 | Stinging/Burning | Grade 1 | 0 Participants |
| ALA X2 | Stinging/Burning | Grade 4 | 0 Participants |
| ALA X3 | Stinging/Burning | Grade 2 | 0 Participants |
| ALA X3 | Stinging/Burning | Grade 0 | 58 Participants |
| ALA X3 | Stinging/Burning | Grade 1 | 1 Participants |
| ALA X3 | Stinging/Burning | Grade 3 | 0 Participants |
| ALA X3 | Stinging/Burning | Grade 4 | 0 Participants |
| VEH-PDT | Stinging/Burning | Grade 4 | 0 Participants |
| VEH-PDT | Stinging/Burning | Grade 3 | 0 Participants |
| VEH-PDT | Stinging/Burning | Grade 0 | 53 Participants |
| VEH-PDT | Stinging/Burning | Grade 2 | 0 Participants |
| VEH-PDT | Stinging/Burning | Grade 1 | 1 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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Stinging/Burning | Grade 3 | 0 Participants |
| ALA X2 | Stinging/Burning | Grade 2 | 0 Participants |
| ALA X2 | Stinging/Burning | Grade 0 | 53 Participants |
| ALA X2 | Stinging/Burning | Grade 1 | 0 Participants |
| ALA X2 | Stinging/Burning | Grade 4 | 0 Participants |
| ALA X3 | Stinging/Burning | Grade 2 | 0 Participants |
| ALA X3 | Stinging/Burning | Grade 0 | 59 Participants |
| ALA X3 | Stinging/Burning | Grade 1 | 0 Participants |
| ALA X3 | Stinging/Burning | Grade 3 | 0 Participants |
| ALA X3 | Stinging/Burning | Grade 4 | 0 Participants |
| VEH-PDT | Stinging/Burning | Grade 4 | 0 Participants |
| VEH-PDT | Stinging/Burning | Grade 3 | 0 Participants |
| VEH-PDT | Stinging/Burning | Grade 0 | 53 Participants |
| VEH-PDT | Stinging/Burning | Grade 2 | 0 Participants |
| VEH-PDT | Stinging/Burning | Grade 1 | 1 Participants |
Other Pre-specified
Stinging/Burning
Immediately after PDT, the most intensive, acute perception of Stinging/Burning DURING treatment will be recorded. 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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA X2 | Stinging/Burning | Grade 0 | 5 Participants |
| ALA X2 | Stinging/Burning | Grade 1 | 18 Participants |
| ALA X2 | Stinging/Burning | Grade 2 | 27 Participants |
| ALA X2 | Stinging/Burning | Grade 3 | 3 Participants |
| ALA X3 | Stinging/Burning | Grade 3 | 1 Participants |
| ALA X3 | Stinging/Burning | Grade 0 | 5 Participants |
| ALA X3 | Stinging/Burning | Grade 2 | 32 Participants |
| ALA X3 | Stinging/Burning | Grade 1 | 21 Participants |
| VEH-PDT | Stinging/Burning | Grade 3 | 0 Participants |
| VEH-PDT | Stinging/Burning | Grade 1 | 11 Participants |
| VEH-PDT | Stinging/Burning | Grade 2 | 1 Participants |
| VEH-PDT | Stinging/Burning | Grade 0 | 42 Participants |