Actinic Keratosis
Conditions
Keywords
Actinic Keratosis
Brief summary
The purpose of this study is to determine the viability of microneedle lesion preparation (MN) to enhance treatment benefit when performed prior to ALA PDT to an actinic keratosis (AK) field on the face.
Interventions
DRUGALA
20% ALA applied to face prior to light treatment
Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment
DEVICEIBL 10 mW
10 J/cm2 blue light delivered at 10 mW/cm2 for 16 minutes 40 seconds
PROCEDUREMicroneedle lesion preparation
Microneedling of all visible/palpable AK lesions prior to solution application.
DEVICEIBL 20 mW
10 J/cm2 blue light delivered at 20 mW/cm2 for 8 minutes 20 seconds
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 eight AKs on the face
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 * 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 * Curettage or Cryotherapy within 2 weeks of initiation of treatment * Retinoids, including tazarotene, adapalene, tretinoin, within 4 weeks * Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5 fluorouracil, 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 |
|---|---|---|
| Complete Clearance Rate | Week 12 | Number of AK Fields with 0 lesions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Clearance Rate | Week 8 | Number of AK Fields with 0 Lesions |
| Subject Satisfaction Score | Week 12 | Subject satisfaction score 1. = Excellent (very satisfied) 2. = Good (moderately satisfied) 3. = Fair (slightly satisfied) 4. = Poor (not satisfied at all) |
| Baseline AKCR | Baseline and Week 8 | AK clearance rate (AKCR) for only those lesions present at Baseline |
| Percent Change | Baseline and Week 8 | Percent change in the total AK number as compared with Baseline |
Other
| Measure | Time frame | Description |
|---|---|---|
| Scaling & Dryness | Baseline | SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling |
| Hyperpigmentation | Baseline | HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas |
| Oozing/Vesiculation/Crusting | Baseline | OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above |
| Hypopigmentation | Baseline | HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas |
| Erythema | Baseline | Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema |
| Edema | Baseline | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area |
| Stinging/Burning | Baseline | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ALA 25 Min 10 mW ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
ALA: 20% ALA applied to face prior to light treatment
MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application.
IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds | 25 |
| ALA 25 Min 20 mW ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.
ALA: 20% ALA applied to face prior to light treatment
MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application.
IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds | 27 |
| ALA 60 Min 10 mW ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
ALA: 20% ALA applied to face prior to light treatment
MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application.
IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds | 29 |
| ALA 60 Min 20 mW ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.
ALA: 20% ALA applied to face prior to light treatment
MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application.
IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds | 26 |
| VEH 60 Min 10 mW Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to VEH application.
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment
IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds | 30 |
| Total | 137 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 | 0 | 1 | 1 | 3 | 3 | 1 | 1 |
Baseline characteristics
| Characteristic | ALA 25 Min 20 mW | ALA 60 Min 10 mW | ALA 60 Min 20 mW | ALA 25 Min 10 mW | VEH 60 Min 10 mW | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 64 years STANDARD_DEVIATION 8 | 67 years STANDARD_DEVIATION 8 | 66 years STANDARD_DEVIATION 9 | 66 years STANDARD_DEVIATION 10 | 64 years STANDARD_DEVIATION 10 | 65 years STANDARD_DEVIATION 9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 28 Participants | 26 Participants | 25 Participants | 30 Participants | 136 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 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 | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 27 Participants | 29 Participants | 26 Participants | 25 Participants | 30 Participants | 137 Participants |
| Sex: Female, Male Female | 7 Participants | 5 Participants | 6 Participants | 8 Participants | 3 Participants | 29 Participants |
| Sex: Female, Male Male | 20 Participants | 24 Participants | 20 Participants | 17 Participants | 27 Participants | 108 Participants |
| Skin Type Type I - Burns easily, never tans | 2 Participants | 2 Participants | 0 Participants | 3 Participants | 0 Participants | 7 Participants |
| Skin Type Type II - Burns easily, tans minimally | 12 Participants | 19 Participants | 14 Participants | 10 Participants | 21 Participants | 76 Participants |
| Skin Type Type III - Burns moderately, tans gradually | 11 Participants | 6 Participants | 10 Participants | 12 Participants | 9 Participants | 48 Participants |
| Skin Type Type IV - Burns minimally, tans well | 2 Participants | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 27 | 0 / 29 | 0 / 26 | 0 / 30 |
| other Total, other adverse events | 1 / 25 | 1 / 27 | 4 / 29 | 7 / 26 | 2 / 30 |
| serious Total, serious adverse events | 0 / 25 | 0 / 27 | 0 / 29 | 1 / 26 | 0 / 30 |
Outcome results
Primary
Complete Clearance Rate
Number of AK Fields with 0 lesions
Time frame: Week 12
Population: Split-face study
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| MN + ALA 25 Min 10 mW | Complete Clearance Rate | 16 AK Fields |
| ALA 25 Min 10 mW | Complete Clearance Rate | 15 AK Fields |
| MN + ALA 25 Min 20 mW | Complete Clearance Rate | 10 AK Fields |
| ALA 25 Min 20 mW | Complete Clearance Rate | 12 AK Fields |
| MN + ALA 60 Min 10mW | Complete Clearance Rate | 19 AK Fields |
| ALA 60 Min 10 mW | Complete Clearance Rate | 15 AK Fields |
| MN + ALA 60 Min 20 mW | Complete Clearance Rate | 18 AK Fields |
| ALA 60 Min 20 mW | Complete Clearance Rate | 18 AK Fields |
| MN + VEH | Complete Clearance Rate | 4 AK Fields |
| VEH PDT | Complete Clearance Rate | 4 AK Fields |
Secondary
Baseline AKCR
AK clearance rate (AKCR) for only those lesions present at Baseline
Time frame: Baseline and Week 8
Population: split-face. Week 8 number of participants and units analyzed is based on observed data at that Visit. Number of subjects at Week 8 may differ from number of subjects completing study as noted in participant flow.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Baseline AKCR | 74.5 percentage cleared | Standard Deviation 24.14 |
| ALA 25 Min 10 mW | Baseline AKCR | 72.3 percentage cleared | Standard Deviation 30.15 |
| MN + ALA 25 Min 20 mW | Baseline AKCR | 75.0 percentage cleared | Standard Deviation 27.03 |
| ALA 25 Min 20 mW | Baseline AKCR | 69.6 percentage cleared | Standard Deviation 31.4 |
| MN + ALA 60 Min 10mW | Baseline AKCR | 85.4 percentage cleared | Standard Deviation 22.26 |
| ALA 60 Min 10 mW | Baseline AKCR | 83.4 percentage cleared | Standard Deviation 22.63 |
| MN + ALA 60 Min 20 mW | Baseline AKCR | 86.1 percentage cleared | Standard Deviation 15.59 |
| ALA 60 Min 20 mW | Baseline AKCR | 80.6 percentage cleared | Standard Deviation 22.61 |
| MN + VEH | Baseline AKCR | 40.6 percentage cleared | Standard Deviation 35.66 |
| VEH PDT | Baseline AKCR | 34.4 percentage cleared | Standard Deviation 36.66 |
Secondary
Baseline AKCR
AK clearance rate for only those lesions present at Baseline
Time frame: Baseline and Week 12
Population: split-face
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Baseline AKCR | 92.2 percentage cleared | Standard Deviation 16.28 |
| ALA 25 Min 10 mW | Baseline AKCR | 89.2 percentage cleared | Standard Deviation 19.96 |
| MN + ALA 25 Min 20 mW | Baseline AKCR | 82.3 percentage cleared | Standard Deviation 22.32 |
| ALA 25 Min 20 mW | Baseline AKCR | 86.7 percentage cleared | Standard Deviation 16.44 |
| MN + ALA 60 Min 10mW | Baseline AKCR | 93.2 percentage cleared | Standard Deviation 13.04 |
| ALA 60 Min 10 mW | Baseline AKCR | 95.1 percentage cleared | Standard Deviation 10.4 |
| MN + ALA 60 Min 20 mW | Baseline AKCR | 96.3 percentage cleared | Standard Deviation 7.49 |
| ALA 60 Min 20 mW | Baseline AKCR | 94.8 percentage cleared | Standard Deviation 13.34 |
| MN + VEH | Baseline AKCR | 40.9 percentage cleared | Standard Deviation 37.24 |
| VEH PDT | Baseline AKCR | 43.1 percentage cleared | Standard Deviation 40.42 |
Secondary
Complete Clearance Rate
Number of AK Fields with 0 Lesions
Time frame: Week 8
Population: split-face. Week 8 number of participants and units analyzed is based on observed data at that Visit. Number of subjects at Week 8 may differ from number of subjects completing study as noted in participant flow.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| MN + ALA 25 Min 10 mW | Complete Clearance Rate | 5 AK Fields |
| ALA 25 Min 10 mW | Complete Clearance Rate | 7 AK Fields |
| MN + ALA 25 Min 20 mW | Complete Clearance Rate | 7 AK Fields |
| ALA 25 Min 20 mW | Complete Clearance Rate | 7 AK Fields |
| MN + ALA 60 Min 10mW | Complete Clearance Rate | 13 AK Fields |
| ALA 60 Min 10 mW | Complete Clearance Rate | 11 AK Fields |
| MN + ALA 60 Min 20 mW | Complete Clearance Rate | 8 AK Fields |
| ALA 60 Min 20 mW | Complete Clearance Rate | 9 AK Fields |
| MN + VEH | Complete Clearance Rate | 4 AK Fields |
| VEH PDT | Complete Clearance Rate | 2 AK Fields |
Secondary
Percent Change
Percent change in the total AK number as compared with Baseline
Time frame: Baseline and Week 12
Population: split-face
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Percent Change | -87.0 percent change | Standard Deviation 22.52 |
| ALA 25 Min 10 mW | Percent Change | -87.3 percent change | Standard Deviation 20.45 |
| MN + ALA 25 Min 20 mW | Percent Change | -75.0 percent change | Standard Deviation 32.35 |
| ALA 25 Min 20 mW | Percent Change | -80.0 percent change | Standard Deviation 25.1 |
| MN + ALA 60 Min 10mW | Percent Change | -88.9 percent change | Standard Deviation 21.36 |
| ALA 60 Min 10 mW | Percent Change | -87.4 percent change | Standard Deviation 17.47 |
| MN + ALA 60 Min 20 mW | Percent Change | -95.5 percent change | Standard Deviation 10.16 |
| ALA 60 Min 20 mW | Percent Change | -92.6 percent change | Standard Deviation 19.08 |
| MN + VEH | Percent Change | -26.0 percent change | Standard Deviation 50.29 |
| VEH PDT | Percent Change | -18.5 percent change | Standard Deviation 54.77 |
Secondary
Percent Change
Percent change in the total AK number as compared with Baseline
Time frame: Baseline and Week 8
Population: split face. Week 8 number of participants and units analyzed is based on observed data at that Visit. Number of subjects at Week 8 may differ from number of subjects completing study as noted in participant flow.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Percent Change | -65.9 percent change | Standard Deviation 28.4 |
| ALA 25 Min 10 mW | Percent Change | -68.6 percent change | Standard Deviation 30.99 |
| MN + ALA 25 Min 20 mW | Percent Change | -64.7 percent change | Standard Deviation 32.32 |
| ALA 25 Min 20 mW | Percent Change | -63.4 percent change | Standard Deviation 36.04 |
| MN + ALA 60 Min 10mW | Percent Change | -72.9 percent change | Standard Deviation 29.58 |
| ALA 60 Min 10 mW | Percent Change | -69.6 percent change | Standard Deviation 34.46 |
| MN + ALA 60 Min 20 mW | Percent Change | -79.4 percent change | Standard Deviation 17.3 |
| ALA 60 Min 20 mW | Percent Change | -74.2 percent change | Standard Deviation 28.56 |
| MN + VEH | Percent Change | -27.9 percent change | Standard Deviation 47.29 |
| VEH PDT | Percent Change | -13.8 percent change | Standard Deviation 49.02 |
Secondary
Subject Satisfaction Score
Subject satisfaction score 1. = Excellent (very satisfied) 2. = Good (moderately satisfied) 3. = Fair (slightly satisfied) 4. = Poor (not satisfied at all)
Time frame: Week 12
Population: split-face.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Subject Satisfaction Score | Good (moderately satisfied) | 8 AK Fields |
| MN + ALA 25 Min 10 mW | Subject Satisfaction Score | Excellent (very satisfied) | 15 AK Fields |
| MN + ALA 25 Min 10 mW | Subject Satisfaction Score | Poor (not satisfied) | 1 AK Fields |
| MN + ALA 25 Min 10 mW | Subject Satisfaction Score | Fair (slightly satisfied) | 1 AK Fields |
| ALA 25 Min 10 mW | Subject Satisfaction Score | Good (moderately satisfied) | 10 AK Fields |
| ALA 25 Min 10 mW | Subject Satisfaction Score | Poor (not satisfied) | 1 AK Fields |
| ALA 25 Min 10 mW | Subject Satisfaction Score | Excellent (very satisfied) | 13 AK Fields |
| ALA 25 Min 10 mW | Subject Satisfaction Score | Fair (slightly satisfied) | 1 AK Fields |
| MN + ALA 25 Min 20 mW | Subject Satisfaction Score | Excellent (very satisfied) | 21 AK Fields |
| MN + ALA 25 Min 20 mW | Subject Satisfaction Score | Good (moderately satisfied) | 5 AK Fields |
| MN + ALA 25 Min 20 mW | Subject Satisfaction Score | Poor (not satisfied) | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Subject Satisfaction Score | Fair (slightly satisfied) | 1 AK Fields |
| ALA 25 Min 20 mW | Subject Satisfaction Score | Excellent (very satisfied) | 21 AK Fields |
| ALA 25 Min 20 mW | Subject Satisfaction Score | Fair (slightly satisfied) | 1 AK Fields |
| ALA 25 Min 20 mW | Subject Satisfaction Score | Poor (not satisfied) | 0 AK Fields |
| ALA 25 Min 20 mW | Subject Satisfaction Score | Good (moderately satisfied) | 5 AK Fields |
| MN + ALA 60 Min 10mW | Subject Satisfaction Score | Good (moderately satisfied) | 10 AK Fields |
| MN + ALA 60 Min 10mW | Subject Satisfaction Score | Excellent (very satisfied) | 18 AK Fields |
| MN + ALA 60 Min 10mW | Subject Satisfaction Score | Poor (not satisfied) | 0 AK Fields |
| MN + ALA 60 Min 10mW | Subject Satisfaction Score | Fair (slightly satisfied) | 0 AK Fields |
| ALA 60 Min 10 mW | Subject Satisfaction Score | Good (moderately satisfied) | 9 AK Fields |
| ALA 60 Min 10 mW | Subject Satisfaction Score | Poor (not satisfied) | 0 AK Fields |
| ALA 60 Min 10 mW | Subject Satisfaction Score | Excellent (very satisfied) | 18 AK Fields |
| ALA 60 Min 10 mW | Subject Satisfaction Score | Fair (slightly satisfied) | 1 AK Fields |
| MN + ALA 60 Min 20 mW | Subject Satisfaction Score | Good (moderately satisfied) | 7 AK Fields |
| MN + ALA 60 Min 20 mW | Subject Satisfaction Score | Excellent (very satisfied) | 15 AK Fields |
| MN + ALA 60 Min 20 mW | Subject Satisfaction Score | Poor (not satisfied) | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Subject Satisfaction Score | Fair (slightly satisfied) | 4 AK Fields |
| ALA 60 Min 20 mW | Subject Satisfaction Score | Good (moderately satisfied) | 8 AK Fields |
| ALA 60 Min 20 mW | Subject Satisfaction Score | Fair (slightly satisfied) | 4 AK Fields |
| ALA 60 Min 20 mW | Subject Satisfaction Score | Excellent (very satisfied) | 14 AK Fields |
| ALA 60 Min 20 mW | Subject Satisfaction Score | Poor (not satisfied) | 0 AK Fields |
| MN + VEH | Subject Satisfaction Score | Good (moderately satisfied) | 3 AK Fields |
| MN + VEH | Subject Satisfaction Score | Excellent (very satisfied) | 8 AK Fields |
| MN + VEH | Subject Satisfaction Score | Fair (slightly satisfied) | 7 AK Fields |
| MN + VEH | Subject Satisfaction Score | Poor (not satisfied) | 12 AK Fields |
| VEH PDT | Subject Satisfaction Score | Poor (not satisfied) | 12 AK Fields |
| VEH PDT | Subject Satisfaction Score | Excellent (very satisfied) | 8 AK Fields |
| VEH PDT | Subject Satisfaction Score | Good (moderately satisfied) | 3 AK Fields |
| VEH PDT | Subject Satisfaction Score | Fair (slightly satisfied) | 7 AK Fields |
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: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Edema | Grade 0 | 24 AK Fields |
| MN + ALA 25 Min 10 mW | Edema | Grade 1 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Edema | Grade 2 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Edema | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Edema | Grade 4 | 0 AK Fields |
| ALA 25 Min 10 mW | Edema | Grade 3 | 0 AK Fields |
| ALA 25 Min 10 mW | Edema | Grade 2 | 0 AK Fields |
| ALA 25 Min 10 mW | Edema | Grade 0 | 24 AK Fields |
| ALA 25 Min 10 mW | Edema | Grade 4 | 0 AK Fields |
| ALA 25 Min 10 mW | Edema | Grade 1 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Edema | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Edema | Grade 0 | 27 AK Fields |
| MN + ALA 25 Min 20 mW | Edema | Grade 2 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Edema | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Edema | Grade 1 | 0 AK Fields |
| ALA 25 Min 20 mW | Edema | Grade 2 | 0 AK Fields |
| ALA 25 Min 20 mW | Edema | Grade 3 | 0 AK Fields |
| ALA 25 Min 20 mW | Edema | Grade 1 | 0 AK Fields |
| ALA 25 Min 20 mW | Edema | Grade 0 | 27 AK Fields |
| ALA 25 Min 20 mW | Edema | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Edema | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Edema | Grade 0 | 28 AK Fields |
| MN + ALA 60 Min 10mW | Edema | Grade 1 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Edema | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Edema | Grade 2 | 0 AK Fields |
| ALA 60 Min 10 mW | Edema | Grade 1 | 0 AK Fields |
| ALA 60 Min 10 mW | Edema | Grade 4 | 0 AK Fields |
| ALA 60 Min 10 mW | Edema | Grade 0 | 28 AK Fields |
| ALA 60 Min 10 mW | Edema | Grade 2 | 0 AK Fields |
| ALA 60 Min 10 mW | Edema | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Edema | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Edema | Grade 0 | 24 AK Fields |
| MN + ALA 60 Min 20 mW | Edema | Grade 1 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Edema | Grade 2 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Edema | Grade 4 | 0 AK Fields |
| ALA 60 Min 20 mW | Edema | Grade 2 | 0 AK Fields |
| ALA 60 Min 20 mW | Edema | Grade 4 | 0 AK Fields |
| ALA 60 Min 20 mW | Edema | Grade 3 | 0 AK Fields |
| ALA 60 Min 20 mW | Edema | Grade 1 | 0 AK Fields |
| ALA 60 Min 20 mW | Edema | Grade 0 | 24 AK Fields |
| MN + VEH | Edema | Grade 3 | 0 AK Fields |
| MN + VEH | Edema | Grade 1 | 0 AK Fields |
| MN + VEH | Edema | Grade 2 | 0 AK Fields |
| MN + VEH | Edema | Grade 0 | 30 AK Fields |
| MN + VEH | Edema | Grade 4 | 0 AK Fields |
| VEH PDT | Edema | Grade 3 | 0 AK Fields |
| VEH PDT | Edema | Grade 1 | 0 AK Fields |
| VEH PDT | Edema | Grade 2 | 0 AK Fields |
| VEH PDT | Edema | Grade 0 | 30 AK Fields |
| VEH PDT | Edema | Grade 4 | 0 AK Fields |
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_UNITS) |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Edema | Grade 1 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Edema | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Edema | Grade 0 | 25 AK Fields |
| MN + ALA 25 Min 10 mW | Edema | Grade 2 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Edema | Grade 4 | 0 AK Fields |
| ALA 25 Min 10 mW | Edema | Grade 0 | 25 AK Fields |
| ALA 25 Min 10 mW | Edema | Grade 1 | 0 AK Fields |
| ALA 25 Min 10 mW | Edema | Grade 2 | 0 AK Fields |
| ALA 25 Min 10 mW | Edema | Grade 3 | 0 AK Fields |
| ALA 25 Min 10 mW | Edema | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Edema | Grade 0 | 27 AK Fields |
| MN + ALA 25 Min 20 mW | Edema | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Edema | Grade 2 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Edema | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Edema | Grade 1 | 0 AK Fields |
| ALA 25 Min 20 mW | Edema | Grade 2 | 0 AK Fields |
| ALA 25 Min 20 mW | Edema | Grade 0 | 27 AK Fields |
| ALA 25 Min 20 mW | Edema | Grade 4 | 0 AK Fields |
| ALA 25 Min 20 mW | Edema | Grade 1 | 0 AK Fields |
| ALA 25 Min 20 mW | Edema | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Edema | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Edema | Grade 1 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Edema | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Edema | Grade 0 | 29 AK Fields |
| MN + ALA 60 Min 10mW | Edema | Grade 2 | 0 AK Fields |
| ALA 60 Min 10 mW | Edema | Grade 0 | 29 AK Fields |
| ALA 60 Min 10 mW | Edema | Grade 1 | 0 AK Fields |
| ALA 60 Min 10 mW | Edema | Grade 2 | 0 AK Fields |
| ALA 60 Min 10 mW | Edema | Grade 3 | 0 AK Fields |
| ALA 60 Min 10 mW | Edema | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Edema | Grade 2 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Edema | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Edema | Grade 0 | 26 AK Fields |
| MN + ALA 60 Min 20 mW | Edema | Grade 1 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Edema | Grade 4 | 0 AK Fields |
| ALA 60 Min 20 mW | Edema | Grade 1 | 0 AK Fields |
| ALA 60 Min 20 mW | Edema | Grade 0 | 26 AK Fields |
| ALA 60 Min 20 mW | Edema | Grade 2 | 0 AK Fields |
| ALA 60 Min 20 mW | Edema | Grade 4 | 0 AK Fields |
| ALA 60 Min 20 mW | Edema | Grade 3 | 0 AK Fields |
| MN + VEH | Edema | Grade 2 | 0 AK Fields |
| MN + VEH | Edema | Grade 1 | 0 AK Fields |
| MN + VEH | Edema | Grade 4 | 0 AK Fields |
| MN + VEH | Edema | Grade 3 | 0 AK Fields |
| MN + VEH | Edema | Grade 0 | 30 AK Fields |
| VEH PDT | Edema | Grade 4 | 0 AK Fields |
| VEH PDT | Edema | Grade 3 | 0 AK Fields |
| VEH PDT | Edema | Grade 0 | 30 AK Fields |
| VEH PDT | Edema | Grade 2 | 0 AK Fields |
| VEH PDT | Edema | Grade 1 | 0 AK Fields |
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_UNITS) |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Edema | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Edema | Grade 0 | 20 AK Fields |
| MN + ALA 25 Min 10 mW | Edema | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Edema | Grade 1 | 3 AK Fields |
| MN + ALA 25 Min 10 mW | Edema | Grade 2 | 2 AK Fields |
| ALA 25 Min 10 mW | Edema | Grade 3 | 0 AK Fields |
| ALA 25 Min 10 mW | Edema | Grade 0 | 20 AK Fields |
| ALA 25 Min 10 mW | Edema | Grade 1 | 4 AK Fields |
| ALA 25 Min 10 mW | Edema | Grade 2 | 1 AK Fields |
| ALA 25 Min 10 mW | Edema | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Edema | Grade 3 | 1 AK Fields |
| MN + ALA 25 Min 20 mW | Edema | Grade 0 | 23 AK Fields |
| MN + ALA 25 Min 20 mW | Edema | Grade 1 | 2 AK Fields |
| MN + ALA 25 Min 20 mW | Edema | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Edema | Grade 2 | 1 AK Fields |
| ALA 25 Min 20 mW | Edema | Grade 2 | 1 AK Fields |
| ALA 25 Min 20 mW | Edema | Grade 4 | 0 AK Fields |
| ALA 25 Min 20 mW | Edema | Grade 3 | 0 AK Fields |
| ALA 25 Min 20 mW | Edema | Grade 0 | 23 AK Fields |
| ALA 25 Min 20 mW | Edema | Grade 1 | 3 AK Fields |
| MN + ALA 60 Min 10mW | Edema | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Edema | Grade 2 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Edema | Grade 1 | 5 AK Fields |
| MN + ALA 60 Min 10mW | Edema | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Edema | Grade 0 | 23 AK Fields |
| ALA 60 Min 10 mW | Edema | Grade 4 | 0 AK Fields |
| ALA 60 Min 10 mW | Edema | Grade 1 | 1 AK Fields |
| ALA 60 Min 10 mW | Edema | Grade 0 | 26 AK Fields |
| ALA 60 Min 10 mW | Edema | Grade 3 | 0 AK Fields |
| ALA 60 Min 10 mW | Edema | Grade 2 | 1 AK Fields |
| MN + ALA 60 Min 20 mW | Edema | Grade 1 | 2 AK Fields |
| MN + ALA 60 Min 20 mW | Edema | Grade 0 | 22 AK Fields |
| MN + ALA 60 Min 20 mW | Edema | Grade 2 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Edema | Grade 3 | 2 AK Fields |
| MN + ALA 60 Min 20 mW | Edema | Grade 4 | 0 AK Fields |
| ALA 60 Min 20 mW | Edema | Grade 2 | 0 AK Fields |
| ALA 60 Min 20 mW | Edema | Grade 3 | 1 AK Fields |
| ALA 60 Min 20 mW | Edema | Grade 1 | 1 AK Fields |
| ALA 60 Min 20 mW | Edema | Grade 0 | 24 AK Fields |
| ALA 60 Min 20 mW | Edema | Grade 4 | 0 AK Fields |
| MN + VEH | Edema | Grade 2 | 0 AK Fields |
| MN + VEH | Edema | Grade 4 | 0 AK Fields |
| MN + VEH | Edema | Grade 1 | 1 AK Fields |
| MN + VEH | Edema | Grade 3 | 0 AK Fields |
| MN + VEH | Edema | Grade 0 | 29 AK Fields |
| VEH PDT | Edema | Grade 3 | 0 AK Fields |
| VEH PDT | Edema | Grade 0 | 28 AK Fields |
| VEH PDT | Edema | Grade 2 | 0 AK Fields |
| VEH PDT | Edema | Grade 4 | 0 AK Fields |
| VEH PDT | Edema | Grade 1 | 2 AK Fields |
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: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Edema | Grade 2 | 3 AK Fields |
| MN + ALA 25 Min 10 mW | Edema | Grade 0 | 13 AK Fields |
| MN + ALA 25 Min 10 mW | Edema | Grade 3 | 1 AK Fields |
| MN + ALA 25 Min 10 mW | Edema | Grade 1 | 8 AK Fields |
| MN + ALA 25 Min 10 mW | Edema | Grade 4 | 0 AK Fields |
| ALA 25 Min 10 mW | Edema | Grade 3 | 1 AK Fields |
| ALA 25 Min 10 mW | Edema | Grade 2 | 2 AK Fields |
| ALA 25 Min 10 mW | Edema | Grade 1 | 4 AK Fields |
| ALA 25 Min 10 mW | Edema | Grade 0 | 18 AK Fields |
| ALA 25 Min 10 mW | Edema | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Edema | Grade 1 | 3 AK Fields |
| MN + ALA 25 Min 20 mW | Edema | Grade 3 | 1 AK Fields |
| MN + ALA 25 Min 20 mW | Edema | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Edema | Grade 2 | 3 AK Fields |
| MN + ALA 25 Min 20 mW | Edema | Grade 0 | 20 AK Fields |
| ALA 25 Min 20 mW | Edema | Grade 1 | 3 AK Fields |
| ALA 25 Min 20 mW | Edema | Grade 2 | 3 AK Fields |
| ALA 25 Min 20 mW | Edema | Grade 4 | 0 AK Fields |
| ALA 25 Min 20 mW | Edema | Grade 3 | 1 AK Fields |
| ALA 25 Min 20 mW | Edema | Grade 0 | 20 AK Fields |
| MN + ALA 60 Min 10mW | Edema | Grade 1 | 5 AK Fields |
| MN + ALA 60 Min 10mW | Edema | Grade 3 | 2 AK Fields |
| MN + ALA 60 Min 10mW | Edema | Grade 2 | 4 AK Fields |
| MN + ALA 60 Min 10mW | Edema | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Edema | Grade 0 | 17 AK Fields |
| ALA 60 Min 10 mW | Edema | Grade 3 | 2 AK Fields |
| ALA 60 Min 10 mW | Edema | Grade 0 | 14 AK Fields |
| ALA 60 Min 10 mW | Edema | Grade 2 | 3 AK Fields |
| ALA 60 Min 10 mW | Edema | Grade 1 | 9 AK Fields |
| ALA 60 Min 10 mW | Edema | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Edema | Grade 1 | 9 AK Fields |
| MN + ALA 60 Min 20 mW | Edema | Grade 3 | 2 AK Fields |
| MN + ALA 60 Min 20 mW | Edema | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Edema | Grade 0 | 8 AK Fields |
| MN + ALA 60 Min 20 mW | Edema | Grade 2 | 6 AK Fields |
| ALA 60 Min 20 mW | Edema | Grade 3 | 3 AK Fields |
| ALA 60 Min 20 mW | Edema | Grade 4 | 1 AK Fields |
| ALA 60 Min 20 mW | Edema | Grade 2 | 3 AK Fields |
| ALA 60 Min 20 mW | Edema | Grade 1 | 5 AK Fields |
| ALA 60 Min 20 mW | Edema | Grade 0 | 13 AK Fields |
| MN + VEH | Edema | Grade 0 | 29 AK Fields |
| MN + VEH | Edema | Grade 1 | 0 AK Fields |
| MN + VEH | Edema | Grade 4 | 0 AK Fields |
| MN + VEH | Edema | Grade 3 | 0 AK Fields |
| MN + VEH | Edema | Grade 2 | 1 AK Fields |
| VEH PDT | Edema | Grade 1 | 1 AK Fields |
| VEH PDT | Edema | Grade 2 | 0 AK Fields |
| VEH PDT | Edema | Grade 0 | 29 AK Fields |
| VEH PDT | Edema | Grade 4 | 0 AK Fields |
| VEH PDT | Edema | Grade 3 | 0 AK Fields |
Other Pre-specified
Edema
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time frame: 2 weeks after PDT #1
Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Edema | Grade 2 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Edema | Grade 1 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Edema | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Edema | Grade 0 | 25 AK Fields |
| MN + ALA 25 Min 10 mW | Edema | Grade 4 | 0 AK Fields |
| ALA 25 Min 10 mW | Edema | Grade 0 | 24 AK Fields |
| ALA 25 Min 10 mW | Edema | Grade 4 | 0 AK Fields |
| ALA 25 Min 10 mW | Edema | Grade 3 | 0 AK Fields |
| ALA 25 Min 10 mW | Edema | Grade 1 | 1 AK Fields |
| ALA 25 Min 10 mW | Edema | Grade 2 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Edema | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Edema | Grade 2 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Edema | Grade 1 | 2 AK Fields |
| MN + ALA 25 Min 20 mW | Edema | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Edema | Grade 0 | 25 AK Fields |
| ALA 25 Min 20 mW | Edema | Grade 0 | 25 AK Fields |
| ALA 25 Min 20 mW | Edema | Grade 3 | 0 AK Fields |
| ALA 25 Min 20 mW | Edema | Grade 4 | 0 AK Fields |
| ALA 25 Min 20 mW | Edema | Grade 1 | 2 AK Fields |
| ALA 25 Min 20 mW | Edema | Grade 2 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Edema | Grade 2 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Edema | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Edema | Grade 0 | 28 AK Fields |
| MN + ALA 60 Min 10mW | Edema | Grade 1 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Edema | Grade 3 | 0 AK Fields |
| ALA 60 Min 10 mW | Edema | Grade 0 | 28 AK Fields |
| ALA 60 Min 10 mW | Edema | Grade 1 | 0 AK Fields |
| ALA 60 Min 10 mW | Edema | Grade 2 | 0 AK Fields |
| ALA 60 Min 10 mW | Edema | Grade 4 | 0 AK Fields |
| ALA 60 Min 10 mW | Edema | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Edema | Grade 1 | 1 AK Fields |
| MN + ALA 60 Min 20 mW | Edema | Grade 0 | 24 AK Fields |
| MN + ALA 60 Min 20 mW | Edema | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Edema | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Edema | Grade 2 | 0 AK Fields |
| ALA 60 Min 20 mW | Edema | Grade 1 | 0 AK Fields |
| ALA 60 Min 20 mW | Edema | Grade 0 | 25 AK Fields |
| ALA 60 Min 20 mW | Edema | Grade 2 | 0 AK Fields |
| ALA 60 Min 20 mW | Edema | Grade 3 | 0 AK Fields |
| ALA 60 Min 20 mW | Edema | Grade 4 | 0 AK Fields |
| MN + VEH | Edema | Grade 2 | 0 AK Fields |
| MN + VEH | Edema | Grade 0 | 30 AK Fields |
| MN + VEH | Edema | Grade 1 | 0 AK Fields |
| MN + VEH | Edema | Grade 4 | 0 AK Fields |
| MN + VEH | Edema | Grade 3 | 0 AK Fields |
| VEH PDT | Edema | Grade 3 | 0 AK Fields |
| VEH PDT | Edema | Grade 4 | 0 AK Fields |
| VEH PDT | Edema | Grade 0 | 30 AK Fields |
| VEH PDT | Edema | Grade 1 | 0 AK Fields |
| VEH PDT | Edema | Grade 2 | 0 AK Fields |
Other Pre-specified
Edema
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time frame: 8 Weeks after PDT #1
Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Edema | Grade 2 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Edema | Grade 1 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Edema | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Edema | Grade 0 | 24 AK Fields |
| MN + ALA 25 Min 10 mW | Edema | Grade 4 | 0 AK Fields |
| ALA 25 Min 10 mW | Edema | Grade 0 | 24 AK Fields |
| ALA 25 Min 10 mW | Edema | Grade 2 | 0 AK Fields |
| ALA 25 Min 10 mW | Edema | Grade 4 | 0 AK Fields |
| ALA 25 Min 10 mW | Edema | Grade 3 | 0 AK Fields |
| ALA 25 Min 10 mW | Edema | Grade 1 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Edema | Grade 0 | 27 AK Fields |
| MN + ALA 25 Min 20 mW | Edema | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Edema | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Edema | Grade 1 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Edema | Grade 2 | 0 AK Fields |
| ALA 25 Min 20 mW | Edema | Grade 0 | 27 AK Fields |
| ALA 25 Min 20 mW | Edema | Grade 2 | 0 AK Fields |
| ALA 25 Min 20 mW | Edema | Grade 4 | 0 AK Fields |
| ALA 25 Min 20 mW | Edema | Grade 3 | 0 AK Fields |
| ALA 25 Min 20 mW | Edema | Grade 1 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Edema | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Edema | Grade 2 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Edema | Grade 0 | 27 AK Fields |
| MN + ALA 60 Min 10mW | Edema | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Edema | Grade 1 | 0 AK Fields |
| ALA 60 Min 10 mW | Edema | Grade 3 | 0 AK Fields |
| ALA 60 Min 10 mW | Edema | Grade 1 | 0 AK Fields |
| ALA 60 Min 10 mW | Edema | Grade 2 | 0 AK Fields |
| ALA 60 Min 10 mW | Edema | Grade 0 | 27 AK Fields |
| ALA 60 Min 10 mW | Edema | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Edema | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Edema | Grade 1 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Edema | Grade 0 | 24 AK Fields |
| MN + ALA 60 Min 20 mW | Edema | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Edema | Grade 2 | 0 AK Fields |
| ALA 60 Min 20 mW | Edema | Grade 3 | 0 AK Fields |
| ALA 60 Min 20 mW | Edema | Grade 2 | 0 AK Fields |
| ALA 60 Min 20 mW | Edema | Grade 0 | 24 AK Fields |
| ALA 60 Min 20 mW | Edema | Grade 1 | 0 AK Fields |
| ALA 60 Min 20 mW | Edema | Grade 4 | 0 AK Fields |
| MN + VEH | Edema | Grade 1 | 0 AK Fields |
| MN + VEH | Edema | Grade 2 | 0 AK Fields |
| MN + VEH | Edema | Grade 0 | 29 AK Fields |
| MN + VEH | Edema | Grade 4 | 0 AK Fields |
| MN + VEH | Edema | Grade 3 | 0 AK Fields |
| VEH PDT | Edema | Grade 3 | 0 AK Fields |
| VEH PDT | Edema | Grade 1 | 0 AK Fields |
| VEH PDT | Edema | Grade 0 | 29 AK Fields |
| VEH PDT | Edema | Grade 2 | 0 AK Fields |
| VEH PDT | Edema | Grade 4 | 0 AK Fields |
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: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Erythema | Grade 1 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Erythema | Grade 0 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Erythema | Grade 2 | 11 AK Fields |
| MN + ALA 25 Min 10 mW | Erythema | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Erythema | Grade 3 | 14 AK Fields |
| ALA 25 Min 10 mW | Erythema | Grade 2 | 14 AK Fields |
| ALA 25 Min 10 mW | Erythema | Grade 3 | 10 AK Fields |
| ALA 25 Min 10 mW | Erythema | Grade 1 | 0 AK Fields |
| ALA 25 Min 10 mW | Erythema | Grade 0 | 1 AK Fields |
| ALA 25 Min 10 mW | Erythema | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Erythema | Grade 2 | 9 AK Fields |
| MN + ALA 25 Min 20 mW | Erythema | Grade 0 | 1 AK Fields |
| MN + ALA 25 Min 20 mW | Erythema | Grade 4 | 3 AK Fields |
| MN + ALA 25 Min 20 mW | Erythema | Grade 3 | 13 AK Fields |
| MN + ALA 25 Min 20 mW | Erythema | Grade 1 | 1 AK Fields |
| ALA 25 Min 20 mW | Erythema | Grade 1 | 2 AK Fields |
| ALA 25 Min 20 mW | Erythema | Grade 4 | 2 AK Fields |
| ALA 25 Min 20 mW | Erythema | Grade 3 | 8 AK Fields |
| ALA 25 Min 20 mW | Erythema | Grade 2 | 14 AK Fields |
| ALA 25 Min 20 mW | Erythema | Grade 0 | 1 AK Fields |
| MN + ALA 60 Min 10mW | Erythema | Grade 0 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Erythema | Grade 1 | 2 AK Fields |
| MN + ALA 60 Min 10mW | Erythema | Grade 2 | 6 AK Fields |
| MN + ALA 60 Min 10mW | Erythema | Grade 3 | 17 AK Fields |
| MN + ALA 60 Min 10mW | Erythema | Grade 4 | 3 AK Fields |
| ALA 60 Min 10 mW | Erythema | Grade 0 | 0 AK Fields |
| ALA 60 Min 10 mW | Erythema | Grade 2 | 9 AK Fields |
| ALA 60 Min 10 mW | Erythema | Grade 1 | 3 AK Fields |
| ALA 60 Min 10 mW | Erythema | Grade 4 | 4 AK Fields |
| ALA 60 Min 10 mW | Erythema | Grade 3 | 12 AK Fields |
| MN + ALA 60 Min 20 mW | Erythema | Grade 2 | 10 AK Fields |
| MN + ALA 60 Min 20 mW | Erythema | Grade 3 | 12 AK Fields |
| MN + ALA 60 Min 20 mW | Erythema | Grade 4 | 3 AK Fields |
| MN + ALA 60 Min 20 mW | Erythema | Grade 0 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Erythema | Grade 1 | 0 AK Fields |
| ALA 60 Min 20 mW | Erythema | Grade 3 | 9 AK Fields |
| ALA 60 Min 20 mW | Erythema | Grade 2 | 10 AK Fields |
| ALA 60 Min 20 mW | Erythema | Grade 0 | 0 AK Fields |
| ALA 60 Min 20 mW | Erythema | Grade 4 | 4 AK Fields |
| ALA 60 Min 20 mW | Erythema | Grade 1 | 2 AK Fields |
| MN + VEH | Erythema | Grade 3 | 0 AK Fields |
| MN + VEH | Erythema | Grade 4 | 0 AK Fields |
| MN + VEH | Erythema | Grade 1 | 9 AK Fields |
| MN + VEH | Erythema | Grade 0 | 11 AK Fields |
| MN + VEH | Erythema | Grade 2 | 10 AK Fields |
| VEH PDT | Erythema | Grade 3 | 0 AK Fields |
| VEH PDT | Erythema | Grade 0 | 12 AK Fields |
| VEH PDT | Erythema | Grade 1 | 10 AK Fields |
| VEH PDT | Erythema | Grade 2 | 8 AK Fields |
| VEH PDT | Erythema | Grade 4 | 0 AK Fields |
Other Pre-specified
Erythema
Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time frame: 2 Weeks after PDT #1
Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Erythema | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Erythema | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Erythema | Grade 0 | 9 AK Fields |
| MN + ALA 25 Min 10 mW | Erythema | Grade 2 | 3 AK Fields |
| MN + ALA 25 Min 10 mW | Erythema | Grade 1 | 13 AK Fields |
| ALA 25 Min 10 mW | Erythema | Grade 4 | 0 AK Fields |
| ALA 25 Min 10 mW | Erythema | Grade 1 | 11 AK Fields |
| ALA 25 Min 10 mW | Erythema | Grade 2 | 3 AK Fields |
| ALA 25 Min 10 mW | Erythema | Grade 0 | 10 AK Fields |
| ALA 25 Min 10 mW | Erythema | Grade 3 | 1 AK Fields |
| MN + ALA 25 Min 20 mW | Erythema | Grade 1 | 9 AK Fields |
| MN + ALA 25 Min 20 mW | Erythema | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Erythema | Grade 0 | 14 AK Fields |
| MN + ALA 25 Min 20 mW | Erythema | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Erythema | Grade 2 | 4 AK Fields |
| ALA 25 Min 20 mW | Erythema | Grade 3 | 0 AK Fields |
| ALA 25 Min 20 mW | Erythema | Grade 0 | 14 AK Fields |
| ALA 25 Min 20 mW | Erythema | Grade 4 | 0 AK Fields |
| ALA 25 Min 20 mW | Erythema | Grade 1 | 10 AK Fields |
| ALA 25 Min 20 mW | Erythema | Grade 2 | 3 AK Fields |
| MN + ALA 60 Min 10mW | Erythema | Grade 1 | 9 AK Fields |
| MN + ALA 60 Min 10mW | Erythema | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Erythema | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Erythema | Grade 0 | 15 AK Fields |
| MN + ALA 60 Min 10mW | Erythema | Grade 2 | 4 AK Fields |
| ALA 60 Min 10 mW | Erythema | Grade 2 | 3 AK Fields |
| ALA 60 Min 10 mW | Erythema | Grade 0 | 15 AK Fields |
| ALA 60 Min 10 mW | Erythema | Grade 1 | 10 AK Fields |
| ALA 60 Min 10 mW | Erythema | Grade 3 | 0 AK Fields |
| ALA 60 Min 10 mW | Erythema | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Erythema | Grade 1 | 11 AK Fields |
| MN + ALA 60 Min 20 mW | Erythema | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Erythema | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Erythema | Grade 0 | 12 AK Fields |
| MN + ALA 60 Min 20 mW | Erythema | Grade 2 | 2 AK Fields |
| ALA 60 Min 20 mW | Erythema | Grade 2 | 3 AK Fields |
| ALA 60 Min 20 mW | Erythema | Grade 1 | 9 AK Fields |
| ALA 60 Min 20 mW | Erythema | Grade 3 | 0 AK Fields |
| ALA 60 Min 20 mW | Erythema | Grade 0 | 13 AK Fields |
| ALA 60 Min 20 mW | Erythema | Grade 4 | 0 AK Fields |
| MN + VEH | Erythema | Grade 0 | 13 AK Fields |
| MN + VEH | Erythema | Grade 2 | 3 AK Fields |
| MN + VEH | Erythema | Grade 1 | 14 AK Fields |
| MN + VEH | Erythema | Grade 3 | 0 AK Fields |
| MN + VEH | Erythema | Grade 4 | 0 AK Fields |
| VEH PDT | Erythema | Grade 3 | 0 AK Fields |
| VEH PDT | Erythema | Grade 0 | 13 AK Fields |
| VEH PDT | Erythema | Grade 4 | 0 AK Fields |
| VEH PDT | Erythema | Grade 1 | 14 AK Fields |
| VEH PDT | Erythema | Grade 2 | 3 AK Fields |
Other Pre-specified
Erythema
Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time frame: 8 Weeks after PDT #1
Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Erythema | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Erythema | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Erythema | Grade 0 | 12 AK Fields |
| MN + ALA 25 Min 10 mW | Erythema | Grade 2 | 2 AK Fields |
| MN + ALA 25 Min 10 mW | Erythema | Grade 1 | 10 AK Fields |
| ALA 25 Min 10 mW | Erythema | Grade 4 | 0 AK Fields |
| ALA 25 Min 10 mW | Erythema | Grade 1 | 10 AK Fields |
| ALA 25 Min 10 mW | Erythema | Grade 2 | 2 AK Fields |
| ALA 25 Min 10 mW | Erythema | Grade 0 | 12 AK Fields |
| ALA 25 Min 10 mW | Erythema | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Erythema | Grade 1 | 9 AK Fields |
| MN + ALA 25 Min 20 mW | Erythema | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Erythema | Grade 0 | 16 AK Fields |
| MN + ALA 25 Min 20 mW | Erythema | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Erythema | Grade 2 | 2 AK Fields |
| ALA 25 Min 20 mW | Erythema | Grade 3 | 0 AK Fields |
| ALA 25 Min 20 mW | Erythema | Grade 0 | 18 AK Fields |
| ALA 25 Min 20 mW | Erythema | Grade 4 | 0 AK Fields |
| ALA 25 Min 20 mW | Erythema | Grade 1 | 7 AK Fields |
| ALA 25 Min 20 mW | Erythema | Grade 2 | 2 AK Fields |
| MN + ALA 60 Min 10mW | Erythema | Grade 1 | 7 AK Fields |
| MN + ALA 60 Min 10mW | Erythema | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Erythema | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Erythema | Grade 0 | 18 AK Fields |
| MN + ALA 60 Min 10mW | Erythema | Grade 2 | 2 AK Fields |
| ALA 60 Min 10 mW | Erythema | Grade 2 | 2 AK Fields |
| ALA 60 Min 10 mW | Erythema | Grade 0 | 17 AK Fields |
| ALA 60 Min 10 mW | Erythema | Grade 1 | 8 AK Fields |
| ALA 60 Min 10 mW | Erythema | Grade 3 | 0 AK Fields |
| ALA 60 Min 10 mW | Erythema | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Erythema | Grade 1 | 7 AK Fields |
| MN + ALA 60 Min 20 mW | Erythema | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Erythema | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Erythema | Grade 0 | 16 AK Fields |
| MN + ALA 60 Min 20 mW | Erythema | Grade 2 | 1 AK Fields |
| ALA 60 Min 20 mW | Erythema | Grade 2 | 0 AK Fields |
| ALA 60 Min 20 mW | Erythema | Grade 1 | 9 AK Fields |
| ALA 60 Min 20 mW | Erythema | Grade 3 | 0 AK Fields |
| ALA 60 Min 20 mW | Erythema | Grade 0 | 15 AK Fields |
| ALA 60 Min 20 mW | Erythema | Grade 4 | 0 AK Fields |
| MN + VEH | Erythema | Grade 0 | 14 AK Fields |
| MN + VEH | Erythema | Grade 2 | 5 AK Fields |
| MN + VEH | Erythema | Grade 1 | 10 AK Fields |
| MN + VEH | Erythema | Grade 3 | 0 AK Fields |
| MN + VEH | Erythema | Grade 4 | 0 AK Fields |
| VEH PDT | Erythema | Grade 3 | 0 AK Fields |
| VEH PDT | Erythema | Grade 0 | 14 AK Fields |
| VEH PDT | Erythema | Grade 4 | 0 AK Fields |
| VEH PDT | Erythema | Grade 1 | 10 AK Fields |
| VEH PDT | Erythema | Grade 2 | 5 AK Fields |
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: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Erythema | Grade 3 | 1 AK Fields |
| MN + ALA 25 Min 10 mW | Erythema | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Erythema | Grade 0 | 15 AK Fields |
| MN + ALA 25 Min 10 mW | Erythema | Grade 2 | 1 AK Fields |
| MN + ALA 25 Min 10 mW | Erythema | Grade 1 | 7 AK Fields |
| ALA 25 Min 10 mW | Erythema | Grade 4 | 0 AK Fields |
| ALA 25 Min 10 mW | Erythema | Grade 1 | 8 AK Fields |
| ALA 25 Min 10 mW | Erythema | Grade 2 | 1 AK Fields |
| ALA 25 Min 10 mW | Erythema | Grade 0 | 14 AK Fields |
| ALA 25 Min 10 mW | Erythema | Grade 3 | 1 AK Fields |
| MN + ALA 25 Min 20 mW | Erythema | Grade 1 | 7 AK Fields |
| MN + ALA 25 Min 20 mW | Erythema | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Erythema | Grade 0 | 19 AK Fields |
| MN + ALA 25 Min 20 mW | Erythema | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Erythema | Grade 2 | 1 AK Fields |
| ALA 25 Min 20 mW | Erythema | Grade 3 | 0 AK Fields |
| ALA 25 Min 20 mW | Erythema | Grade 0 | 18 AK Fields |
| ALA 25 Min 20 mW | Erythema | Grade 4 | 0 AK Fields |
| ALA 25 Min 20 mW | Erythema | Grade 1 | 8 AK Fields |
| ALA 25 Min 20 mW | Erythema | Grade 2 | 1 AK Fields |
| MN + ALA 60 Min 10mW | Erythema | Grade 1 | 7 AK Fields |
| MN + ALA 60 Min 10mW | Erythema | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Erythema | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Erythema | Grade 0 | 20 AK Fields |
| MN + ALA 60 Min 10mW | Erythema | Grade 2 | 1 AK Fields |
| ALA 60 Min 10 mW | Erythema | Grade 2 | 1 AK Fields |
| ALA 60 Min 10 mW | Erythema | Grade 0 | 19 AK Fields |
| ALA 60 Min 10 mW | Erythema | Grade 1 | 8 AK Fields |
| ALA 60 Min 10 mW | Erythema | Grade 3 | 0 AK Fields |
| ALA 60 Min 10 mW | Erythema | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Erythema | Grade 1 | 8 AK Fields |
| MN + ALA 60 Min 20 mW | Erythema | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Erythema | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Erythema | Grade 0 | 16 AK Fields |
| MN + ALA 60 Min 20 mW | Erythema | Grade 2 | 0 AK Fields |
| ALA 60 Min 20 mW | Erythema | Grade 2 | 0 AK Fields |
| ALA 60 Min 20 mW | Erythema | Grade 1 | 7 AK Fields |
| ALA 60 Min 20 mW | Erythema | Grade 3 | 0 AK Fields |
| ALA 60 Min 20 mW | Erythema | Grade 0 | 17 AK Fields |
| ALA 60 Min 20 mW | Erythema | Grade 4 | 0 AK Fields |
| MN + VEH | Erythema | Grade 0 | 15 AK Fields |
| MN + VEH | Erythema | Grade 2 | 7 AK Fields |
| MN + VEH | Erythema | Grade 1 | 8 AK Fields |
| MN + VEH | Erythema | Grade 3 | 0 AK Fields |
| MN + VEH | Erythema | Grade 4 | 0 AK Fields |
| VEH PDT | Erythema | Grade 3 | 0 AK Fields |
| VEH PDT | Erythema | Grade 0 | 14 AK Fields |
| VEH PDT | Erythema | Grade 4 | 0 AK Fields |
| VEH PDT | Erythema | Grade 1 | 9 AK Fields |
| VEH PDT | Erythema | Grade 2 | 7 AK Fields |
Other Pre-specified
Erythema
Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time frame: Baseline
Population: split face
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Erythema | Grade 1 | 10 AK Fields |
| MN + ALA 25 Min 10 mW | Erythema | Grade 0 | 12 AK Fields |
| MN + ALA 25 Min 10 mW | Erythema | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Erythema | Grade 2 | 2 AK Fields |
| MN + ALA 25 Min 10 mW | Erythema | Grade 3 | 1 AK Fields |
| ALA 25 Min 10 mW | Erythema | Grade 3 | 1 AK Fields |
| ALA 25 Min 10 mW | Erythema | Grade 0 | 12 AK Fields |
| ALA 25 Min 10 mW | Erythema | Grade 2 | 1 AK Fields |
| ALA 25 Min 10 mW | Erythema | Grade 1 | 11 AK Fields |
| ALA 25 Min 10 mW | Erythema | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Erythema | Grade 1 | 8 AK Fields |
| MN + ALA 25 Min 20 mW | Erythema | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Erythema | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Erythema | Grade 0 | 16 AK Fields |
| MN + ALA 25 Min 20 mW | Erythema | Grade 2 | 3 AK Fields |
| ALA 25 Min 20 mW | Erythema | Grade 0 | 16 AK Fields |
| ALA 25 Min 20 mW | Erythema | Grade 1 | 8 AK Fields |
| ALA 25 Min 20 mW | Erythema | Grade 4 | 0 AK Fields |
| ALA 25 Min 20 mW | Erythema | Grade 2 | 3 AK Fields |
| ALA 25 Min 20 mW | Erythema | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Erythema | Grade 0 | 17 AK Fields |
| MN + ALA 60 Min 10mW | Erythema | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Erythema | Grade 2 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Erythema | Grade 1 | 12 AK Fields |
| MN + ALA 60 Min 10mW | Erythema | Grade 3 | 0 AK Fields |
| ALA 60 Min 10 mW | Erythema | Grade 4 | 0 AK Fields |
| ALA 60 Min 10 mW | Erythema | Grade 3 | 0 AK Fields |
| ALA 60 Min 10 mW | Erythema | Grade 0 | 16 AK Fields |
| ALA 60 Min 10 mW | Erythema | Grade 1 | 12 AK Fields |
| ALA 60 Min 10 mW | Erythema | Grade 2 | 1 AK Fields |
| MN + ALA 60 Min 20 mW | Erythema | Grade 2 | 1 AK Fields |
| MN + ALA 60 Min 20 mW | Erythema | Grade 0 | 16 AK Fields |
| MN + ALA 60 Min 20 mW | Erythema | Grade 1 | 9 AK Fields |
| MN + ALA 60 Min 20 mW | Erythema | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Erythema | Grade 4 | 0 AK Fields |
| ALA 60 Min 20 mW | Erythema | Grade 0 | 15 AK Fields |
| ALA 60 Min 20 mW | Erythema | Grade 3 | 0 AK Fields |
| ALA 60 Min 20 mW | Erythema | Grade 1 | 9 AK Fields |
| ALA 60 Min 20 mW | Erythema | Grade 4 | 0 AK Fields |
| ALA 60 Min 20 mW | Erythema | Grade 2 | 2 AK Fields |
| MN + VEH | Erythema | Grade 2 | 3 AK Fields |
| MN + VEH | Erythema | Grade 3 | 0 AK Fields |
| MN + VEH | Erythema | Grade 1 | 12 AK Fields |
| MN + VEH | Erythema | Grade 0 | 15 AK Fields |
| MN + VEH | Erythema | Grade 4 | 0 AK Fields |
| VEH PDT | Erythema | Grade 1 | 11 AK Fields |
| VEH PDT | Erythema | Grade 3 | 0 AK Fields |
| VEH PDT | Erythema | Grade 4 | 0 AK Fields |
| VEH PDT | Erythema | Grade 0 | 15 AK Fields |
| VEH PDT | Erythema | Grade 2 | 4 AK Fields |
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_UNITS) |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Erythema | Grade 1 | 3 AK Fields |
| MN + ALA 25 Min 10 mW | Erythema | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Erythema | Grade 0 | 3 AK Fields |
| MN + ALA 25 Min 10 mW | Erythema | Grade 3 | 4 AK Fields |
| MN + ALA 25 Min 10 mW | Erythema | Grade 2 | 15 AK Fields |
| ALA 25 Min 10 mW | Erythema | Grade 2 | 13 AK Fields |
| ALA 25 Min 10 mW | Erythema | Grade 4 | 0 AK Fields |
| ALA 25 Min 10 mW | Erythema | Grade 3 | 3 AK Fields |
| ALA 25 Min 10 mW | Erythema | Grade 0 | 4 AK Fields |
| ALA 25 Min 10 mW | Erythema | Grade 1 | 5 AK Fields |
| MN + ALA 25 Min 20 mW | Erythema | Grade 2 | 4 AK Fields |
| MN + ALA 25 Min 20 mW | Erythema | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Erythema | Grade 0 | 3 AK Fields |
| MN + ALA 25 Min 20 mW | Erythema | Grade 3 | 11 AK Fields |
| MN + ALA 25 Min 20 mW | Erythema | Grade 1 | 9 AK Fields |
| ALA 25 Min 20 mW | Erythema | Grade 0 | 3 AK Fields |
| ALA 25 Min 20 mW | Erythema | Grade 4 | 0 AK Fields |
| ALA 25 Min 20 mW | Erythema | Grade 2 | 7 AK Fields |
| ALA 25 Min 20 mW | Erythema | Grade 1 | 9 AK Fields |
| ALA 25 Min 20 mW | Erythema | Grade 3 | 8 AK Fields |
| MN + ALA 60 Min 10mW | Erythema | Grade 1 | 2 AK Fields |
| MN + ALA 60 Min 10mW | Erythema | Grade 0 | 2 AK Fields |
| MN + ALA 60 Min 10mW | Erythema | Grade 2 | 12 AK Fields |
| MN + ALA 60 Min 10mW | Erythema | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Erythema | Grade 3 | 12 AK Fields |
| ALA 60 Min 10 mW | Erythema | Grade 3 | 10 AK Fields |
| ALA 60 Min 10 mW | Erythema | Grade 0 | 2 AK Fields |
| ALA 60 Min 10 mW | Erythema | Grade 1 | 4 AK Fields |
| ALA 60 Min 10 mW | Erythema | Grade 2 | 12 AK Fields |
| ALA 60 Min 10 mW | Erythema | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Erythema | Grade 0 | 1 AK Fields |
| MN + ALA 60 Min 20 mW | Erythema | Grade 4 | 1 AK Fields |
| MN + ALA 60 Min 20 mW | Erythema | Grade 2 | 9 AK Fields |
| MN + ALA 60 Min 20 mW | Erythema | Grade 1 | 6 AK Fields |
| MN + ALA 60 Min 20 mW | Erythema | Grade 3 | 9 AK Fields |
| ALA 60 Min 20 mW | Erythema | Grade 1 | 8 AK Fields |
| ALA 60 Min 20 mW | Erythema | Grade 2 | 10 AK Fields |
| ALA 60 Min 20 mW | Erythema | Grade 0 | 1 AK Fields |
| ALA 60 Min 20 mW | Erythema | Grade 3 | 5 AK Fields |
| ALA 60 Min 20 mW | Erythema | Grade 4 | 2 AK Fields |
| MN + VEH | Erythema | Grade 2 | 10 AK Fields |
| MN + VEH | Erythema | Grade 4 | 0 AK Fields |
| MN + VEH | Erythema | Grade 1 | 7 AK Fields |
| MN + VEH | Erythema | Grade 3 | 1 AK Fields |
| MN + VEH | Erythema | Grade 0 | 12 AK Fields |
| VEH PDT | Erythema | Grade 3 | 1 AK Fields |
| VEH PDT | Erythema | Grade 1 | 9 AK Fields |
| VEH PDT | Erythema | Grade 0 | 12 AK Fields |
| VEH PDT | Erythema | Grade 2 | 8 AK Fields |
| VEH PDT | Erythema | Grade 4 | 0 AK Fields |
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: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Hyperpigmentation | Grade 2 | 1 AK Fields |
| MN + ALA 25 Min 10 mW | Hyperpigmentation | Grade 0 | 10 AK Fields |
| MN + ALA 25 Min 10 mW | Hyperpigmentation | Grade 1 | 12 AK Fields |
| MN + ALA 25 Min 10 mW | Hyperpigmentation | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Hyperpigmentation | Grade 3 | 1 AK Fields |
| ALA 25 Min 10 mW | Hyperpigmentation | Grade 2 | 1 AK Fields |
| ALA 25 Min 10 mW | Hyperpigmentation | Grade 1 | 12 AK Fields |
| ALA 25 Min 10 mW | Hyperpigmentation | Grade 3 | 0 AK Fields |
| ALA 25 Min 10 mW | Hyperpigmentation | Grade 0 | 10 AK Fields |
| ALA 25 Min 10 mW | Hyperpigmentation | Grade 4 | 1 AK Fields |
| MN + ALA 25 Min 20 mW | Hyperpigmentation | Grade 2 | 5 AK Fields |
| MN + ALA 25 Min 20 mW | Hyperpigmentation | Grade 0 | 15 AK Fields |
| MN + ALA 25 Min 20 mW | Hyperpigmentation | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Hyperpigmentation | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Hyperpigmentation | Grade 1 | 7 AK Fields |
| ALA 25 Min 20 mW | Hyperpigmentation | Grade 4 | 0 AK Fields |
| ALA 25 Min 20 mW | Hyperpigmentation | Grade 1 | 7 AK Fields |
| ALA 25 Min 20 mW | Hyperpigmentation | Grade 3 | 0 AK Fields |
| ALA 25 Min 20 mW | Hyperpigmentation | Grade 2 | 5 AK Fields |
| ALA 25 Min 20 mW | Hyperpigmentation | Grade 0 | 15 AK Fields |
| MN + ALA 60 Min 10mW | Hyperpigmentation | Grade 0 | 19 AK Fields |
| MN + ALA 60 Min 10mW | Hyperpigmentation | Grade 1 | 8 AK Fields |
| MN + ALA 60 Min 10mW | Hyperpigmentation | Grade 2 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Hyperpigmentation | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Hyperpigmentation | Grade 4 | 1 AK Fields |
| ALA 60 Min 10 mW | Hyperpigmentation | Grade 4 | 1 AK Fields |
| ALA 60 Min 10 mW | Hyperpigmentation | Grade 2 | 0 AK Fields |
| ALA 60 Min 10 mW | Hyperpigmentation | Grade 1 | 8 AK Fields |
| ALA 60 Min 10 mW | Hyperpigmentation | Grade 0 | 19 AK Fields |
| ALA 60 Min 10 mW | Hyperpigmentation | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Hyperpigmentation | Grade 0 | 10 AK Fields |
| MN + ALA 60 Min 20 mW | Hyperpigmentation | Grade 2 | 1 AK Fields |
| MN + ALA 60 Min 20 mW | Hyperpigmentation | Grade 4 | 1 AK Fields |
| MN + ALA 60 Min 20 mW | Hyperpigmentation | Grade 1 | 10 AK Fields |
| MN + ALA 60 Min 20 mW | Hyperpigmentation | Grade 3 | 2 AK Fields |
| ALA 60 Min 20 mW | Hyperpigmentation | Grade 1 | 9 AK Fields |
| ALA 60 Min 20 mW | Hyperpigmentation | Grade 2 | 3 AK Fields |
| ALA 60 Min 20 mW | Hyperpigmentation | Grade 0 | 10 AK Fields |
| ALA 60 Min 20 mW | Hyperpigmentation | Grade 3 | 1 AK Fields |
| ALA 60 Min 20 mW | Hyperpigmentation | Grade 4 | 1 AK Fields |
| MN + VEH | Hyperpigmentation | Grade 1 | 10 AK Fields |
| MN + VEH | Hyperpigmentation | Grade 2 | 2 AK Fields |
| MN + VEH | Hyperpigmentation | Grade 4 | 0 AK Fields |
| MN + VEH | Hyperpigmentation | Grade 3 | 2 AK Fields |
| MN + VEH | Hyperpigmentation | Grade 0 | 16 AK Fields |
| VEH PDT | Hyperpigmentation | Grade 3 | 2 AK Fields |
| VEH PDT | Hyperpigmentation | Grade 0 | 16 AK Fields |
| VEH PDT | Hyperpigmentation | Grade 4 | 0 AK Fields |
| VEH PDT | Hyperpigmentation | Grade 2 | 1 AK Fields |
| VEH PDT | Hyperpigmentation | Grade 1 | 11 AK Fields |
Other Pre-specified
Hyperpigmentation
HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Time frame: 2 Weeks after PDT #1
Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Hyperpigmentation | Grade 3 | 1 AK Fields |
| MN + ALA 25 Min 10 mW | Hyperpigmentation | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Hyperpigmentation | Grade 0 | 11 AK Fields |
| MN + ALA 25 Min 10 mW | Hyperpigmentation | Grade 2 | 1 AK Fields |
| MN + ALA 25 Min 10 mW | Hyperpigmentation | Grade 1 | 12 AK Fields |
| ALA 25 Min 10 mW | Hyperpigmentation | Grade 4 | 0 AK Fields |
| ALA 25 Min 10 mW | Hyperpigmentation | Grade 1 | 12 AK Fields |
| ALA 25 Min 10 mW | Hyperpigmentation | Grade 2 | 1 AK Fields |
| ALA 25 Min 10 mW | Hyperpigmentation | Grade 0 | 11 AK Fields |
| ALA 25 Min 10 mW | Hyperpigmentation | Grade 3 | 1 AK Fields |
| MN + ALA 25 Min 20 mW | Hyperpigmentation | Grade 1 | 8 AK Fields |
| MN + ALA 25 Min 20 mW | Hyperpigmentation | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Hyperpigmentation | Grade 0 | 14 AK Fields |
| MN + ALA 25 Min 20 mW | Hyperpigmentation | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Hyperpigmentation | Grade 2 | 5 AK Fields |
| ALA 25 Min 20 mW | Hyperpigmentation | Grade 3 | 0 AK Fields |
| ALA 25 Min 20 mW | Hyperpigmentation | Grade 0 | 14 AK Fields |
| ALA 25 Min 20 mW | Hyperpigmentation | Grade 4 | 0 AK Fields |
| ALA 25 Min 20 mW | Hyperpigmentation | Grade 1 | 8 AK Fields |
| ALA 25 Min 20 mW | Hyperpigmentation | Grade 2 | 5 AK Fields |
| MN + ALA 60 Min 10mW | Hyperpigmentation | Grade 1 | 9 AK Fields |
| MN + ALA 60 Min 10mW | Hyperpigmentation | Grade 4 | 1 AK Fields |
| MN + ALA 60 Min 10mW | Hyperpigmentation | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Hyperpigmentation | Grade 0 | 16 AK Fields |
| MN + ALA 60 Min 10mW | Hyperpigmentation | Grade 2 | 2 AK Fields |
| ALA 60 Min 10 mW | Hyperpigmentation | Grade 2 | 2 AK Fields |
| ALA 60 Min 10 mW | Hyperpigmentation | Grade 0 | 16 AK Fields |
| ALA 60 Min 10 mW | Hyperpigmentation | Grade 1 | 9 AK Fields |
| ALA 60 Min 10 mW | Hyperpigmentation | Grade 3 | 0 AK Fields |
| ALA 60 Min 10 mW | Hyperpigmentation | Grade 4 | 1 AK Fields |
| MN + ALA 60 Min 20 mW | Hyperpigmentation | Grade 1 | 8 AK Fields |
| MN + ALA 60 Min 20 mW | Hyperpigmentation | Grade 3 | 2 AK Fields |
| MN + ALA 60 Min 20 mW | Hyperpigmentation | Grade 4 | 1 AK Fields |
| MN + ALA 60 Min 20 mW | Hyperpigmentation | Grade 0 | 12 AK Fields |
| MN + ALA 60 Min 20 mW | Hyperpigmentation | Grade 2 | 2 AK Fields |
| ALA 60 Min 20 mW | Hyperpigmentation | Grade 2 | 3 AK Fields |
| ALA 60 Min 20 mW | Hyperpigmentation | Grade 1 | 8 AK Fields |
| ALA 60 Min 20 mW | Hyperpigmentation | Grade 3 | 1 AK Fields |
| ALA 60 Min 20 mW | Hyperpigmentation | Grade 0 | 12 AK Fields |
| ALA 60 Min 20 mW | Hyperpigmentation | Grade 4 | 1 AK Fields |
| MN + VEH | Hyperpigmentation | Grade 0 | 16 AK Fields |
| MN + VEH | Hyperpigmentation | Grade 2 | 2 AK Fields |
| MN + VEH | Hyperpigmentation | Grade 1 | 11 AK Fields |
| MN + VEH | Hyperpigmentation | Grade 3 | 1 AK Fields |
| MN + VEH | Hyperpigmentation | Grade 4 | 0 AK Fields |
| VEH PDT | Hyperpigmentation | Grade 3 | 2 AK Fields |
| VEH PDT | Hyperpigmentation | Grade 0 | 15 AK Fields |
| VEH PDT | Hyperpigmentation | Grade 4 | 0 AK Fields |
| VEH PDT | Hyperpigmentation | Grade 1 | 13 AK Fields |
| VEH PDT | Hyperpigmentation | Grade 2 | 0 AK Fields |
Other Pre-specified
Hyperpigmentation
HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Time frame: 24-48 hours after PDT #1
Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Hyperpigmentation | Grade 1 | 11 AK Fields |
| MN + ALA 25 Min 10 mW | Hyperpigmentation | Grade 3 | 1 AK Fields |
| MN + ALA 25 Min 10 mW | Hyperpigmentation | Grade 0 | 12 AK Fields |
| MN + ALA 25 Min 10 mW | Hyperpigmentation | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Hyperpigmentation | Grade 2 | 1 AK Fields |
| ALA 25 Min 10 mW | Hyperpigmentation | Grade 1 | 11 AK Fields |
| ALA 25 Min 10 mW | Hyperpigmentation | Grade 0 | 12 AK Fields |
| ALA 25 Min 10 mW | Hyperpigmentation | Grade 4 | 1 AK Fields |
| ALA 25 Min 10 mW | Hyperpigmentation | Grade 2 | 1 AK Fields |
| ALA 25 Min 10 mW | Hyperpigmentation | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Hyperpigmentation | Grade 0 | 15 AK Fields |
| MN + ALA 25 Min 20 mW | Hyperpigmentation | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Hyperpigmentation | Grade 2 | 6 AK Fields |
| MN + ALA 25 Min 20 mW | Hyperpigmentation | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Hyperpigmentation | Grade 1 | 6 AK Fields |
| ALA 25 Min 20 mW | Hyperpigmentation | Grade 1 | 7 AK Fields |
| ALA 25 Min 20 mW | Hyperpigmentation | Grade 2 | 5 AK Fields |
| ALA 25 Min 20 mW | Hyperpigmentation | Grade 3 | 0 AK Fields |
| ALA 25 Min 20 mW | Hyperpigmentation | Grade 4 | 0 AK Fields |
| ALA 25 Min 20 mW | Hyperpigmentation | Grade 0 | 15 AK Fields |
| MN + ALA 60 Min 10mW | Hyperpigmentation | Grade 4 | 1 AK Fields |
| MN + ALA 60 Min 10mW | Hyperpigmentation | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Hyperpigmentation | Grade 0 | 14 AK Fields |
| MN + ALA 60 Min 10mW | Hyperpigmentation | Grade 2 | 2 AK Fields |
| MN + ALA 60 Min 10mW | Hyperpigmentation | Grade 1 | 11 AK Fields |
| ALA 60 Min 10 mW | Hyperpigmentation | Grade 1 | 10 AK Fields |
| ALA 60 Min 10 mW | Hyperpigmentation | Grade 4 | 1 AK Fields |
| ALA 60 Min 10 mW | Hyperpigmentation | Grade 3 | 0 AK Fields |
| ALA 60 Min 10 mW | Hyperpigmentation | Grade 2 | 2 AK Fields |
| ALA 60 Min 10 mW | Hyperpigmentation | Grade 0 | 15 AK Fields |
| MN + ALA 60 Min 20 mW | Hyperpigmentation | Grade 0 | 10 AK Fields |
| MN + ALA 60 Min 20 mW | Hyperpigmentation | Grade 3 | 2 AK Fields |
| MN + ALA 60 Min 20 mW | Hyperpigmentation | Grade 2 | 1 AK Fields |
| MN + ALA 60 Min 20 mW | Hyperpigmentation | Grade 4 | 1 AK Fields |
| MN + ALA 60 Min 20 mW | Hyperpigmentation | Grade 1 | 11 AK Fields |
| ALA 60 Min 20 mW | Hyperpigmentation | Grade 2 | 2 AK Fields |
| ALA 60 Min 20 mW | Hyperpigmentation | Grade 3 | 1 AK Fields |
| ALA 60 Min 20 mW | Hyperpigmentation | Grade 1 | 11 AK Fields |
| ALA 60 Min 20 mW | Hyperpigmentation | Grade 4 | 1 AK Fields |
| ALA 60 Min 20 mW | Hyperpigmentation | Grade 0 | 10 AK Fields |
| MN + VEH | Hyperpigmentation | Grade 4 | 0 AK Fields |
| MN + VEH | Hyperpigmentation | Grade 1 | 12 AK Fields |
| MN + VEH | Hyperpigmentation | Grade 3 | 2 AK Fields |
| MN + VEH | Hyperpigmentation | Grade 0 | 15 AK Fields |
| MN + VEH | Hyperpigmentation | Grade 2 | 1 AK Fields |
| VEH PDT | Hyperpigmentation | Grade 2 | 0 AK Fields |
| VEH PDT | Hyperpigmentation | Grade 0 | 15 AK Fields |
| VEH PDT | Hyperpigmentation | Grade 4 | 1 AK Fields |
| VEH PDT | Hyperpigmentation | Grade 3 | 1 AK Fields |
| VEH PDT | Hyperpigmentation | Grade 1 | 13 AK Fields |
Other Pre-specified
Hyperpigmentation
HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Time frame: Baseline
Population: split-face
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Hyperpigmentation | Grade 2 | 2 AK Fields |
| MN + ALA 25 Min 10 mW | Hyperpigmentation | Grade 3 | 1 AK Fields |
| MN + ALA 25 Min 10 mW | Hyperpigmentation | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Hyperpigmentation | Grade 0 | 12 AK Fields |
| MN + ALA 25 Min 10 mW | Hyperpigmentation | Grade 1 | 10 AK Fields |
| ALA 25 Min 10 mW | Hyperpigmentation | Grade 3 | 0 AK Fields |
| ALA 25 Min 10 mW | Hyperpigmentation | Grade 0 | 12 AK Fields |
| ALA 25 Min 10 mW | Hyperpigmentation | Grade 2 | 1 AK Fields |
| ALA 25 Min 10 mW | Hyperpigmentation | Grade 4 | 1 AK Fields |
| ALA 25 Min 10 mW | Hyperpigmentation | Grade 1 | 11 AK Fields |
| MN + ALA 25 Min 20 mW | Hyperpigmentation | Grade 0 | 16 AK Fields |
| MN + ALA 25 Min 20 mW | Hyperpigmentation | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Hyperpigmentation | Grade 2 | 5 AK Fields |
| MN + ALA 25 Min 20 mW | Hyperpigmentation | Grade 1 | 6 AK Fields |
| MN + ALA 25 Min 20 mW | Hyperpigmentation | Grade 4 | 0 AK Fields |
| ALA 25 Min 20 mW | Hyperpigmentation | Grade 0 | 16 AK Fields |
| ALA 25 Min 20 mW | Hyperpigmentation | Grade 3 | 0 AK Fields |
| ALA 25 Min 20 mW | Hyperpigmentation | Grade 4 | 0 AK Fields |
| ALA 25 Min 20 mW | Hyperpigmentation | Grade 2 | 5 AK Fields |
| ALA 25 Min 20 mW | Hyperpigmentation | Grade 1 | 6 AK Fields |
| MN + ALA 60 Min 10mW | Hyperpigmentation | Grade 2 | 1 AK Fields |
| MN + ALA 60 Min 10mW | Hyperpigmentation | Grade 0 | 16 AK Fields |
| MN + ALA 60 Min 10mW | Hyperpigmentation | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Hyperpigmentation | Grade 1 | 11 AK Fields |
| MN + ALA 60 Min 10mW | Hyperpigmentation | Grade 4 | 1 AK Fields |
| ALA 60 Min 10 mW | Hyperpigmentation | Grade 3 | 0 AK Fields |
| ALA 60 Min 10 mW | Hyperpigmentation | Grade 1 | 9 AK Fields |
| ALA 60 Min 10 mW | Hyperpigmentation | Grade 2 | 3 AK Fields |
| ALA 60 Min 10 mW | Hyperpigmentation | Grade 0 | 16 AK Fields |
| ALA 60 Min 10 mW | Hyperpigmentation | Grade 4 | 1 AK Fields |
| MN + ALA 60 Min 20 mW | Hyperpigmentation | Grade 2 | 3 AK Fields |
| MN + ALA 60 Min 20 mW | Hyperpigmentation | Grade 1 | 8 AK Fields |
| MN + ALA 60 Min 20 mW | Hyperpigmentation | Grade 0 | 13 AK Fields |
| MN + ALA 60 Min 20 mW | Hyperpigmentation | Grade 3 | 1 AK Fields |
| MN + ALA 60 Min 20 mW | Hyperpigmentation | Grade 4 | 1 AK Fields |
| ALA 60 Min 20 mW | Hyperpigmentation | Grade 3 | 1 AK Fields |
| ALA 60 Min 20 mW | Hyperpigmentation | Grade 0 | 13 AK Fields |
| ALA 60 Min 20 mW | Hyperpigmentation | Grade 1 | 8 AK Fields |
| ALA 60 Min 20 mW | Hyperpigmentation | Grade 2 | 3 AK Fields |
| ALA 60 Min 20 mW | Hyperpigmentation | Grade 4 | 1 AK Fields |
| MN + VEH | Hyperpigmentation | Grade 3 | 2 AK Fields |
| MN + VEH | Hyperpigmentation | Grade 2 | 1 AK Fields |
| MN + VEH | Hyperpigmentation | Grade 4 | 0 AK Fields |
| MN + VEH | Hyperpigmentation | Grade 0 | 15 AK Fields |
| MN + VEH | Hyperpigmentation | Grade 1 | 12 AK Fields |
| VEH PDT | Hyperpigmentation | Grade 4 | 1 AK Fields |
| VEH PDT | Hyperpigmentation | Grade 2 | 0 AK Fields |
| VEH PDT | Hyperpigmentation | Grade 1 | 13 AK Fields |
| VEH PDT | Hyperpigmentation | Grade 3 | 1 AK Fields |
| VEH PDT | Hyperpigmentation | Grade 0 | 15 AK Fields |
Other Pre-specified
Hyperpigmentation
HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Time frame: 8 Weeks after PDT #1
Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Hyperpigmentation | Grade 0 | 11 AK Fields |
| MN + ALA 25 Min 10 mW | Hyperpigmentation | Grade 3 | 1 AK Fields |
| MN + ALA 25 Min 10 mW | Hyperpigmentation | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Hyperpigmentation | Grade 1 | 11 AK Fields |
| MN + ALA 25 Min 10 mW | Hyperpigmentation | Grade 2 | 1 AK Fields |
| ALA 25 Min 10 mW | Hyperpigmentation | Grade 2 | 1 AK Fields |
| ALA 25 Min 10 mW | Hyperpigmentation | Grade 4 | 1 AK Fields |
| ALA 25 Min 10 mW | Hyperpigmentation | Grade 0 | 11 AK Fields |
| ALA 25 Min 10 mW | Hyperpigmentation | Grade 1 | 11 AK Fields |
| ALA 25 Min 10 mW | Hyperpigmentation | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Hyperpigmentation | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Hyperpigmentation | Grade 0 | 16 AK Fields |
| MN + ALA 25 Min 20 mW | Hyperpigmentation | Grade 1 | 6 AK Fields |
| MN + ALA 25 Min 20 mW | Hyperpigmentation | Grade 2 | 5 AK Fields |
| MN + ALA 25 Min 20 mW | Hyperpigmentation | Grade 3 | 0 AK Fields |
| ALA 25 Min 20 mW | Hyperpigmentation | Grade 3 | 0 AK Fields |
| ALA 25 Min 20 mW | Hyperpigmentation | Grade 2 | 5 AK Fields |
| ALA 25 Min 20 mW | Hyperpigmentation | Grade 0 | 16 AK Fields |
| ALA 25 Min 20 mW | Hyperpigmentation | Grade 1 | 6 AK Fields |
| ALA 25 Min 20 mW | Hyperpigmentation | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Hyperpigmentation | Grade 0 | 16 AK Fields |
| MN + ALA 60 Min 10mW | Hyperpigmentation | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Hyperpigmentation | Grade 2 | 3 AK Fields |
| MN + ALA 60 Min 10mW | Hyperpigmentation | Grade 1 | 7 AK Fields |
| MN + ALA 60 Min 10mW | Hyperpigmentation | Grade 4 | 1 AK Fields |
| ALA 60 Min 10 mW | Hyperpigmentation | Grade 4 | 1 AK Fields |
| ALA 60 Min 10 mW | Hyperpigmentation | Grade 0 | 16 AK Fields |
| ALA 60 Min 10 mW | Hyperpigmentation | Grade 1 | 8 AK Fields |
| ALA 60 Min 10 mW | Hyperpigmentation | Grade 2 | 2 AK Fields |
| ALA 60 Min 10 mW | Hyperpigmentation | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Hyperpigmentation | Grade 2 | 3 AK Fields |
| MN + ALA 60 Min 20 mW | Hyperpigmentation | Grade 1 | 9 AK Fields |
| MN + ALA 60 Min 20 mW | Hyperpigmentation | Grade 4 | 1 AK Fields |
| MN + ALA 60 Min 20 mW | Hyperpigmentation | Grade 3 | 1 AK Fields |
| MN + ALA 60 Min 20 mW | Hyperpigmentation | Grade 0 | 10 AK Fields |
| ALA 60 Min 20 mW | Hyperpigmentation | Grade 0 | 10 AK Fields |
| ALA 60 Min 20 mW | Hyperpigmentation | Grade 3 | 1 AK Fields |
| ALA 60 Min 20 mW | Hyperpigmentation | Grade 2 | 3 AK Fields |
| ALA 60 Min 20 mW | Hyperpigmentation | Grade 4 | 1 AK Fields |
| ALA 60 Min 20 mW | Hyperpigmentation | Grade 1 | 9 AK Fields |
| MN + VEH | Hyperpigmentation | Grade 3 | 2 AK Fields |
| MN + VEH | Hyperpigmentation | Grade 0 | 16 AK Fields |
| MN + VEH | Hyperpigmentation | Grade 4 | 0 AK Fields |
| MN + VEH | Hyperpigmentation | Grade 1 | 10 AK Fields |
| MN + VEH | Hyperpigmentation | Grade 2 | 1 AK Fields |
| VEH PDT | Hyperpigmentation | Grade 1 | 10 AK Fields |
| VEH PDT | Hyperpigmentation | Grade 4 | 0 AK Fields |
| VEH PDT | Hyperpigmentation | Grade 0 | 16 AK Fields |
| VEH PDT | Hyperpigmentation | Grade 2 | 1 AK Fields |
| VEH PDT | Hyperpigmentation | Grade 3 | 2 AK Fields |
Other Pre-specified
Hypopigmentation
HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Time frame: 24-48 hours after PDT #1
Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Hypopigmentation | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Hypopigmentation | Grade 2 | 1 AK Fields |
| MN + ALA 25 Min 10 mW | Hypopigmentation | Grade 0 | 17 AK Fields |
| MN + ALA 25 Min 10 mW | Hypopigmentation | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Hypopigmentation | Grade 1 | 7 AK Fields |
| ALA 25 Min 10 mW | Hypopigmentation | Grade 0 | 18 AK Fields |
| ALA 25 Min 10 mW | Hypopigmentation | Grade 4 | 0 AK Fields |
| ALA 25 Min 10 mW | Hypopigmentation | Grade 3 | 0 AK Fields |
| ALA 25 Min 10 mW | Hypopigmentation | Grade 1 | 6 AK Fields |
| ALA 25 Min 10 mW | Hypopigmentation | Grade 2 | 1 AK Fields |
| MN + ALA 25 Min 20 mW | Hypopigmentation | Grade 0 | 20 AK Fields |
| MN + ALA 25 Min 20 mW | Hypopigmentation | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Hypopigmentation | Grade 1 | 7 AK Fields |
| MN + ALA 25 Min 20 mW | Hypopigmentation | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Hypopigmentation | Grade 2 | 0 AK Fields |
| ALA 25 Min 20 mW | Hypopigmentation | Grade 4 | 0 AK Fields |
| ALA 25 Min 20 mW | Hypopigmentation | Grade 0 | 21 AK Fields |
| ALA 25 Min 20 mW | Hypopigmentation | Grade 1 | 6 AK Fields |
| ALA 25 Min 20 mW | Hypopigmentation | Grade 2 | 0 AK Fields |
| ALA 25 Min 20 mW | Hypopigmentation | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Hypopigmentation | Grade 1 | 5 AK Fields |
| MN + ALA 60 Min 10mW | Hypopigmentation | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Hypopigmentation | Grade 0 | 22 AK Fields |
| MN + ALA 60 Min 10mW | Hypopigmentation | Grade 2 | 1 AK Fields |
| MN + ALA 60 Min 10mW | Hypopigmentation | Grade 3 | 0 AK Fields |
| ALA 60 Min 10 mW | Hypopigmentation | Grade 4 | 0 AK Fields |
| ALA 60 Min 10 mW | Hypopigmentation | Grade 2 | 1 AK Fields |
| ALA 60 Min 10 mW | Hypopigmentation | Grade 3 | 0 AK Fields |
| ALA 60 Min 10 mW | Hypopigmentation | Grade 0 | 23 AK Fields |
| ALA 60 Min 10 mW | Hypopigmentation | Grade 1 | 4 AK Fields |
| MN + ALA 60 Min 20 mW | Hypopigmentation | Grade 3 | 1 AK Fields |
| MN + ALA 60 Min 20 mW | Hypopigmentation | Grade 2 | 1 AK Fields |
| MN + ALA 60 Min 20 mW | Hypopigmentation | Grade 0 | 18 AK Fields |
| MN + ALA 60 Min 20 mW | Hypopigmentation | Grade 1 | 5 AK Fields |
| MN + ALA 60 Min 20 mW | Hypopigmentation | Grade 4 | 0 AK Fields |
| ALA 60 Min 20 mW | Hypopigmentation | Grade 1 | 5 AK Fields |
| ALA 60 Min 20 mW | Hypopigmentation | Grade 2 | 1 AK Fields |
| ALA 60 Min 20 mW | Hypopigmentation | Grade 3 | 1 AK Fields |
| ALA 60 Min 20 mW | Hypopigmentation | Grade 0 | 18 AK Fields |
| ALA 60 Min 20 mW | Hypopigmentation | Grade 4 | 0 AK Fields |
| MN + VEH | Hypopigmentation | Grade 2 | 0 AK Fields |
| MN + VEH | Hypopigmentation | Grade 4 | 0 AK Fields |
| MN + VEH | Hypopigmentation | Grade 1 | 4 AK Fields |
| MN + VEH | Hypopigmentation | Grade 3 | 0 AK Fields |
| MN + VEH | Hypopigmentation | Grade 0 | 26 AK Fields |
| VEH PDT | Hypopigmentation | Grade 3 | 0 AK Fields |
| VEH PDT | Hypopigmentation | Grade 1 | 3 AK Fields |
| VEH PDT | Hypopigmentation | Grade 0 | 27 AK Fields |
| VEH PDT | Hypopigmentation | Grade 2 | 0 AK Fields |
| VEH PDT | Hypopigmentation | Grade 4 | 0 AK Fields |
Other Pre-specified
Hypopigmentation
HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Time frame: 2 Weeks after PDT #1
Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Hypopigmentation | Grade 2 | 1 AK Fields |
| MN + ALA 25 Min 10 mW | Hypopigmentation | Grade 0 | 15 AK Fields |
| MN + ALA 25 Min 10 mW | Hypopigmentation | Grade 1 | 9 AK Fields |
| MN + ALA 25 Min 10 mW | Hypopigmentation | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Hypopigmentation | Grade 4 | 0 AK Fields |
| ALA 25 Min 10 mW | Hypopigmentation | Grade 4 | 0 AK Fields |
| ALA 25 Min 10 mW | Hypopigmentation | Grade 1 | 7 AK Fields |
| ALA 25 Min 10 mW | Hypopigmentation | Grade 2 | 1 AK Fields |
| ALA 25 Min 10 mW | Hypopigmentation | Grade 3 | 0 AK Fields |
| ALA 25 Min 10 mW | Hypopigmentation | Grade 0 | 17 AK Fields |
| MN + ALA 25 Min 20 mW | Hypopigmentation | Grade 1 | 6 AK Fields |
| MN + ALA 25 Min 20 mW | Hypopigmentation | Grade 2 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Hypopigmentation | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Hypopigmentation | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Hypopigmentation | Grade 0 | 21 AK Fields |
| ALA 25 Min 20 mW | Hypopigmentation | Grade 0 | 22 AK Fields |
| ALA 25 Min 20 mW | Hypopigmentation | Grade 4 | 0 AK Fields |
| ALA 25 Min 20 mW | Hypopigmentation | Grade 2 | 0 AK Fields |
| ALA 25 Min 20 mW | Hypopigmentation | Grade 3 | 0 AK Fields |
| ALA 25 Min 20 mW | Hypopigmentation | Grade 1 | 5 AK Fields |
| MN + ALA 60 Min 10mW | Hypopigmentation | Grade 2 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Hypopigmentation | Grade 0 | 21 AK Fields |
| MN + ALA 60 Min 10mW | Hypopigmentation | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Hypopigmentation | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Hypopigmentation | Grade 1 | 7 AK Fields |
| ALA 60 Min 10 mW | Hypopigmentation | Grade 1 | 4 AK Fields |
| ALA 60 Min 10 mW | Hypopigmentation | Grade 2 | 1 AK Fields |
| ALA 60 Min 10 mW | Hypopigmentation | Grade 3 | 0 AK Fields |
| ALA 60 Min 10 mW | Hypopigmentation | Grade 4 | 0 AK Fields |
| ALA 60 Min 10 mW | Hypopigmentation | Grade 0 | 23 AK Fields |
| MN + ALA 60 Min 20 mW | Hypopigmentation | Grade 1 | 8 AK Fields |
| MN + ALA 60 Min 20 mW | Hypopigmentation | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Hypopigmentation | Grade 0 | 16 AK Fields |
| MN + ALA 60 Min 20 mW | Hypopigmentation | Grade 2 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Hypopigmentation | Grade 4 | 1 AK Fields |
| ALA 60 Min 20 mW | Hypopigmentation | Grade 1 | 8 AK Fields |
| ALA 60 Min 20 mW | Hypopigmentation | Grade 0 | 16 AK Fields |
| ALA 60 Min 20 mW | Hypopigmentation | Grade 2 | 0 AK Fields |
| ALA 60 Min 20 mW | Hypopigmentation | Grade 4 | 1 AK Fields |
| ALA 60 Min 20 mW | Hypopigmentation | Grade 3 | 0 AK Fields |
| MN + VEH | Hypopigmentation | Grade 0 | 25 AK Fields |
| MN + VEH | Hypopigmentation | Grade 2 | 0 AK Fields |
| MN + VEH | Hypopigmentation | Grade 3 | 0 AK Fields |
| MN + VEH | Hypopigmentation | Grade 1 | 5 AK Fields |
| MN + VEH | Hypopigmentation | Grade 4 | 0 AK Fields |
| VEH PDT | Hypopigmentation | Grade 1 | 4 AK Fields |
| VEH PDT | Hypopigmentation | Grade 0 | 26 AK Fields |
| VEH PDT | Hypopigmentation | Grade 2 | 0 AK Fields |
| VEH PDT | Hypopigmentation | Grade 4 | 0 AK Fields |
| VEH PDT | Hypopigmentation | Grade 3 | 0 AK Fields |
Other Pre-specified
Hypopigmentation
HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Time frame: 8 Weeks after PDT #1
Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Hypopigmentation | Grade 1 | 8 AK Fields |
| MN + ALA 25 Min 10 mW | Hypopigmentation | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Hypopigmentation | Grade 0 | 15 AK Fields |
| MN + ALA 25 Min 10 mW | Hypopigmentation | Grade 2 | 1 AK Fields |
| MN + ALA 25 Min 10 mW | Hypopigmentation | Grade 4 | 0 AK Fields |
| ALA 25 Min 10 mW | Hypopigmentation | Grade 2 | 1 AK Fields |
| ALA 25 Min 10 mW | Hypopigmentation | Grade 3 | 0 AK Fields |
| ALA 25 Min 10 mW | Hypopigmentation | Grade 1 | 6 AK Fields |
| ALA 25 Min 10 mW | Hypopigmentation | Grade 0 | 17 AK Fields |
| ALA 25 Min 10 mW | Hypopigmentation | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Hypopigmentation | Grade 2 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Hypopigmentation | Grade 0 | 21 AK Fields |
| MN + ALA 25 Min 20 mW | Hypopigmentation | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Hypopigmentation | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Hypopigmentation | Grade 1 | 6 AK Fields |
| ALA 25 Min 20 mW | Hypopigmentation | Grade 1 | 6 AK Fields |
| ALA 25 Min 20 mW | Hypopigmentation | Grade 3 | 0 AK Fields |
| ALA 25 Min 20 mW | Hypopigmentation | Grade 4 | 0 AK Fields |
| ALA 25 Min 20 mW | Hypopigmentation | Grade 2 | 0 AK Fields |
| ALA 25 Min 20 mW | Hypopigmentation | Grade 0 | 21 AK Fields |
| MN + ALA 60 Min 10mW | Hypopigmentation | Grade 0 | 18 AK Fields |
| MN + ALA 60 Min 10mW | Hypopigmentation | Grade 1 | 8 AK Fields |
| MN + ALA 60 Min 10mW | Hypopigmentation | Grade 2 | 1 AK Fields |
| MN + ALA 60 Min 10mW | Hypopigmentation | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Hypopigmentation | Grade 4 | 0 AK Fields |
| ALA 60 Min 10 mW | Hypopigmentation | Grade 3 | 0 AK Fields |
| ALA 60 Min 10 mW | Hypopigmentation | Grade 1 | 7 AK Fields |
| ALA 60 Min 10 mW | Hypopigmentation | Grade 2 | 1 AK Fields |
| ALA 60 Min 10 mW | Hypopigmentation | Grade 4 | 0 AK Fields |
| ALA 60 Min 10 mW | Hypopigmentation | Grade 0 | 19 AK Fields |
| MN + ALA 60 Min 20 mW | Hypopigmentation | Grade 1 | 8 AK Fields |
| MN + ALA 60 Min 20 mW | Hypopigmentation | Grade 2 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Hypopigmentation | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Hypopigmentation | Grade 0 | 15 AK Fields |
| MN + ALA 60 Min 20 mW | Hypopigmentation | Grade 4 | 1 AK Fields |
| ALA 60 Min 20 mW | Hypopigmentation | Grade 0 | 15 AK Fields |
| ALA 60 Min 20 mW | Hypopigmentation | Grade 3 | 0 AK Fields |
| ALA 60 Min 20 mW | Hypopigmentation | Grade 2 | 0 AK Fields |
| ALA 60 Min 20 mW | Hypopigmentation | Grade 4 | 1 AK Fields |
| ALA 60 Min 20 mW | Hypopigmentation | Grade 1 | 8 AK Fields |
| MN + VEH | Hypopigmentation | Grade 3 | 0 AK Fields |
| MN + VEH | Hypopigmentation | Grade 1 | 6 AK Fields |
| MN + VEH | Hypopigmentation | Grade 2 | 0 AK Fields |
| MN + VEH | Hypopigmentation | Grade 0 | 23 AK Fields |
| MN + VEH | Hypopigmentation | Grade 4 | 0 AK Fields |
| VEH PDT | Hypopigmentation | Grade 3 | 0 AK Fields |
| VEH PDT | Hypopigmentation | Grade 2 | 0 AK Fields |
| VEH PDT | Hypopigmentation | Grade 0 | 23 AK Fields |
| VEH PDT | Hypopigmentation | Grade 1 | 6 AK Fields |
| VEH PDT | Hypopigmentation | Grade 4 | 0 AK Fields |
Other Pre-specified
Hypopigmentation
HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Time frame: 12 Weeks after PDT #1
Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Hypopigmentation | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Hypopigmentation | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Hypopigmentation | Grade 2 | 1 AK Fields |
| MN + ALA 25 Min 10 mW | Hypopigmentation | Grade 1 | 7 AK Fields |
| MN + ALA 25 Min 10 mW | Hypopigmentation | Grade 0 | 16 AK Fields |
| ALA 25 Min 10 mW | Hypopigmentation | Grade 1 | 5 AK Fields |
| ALA 25 Min 10 mW | Hypopigmentation | Grade 4 | 0 AK Fields |
| ALA 25 Min 10 mW | Hypopigmentation | Grade 0 | 18 AK Fields |
| ALA 25 Min 10 mW | Hypopigmentation | Grade 2 | 1 AK Fields |
| ALA 25 Min 10 mW | Hypopigmentation | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Hypopigmentation | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Hypopigmentation | Grade 0 | 18 AK Fields |
| MN + ALA 25 Min 20 mW | Hypopigmentation | Grade 1 | 9 AK Fields |
| MN + ALA 25 Min 20 mW | Hypopigmentation | Grade 2 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Hypopigmentation | Grade 4 | 0 AK Fields |
| ALA 25 Min 20 mW | Hypopigmentation | Grade 3 | 0 AK Fields |
| ALA 25 Min 20 mW | Hypopigmentation | Grade 0 | 20 AK Fields |
| ALA 25 Min 20 mW | Hypopigmentation | Grade 4 | 0 AK Fields |
| ALA 25 Min 20 mW | Hypopigmentation | Grade 1 | 7 AK Fields |
| ALA 25 Min 20 mW | Hypopigmentation | Grade 2 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Hypopigmentation | Grade 1 | 7 AK Fields |
| MN + ALA 60 Min 10mW | Hypopigmentation | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Hypopigmentation | Grade 0 | 21 AK Fields |
| MN + ALA 60 Min 10mW | Hypopigmentation | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Hypopigmentation | Grade 2 | 0 AK Fields |
| ALA 60 Min 10 mW | Hypopigmentation | Grade 1 | 7 AK Fields |
| ALA 60 Min 10 mW | Hypopigmentation | Grade 2 | 0 AK Fields |
| ALA 60 Min 10 mW | Hypopigmentation | Grade 3 | 0 AK Fields |
| ALA 60 Min 10 mW | Hypopigmentation | Grade 4 | 0 AK Fields |
| ALA 60 Min 10 mW | Hypopigmentation | Grade 0 | 21 AK Fields |
| MN + ALA 60 Min 20 mW | Hypopigmentation | Grade 1 | 7 AK Fields |
| MN + ALA 60 Min 20 mW | Hypopigmentation | Grade 0 | 16 AK Fields |
| MN + ALA 60 Min 20 mW | Hypopigmentation | Grade 2 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Hypopigmentation | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Hypopigmentation | Grade 4 | 1 AK Fields |
| ALA 60 Min 20 mW | Hypopigmentation | Grade 4 | 1 AK Fields |
| ALA 60 Min 20 mW | Hypopigmentation | Grade 1 | 7 AK Fields |
| ALA 60 Min 20 mW | Hypopigmentation | Grade 3 | 0 AK Fields |
| ALA 60 Min 20 mW | Hypopigmentation | Grade 2 | 0 AK Fields |
| ALA 60 Min 20 mW | Hypopigmentation | Grade 0 | 16 AK Fields |
| MN + VEH | Hypopigmentation | Grade 1 | 7 AK Fields |
| MN + VEH | Hypopigmentation | Grade 4 | 0 AK Fields |
| MN + VEH | Hypopigmentation | Grade 2 | 0 AK Fields |
| MN + VEH | Hypopigmentation | Grade 3 | 0 AK Fields |
| MN + VEH | Hypopigmentation | Grade 0 | 23 AK Fields |
| VEH PDT | Hypopigmentation | Grade 0 | 22 AK Fields |
| VEH PDT | Hypopigmentation | Grade 3 | 0 AK Fields |
| VEH PDT | Hypopigmentation | Grade 1 | 8 AK Fields |
| VEH PDT | Hypopigmentation | Grade 2 | 0 AK Fields |
| VEH PDT | Hypopigmentation | Grade 4 | 0 AK Fields |
Other Pre-specified
Hypopigmentation
HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Time frame: Baseline
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Hypopigmentation | Grade 0 | 16 AK Fields |
| MN + ALA 25 Min 10 mW | Hypopigmentation | Grade 2 | 1 AK Fields |
| MN + ALA 25 Min 10 mW | Hypopigmentation | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Hypopigmentation | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Hypopigmentation | Grade 1 | 8 AK Fields |
| ALA 25 Min 10 mW | Hypopigmentation | Grade 1 | 6 AK Fields |
| ALA 25 Min 10 mW | Hypopigmentation | Grade 3 | 0 AK Fields |
| ALA 25 Min 10 mW | Hypopigmentation | Grade 0 | 18 AK Fields |
| ALA 25 Min 10 mW | Hypopigmentation | Grade 4 | 0 AK Fields |
| ALA 25 Min 10 mW | Hypopigmentation | Grade 2 | 1 AK Fields |
| MN + ALA 25 Min 20 mW | Hypopigmentation | Grade 2 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Hypopigmentation | Grade 0 | 20 AK Fields |
| MN + ALA 25 Min 20 mW | Hypopigmentation | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Hypopigmentation | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Hypopigmentation | Grade 1 | 7 AK Fields |
| ALA 25 Min 20 mW | Hypopigmentation | Grade 0 | 21 AK Fields |
| ALA 25 Min 20 mW | Hypopigmentation | Grade 3 | 0 AK Fields |
| ALA 25 Min 20 mW | Hypopigmentation | Grade 2 | 0 AK Fields |
| ALA 25 Min 20 mW | Hypopigmentation | Grade 1 | 6 AK Fields |
| ALA 25 Min 20 mW | Hypopigmentation | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Hypopigmentation | Grade 0 | 23 AK Fields |
| MN + ALA 60 Min 10mW | Hypopigmentation | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Hypopigmentation | Grade 1 | 5 AK Fields |
| MN + ALA 60 Min 10mW | Hypopigmentation | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Hypopigmentation | Grade 2 | 1 AK Fields |
| ALA 60 Min 10 mW | Hypopigmentation | Grade 4 | 0 AK Fields |
| ALA 60 Min 10 mW | Hypopigmentation | Grade 1 | 4 AK Fields |
| ALA 60 Min 10 mW | Hypopigmentation | Grade 0 | 24 AK Fields |
| ALA 60 Min 10 mW | Hypopigmentation | Grade 2 | 1 AK Fields |
| ALA 60 Min 10 mW | Hypopigmentation | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Hypopigmentation | Grade 0 | 20 AK Fields |
| MN + ALA 60 Min 20 mW | Hypopigmentation | Grade 2 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Hypopigmentation | Grade 1 | 5 AK Fields |
| MN + ALA 60 Min 20 mW | Hypopigmentation | Grade 3 | 01 AK Fields |
| MN + ALA 60 Min 20 mW | Hypopigmentation | Grade 4 | 0 AK Fields |
| ALA 60 Min 20 mW | Hypopigmentation | Grade 2 | 0 AK Fields |
| ALA 60 Min 20 mW | Hypopigmentation | Grade 0 | 20 AK Fields |
| ALA 60 Min 20 mW | Hypopigmentation | Grade 1 | 5 AK Fields |
| ALA 60 Min 20 mW | Hypopigmentation | Grade 3 | 1 AK Fields |
| ALA 60 Min 20 mW | Hypopigmentation | Grade 4 | 0 AK Fields |
| MN + VEH | Hypopigmentation | Grade 0 | 25 AK Fields |
| MN + VEH | Hypopigmentation | Grade 4 | 0 AK Fields |
| MN + VEH | Hypopigmentation | Grade 3 | 0 AK Fields |
| MN + VEH | Hypopigmentation | Grade 2 | 0 AK Fields |
| MN + VEH | Hypopigmentation | Grade 1 | 5 AK Fields |
| VEH PDT | Hypopigmentation | Grade 1 | 4 AK Fields |
| VEH PDT | Hypopigmentation | Grade 4 | 0 AK Fields |
| VEH PDT | Hypopigmentation | Grade 3 | 0 AK Fields |
| VEH PDT | Hypopigmentation | Grade 2 | 0 AK Fields |
| VEH PDT | Hypopigmentation | Grade 0 | 26 AK Fields |
Other Pre-specified
Oozing/Vesiculation/Crusting
OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Time frame: 8 Weeks after PDT #1
Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 0 | 23 AK Fields |
| MN + ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 2 | 1 AK Fields |
| MN + ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 1 | 0 AK Fields |
| ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 1 | 0 AK Fields |
| ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 2 | 1 AK Fields |
| ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 0 | 23 AK Fields |
| ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 1 | 1 AK Fields |
| MN + ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 0 | 25 AK Fields |
| MN + ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 2 | 1 AK Fields |
| ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 0 | 25 AK Fields |
| ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 1 | 2 AK Fields |
| ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 2 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Oozing/Vesiculation/Crusting | Grade 1 | 2 AK Fields |
| MN + ALA 60 Min 10mW | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Oozing/Vesiculation/Crusting | Grade 0 | 25 AK Fields |
| MN + ALA 60 Min 10mW | Oozing/Vesiculation/Crusting | Grade 2 | 0 AK Fields |
| ALA 60 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 2 | 0 AK Fields |
| ALA 60 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 0 | 26 AK Fields |
| ALA 60 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 1 | 1 AK Fields |
| ALA 60 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| ALA 60 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 1 | 1 AK Fields |
| MN + ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 0 | 23 AK Fields |
| MN + ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 2 | 0 AK Fields |
| ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 2 | 0 AK Fields |
| ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 1 | 1 AK Fields |
| ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 0 | 23 AK Fields |
| ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| MN + VEH | Oozing/Vesiculation/Crusting | Grade 0 | 26 AK Fields |
| MN + VEH | Oozing/Vesiculation/Crusting | Grade 2 | 2 AK Fields |
| MN + VEH | Oozing/Vesiculation/Crusting | Grade 1 | 1 AK Fields |
| MN + VEH | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| MN + VEH | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| VEH PDT | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| VEH PDT | Oozing/Vesiculation/Crusting | Grade 0 | 26 AK Fields |
| VEH PDT | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| VEH PDT | Oozing/Vesiculation/Crusting | Grade 1 | 1 AK Fields |
| VEH PDT | Oozing/Vesiculation/Crusting | Grade 2 | 2 AK Fields |
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: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 2 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 0 | 24 AK Fields |
| MN + ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 1 | 0 AK Fields |
| ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 1 | 0 AK Fields |
| ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 2 | 0 AK Fields |
| ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 0 | 24 AK Fields |
| ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 1 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 0 | 27 AK Fields |
| MN + ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 2 | 0 AK Fields |
| ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 2 | 0 AK Fields |
| ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 0 | 27 AK Fields |
| ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 1 | 0 AK Fields |
| ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Oozing/Vesiculation/Crusting | Grade 1 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Oozing/Vesiculation/Crusting | Grade 0 | 28 AK Fields |
| MN + ALA 60 Min 10mW | Oozing/Vesiculation/Crusting | Grade 2 | 0 AK Fields |
| ALA 60 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 0 | 28 AK Fields |
| ALA 60 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 1 | 0 AK Fields |
| ALA 60 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 2 | 0 AK Fields |
| ALA 60 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| ALA 60 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 2 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 1 | 1 AK Fields |
| MN + ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 0 | 23 AK Fields |
| MN + ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 2 | 0 AK Fields |
| ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 0 | 23 AK Fields |
| ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 1 | 1 AK Fields |
| ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| MN + VEH | Oozing/Vesiculation/Crusting | Grade 2 | 1 AK Fields |
| MN + VEH | Oozing/Vesiculation/Crusting | Grade 1 | 0 AK Fields |
| MN + VEH | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| MN + VEH | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| MN + VEH | Oozing/Vesiculation/Crusting | Grade 0 | 29 AK Fields |
| VEH PDT | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| VEH PDT | Oozing/Vesiculation/Crusting | Grade 2 | 1 AK Fields |
| VEH PDT | Oozing/Vesiculation/Crusting | Grade 0 | 29 AK Fields |
| VEH PDT | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| VEH PDT | Oozing/Vesiculation/Crusting | Grade 1 | 0 AK Fields |
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: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 3 | 1 AK Fields |
| MN + ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 0 | 18 AK Fields |
| MN + ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 1 | 4 AK Fields |
| MN + ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 2 | 2 AK Fields |
| ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 1 | 2 AK Fields |
| ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 2 | 2 AK Fields |
| ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 0 | 20 AK Fields |
| ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 3 | 1 AK Fields |
| ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 1 | 3 AK Fields |
| MN + ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 2 | 2 AK Fields |
| MN + ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 3 | 1 AK Fields |
| MN + ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 0 | 21 AK Fields |
| ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 2 | 2 AK Fields |
| ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 1 | 2 AK Fields |
| ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 0 | 23 AK Fields |
| ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Oozing/Vesiculation/Crusting | Grade 1 | 2 AK Fields |
| MN + ALA 60 Min 10mW | Oozing/Vesiculation/Crusting | Grade 0 | 24 AK Fields |
| MN + ALA 60 Min 10mW | Oozing/Vesiculation/Crusting | Grade 2 | 2 AK Fields |
| ALA 60 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 1 | 1 AK Fields |
| ALA 60 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 0 | 25 AK Fields |
| ALA 60 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 2 | 2 AK Fields |
| ALA 60 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| ALA 60 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 0 | 20 AK Fields |
| MN + ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 2 | 1 AK Fields |
| MN + ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 1 | 4 AK Fields |
| MN + ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 0 | 19 AK Fields |
| ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 1 | 5 AK Fields |
| ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 2 | 1 AK Fields |
| MN + VEH | Oozing/Vesiculation/Crusting | Grade 1 | 0 AK Fields |
| MN + VEH | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| MN + VEH | Oozing/Vesiculation/Crusting | Grade 0 | 29 AK Fields |
| MN + VEH | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| MN + VEH | Oozing/Vesiculation/Crusting | Grade 2 | 1 AK Fields |
| VEH PDT | Oozing/Vesiculation/Crusting | Grade 0 | 29 AK Fields |
| VEH PDT | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| VEH PDT | Oozing/Vesiculation/Crusting | Grade 1 | 0 AK Fields |
| VEH PDT | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| VEH PDT | Oozing/Vesiculation/Crusting | Grade 2 | 1 AK Fields |
Other Pre-specified
Oozing/Vesiculation/Crusting
OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Time frame: 2 Weeks after PDT #1
Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 3 | 1 AK Fields |
| MN + ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 0 | 23 AK Fields |
| MN + ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 2 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 1 | 1 AK Fields |
| ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 1 | 0 AK Fields |
| ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 2 | 0 AK Fields |
| ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 0 | 24 AK Fields |
| ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 3 | 1 AK Fields |
| MN + ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 1 | 2 AK Fields |
| MN + ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 0 | 25 AK Fields |
| MN + ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 2 | 0 AK Fields |
| ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 0 | 26 AK Fields |
| ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 1 | 0 AK Fields |
| ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 2 | 1 AK Fields |
| MN + ALA 60 Min 10mW | Oozing/Vesiculation/Crusting | Grade 1 | 2 AK Fields |
| MN + ALA 60 Min 10mW | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Oozing/Vesiculation/Crusting | Grade 0 | 26 AK Fields |
| MN + ALA 60 Min 10mW | Oozing/Vesiculation/Crusting | Grade 2 | 0 AK Fields |
| ALA 60 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 2 | 0 AK Fields |
| ALA 60 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 0 | 27 AK Fields |
| ALA 60 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 1 | 1 AK Fields |
| ALA 60 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| ALA 60 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 1 | 1 AK Fields |
| MN + ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 0 | 24 AK Fields |
| MN + ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 2 | 0 AK Fields |
| ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 2 | 0 AK Fields |
| ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 1 | 0 AK Fields |
| ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 0 | 25 AK Fields |
| ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| MN + VEH | Oozing/Vesiculation/Crusting | Grade 0 | 28 AK Fields |
| MN + VEH | Oozing/Vesiculation/Crusting | Grade 2 | 1 AK Fields |
| MN + VEH | Oozing/Vesiculation/Crusting | Grade 1 | 1 AK Fields |
| MN + VEH | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| MN + VEH | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| VEH PDT | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| VEH PDT | Oozing/Vesiculation/Crusting | Grade 0 | 28 AK Fields |
| VEH PDT | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| VEH PDT | Oozing/Vesiculation/Crusting | Grade 1 | 1 AK Fields |
| VEH PDT | Oozing/Vesiculation/Crusting | Grade 2 | 1 AK Fields |
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_UNITS) |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 1 | 1 AK Fields |
| MN + ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 2 | 1 AK Fields |
| MN + ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 0 | 23 AK Fields |
| MN + ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 1 | 0 AK Fields |
| ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 0 | 24 AK Fields |
| ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 3 | 1 AK Fields |
| ALA 25 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 2 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 1 | 2 AK Fields |
| MN + ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 0 | 24 AK Fields |
| MN + ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 2 | 1 AK Fields |
| ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 0 | 25 AK Fields |
| ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 2 | 1 AK Fields |
| ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 1 | 1 AK Fields |
| ALA 25 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Oozing/Vesiculation/Crusting | Grade 1 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Oozing/Vesiculation/Crusting | Grade 0 | 29 AK Fields |
| MN + ALA 60 Min 10mW | Oozing/Vesiculation/Crusting | Grade 2 | 0 AK Fields |
| ALA 60 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 0 | 29 AK Fields |
| ALA 60 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 1 | 0 AK Fields |
| ALA 60 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 2 | 0 AK Fields |
| ALA 60 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| ALA 60 Min 10 mW | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 1 | 2 AK Fields |
| MN + ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 0 | 24 AK Fields |
| MN + ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 2 | 0 AK Fields |
| ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 2 | 0 AK Fields |
| ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 1 | 2 AK Fields |
| ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 0 | 24 AK Fields |
| ALA 60 Min 20 mW | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| MN + VEH | Oozing/Vesiculation/Crusting | Grade 0 | 29 AK Fields |
| MN + VEH | Oozing/Vesiculation/Crusting | Grade 2 | 1 AK Fields |
| MN + VEH | Oozing/Vesiculation/Crusting | Grade 1 | 0 AK Fields |
| MN + VEH | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| MN + VEH | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| VEH PDT | Oozing/Vesiculation/Crusting | Grade 3 | 0 AK Fields |
| VEH PDT | Oozing/Vesiculation/Crusting | Grade 0 | 29 AK Fields |
| VEH PDT | Oozing/Vesiculation/Crusting | Grade 4 | 0 AK Fields |
| VEH PDT | Oozing/Vesiculation/Crusting | Grade 1 | 0 AK Fields |
| VEH PDT | Oozing/Vesiculation/Crusting | Grade 2 | 1 AK Fields |
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: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Scaling & Dryness | Grade 1 | 7 AK Fields |
| MN + ALA 25 Min 10 mW | Scaling & Dryness | Grade 0 | 15 AK Fields |
| MN + ALA 25 Min 10 mW | Scaling & Dryness | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Scaling & Dryness | Grade 2 | 1 AK Fields |
| MN + ALA 25 Min 10 mW | Scaling & Dryness | Grade 3 | 2 AK Fields |
| ALA 25 Min 10 mW | Scaling & Dryness | Grade 3 | 1 AK Fields |
| ALA 25 Min 10 mW | Scaling & Dryness | Grade 2 | 2 AK Fields |
| ALA 25 Min 10 mW | Scaling & Dryness | Grade 4 | 0 AK Fields |
| ALA 25 Min 10 mW | Scaling & Dryness | Grade 1 | 7 AK Fields |
| ALA 25 Min 10 mW | Scaling & Dryness | Grade 0 | 15 AK Fields |
| MN + ALA 25 Min 20 mW | Scaling & Dryness | Grade 0 | 16 AK Fields |
| MN + ALA 25 Min 20 mW | Scaling & Dryness | Grade 2 | 3 AK Fields |
| MN + ALA 25 Min 20 mW | Scaling & Dryness | Grade 1 | 7 AK Fields |
| MN + ALA 25 Min 20 mW | Scaling & Dryness | Grade 3 | 1 AK Fields |
| MN + ALA 25 Min 20 mW | Scaling & Dryness | Grade 4 | 0 AK Fields |
| ALA 25 Min 20 mW | Scaling & Dryness | Grade 4 | 0 AK Fields |
| ALA 25 Min 20 mW | Scaling & Dryness | Grade 2 | 3 AK Fields |
| ALA 25 Min 20 mW | Scaling & Dryness | Grade 0 | 17 AK Fields |
| ALA 25 Min 20 mW | Scaling & Dryness | Grade 3 | 0 AK Fields |
| ALA 25 Min 20 mW | Scaling & Dryness | Grade 1 | 7 AK Fields |
| MN + ALA 60 Min 10mW | Scaling & Dryness | Grade 1 | 6 AK Fields |
| MN + ALA 60 Min 10mW | Scaling & Dryness | Grade 3 | 1 AK Fields |
| MN + ALA 60 Min 10mW | Scaling & Dryness | Grade 4 | 1 AK Fields |
| MN + ALA 60 Min 10mW | Scaling & Dryness | Grade 0 | 16 AK Fields |
| MN + ALA 60 Min 10mW | Scaling & Dryness | Grade 2 | 4 AK Fields |
| ALA 60 Min 10 mW | Scaling & Dryness | Grade 3 | 1 AK Fields |
| ALA 60 Min 10 mW | Scaling & Dryness | Grade 4 | 1 AK Fields |
| ALA 60 Min 10 mW | Scaling & Dryness | Grade 0 | 17 AK Fields |
| ALA 60 Min 10 mW | Scaling & Dryness | Grade 2 | 2 AK Fields |
| ALA 60 Min 10 mW | Scaling & Dryness | Grade 1 | 7 AK Fields |
| MN + ALA 60 Min 20 mW | Scaling & Dryness | Grade 1 | 3 AK Fields |
| MN + ALA 60 Min 20 mW | Scaling & Dryness | Grade 3 | 2 AK Fields |
| MN + ALA 60 Min 20 mW | Scaling & Dryness | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Scaling & Dryness | Grade 0 | 17 AK Fields |
| MN + ALA 60 Min 20 mW | Scaling & Dryness | Grade 2 | 3 AK Fields |
| ALA 60 Min 20 mW | Scaling & Dryness | Grade 0 | 16 AK Fields |
| ALA 60 Min 20 mW | Scaling & Dryness | Grade 4 | 0 AK Fields |
| ALA 60 Min 20 mW | Scaling & Dryness | Grade 1 | 6 AK Fields |
| ALA 60 Min 20 mW | Scaling & Dryness | Grade 2 | 2 AK Fields |
| ALA 60 Min 20 mW | Scaling & Dryness | Grade 3 | 1 AK Fields |
| MN + VEH | Scaling & Dryness | Grade 3 | 1 AK Fields |
| MN + VEH | Scaling & Dryness | Grade 1 | 7 AK Fields |
| MN + VEH | Scaling & Dryness | Grade 4 | 0 AK Fields |
| MN + VEH | Scaling & Dryness | Grade 2 | 2 AK Fields |
| MN + VEH | Scaling & Dryness | Grade 0 | 20 AK Fields |
| VEH PDT | Scaling & Dryness | Grade 1 | 8 AK Fields |
| VEH PDT | Scaling & Dryness | Grade 2 | 1 AK Fields |
| VEH PDT | Scaling & Dryness | Grade 3 | 1 AK Fields |
| VEH PDT | Scaling & Dryness | Grade 4 | 0 AK Fields |
| VEH PDT | Scaling & Dryness | Grade 0 | 20 AK Fields |
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_UNITS) |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Scaling & Dryness | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Scaling & Dryness | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Scaling & Dryness | Grade 0 | 19 AK Fields |
| MN + ALA 25 Min 10 mW | Scaling & Dryness | Grade 2 | 1 AK Fields |
| MN + ALA 25 Min 10 mW | Scaling & Dryness | Grade 1 | 5 AK Fields |
| ALA 25 Min 10 mW | Scaling & Dryness | Grade 4 | 0 AK Fields |
| ALA 25 Min 10 mW | Scaling & Dryness | Grade 1 | 5 AK Fields |
| ALA 25 Min 10 mW | Scaling & Dryness | Grade 2 | 1 AK Fields |
| ALA 25 Min 10 mW | Scaling & Dryness | Grade 0 | 19 AK Fields |
| ALA 25 Min 10 mW | Scaling & Dryness | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Scaling & Dryness | Grade 1 | 7 AK Fields |
| MN + ALA 25 Min 20 mW | Scaling & Dryness | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Scaling & Dryness | Grade 0 | 18 AK Fields |
| MN + ALA 25 Min 20 mW | Scaling & Dryness | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Scaling & Dryness | Grade 2 | 2 AK Fields |
| ALA 25 Min 20 mW | Scaling & Dryness | Grade 3 | 1 AK Fields |
| ALA 25 Min 20 mW | Scaling & Dryness | Grade 0 | 18 AK Fields |
| ALA 25 Min 20 mW | Scaling & Dryness | Grade 4 | 0 AK Fields |
| ALA 25 Min 20 mW | Scaling & Dryness | Grade 1 | 8 AK Fields |
| ALA 25 Min 20 mW | Scaling & Dryness | Grade 2 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Scaling & Dryness | Grade 1 | 12 AK Fields |
| MN + ALA 60 Min 10mW | Scaling & Dryness | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Scaling & Dryness | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Scaling & Dryness | Grade 0 | 16 AK Fields |
| MN + ALA 60 Min 10mW | Scaling & Dryness | Grade 2 | 1 AK Fields |
| ALA 60 Min 10 mW | Scaling & Dryness | Grade 2 | 3 AK Fields |
| ALA 60 Min 10 mW | Scaling & Dryness | Grade 0 | 16 AK Fields |
| ALA 60 Min 10 mW | Scaling & Dryness | Grade 1 | 10 AK Fields |
| ALA 60 Min 10 mW | Scaling & Dryness | Grade 3 | 0 AK Fields |
| ALA 60 Min 10 mW | Scaling & Dryness | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Scaling & Dryness | Grade 1 | 8 AK Fields |
| MN + ALA 60 Min 20 mW | Scaling & Dryness | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Scaling & Dryness | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Scaling & Dryness | Grade 0 | 17 AK Fields |
| MN + ALA 60 Min 20 mW | Scaling & Dryness | Grade 2 | 1 AK Fields |
| ALA 60 Min 20 mW | Scaling & Dryness | Grade 2 | 2 AK Fields |
| ALA 60 Min 20 mW | Scaling & Dryness | Grade 1 | 7 AK Fields |
| ALA 60 Min 20 mW | Scaling & Dryness | Grade 3 | 0 AK Fields |
| ALA 60 Min 20 mW | Scaling & Dryness | Grade 0 | 17 AK Fields |
| ALA 60 Min 20 mW | Scaling & Dryness | Grade 4 | 0 AK Fields |
| MN + VEH | Scaling & Dryness | Grade 0 | 19 AK Fields |
| MN + VEH | Scaling & Dryness | Grade 2 | 3 AK Fields |
| MN + VEH | Scaling & Dryness | Grade 1 | 8 AK Fields |
| MN + VEH | Scaling & Dryness | Grade 3 | 0 AK Fields |
| MN + VEH | Scaling & Dryness | Grade 4 | 0 AK Fields |
| VEH PDT | Scaling & Dryness | Grade 3 | 0 AK Fields |
| VEH PDT | Scaling & Dryness | Grade 0 | 19 AK Fields |
| VEH PDT | Scaling & Dryness | Grade 4 | 0 AK Fields |
| VEH PDT | Scaling & Dryness | Grade 1 | 8 AK Fields |
| VEH PDT | Scaling & Dryness | Grade 2 | 3 AK Fields |
Other Pre-specified
Scaling & Dryness
SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Time frame: 2 Weeks after PDT #1
Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Scaling & Dryness | Grade 2 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Scaling & Dryness | Grade 0 | 16 AK Fields |
| MN + ALA 25 Min 10 mW | Scaling & Dryness | Grade 3 | 1 AK Fields |
| MN + ALA 25 Min 10 mW | Scaling & Dryness | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Scaling & Dryness | Grade 1 | 8 AK Fields |
| ALA 25 Min 10 mW | Scaling & Dryness | Grade 1 | 7 AK Fields |
| ALA 25 Min 10 mW | Scaling & Dryness | Grade 2 | 0 AK Fields |
| ALA 25 Min 10 mW | Scaling & Dryness | Grade 3 | 1 AK Fields |
| ALA 25 Min 10 mW | Scaling & Dryness | Grade 0 | 17 AK Fields |
| ALA 25 Min 10 mW | Scaling & Dryness | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Scaling & Dryness | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Scaling & Dryness | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Scaling & Dryness | Grade 1 | 10 AK Fields |
| MN + ALA 25 Min 20 mW | Scaling & Dryness | Grade 0 | 16 AK Fields |
| MN + ALA 25 Min 20 mW | Scaling & Dryness | Grade 2 | 1 AK Fields |
| ALA 25 Min 20 mW | Scaling & Dryness | Grade 2 | 4 AK Fields |
| ALA 25 Min 20 mW | Scaling & Dryness | Grade 0 | 16 AK Fields |
| ALA 25 Min 20 mW | Scaling & Dryness | Grade 4 | 0 AK Fields |
| ALA 25 Min 20 mW | Scaling & Dryness | Grade 1 | 7 AK Fields |
| ALA 25 Min 20 mW | Scaling & Dryness | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Scaling & Dryness | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Scaling & Dryness | Grade 1 | 5 AK Fields |
| MN + ALA 60 Min 10mW | Scaling & Dryness | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Scaling & Dryness | Grade 0 | 20 AK Fields |
| MN + ALA 60 Min 10mW | Scaling & Dryness | Grade 2 | 3 AK Fields |
| ALA 60 Min 10 mW | Scaling & Dryness | Grade 0 | 21 AK Fields |
| ALA 60 Min 10 mW | Scaling & Dryness | Grade 1 | 4 AK Fields |
| ALA 60 Min 10 mW | Scaling & Dryness | Grade 2 | 3 AK Fields |
| ALA 60 Min 10 mW | Scaling & Dryness | Grade 3 | 0 AK Fields |
| ALA 60 Min 10 mW | Scaling & Dryness | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Scaling & Dryness | Grade 2 | 1 AK Fields |
| MN + ALA 60 Min 20 mW | Scaling & Dryness | Grade 3 | 1 AK Fields |
| MN + ALA 60 Min 20 mW | Scaling & Dryness | Grade 1 | 3 AK Fields |
| MN + ALA 60 Min 20 mW | Scaling & Dryness | Grade 0 | 20 AK Fields |
| MN + ALA 60 Min 20 mW | Scaling & Dryness | Grade 4 | 0 AK Fields |
| ALA 60 Min 20 mW | Scaling & Dryness | Grade 2 | 2 AK Fields |
| ALA 60 Min 20 mW | Scaling & Dryness | Grade 0 | 21 AK Fields |
| ALA 60 Min 20 mW | Scaling & Dryness | Grade 3 | 1 AK Fields |
| ALA 60 Min 20 mW | Scaling & Dryness | Grade 1 | 1 AK Fields |
| ALA 60 Min 20 mW | Scaling & Dryness | Grade 4 | 0 AK Fields |
| MN + VEH | Scaling & Dryness | Grade 2 | 0 AK Fields |
| MN + VEH | Scaling & Dryness | Grade 1 | 8 AK Fields |
| MN + VEH | Scaling & Dryness | Grade 4 | 0 AK Fields |
| MN + VEH | Scaling & Dryness | Grade 3 | 0 AK Fields |
| MN + VEH | Scaling & Dryness | Grade 0 | 22 AK Fields |
| VEH PDT | Scaling & Dryness | Grade 4 | 0 AK Fields |
| VEH PDT | Scaling & Dryness | Grade 2 | 0 AK Fields |
| VEH PDT | Scaling & Dryness | Grade 0 | 23 AK Fields |
| VEH PDT | Scaling & Dryness | Grade 3 | 0 AK Fields |
| VEH PDT | Scaling & Dryness | Grade 1 | 7 AK Fields |
Other Pre-specified
Scaling & Dryness
SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Time frame: 8 Weeks after PDT #1
Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Scaling & Dryness | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Scaling & Dryness | Grade 0 | 19 AK Fields |
| MN + ALA 25 Min 10 mW | Scaling & Dryness | Grade 1 | 4 AK Fields |
| MN + ALA 25 Min 10 mW | Scaling & Dryness | Grade 3 | 1 AK Fields |
| MN + ALA 25 Min 10 mW | Scaling & Dryness | Grade 2 | 0 AK Fields |
| ALA 25 Min 10 mW | Scaling & Dryness | Grade 1 | 3 AK Fields |
| ALA 25 Min 10 mW | Scaling & Dryness | Grade 3 | 1 AK Fields |
| ALA 25 Min 10 mW | Scaling & Dryness | Grade 0 | 20 AK Fields |
| ALA 25 Min 10 mW | Scaling & Dryness | Grade 4 | 0 AK Fields |
| ALA 25 Min 10 mW | Scaling & Dryness | Grade 2 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Scaling & Dryness | Grade 2 | 1 AK Fields |
| MN + ALA 25 Min 20 mW | Scaling & Dryness | Grade 1 | 6 AK Fields |
| MN + ALA 25 Min 20 mW | Scaling & Dryness | Grade 0 | 20 AK Fields |
| MN + ALA 25 Min 20 mW | Scaling & Dryness | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Scaling & Dryness | Grade 3 | 0 AK Fields |
| ALA 25 Min 20 mW | Scaling & Dryness | Grade 4 | 0 AK Fields |
| ALA 25 Min 20 mW | Scaling & Dryness | Grade 2 | 1 AK Fields |
| ALA 25 Min 20 mW | Scaling & Dryness | Grade 1 | 5 AK Fields |
| ALA 25 Min 20 mW | Scaling & Dryness | Grade 0 | 21 AK Fields |
| ALA 25 Min 20 mW | Scaling & Dryness | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Scaling & Dryness | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Scaling & Dryness | Grade 2 | 2 AK Fields |
| MN + ALA 60 Min 10mW | Scaling & Dryness | Grade 0 | 22 AK Fields |
| MN + ALA 60 Min 10mW | Scaling & Dryness | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Scaling & Dryness | Grade 1 | 3 AK Fields |
| ALA 60 Min 10 mW | Scaling & Dryness | Grade 2 | 2 AK Fields |
| ALA 60 Min 10 mW | Scaling & Dryness | Grade 0 | 22 AK Fields |
| ALA 60 Min 10 mW | Scaling & Dryness | Grade 1 | 3 AK Fields |
| ALA 60 Min 10 mW | Scaling & Dryness | Grade 3 | 0 AK Fields |
| ALA 60 Min 10 mW | Scaling & Dryness | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Scaling & Dryness | Grade 1 | 4 AK Fields |
| MN + ALA 60 Min 20 mW | Scaling & Dryness | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Scaling & Dryness | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Scaling & Dryness | Grade 0 | 18 AK Fields |
| MN + ALA 60 Min 20 mW | Scaling & Dryness | Grade 2 | 2 AK Fields |
| ALA 60 Min 20 mW | Scaling & Dryness | Grade 2 | 2 AK Fields |
| ALA 60 Min 20 mW | Scaling & Dryness | Grade 1 | 3 AK Fields |
| ALA 60 Min 20 mW | Scaling & Dryness | Grade 3 | 0 AK Fields |
| ALA 60 Min 20 mW | Scaling & Dryness | Grade 0 | 19 AK Fields |
| ALA 60 Min 20 mW | Scaling & Dryness | Grade 4 | 0 AK Fields |
| MN + VEH | Scaling & Dryness | Grade 0 | 22 AK Fields |
| MN + VEH | Scaling & Dryness | Grade 2 | 2 AK Fields |
| MN + VEH | Scaling & Dryness | Grade 1 | 4 AK Fields |
| MN + VEH | Scaling & Dryness | Grade 3 | 1 AK Fields |
| MN + VEH | Scaling & Dryness | Grade 4 | 0 AK Fields |
| VEH PDT | Scaling & Dryness | Grade 3 | 1 AK Fields |
| VEH PDT | Scaling & Dryness | Grade 0 | 22 AK Fields |
| VEH PDT | Scaling & Dryness | Grade 4 | 0 AK Fields |
| VEH PDT | Scaling & Dryness | Grade 1 | 3 AK Fields |
| VEH PDT | Scaling & Dryness | Grade 2 | 3 AK Fields |
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: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Scaling & Dryness | Grade 2 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Scaling & Dryness | Grade 0 | 23 AK Fields |
| MN + ALA 25 Min 10 mW | Scaling & Dryness | Grade 1 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Scaling & Dryness | Grade 3 | 1 AK Fields |
| MN + ALA 25 Min 10 mW | Scaling & Dryness | Grade 4 | 0 AK Fields |
| ALA 25 Min 10 mW | Scaling & Dryness | Grade 2 | 0 AK Fields |
| ALA 25 Min 10 mW | Scaling & Dryness | Grade 1 | 1 AK Fields |
| ALA 25 Min 10 mW | Scaling & Dryness | Grade 3 | 1 AK Fields |
| ALA 25 Min 10 mW | Scaling & Dryness | Grade 0 | 22 AK Fields |
| ALA 25 Min 10 mW | Scaling & Dryness | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Scaling & Dryness | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Scaling & Dryness | Grade 4 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Scaling & Dryness | Grade 0 | 23 AK Fields |
| MN + ALA 25 Min 20 mW | Scaling & Dryness | Grade 1 | 4 AK Fields |
| MN + ALA 25 Min 20 mW | Scaling & Dryness | Grade 2 | 0 AK Fields |
| ALA 25 Min 20 mW | Scaling & Dryness | Grade 1 | 5 AK Fields |
| ALA 25 Min 20 mW | Scaling & Dryness | Grade 4 | 0 AK Fields |
| ALA 25 Min 20 mW | Scaling & Dryness | Grade 0 | 22 AK Fields |
| ALA 25 Min 20 mW | Scaling & Dryness | Grade 2 | 0 AK Fields |
| ALA 25 Min 20 mW | Scaling & Dryness | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Scaling & Dryness | Grade 2 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Scaling & Dryness | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Scaling & Dryness | Grade 1 | 3 AK Fields |
| MN + ALA 60 Min 10mW | Scaling & Dryness | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Scaling & Dryness | Grade 0 | 25 AK Fields |
| ALA 60 Min 10 mW | Scaling & Dryness | Grade 2 | 1 AK Fields |
| ALA 60 Min 10 mW | Scaling & Dryness | Grade 0 | 24 AK Fields |
| ALA 60 Min 10 mW | Scaling & Dryness | Grade 1 | 3 AK Fields |
| ALA 60 Min 10 mW | Scaling & Dryness | Grade 3 | 0 AK Fields |
| ALA 60 Min 10 mW | Scaling & Dryness | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Scaling & Dryness | Grade 1 | 3 AK Fields |
| MN + ALA 60 Min 20 mW | Scaling & Dryness | Grade 3 | 1 AK Fields |
| MN + ALA 60 Min 20 mW | Scaling & Dryness | Grade 4 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Scaling & Dryness | Grade 0 | 20 AK Fields |
| MN + ALA 60 Min 20 mW | Scaling & Dryness | Grade 2 | 0 AK Fields |
| ALA 60 Min 20 mW | Scaling & Dryness | Grade 2 | 1 AK Fields |
| ALA 60 Min 20 mW | Scaling & Dryness | Grade 1 | 2 AK Fields |
| ALA 60 Min 20 mW | Scaling & Dryness | Grade 3 | 0 AK Fields |
| ALA 60 Min 20 mW | Scaling & Dryness | Grade 0 | 21 AK Fields |
| ALA 60 Min 20 mW | Scaling & Dryness | Grade 4 | 0 AK Fields |
| MN + VEH | Scaling & Dryness | Grade 0 | 23 AK Fields |
| MN + VEH | Scaling & Dryness | Grade 2 | 1 AK Fields |
| MN + VEH | Scaling & Dryness | Grade 1 | 6 AK Fields |
| MN + VEH | Scaling & Dryness | Grade 3 | 0 AK Fields |
| MN + VEH | Scaling & Dryness | Grade 4 | 0 AK Fields |
| VEH PDT | Scaling & Dryness | Grade 3 | 0 AK Fields |
| VEH PDT | Scaling & Dryness | Grade 0 | 23 AK Fields |
| VEH PDT | Scaling & Dryness | Grade 4 | 0 AK Fields |
| VEH PDT | Scaling & Dryness | Grade 1 | 6 AK Fields |
| VEH PDT | Scaling & Dryness | Grade 2 | 1 AK Fields |
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_UNITS) |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Stinging/Burning | Grade 0 | 6 AK Fields |
| MN + ALA 25 Min 10 mW | Stinging/Burning | Grade 1 | 16 AK Fields |
| MN + ALA 25 Min 10 mW | Stinging/Burning | Grade 2 | 3 AK Fields |
| MN + ALA 25 Min 10 mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| ALA 25 Min 10 mW | Stinging/Burning | Grade 1 | 14 AK Fields |
| ALA 25 Min 10 mW | Stinging/Burning | Grade 0 | 9 AK Fields |
| ALA 25 Min 10 mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| ALA 25 Min 10 mW | Stinging/Burning | Grade 2 | 2 AK Fields |
| MN + ALA 25 Min 20 mW | Stinging/Burning | Grade 1 | 12 AK Fields |
| MN + ALA 25 Min 20 mW | Stinging/Burning | Grade 0 | 7 AK Fields |
| MN + ALA 25 Min 20 mW | Stinging/Burning | Grade 2 | 8 AK Fields |
| MN + ALA 25 Min 20 mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| ALA 25 Min 20 mW | Stinging/Burning | Grade 0 | 9 AK Fields |
| ALA 25 Min 20 mW | Stinging/Burning | Grade 1 | 13 AK Fields |
| ALA 25 Min 20 mW | Stinging/Burning | Grade 2 | 5 AK Fields |
| ALA 25 Min 20 mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Stinging/Burning | Grade 2 | 7 AK Fields |
| MN + ALA 60 Min 10mW | Stinging/Burning | Grade 1 | 16 AK Fields |
| MN + ALA 60 Min 10mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Stinging/Burning | Grade 0 | 5 AK Fields |
| ALA 60 Min 10 mW | Stinging/Burning | Grade 2 | 4 AK Fields |
| ALA 60 Min 10 mW | Stinging/Burning | Grade 1 | 19 AK Fields |
| ALA 60 Min 10 mW | Stinging/Burning | Grade 0 | 5 AK Fields |
| ALA 60 Min 10 mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Stinging/Burning | Grade 1 | 9 AK Fields |
| MN + ALA 60 Min 20 mW | Stinging/Burning | Grade 2 | 11 AK Fields |
| MN + ALA 60 Min 20 mW | Stinging/Burning | Grade 3 | 1 AK Fields |
| MN + ALA 60 Min 20 mW | Stinging/Burning | Grade 0 | 5 AK Fields |
| ALA 60 Min 20 mW | Stinging/Burning | Grade 0 | 7 AK Fields |
| ALA 60 Min 20 mW | Stinging/Burning | Grade 3 | 1 AK Fields |
| ALA 60 Min 20 mW | Stinging/Burning | Grade 1 | 11 AK Fields |
| ALA 60 Min 20 mW | Stinging/Burning | Grade 2 | 7 AK Fields |
| MN + VEH | Stinging/Burning | Grade 3 | 0 AK Fields |
| MN + VEH | Stinging/Burning | Grade 0 | 28 AK Fields |
| MN + VEH | Stinging/Burning | Grade 2 | 0 AK Fields |
| MN + VEH | Stinging/Burning | Grade 1 | 2 AK Fields |
| VEH PDT | Stinging/Burning | Grade 2 | 0 AK Fields |
| VEH PDT | Stinging/Burning | Grade 0 | 29 AK Fields |
| VEH PDT | Stinging/Burning | Grade 3 | 0 AK Fields |
| VEH PDT | Stinging/Burning | Grade 1 | 1 AK Fields |
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_UNITS) |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Stinging/Burning | Grade 1 | 9 AK Fields |
| MN + ALA 25 Min 10 mW | Stinging/Burning | Grade 0 | 1 AK Fields |
| MN + ALA 25 Min 10 mW | Stinging/Burning | Grade 3 | 2 AK Fields |
| MN + ALA 25 Min 10 mW | Stinging/Burning | Grade 2 | 13 AK Fields |
| ALA 25 Min 10 mW | Stinging/Burning | Grade 1 | 14 AK Fields |
| ALA 25 Min 10 mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| ALA 25 Min 10 mW | Stinging/Burning | Grade 2 | 9 AK Fields |
| ALA 25 Min 10 mW | Stinging/Burning | Grade 0 | 2 AK Fields |
| MN + ALA 25 Min 20 mW | Stinging/Burning | Grade 3 | 3 AK Fields |
| MN + ALA 25 Min 20 mW | Stinging/Burning | Grade 1 | 7 AK Fields |
| MN + ALA 25 Min 20 mW | Stinging/Burning | Grade 2 | 16 AK Fields |
| MN + ALA 25 Min 20 mW | Stinging/Burning | Grade 0 | 1 AK Fields |
| ALA 25 Min 20 mW | Stinging/Burning | Grade 2 | 7 AK Fields |
| ALA 25 Min 20 mW | Stinging/Burning | Grade 0 | 1 AK Fields |
| ALA 25 Min 20 mW | Stinging/Burning | Grade 3 | 3 AK Fields |
| ALA 25 Min 20 mW | Stinging/Burning | Grade 1 | 16 AK Fields |
| MN + ALA 60 Min 10mW | Stinging/Burning | Grade 1 | 5 AK Fields |
| MN + ALA 60 Min 10mW | Stinging/Burning | Grade 0 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Stinging/Burning | Grade 3 | 9 AK Fields |
| MN + ALA 60 Min 10mW | Stinging/Burning | Grade 2 | 15 AK Fields |
| ALA 60 Min 10 mW | Stinging/Burning | Grade 0 | 0 AK Fields |
| ALA 60 Min 10 mW | Stinging/Burning | Grade 3 | 7 AK Fields |
| ALA 60 Min 10 mW | Stinging/Burning | Grade 1 | 5 AK Fields |
| ALA 60 Min 10 mW | Stinging/Burning | Grade 2 | 17 AK Fields |
| MN + ALA 60 Min 20 mW | Stinging/Burning | Grade 3 | 11 AK Fields |
| MN + ALA 60 Min 20 mW | Stinging/Burning | Grade 0 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Stinging/Burning | Grade 1 | 5 AK Fields |
| MN + ALA 60 Min 20 mW | Stinging/Burning | Grade 2 | 10 AK Fields |
| ALA 60 Min 20 mW | Stinging/Burning | Grade 2 | 12 AK Fields |
| ALA 60 Min 20 mW | Stinging/Burning | Grade 0 | 0 AK Fields |
| ALA 60 Min 20 mW | Stinging/Burning | Grade 1 | 6 AK Fields |
| ALA 60 Min 20 mW | Stinging/Burning | Grade 3 | 8 AK Fields |
| MN + VEH | Stinging/Burning | Grade 0 | 21 AK Fields |
| MN + VEH | Stinging/Burning | Grade 1 | 9 AK Fields |
| MN + VEH | Stinging/Burning | Grade 2 | 0 AK Fields |
| MN + VEH | Stinging/Burning | Grade 3 | 0 AK Fields |
| VEH PDT | Stinging/Burning | Grade 3 | 0 AK Fields |
| VEH PDT | Stinging/Burning | Grade 0 | 24 AK Fields |
| VEH PDT | Stinging/Burning | Grade 1 | 6 AK Fields |
| VEH PDT | Stinging/Burning | Grade 2 | 0 AK Fields |
Other Pre-specified
Stinging/Burning
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: 8 Weeks after PDT #1
Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Stinging/Burning | Grade 0 | 24 AK Fields |
| MN + ALA 25 Min 10 mW | Stinging/Burning | Grade 1 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Stinging/Burning | Grade 2 | 0 AK Fields |
| ALA 25 Min 10 mW | Stinging/Burning | Grade 0 | 24 AK Fields |
| ALA 25 Min 10 mW | Stinging/Burning | Grade 1 | 0 AK Fields |
| ALA 25 Min 10 mW | Stinging/Burning | Grade 2 | 0 AK Fields |
| ALA 25 Min 10 mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Stinging/Burning | Grade 0 | 27 AK Fields |
| MN + ALA 25 Min 20 mW | Stinging/Burning | Grade 2 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Stinging/Burning | Grade 1 | 0 AK Fields |
| ALA 25 Min 20 mW | Stinging/Burning | Grade 2 | 0 AK Fields |
| ALA 25 Min 20 mW | Stinging/Burning | Grade 0 | 27 AK Fields |
| ALA 25 Min 20 mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| ALA 25 Min 20 mW | Stinging/Burning | Grade 1 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Stinging/Burning | Grade 2 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Stinging/Burning | Grade 1 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Stinging/Burning | Grade 0 | 27 AK Fields |
| MN + ALA 60 Min 10mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| ALA 60 Min 10 mW | Stinging/Burning | Grade 2 | 0 AK Fields |
| ALA 60 Min 10 mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| ALA 60 Min 10 mW | Stinging/Burning | Grade 1 | 0 AK Fields |
| ALA 60 Min 10 mW | Stinging/Burning | Grade 0 | 27 AK Fields |
| MN + ALA 60 Min 20 mW | Stinging/Burning | Grade 1 | 1 AK Fields |
| MN + ALA 60 Min 20 mW | Stinging/Burning | Grade 0 | 23 AK Fields |
| MN + ALA 60 Min 20 mW | Stinging/Burning | Grade 2 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| ALA 60 Min 20 mW | Stinging/Burning | Grade 2 | 0 AK Fields |
| ALA 60 Min 20 mW | Stinging/Burning | Grade 0 | 22 AK Fields |
| ALA 60 Min 20 mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| ALA 60 Min 20 mW | Stinging/Burning | Grade 1 | 2 AK Fields |
| MN + VEH | Stinging/Burning | Grade 1 | 1 AK Fields |
| MN + VEH | Stinging/Burning | Grade 0 | 28 AK Fields |
| MN + VEH | Stinging/Burning | Grade 2 | 0 AK Fields |
| MN + VEH | Stinging/Burning | Grade 3 | 0 AK Fields |
| VEH PDT | Stinging/Burning | Grade 3 | 0 AK Fields |
| VEH PDT | Stinging/Burning | Grade 1 | 0 AK Fields |
| VEH PDT | Stinging/Burning | Grade 2 | 0 AK Fields |
| VEH PDT | Stinging/Burning | Grade 0 | 29 AK Fields |
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: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Stinging/Burning | Grade 0 | 24 AK Fields |
| MN + ALA 25 Min 10 mW | Stinging/Burning | Grade 1 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Stinging/Burning | Grade 2 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| ALA 25 Min 10 mW | Stinging/Burning | Grade 1 | 0 AK Fields |
| ALA 25 Min 10 mW | Stinging/Burning | Grade 0 | 24 AK Fields |
| ALA 25 Min 10 mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| ALA 25 Min 10 mW | Stinging/Burning | Grade 2 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Stinging/Burning | Grade 1 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Stinging/Burning | Grade 0 | 27 AK Fields |
| MN + ALA 25 Min 20 mW | Stinging/Burning | Grade 2 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| ALA 25 Min 20 mW | Stinging/Burning | Grade 0 | 26 AK Fields |
| ALA 25 Min 20 mW | Stinging/Burning | Grade 1 | 1 AK Fields |
| ALA 25 Min 20 mW | Stinging/Burning | Grade 2 | 0 AK Fields |
| ALA 25 Min 20 mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Stinging/Burning | Grade 2 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Stinging/Burning | Grade 1 | 1 AK Fields |
| MN + ALA 60 Min 10mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Stinging/Burning | Grade 0 | 27 AK Fields |
| ALA 60 Min 10 mW | Stinging/Burning | Grade 2 | 0 AK Fields |
| ALA 60 Min 10 mW | Stinging/Burning | Grade 1 | 1 AK Fields |
| ALA 60 Min 10 mW | Stinging/Burning | Grade 0 | 27 AK Fields |
| ALA 60 Min 10 mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Stinging/Burning | Grade 1 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Stinging/Burning | Grade 2 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Stinging/Burning | Grade 0 | 24 AK Fields |
| ALA 60 Min 20 mW | Stinging/Burning | Grade 0 | 24 AK Fields |
| ALA 60 Min 20 mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| ALA 60 Min 20 mW | Stinging/Burning | Grade 1 | 0 AK Fields |
| ALA 60 Min 20 mW | Stinging/Burning | Grade 2 | 0 AK Fields |
| MN + VEH | Stinging/Burning | Grade 3 | 0 AK Fields |
| MN + VEH | Stinging/Burning | Grade 0 | 30 AK Fields |
| MN + VEH | Stinging/Burning | Grade 2 | 0 AK Fields |
| MN + VEH | Stinging/Burning | Grade 1 | 0 AK Fields |
| VEH PDT | Stinging/Burning | Grade 2 | 0 AK Fields |
| VEH PDT | Stinging/Burning | Grade 0 | 30 AK Fields |
| VEH PDT | Stinging/Burning | Grade 3 | 0 AK Fields |
| VEH PDT | Stinging/Burning | Grade 1 | 0 AK Fields |
Other Pre-specified
Stinging/Burning
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: 2 Weeks after PDT #1
Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Stinging/Burning | Grade 1 | 1 AK Fields |
| MN + ALA 25 Min 10 mW | Stinging/Burning | Grade 0 | 24 AK Fields |
| MN + ALA 25 Min 10 mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Stinging/Burning | Grade 2 | 0 AK Fields |
| ALA 25 Min 10 mW | Stinging/Burning | Grade 0 | 24 AK Fields |
| ALA 25 Min 10 mW | Stinging/Burning | Grade 1 | 1 AK Fields |
| ALA 25 Min 10 mW | Stinging/Burning | Grade 2 | 0 AK Fields |
| ALA 25 Min 10 mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Stinging/Burning | Grade 1 | 1 AK Fields |
| MN + ALA 25 Min 20 mW | Stinging/Burning | Grade 0 | 26 AK Fields |
| MN + ALA 25 Min 20 mW | Stinging/Burning | Grade 2 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| ALA 25 Min 20 mW | Stinging/Burning | Grade 0 | 26 AK Fields |
| ALA 25 Min 20 mW | Stinging/Burning | Grade 1 | 1 AK Fields |
| ALA 25 Min 20 mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| ALA 25 Min 20 mW | Stinging/Burning | Grade 2 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Stinging/Burning | Grade 2 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Stinging/Burning | Grade 0 | 28 AK Fields |
| MN + ALA 60 Min 10mW | Stinging/Burning | Grade 1 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| ALA 60 Min 10 mW | Stinging/Burning | Grade 0 | 28 AK Fields |
| ALA 60 Min 10 mW | Stinging/Burning | Grade 1 | 0 AK Fields |
| ALA 60 Min 10 mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| ALA 60 Min 10 mW | Stinging/Burning | Grade 2 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Stinging/Burning | Grade 1 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Stinging/Burning | Grade 0 | 25 AK Fields |
| MN + ALA 60 Min 20 mW | Stinging/Burning | Grade 2 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| ALA 60 Min 20 mW | Stinging/Burning | Grade 0 | 25 AK Fields |
| ALA 60 Min 20 mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| ALA 60 Min 20 mW | Stinging/Burning | Grade 1 | 0 AK Fields |
| ALA 60 Min 20 mW | Stinging/Burning | Grade 2 | 0 AK Fields |
| MN + VEH | Stinging/Burning | Grade 2 | 0 AK Fields |
| MN + VEH | Stinging/Burning | Grade 1 | 0 AK Fields |
| MN + VEH | Stinging/Burning | Grade 3 | 0 AK Fields |
| MN + VEH | Stinging/Burning | Grade 0 | 30 AK Fields |
| VEH PDT | Stinging/Burning | Grade 1 | 0 AK Fields |
| VEH PDT | Stinging/Burning | Grade 2 | 0 AK Fields |
| VEH PDT | Stinging/Burning | Grade 3 | 0 AK Fields |
| VEH PDT | Stinging/Burning | Grade 0 | 30 AK Fields |
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_UNITS) |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Stinging/Burning | Grade 0 | 24 AK Fields |
| MN + ALA 25 Min 10 mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Stinging/Burning | Grade 2 | 0 AK Fields |
| MN + ALA 25 Min 10 mW | Stinging/Burning | Grade 1 | 1 AK Fields |
| ALA 25 Min 10 mW | Stinging/Burning | Grade 0 | 24 AK Fields |
| ALA 25 Min 10 mW | Stinging/Burning | Grade 2 | 0 AK Fields |
| ALA 25 Min 10 mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| ALA 25 Min 10 mW | Stinging/Burning | Grade 1 | 1 AK Fields |
| MN + ALA 25 Min 20 mW | Stinging/Burning | Grade 2 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Stinging/Burning | Grade 1 | 0 AK Fields |
| MN + ALA 25 Min 20 mW | Stinging/Burning | Grade 0 | 27 AK Fields |
| MN + ALA 25 Min 20 mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| ALA 25 Min 20 mW | Stinging/Burning | Grade 2 | 0 AK Fields |
| ALA 25 Min 20 mW | Stinging/Burning | Grade 0 | 27 AK Fields |
| ALA 25 Min 20 mW | Stinging/Burning | Grade 1 | 0 AK Fields |
| ALA 25 Min 20 mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Stinging/Burning | Grade 0 | 29 AK Fields |
| MN + ALA 60 Min 10mW | Stinging/Burning | Grade 2 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Stinging/Burning | Grade 1 | 0 AK Fields |
| ALA 60 Min 10 mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| ALA 60 Min 10 mW | Stinging/Burning | Grade 0 | 29 AK Fields |
| ALA 60 Min 10 mW | Stinging/Burning | Grade 1 | 0 AK Fields |
| ALA 60 Min 10 mW | Stinging/Burning | Grade 2 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Stinging/Burning | Grade 2 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Stinging/Burning | Grade 1 | 1 AK Fields |
| MN + ALA 60 Min 20 mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Stinging/Burning | Grade 0 | 25 AK Fields |
| ALA 60 Min 20 mW | Stinging/Burning | Grade 0 | 25 AK Fields |
| ALA 60 Min 20 mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| ALA 60 Min 20 mW | Stinging/Burning | Grade 1 | 1 AK Fields |
| ALA 60 Min 20 mW | Stinging/Burning | Grade 2 | 0 AK Fields |
| MN + VEH | Stinging/Burning | Grade 1 | 1 AK Fields |
| MN + VEH | Stinging/Burning | Grade 2 | 0 AK Fields |
| MN + VEH | Stinging/Burning | Grade 0 | 29 AK Fields |
| MN + VEH | Stinging/Burning | Grade 3 | 0 AK Fields |
| VEH PDT | Stinging/Burning | Grade 1 | 0 AK Fields |
| VEH PDT | Stinging/Burning | Grade 0 | 30 AK Fields |
| VEH PDT | Stinging/Burning | Grade 3 | 0 AK Fields |
| VEH PDT | Stinging/Burning | Grade 2 | 0 AK Fields |
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: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| MN + ALA 25 Min 10 mW | Stinging/Burning | Grade 0 | 9 AK Fields |
| MN + ALA 25 Min 10 mW | Stinging/Burning | Grade 1 | 6 AK Fields |
| MN + ALA 25 Min 10 mW | Stinging/Burning | Grade 2 | 10 AK Fields |
| MN + ALA 25 Min 10 mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| ALA 25 Min 10 mW | Stinging/Burning | Grade 1 | 14 AK Fields |
| ALA 25 Min 10 mW | Stinging/Burning | Grade 0 | 8 AK Fields |
| ALA 25 Min 10 mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| ALA 25 Min 10 mW | Stinging/Burning | Grade 2 | 3 AK Fields |
| MN + ALA 25 Min 20 mW | Stinging/Burning | Grade 1 | 8 AK Fields |
| MN + ALA 25 Min 20 mW | Stinging/Burning | Grade 0 | 12 AK Fields |
| MN + ALA 25 Min 20 mW | Stinging/Burning | Grade 2 | 6 AK Fields |
| MN + ALA 25 Min 20 mW | Stinging/Burning | Grade 3 | 1 AK Fields |
| ALA 25 Min 20 mW | Stinging/Burning | Grade 0 | 13 AK Fields |
| ALA 25 Min 20 mW | Stinging/Burning | Grade 1 | 11 AK Fields |
| ALA 25 Min 20 mW | Stinging/Burning | Grade 2 | 3 AK Fields |
| ALA 25 Min 20 mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Stinging/Burning | Grade 2 | 6 AK Fields |
| MN + ALA 60 Min 10mW | Stinging/Burning | Grade 1 | 15 AK Fields |
| MN + ALA 60 Min 10mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 10mW | Stinging/Burning | Grade 0 | 7 AK Fields |
| ALA 60 Min 10 mW | Stinging/Burning | Grade 2 | 6 AK Fields |
| ALA 60 Min 10 mW | Stinging/Burning | Grade 1 | 16 AK Fields |
| ALA 60 Min 10 mW | Stinging/Burning | Grade 0 | 6 AK Fields |
| ALA 60 Min 10 mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Stinging/Burning | Grade 1 | 9 AK Fields |
| MN + ALA 60 Min 20 mW | Stinging/Burning | Grade 2 | 8 AK Fields |
| MN + ALA 60 Min 20 mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| MN + ALA 60 Min 20 mW | Stinging/Burning | Grade 0 | 8 AK Fields |
| ALA 60 Min 20 mW | Stinging/Burning | Grade 0 | 9 AK Fields |
| ALA 60 Min 20 mW | Stinging/Burning | Grade 3 | 0 AK Fields |
| ALA 60 Min 20 mW | Stinging/Burning | Grade 1 | 10 AK Fields |
| ALA 60 Min 20 mW | Stinging/Burning | Grade 2 | 6 AK Fields |
| MN + VEH | Stinging/Burning | Grade 3 | 0 AK Fields |
| MN + VEH | Stinging/Burning | Grade 0 | 28 AK Fields |
| MN + VEH | Stinging/Burning | Grade 2 | 0 AK Fields |
| MN + VEH | Stinging/Burning | Grade 1 | 2 AK Fields |
| VEH PDT | Stinging/Burning | Grade 2 | 0 AK Fields |
| VEH PDT | Stinging/Burning | Grade 0 | 28 AK Fields |
| VEH PDT | Stinging/Burning | Grade 3 | 0 AK Fields |
| VEH PDT | Stinging/Burning | Grade 1 | 2 AK Fields |