| Primary | Change in Inflammatory Lesion Counts Relative to Baseline | | | Posted | | Median | Standard Deviation | change in lesion count | | Baseline and 3 weeks after final treatment | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 | Vehicle 500 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds) |
| | Units | Counts |
|---|
| Participants | - OG00068
- OG00165
- OG00267
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-18.0± 26.3
- OG001-14.0± 26.8
- OG002-19.0± 22.8
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Null hypothesis: equal median changes from baseline in total inflammatory lesion counts among the treatments | ANCOVA | Rank ANCOVA with baseline total inflammatory lesion counts serving as the covariate. | 0.7680 | | | | | | | 95 | | | | | | No | Superiority or Other | | |
|
| Primary | Investigator Global Assessment of Acne Severity Successes | Scale consists of Grade 0 (clear skin) to Grade 4 (severe: up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions) This assessment uses a dichotomized success/failure assessment - with success defined as a 2 point or more improvement on the IGA scale since baseline. | | Posted | | Number | | participants | | Baseline and 3 weeks after final treatment | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 | Vehicle 500 Seconds |
|
| Secondary | Percent Change in Inflammatory Lesion Counts Relative to Baseline | | | Posted | | Median | Standard Deviation | percent change in lesion count | | Baseline and 3 weeks after final treatment | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 | Vehicle 500 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds) |
| |
| Secondary | Percent Change in Inflammatory Lesion Counts Relative to Baseline | | | Posted | | Median | Standard Deviation | percent change in lesion count | | Baseline and 6 weeks after final treatment | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 | Vehicle 500 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds) |
| |
| Secondary | Subject Satisfaction Score | Subject satisfaction score
- = Excellent (very satisfied)
- = Good (moderately satisfied)
- = Fair (slightly satisfied)
- = Poor (not satisfied at all)
| | Posted | | Number | | participants | | 6 weeks after final treatment | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 | Vehicle 500 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds) |
|
| Secondary | Change in Inflammatory Lesion Counts Relative to Baseline | change in lesion counts compared to baseline | | Posted | | Median | Standard Deviation | change in lesion count | | Baseline and 6 weeks after final treatment | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 | Vehicle 500 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds) |
|
| Secondary | Investigator Global Assessment of Acne Severity Successes | Assessment uses a dichotomized success/failure assessment with success defined as a 2 point or more improvement since baseline. 0 Clear skin with no inflam or non-inflam lesions
- Almost clear; rare non-inflam lesions with no more than a few small inflam lesions
- Mild; > Grade 1; some non-inflam lesions with some inflam lesions (papules/pustules only; no nodules)
- Moderate; > Grade 2; up to many non-inflam lesions and a moderate number of inflam lesions but no more than one small nodule
- Severe; > Grade 3; up to many non-inflam and inflam lesions, but no more than a few nodules
| | Posted | | Number | | participants | | Baesline and 6 weeks after final treatment | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) |
|
| Secondary | Hyperpigmentation 48 Hours After PDT #1 | HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas | | Posted | | Number | | participants | | 48 hours after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 |
|
| Secondary | Hyperpigmentation at Visit 3 (Week 3) | HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas | | Posted | | Number | | participants | | Visit 3 (Week 3) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 |
|
| Secondary | Hyperpigmentation at Visit 5 (Week 6) | HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas | | Posted | | Number | | participants | | Visit 5 (Week 6) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 |
|
| Secondary | Hyperpigmentation at Visit 7 (Week 9) | 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 | | Posted | | Number | | participant | | Visit 7 (Week 9) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 |
|
| Secondary | Hyperpigmentation at Visit 9 (3 Weeks After Final PDT) | 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 | | Posted | | Number | | participants | | Visit 9 (3 weeks after final PDT) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | |
|
| Secondary | Hyperpigmentation at Visit 10 (6 Weeks After Final PDT) | 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 | | Posted | | Number | | participants | | Visit 10 (6 weeks after final PDT) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | |
|
| Secondary | Hypopigmentation 48 Hours Post PDT #1 | HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas | | Posted | | Number | | participants | | 48 hours post PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 |
|
| Secondary | Hypopigmentation at Visit 3 (Week 3) | HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas | | Posted | | Number | | participants | | Visit 3 (Week 3) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 |
|
| Secondary | Hypopigmentation at Visit 5 (Week 6) | HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas | | Posted | | Number | | participants | | Visit 5 (Week 6) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 |
|
| Secondary | Hypopigmentation at Visit 7 (Week 9) | 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 | | Posted | | Number | | participants | | Visit 7 (Week 9) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 |
|
| Secondary | Hypopigmentation at Visit 9 (3 Weeks After Final PDT) | 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 | | Posted | | Number | | participants | | Visit 9 (3 weeks after final PDT) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | |
|
| Secondary | Hypopigmentation at Visit 10 (6 Weeks After Final PDT) | 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 | | Posted | | Number | | participants | | Visit 10 (6 weeks after final PDT) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | |
|
| Secondary | Erythema at Baseline (Pre-light) | After solution application, prior to light treatment 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 | | Posted | | Number | | participants | | Baseline (pre-light) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) |
|
| Secondary | Erythema at Baseline - Post Light Treatment | 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 | | Posted | | Number | | participants | | Baseline - post light treatment | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) |
|
| Secondary | Erythema 48 Hours After PDT #1 | 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 | | Posted | | Number | | participants | | 48 hours after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) |
|
| Secondary | Erythema at Visit 3 (Week 3 - Pre Study Drug Application) | 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 | | Posted | | Number | | participants | | Visit 3 (Week 3 - pre study drug application) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) |
|
| Secondary | Erythema at Visit 3 (Week 3 - Pre-light) | 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 | | Posted | | Number | | participants | | Visit 3 (Week 3 - pre-light) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) |
|
| Secondary | Erythema at Visit 3 (Week 3 - Post Light Treatment) | 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 | | Posted | | Number | | participants | | Visit 3 (Week 3 - post light treatment) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) |
|
| Secondary | Erythema at Visit 5 (Week 6 - Prior to Study Drug Application) | 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 | | Posted | | Number | | participants | | Visit 5 (Week 6 - prior to study drug application) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) |
|
| Secondary | Erythema at Visit 5 (Weeks 6 - Pre-light Treatment) | 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 | | Posted | | Number | | participants | | Visit 5 (Weeks 6 - pre-light treatment) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) |
|
| Secondary | Erythema at Visit 5 (Week 6 - Post Light Treatment) | 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 | | Posted | | Number | | participants | | Visit 5 (Week 6 - post light treatment) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) |
|
| Secondary | Erythema at Visit 7 (Week 9 - Prior to Study Drug Application) | 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 | | Posted | | Number | | participants | | Visit 7 (Week 9 - prior to study drug application) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) |
|
| Secondary | Erythema at Visit 7 (Week 9 - Pre Light Treatment) | 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 | | Posted | | Number | | participants | | Visit 7 (Week 9 - pre light treatment) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) |
|
| Secondary | Erythema at Visit 7 (Week 9 - Post Light Treatment) | 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 | | Posted | | Number | | participant | | Visit 7 (Week 9 - post light treatment) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) |
|
| Secondary | Erythema 3 Weeks After Final PDT | 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 | | Posted | | Number | | participants | | 3 Weeks after Final PDT | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) |
|
| Secondary | Erythema 6 Weeks After Final PDT | 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 | | Posted | | Number | | participants | | 6 Weeks after Final PDT | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) |
|
| Secondary | Edema at Baseline - Pre Light Treatment | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area | | Posted | | Number | | participants | | Baseline - pre light treatment | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 | Vehicle 500 Seconds |
|
| Secondary | Edema at Baseline - Post Light Treatment | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area | | Posted | | Number | | participants | | Baseline - Post Light Treatment | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 | Vehicle 500 Seconds |
|
| Secondary | Edema 48 Hours After PDT #1 | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area | | Posted | | Number | | participants | | 48 hours after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 | Vehicle 500 Seconds |
|
| Secondary | Edema at Visit 3 (Week 3 - Before Study Drug Application) | 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 | | Posted | | Number | | participants | | Visit 3 (Week 3 - before study drug application) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 |
|
| Secondary | Edema at Visit 3 (Week 3 - Before Light Treatment) | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area | | Posted | | Number | | participants | | Visit 3 (Week 3 - before light treatment) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 |
|
| Secondary | Edema at Visit 3 (Week 3 - Post Light Treatment) | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area | | Posted | | Number | | participants | | Visit 3 (Week 3 - post light treatment) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 |
|
| Secondary | Edema at Visit 5 (Week 6 - Before Study Drug Application) | 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 | | Posted | | Number | | participants | | Visit 5 (Week 6 - before study drug application) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 |
|
| Secondary | Edema at Visit 5 (Week 6 - Pre Light Treatment) | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area | | Posted | | Number | | participants | | Visit 5 (Week 6 - pre light treatment) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 |
|
| Secondary | Edema at Visit 5 (Week 6 - Post Light Treatment) | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area | | Posted | | Number | | participants | | Visit 5 (Week 6 - post light treatment) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 |
|
| Secondary | Edema at Visit 7 (Week 9 - Before Study Drug Application) | 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 | | Posted | | Number | | participants | | Visit 7 (Week 9 - before study drug application) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 |
|
| Secondary | Edema at Visit 7 (Week 9 - Prior to Light Treatment) | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area | | Posted | | Number | | participants | | Visit 7 (Week 9 - prior to light treatment) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 |
|
| Secondary | Edema at Visit 7 (Week 9 - Post Light Treatment) | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area | | Posted | | Number | | participants | | Visit 7 (Week 9 - post light treatment) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 |
|
| Secondary | Edema 3 Weeks After Final PDT | 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 | | Posted | | Number | | participants | | 3 weeks after final PDT | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 | Vehicle 500 Seconds |
|
| Secondary | Edema 6 Weeks After Final PDT | 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 | | Posted | | Number | | participants | | 6 weeks after final PDT | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 | Vehicle 500 Seconds |
|
| Secondary | Stinging/Burning at Baseline - Before Light Treatment | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable | | Posted | | Number | | participants | | Baseline - before light treatment | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 | Vehicle 500 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds) |
|
| Secondary | Stinging/Burning at Baseline - During Light | 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 | | Posted | | Number | | participants | | Baseline - during light | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 | Vehicle 500 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds) |
|
| Secondary | Stinging/Burning at Baseline - Post Light Treatment | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable | | Posted | | Number | | participants | | Baseline - post light treatment | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 | Vehicle 500 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds) |
|
| Secondary | Stinging/Burning 48 Hours Post PDT #1 | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable | | Posted | | Number | | participants | | 48 hours post PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 | Vehicle 500 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds) |
|
| Secondary | Stinging/Burning at Visit 3 (Week 3 - Before Study Drug Application) | 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 | | Posted | | Number | | participants | | Visit 3 (Week 3 - before study drug application) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 | Vehicle 500 Seconds | |
|
| Secondary | Stinging/Burning at Visit 3 (Week 3 - Before Light Treatment) | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable | | Posted | | Number | | participants | | Visit 3 (Week 3 - before light treatment) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 | Vehicle 500 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds) |
|
| Secondary | Stinging/Burning at Visit 3 (Week 3 - During Light Treatment) | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable | | Posted | | Number | | participants | | Visit 3 (Week 3 - during light treatment) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 | Vehicle 500 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds) |
|
| Secondary | Stinging/Burning at Visit 3 (Week 3 - Post Light Treatment) | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable | | Posted | | Number | | participants | | Visit 3 (Week 3 - post light treatment) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 | Vehicle 500 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds) |
|
| Secondary | Stinging/Burning at Visit 5 (Week 6 - Before Study Drug Application) | 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 | | Posted | | Number | | participants | | Visit 5 (Week 6 - before study drug application) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 | Vehicle 500 Seconds | |
|
| Secondary | Stinging/Burning at Visit 5 (Week 6 - Prior to Light Treatment) | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable | | Posted | | Number | | participants | | Visit 5 (Week 6 - prior to light treatment) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 | Vehicle 500 Seconds | |
|
| Secondary | Stinging/Burning at Visit 5 (Week 6 - During Light Treatment) | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable | | Posted | | Number | | participants | | Visit 5 (Week 6 - during light treatment) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 | Vehicle 500 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds) |
|
| Secondary | Stinging/Burning at Visit 5 (Week 6 - Post Light Treatment) | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable | | Posted | | Number | | participants | | Visit 5 (Week 6 - post light treatment) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 | Vehicle 500 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds) |
|
| Secondary | Stinging/Burning at Visit 7 (Week 9 - Before Study Drug Application) | 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 | | Posted | | Number | | participants | | Visit 7 (Week 9 - before study drug application) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 | Vehicle 500 Seconds | |
|
| Secondary | Stinging/Burning at Visit 7 (Week 9 - Prior to Light Treatment) | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable | | Posted | | Number | | participants | | Visit 7 (Week 9 - prior to light treatment) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 | Vehicle 500 Seconds | |
|
| Secondary | Stinging/Burning at Visit 7 (Week 9 - During Light Treatment) | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable | | Posted | | Number | | participants | | Visit 7 (Week 9 - during light treatment) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 | Vehicle 500 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds) |
|
| Secondary | Stinging/Burning at Visit 7 (Week 9 - Post Light Treatment) | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable | | Posted | | Number | | participants | | Visit 7 (Week 9 - post light treatment) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 | Vehicle 500 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds) |
|
| Secondary | Stinging/Burning at Visit 9 (3 Weeks After Final PDT) | 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 | | Posted | | Number | | participants | | Visit 9 (3 Weeks after Final PDT) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 | Vehicle 500 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds) |
|
| Secondary | Stinging/Burning at Visit 10 (6 Weeks After Final PDT) | 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 | | Posted | | Number | | participants | | Visit 10 (6 Weeks after Final PDT) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 | Vehicle 500 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds) |
|
| Secondary | Scaling and Dryness 48 Hours After PDT #1 | SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling | | Posted | | Number | | participants | | 48 hours after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 |
|
| Secondary | Scaling and Dryness at Visit 3 (Week 3) | SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling | | Posted | | Number | | participants | | Visit 3 (Week 3) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 |
|
| Secondary | Scaling and Dryness at Visit 5 (Week 6) | SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling | | Posted | | Number | | participants | | Visit 5 (Week 6) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 |
|
| Secondary | Scaling and Dryness at Visit 7 (Week 9) | 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 | | Posted | | Number | | participants | | Visit 7 (Week 9) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 |
|
| Secondary | Scaling and Dryness at Visit 9 (3 Weeks After Final PDT) | 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 | | Posted | | Number | | participants | | Visit 9 (3 Weeks after Final PDT) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 |
|
| Secondary | Scaling and Dryness at Visit 10 (6 Weeks After Final PDT) | 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 | | Posted | | Number | | participants | | Visit 10 (6 Weeks after Final PDT) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG003 |
|
| Secondary | Oozing/Vesiculation/Crusting 48 Hours After PDT #1 | OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above | | Posted | | Number | | participants | | 48 hours after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) |
|
| Secondary | Oozing/Vesiculation/Crusting at Visit 3 (Week 3) | OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above | | Posted | | Number | | participants | | Visit 3 (Week 3) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) |
|
| Secondary | Oozing/Vesiculation/Crusting at Visit 5 (Week 6) | OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above | | Posted | | Number | | participant | | Visit 5 (Week 6) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) |
|
| Secondary | Oozing/Vesiculation/Crusting at Visit 7 (Week 9) | 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 | | Posted | | Number | | participants | | Visit 7 (Week 9) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) |
|
| Secondary | Oozing/Vesiculation/Crusting at Visit 9 (3 Weeks After Final PDT) | 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 | | Posted | | Number | | participants | | Visit 9 (3 Weeks after Final PDT) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) |
|
| Secondary | Oozing/Vesiculation/Crusting at Visit 10 (6 Weeks After Final PDT) | 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 | | Posted | | Number | | particpants | | Visit 10 (6 Weeks after Final PDT) | | | | ID | Title | Description |
|---|
| OG000 | ALA 1000 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | | OG001 | ALA 500 Seconds | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | | OG002 | Vehicle 1000 Seconds | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) |
|