| Primary | Complete Clearance Rate | The proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area | Intent to Treat (ITT) with last observation carried forward (LOCF) to impute missing data | Posted | | Number | | participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5. | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5. | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5. | | OG003 | Spot ALA 2-hour + BLUE Light Treatment | Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5. | | OG004 | Vehicle + BLUE Light Treatment | VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group. Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group. |
| | Units | Counts |
|---|
| Participants | - OG00047
- OG00148
- OG00247
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00014
- OG0017
- OG00213
- 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 |
|---|
- OG000
- OG001
- OG002
- OG003
- OG004
| | Chi-squared | | 0.0041 | | | | | | | 95 | | | | | | No | Superiority or Other | | |
|
| Secondary | Complete Clearance Rate | The proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area | | Posted | | Number | | participants | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5. | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5. | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5. | | OG003 | Spot ALA 2-hour + BLUE Light Treatment | Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5. |
|
| Secondary | Complete Clearance Rate | The proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area | | Posted | | Number | | participants | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5. | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation,prior to BLUE light treatment at Visits 1 and 5. | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5. | | OG003 | Spot ALA 2-hour + BLUE Light Treatment | Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5. | | OG004 |
|
| Secondary | Complete Clearance Rate | the proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area | | Posted | | Number | | participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5. | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5. | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5. | | OG003 | Spot ALA 2-hour + BLUE Light Treatment | Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5. | | OG004 |
|
| Secondary | Partial Clearance Rate | proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline. | | Posted | | Number | | participants | | Baseline, Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5. | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5. | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5. | | OG003 | Spot ALA 2-hour + BLUE Light Treatment | Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5. | |
|
| Secondary | Partial Clearance Rate | proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline. | | Posted | | Number | | participants | | Baseline, Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5. | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5. | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5. | | OG003 | Spot ALA 2-hour + BLUE Light Treatment | Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5. | |
|
| Secondary | Partial Clearance Rate | proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline. | | Posted | | Number | | participants | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5. | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5. | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5. | | OG003 | Spot ALA 2-hour + BLUE Light Treatment | Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5. | |
|
| Secondary | Partial Clearance Rate | proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline. | | Posted | | Number | | participants | | Baseline Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5. | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5. | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5. | | OG003 | Spot ALA 2-hour + BLUE Light Treatment | Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5. | |
|
| Secondary | AK Clearance Rate | AK Clearance Rate (AKCR) for a subject is defined as: 100% x [1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)] | | Posted | | Median | Standard Deviation | percent clearance | | Baseline, Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5. | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5. | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5. | | OG003 | Spot ALA 2-hour + BLUE Light Treatment | Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5. |
|
| Secondary | AK Clearance Rate | AK Clearance Rate (AKCR) for a subject is defined as: 100% x [1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)] | | Posted | | Median | Standard Deviation | percent clearance | | Baseline, Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG003 | Spot ALA 2-hour + BLUE Light Treatment | Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 |
|
| Secondary | AK Clearance Rate | AK Clearance Rate (AKCR) for a subject is defined as: 100% x [1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)] | | Posted | | Median | Standard Deviation | percent clearance | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation prior to BLUE light treatment at Vist 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG003 | Spot ALA 2-hour + BLUE Light Treatment | Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 |
|
| Secondary | AK Clearance Rate | AK Clearance Rate (AKCR) for a subject is defined as: 100% x [1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)] | | Posted | | Median | Standard Deviation | percent clearance | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG003 | Spot ALA 2-hour + BLUE Light Treatment | Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 |
|
| Secondary | Subject Satisfaction Score | 0 = no improvement or worsening (not satisfied at all)
- = slight improvement (slightly satisfied)
- = moderate improvement (moderately satisfied)
- = excellent improvement (very satisfied)
| | Posted | | Number | | participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG003 | Spot ALA 2-hour + BLUE Light Treatment | Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 |
|
| Secondary | Hyperpigmentation at Baseline | HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas | | Posted | | Number | | participants | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG003 | Spot ALA 2-hour + BLUE Light Treatment |
|
| Secondary | Hyperpigmentation at Visit 2 | 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 | | 24-48 Hours after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG003 | Spot ALA 2-hour + BLUE Light Treatment |
|
| Secondary | Hyperpigmentation at Visit 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 | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG003 | Spot ALA 2-hour + BLUE Light Treatment |
|
| Secondary | Hyperpigmentation at Visit 4 | 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 | Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data. | Posted | | Number | | participants | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 |
|
| Secondary | Hyperpigmentation at Visit 5 | 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 | Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data. | Posted | | Number | | participants | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 |
|
| Secondary | Hyperpigmentation at Visit 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 | Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data. | Posted | | Number | | participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 |
|
| Secondary | Hyperpigmentation at Visit 7 | 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 | Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data. | Posted | | Number | | participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 |
|
| Secondary | Hypopigmentation at Baseline | HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas | | Posted | | Number | | participants | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG003 | Spot ALA 2-hour + BLUE Light Treatment |
|
| Secondary | Hypopigmentation at Visit 2 | 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 | | 24-48 Hours after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG003 | Spot ALA 2-hour + BLUE Light Treatment |
|
| Secondary | Hypopigmentation at Visit 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 | Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data. | Posted | | Number | | participants | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 |
|
| Secondary | Hypopigmentation at Visit 4 | 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 | Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data. | Posted | | Number | | participants | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 |
|
| Secondary | Hypopigmentation at Visit 5 | 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 | Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data. | Posted | | Number | | participants | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 |
|
| Secondary | Hypopigmentation at Visit 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 | Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data. | Posted | | Number | | participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 |
|
| Secondary | Hypopigmentation at Visit 7 | 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 | Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data. | Posted | | Number | | participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 |
|
| Secondary | Erythema at Baseline | Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema | | Posted | | Number | | participants | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG003 |
|
| Secondary | Erythema Post-Light Treatment | 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 | | Posted | | Number | | participants | | 5 minutes after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | |
|
| Secondary | Erythema at Visit 2 | 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 | | Posted | | Number | | participants | | 24-48 hours after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | |
|
| Secondary | Erythema at Visit 3 | 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 | Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data. | Posted | | Number | | participants | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 |
|
| Secondary | Erythema at Visit 4 | 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 | Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data. | Posted | | Number | | participants | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 |
|
| Secondary | Erythema at Visit 5 (Pre-drug) | 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 | Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data. | Posted | | Number | | participants | | Week 8 pre-drug | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 |
|
| Secondary | Erythema at Visit 5 (Post-light) | 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 | Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data. | Posted | | Number | | participants | | Week 8 5 minutes post light treatment | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 |
|
| Secondary | Erythema at Visit 6 | 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 | Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data. | Posted | | Number | | participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 |
|
| Secondary | Erythema at Visit 7 | 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 | Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data. | Posted | | Number | | participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment at Visit 1 and Vi | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 |
|
| Secondary | Edema at Baseline | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area | | Posted | | Number | | participants | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation prior to BLUE light treatment at Visit 1 and Visit 5 | | OG003 | Spot ALA 2-hour + BLUE Light Treatment | |
|
| Secondary | Edema 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 | | 5 minutes after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG003 | Spot ALA 2-hour + BLUE Light Treatment |
|
| Secondary | Edema at Visit 2 | 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 | | 24-48 hours post PDT#1 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG003 | Spot ALA 2-hour + BLUE Light Treatment |
|
| Secondary | Edema at Visit 3 | 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 | Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data. | Posted | | Number | | participants | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | |
|
| Secondary | Edema at Visit 4 | 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 | Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data. | Posted | | Number | | participants | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | |
|
| Secondary | Edema at Visit 5 (Pre-drug) | 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 | Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data. | Posted | | Number | | participants | | Week 8 pre-drug | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 |
|
| Secondary | Edema Post PDT #2 | 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 | Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data. | Posted | | Number | | participants | | 5 minutes post PDT #2 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 |
|
| Secondary | Edema at Week 12 | 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 | Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data. | Posted | | Number | | participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | |
|
| Secondary | Edema at Week 24 | 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 | Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data. | Posted | | Number | | participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | |
|
| Secondary | Stinging/Burning at Baseline | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded. | | Posted | | Number | | participants | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG003 | Spot ALA 2-hour + BLUE Light Treatment | |
|
| Secondary | Stinging/Burning 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 The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded. | | Posted | | Number | | participants | | During PDT #1 (most intense sensation) | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG003 | Spot ALA 2-hour + BLUE Light Treatment | |
|
| Secondary | Stinging/Burning 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 The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded. | | Posted | | Number | | participants | | 5 minutes post PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG003 | Spot ALA 2-hour + BLUE Light Treatment | |
|
| Secondary | Stinging/Burning at Visit 2 | 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 The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded. | | Posted | | Number | | participants | | 24-48 hours post PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG003 | Spot ALA 2-hour + BLUE Light Treatment | |
|
| Secondary | Stinging/Burning at Visit 3 | 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 The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded. | Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data. | Posted | | Number | | participants | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG003 |
|
| Secondary | Stinging/Burning at Visit 4 | 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 The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded. | Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data. | Posted | | Number | | participants | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG003 |
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| Secondary | Stinging/Burning at Visit 5 (Pre-drug) | 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 The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded. | Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data. | Posted | | Number | | participants | | Week 8 prior to drug | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | |
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| Secondary | Stinging/Burning at Visit 5 During PDT#2 | 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 The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded. | Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data. | Posted | | Number | | participants | | during PDT #2 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | |
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| Secondary | Stinging/Burning at Visit 5 Post PDT#2 | 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 The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded. | Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data. | Posted | | Number | | participants | | 5 minutes post PDT #2 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | |
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| Secondary | Stinging/Burning at Visit 6 | 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 The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded. | Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data. | Posted | | Number | | participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG003 |
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| Secondary | Stinging/Burning at Visit 7 | 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 The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded. | Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data. | Posted | | Number | | participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG003 |
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| Secondary | Scaling and Dryness at Baseline | SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling | | Posted | | Number | | participants | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG003 | Spot ALA 2-hour + BLUE Light Treatment |
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| Secondary | Scaling and Dryness at Visit 2 | 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 | | 24-48 hours after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG003 | Spot ALA 2-hour + BLUE Light Treatment |
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| Secondary | Scaling and Dryness at Visit 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 | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG003 | Spot ALA 2-hour + BLUE Light Treatment |
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| Secondary | Scaling and Dryness at Visit 4 | 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 | Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data. | Posted | | Number | | participants | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 |
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| Secondary | Scaling and Dryness at Visit 5 | 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 | Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data. | Posted | | Number | | participants | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 |
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| Secondary | Scaling and Dryness at Visit 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 | Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data. | Posted | | Number | | participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 |
|
| Secondary | Scaling and Dryness at Visit 7 | 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 | Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data. | Posted | | Number | | participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 |
|
| Secondary | Oozing/Vesiculation/Crusting at Baseline | OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above | | Posted | | Number | | participants | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 |
|
| Secondary | Oozing/Vesiculation/Crusting at Visit 2 | 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 | | 24-48 hours after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 |
|
| Secondary | Oozing/Vesiculation/Crusting at Visit 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 | Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data. | Posted | | Number | | participants | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 |
|
| Secondary | Oozing/Vesiculation/Crusting at Visit 4 | 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 | Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data. | Posted | | Number | | participants | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 |
|
| Secondary | Oozing/Vesiculation/Crusting at Visit 5 | 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 | Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data. | Posted | | Number | | participants | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 |
|
| Secondary | Oozing/Vesiculation/Crusting at Visit 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 | Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data. | Posted | | Number | | participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 |
|
| Secondary | Oozing/Vesiculation/Crusting at Visit 7 | 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 | Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data. | Posted | | Number | | participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Broad Area ALA 1-hour + BLUE Light Treatment | Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG001 | Broad Area ALA 2-hour + BLUE Light Treatment | Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 | | OG002 | Broad Area ALA 3-hour + BLUE Light Treatment | broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5 |
|