| Primary | Total Number of AKs in Treatment Area | Count of observed lesions in the treatment area, which include lesions that recurred after on-study cryotherapy as well as newly occurring lesions. AK lesions in the treatment area at baseline (maximum of 2) were excluded for this endpoint. | Analysis population consisted of observed data; ie. subjects remaining on-study at Week 52. | Posted | | Least Squares Mean | Standard Error | lesions | | Week 52 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT | Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0003.0± 0.91
- OG0012.1± 0.84
- OG0024.7± 0.86
|
|
| | 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 |
|---|
| | ANCOVA | | 0.0166 | | | | | | | | | | | | | | Superiority | | |
|
| Secondary | Proportion of Subjects With 0 AKs | Normalized based on number of lesions present at Baseline | Analysis population consisted of observed data; ie. subjects with data at Week 4. | Posted | | Count of Participants | | Participants | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT | Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. |
|
| Secondary | Subject Satisfaction Score | Subject satisfaction score
- = Excellent (very satisfied)
- = Good (moderately satisfied)
- = Fair (slightly satisfied)
- = Poor (not satisfied at all) Unknown
| | Posted | | Count of Participants | | Participants | | Week 52 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT | Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. |
|
| Secondary | Proportion of Subjects With 0 AKs | Normalized based on number of lesions present at Baseline | Analysis population consisted of observed data; ie. subjects with data at Week 12. | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT | Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. |
|
| Secondary | Proportion of Subjects With 0 AKs | Normalized based on number of lesions present at Baseline | Analysis population consisted of observed data only. | Posted | | Count of Participants | | Participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT | Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. |
|
| Secondary | Proportion of Subjects With 0 AKs | Normalized based on number of lesions present at Baseline | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | Week 36 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT | Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. |
|
| Secondary | Proportion of Subjects With 0 AKs | Normalized based on number of lesions present at Baseline | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | Week 52 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT | Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. |
|
| Secondary | Recurrence Rate | Recurrence rate of all lesions that were complete responses following on-study cryotherapy (at Visit 3/Baseline). | Analysis population consisted of observed data only | Posted | | Count of Units | | number of lesions | | Week 52 | number of lesions | number of lesions | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT | Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. |
|
| Secondary | Duration of Response | Duration of response is the elapsed number of weeks from the Baseline visit until a lesion recurred or Week 52, whichever comes first | Subjects who discontinued prior to Week 52 were excluded; analysis used observed data only. | Posted | | Mean | Standard Deviation | weeks | | within 52 weeks after Baseline | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT | Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. |
|
| Other Pre-specified | Hyperpigmentation | HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas | | Posted | | Count of Participants | | Participants | | Screening | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT | |
|
| Other Pre-specified | Hyperpigmentation | HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas | | Posted | | Count of Participants | | Participants | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT | |
|
| Other Pre-specified | Hyperpigmentation | HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | 24-48 hours after photodynamic therapy (PDT) #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 |
|
| Other Pre-specified | Hyperpigmentation | HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | 4 Weeks after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 |
|
| Other Pre-specified | Hyperpigmentation | HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | 12 Weeks after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 |
|
| Other Pre-specified | Hyperpigmentation | HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | 24 Weeks after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 |
|
| Other Pre-specified | Hyperpigmentation | HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | 36 Weeks after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 |
|
| Other Pre-specified | Hyperpigmentation | HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | 52 Weeks after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 |
|
| Other Pre-specified | Hypopigmentation | HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation | | Posted | | Count of Participants | | Participants | | Screening | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT | Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. |
|
| Other Pre-specified | Hypopigmentation | HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation | | Posted | | Count of Participants | | Participants | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT | Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. |
|
| Other Pre-specified | Hypopigmentation | HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | 24-48 hours after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT |
|
| Other Pre-specified | Hypopigmentation | HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | 4 Weeks after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT | |
|
| Other Pre-specified | Hypopigmentation | HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | 12 Weeks after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT | |
|
| Other Pre-specified | Hypopigmentation | HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | 24 Weeks after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT | |
|
| Other Pre-specified | Hypopigmentation | HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | 36 Weeks after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT | |
|
| Other Pre-specified | Hypopigmentation | HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | 52 Weeks after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT | |
|
| Other Pre-specified | Erythema | Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema | | Posted | | Count of Participants | | Participants | | Screening | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT |
|
| Other Pre-specified | Erythema | Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema | | Posted | | Count of Participants | | Participants | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT |
|
| Other Pre-specified | Erythema | Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema | | Posted | | Count of Participants | | Participants | | 5 minutes after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT |
|
| Other Pre-specified | Erythema | Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | 24-48 hours after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | |
|
| Other Pre-specified | Erythema | Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | 4 Weeks after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | |
|
| Other Pre-specified | Erythema | Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | 12 Weeks after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | |
|
| Other Pre-specified | Erythema | Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | 24 Weeks after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | |
|
| Other Pre-specified | Erythema | Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | 36 Weeks after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | |
|
| Other Pre-specified | Erythema | Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | 52 Weeks after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | |
|
| Other Pre-specified | Edema | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area | | Posted | | Count of Participants | | Participants | | Screening | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT | Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. |
|
| Other Pre-specified | Edema | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area | | Posted | | Count of Participants | | Participants | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT | Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. |
|
| Other Pre-specified | Edema | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area | | Posted | | Count of Participants | | Participants | | 5 minutes after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT | Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. |
|
| Other Pre-specified | Edema | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | 24-48 hours after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT |
|
| Other Pre-specified | Edema | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | 4 Weeks after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT | |
|
| Other Pre-specified | Edema | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | 12 Weeks after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT | |
|
| Other Pre-specified | Edema | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | 24 weeks after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT | |
|
| Other Pre-specified | Edema | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | 36 Weeks after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT | |
|
| Other Pre-specified | Edema | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | 52 Weeks after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT | |
|
| Other Pre-specified | Stinging/Burning | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable | | Posted | | Count of Participants | | Participants | | Screening | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT | Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. |
|
| Other Pre-specified | Stinging/Burning | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable | | Posted | | Count of Participants | | Participants | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT | Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. |
|
| Other Pre-specified | Stinging/Burning | Immediately after PDT, the most intensive, acute perception of Stinging/Burning DURING treatment will be recorded. STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable | | Posted | | Count of Participants | | Participants | | During PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT | Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. |
|
| Other Pre-specified | Stinging/Burning | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable | | Posted | | Count of Participants | | Participants | | 5 minutes after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT | Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. |
|
| Other Pre-specified | Stinging/Burning | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | 24-48 hours after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT | Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. |
|
| Other Pre-specified | Stinging/Burning | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | 4 Weeks after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT | Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. |
|
| Other Pre-specified | Stinging/Burning | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | 12 Weeks after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT | Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. |
|
| Other Pre-specified | Stinging/Burning | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | 24 Weeks after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT | Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. |
|
| Other Pre-specified | Stinging/Burning | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | 36 Weeks after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT | Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. |
|
| Other Pre-specified | Stinging/Burning | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | 52 Weeks after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT | Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. |
|
| Other Pre-specified | Scaling & Dryness | SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling | | Posted | | Count of Participants | | Participants | | Screening | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT | Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. |
|
| Other Pre-specified | Scaling & Dryness | SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling | | Posted | | Count of Participants | | Participants | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT | Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. |
|
| Other Pre-specified | Scaling & Dryness | SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | 24-48 hours after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT |
|
| Other Pre-specified | Scaling & Dryness | SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | 4 Weeks after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT |
|
| Other Pre-specified | Scaling & Dryness | SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | 12 Weeks after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT |
|
| Other Pre-specified | Scaling & Dryness | SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | 24 Weeks after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT |
|
| Other Pre-specified | Scaling & Dryness | SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | 36 Weeks after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT |
|
| Other Pre-specified | Scaling & Dryness | SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | 52 Weeks after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 | VEH-PDT |
|
| Other Pre-specified | Oozing/Vesiculation/Crusting | OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above | | Posted | | Count of Participants | | Participants | | Screening | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 |
|
| Other Pre-specified | Oozing/Vesiculation/Crusting | OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above | | Posted | | Count of Participants | | Participants | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG002 |
|
| Other Pre-specified | Oozing/Vesiculation/Crusting | OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | 24-48 hours after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. |
|
| Other Pre-specified | Oozing/Vesiculation/Crusting | OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | 4 Weeks after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. |
|
| Other Pre-specified | Oozing/Vesiculation/Crusting | OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | 12 Weeks after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. |
|
| Other Pre-specified | Oozing/Vesiculation/Crusting | OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | 24 Weeks after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. |
|
| Other Pre-specified | Oozing/Vesiculation/Crusting | OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | 36 Weeks after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. |
|
| Other Pre-specified | Oozing/Vesiculation/Crusting | OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above | Analysis population consisted of observed data only | Posted | | Count of Participants | | Participants | | 52 Weeks after PDT #1 | | | | ID | Title | Description |
|---|
| OG000 | ALA X2 | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. | | OG001 | ALA X3 | Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening. |
|