Keratosis, Actinic
Conditions
Keywords
Actinic keratosis
Brief summary
The purpose of this study is to evaluate the potential for systemic exposure of aminolevulinic acid (ALA) and protoporphyrin IX (PpIX) when applied topically under occlusion, in a maximal use setting in patients with multiple actinic keratoses (AK) involving the upper extremities.
Interventions
DEVICEBLU-U
10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
Sponsors
DUSA Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 6 Grade 1/2 AKs on one upper extremity AND * At least 12 Grade 1/2 AKs on the OTHER upper extremity
Exclusion criteria
* Pregnancy * history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis * lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the Treatment Area * Body Mass Index (BMI) \> 32.0 kg/m2 * skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy * significant blood loss within 60 days or donated blood/plasma within 72 hours prior to Visit 2 (Baseline) * tested positive at screening for human immunodeficiency virus (HIV) or was known to be seropositive for HIV * a history of lead poisoning or a history of a significant exposure to lead * tested positive at screening for hepatitis B surface antigen, hepatitis C antibody or had a history of a positive result * positive drug screen at Screening * Screening safety labs are clinically significant in the opinion of the investigator * major surgery within 30 days prior to Visit 2 (Baseline) or plans to have surgery during the study * Subject is immunosuppressed * currently enrolled in an investigational drug or device study * has received an investigational drug or been treated with an investigational device within 30 days prior to Visit 2 (Baseline) * known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol) * use of the following topical preparations on the extremities to be treated: * Keratolytics including urea (greater than 5%), alpha hydroxyacids \[e.g.glycolic acid, lactic acid, etc. greater than 5%\], salicylic acid (greater than 2%) within 2 days of initiation of treatment * Cryotherapy within 2 weeks of initiation of treatment * Retinoids, including tazarotene, adapalene, tretinoin, retinol, within 4 weeks of initiation of treatment * Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, imiquimod or other topical treatments for AK within 8 weeks of initiation of treatment * use of systemic retinoid therapy within 6 months of initiation of treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCt/AUCBL for PpIX | 0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours post-dose | The ratio of AUCt to AUCBL for PpIX |
| Maximum Baseline Corrected Plasma Concentration (Cmax) for ALA | 2 days | Maximum baseline corrected plasma concentration (Cmax) for ALA over the 24 hour sampling time period. Blood samples were taken before ALA application and at 15 and 30 minutes, 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours following study medication application. |
| Time at Which Cmax is Attained (Tmax) for ALA | 2 days | Time of the maximum baseline corrected plasma concentration for ALA measured at at 15 and 30 minutes, 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours following study medication application.If a maximum value occurred at more than one timepoint Tmax is defined as the first timepoint with this value. |
| AUCt | 0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24 hours post-dose | AUCt is the area under the baseline corrected plasma concentration-time profile up to the last quantifiable/non-negative plasma concentration |
| The Terminal Exponential Half-life (T1/2,z) for ALA | 2 days | The terminal slope was calculated by linear least squares regression of the log plasma concentration-time data. The terminal exponential half-life (T1/2,z) will be calculated as 0.693 divided by the absolute value of slope. |
| Maximum Baseline Corrected Plasma Concentration (Cmax) for PpIX | 2 days | Maximum baseline corrected plasma concentration (Cmax) for PpIX over the 48 hour sampling time period. Blood samples were taken before ALA application and at 15 and 30 minutes, 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours following study medication application. |
| Time at Which Cmax is Attained (Tmax) for PpIX | 2 days | Time of the maximum baseline corrected plasma concentration for PpIX measured at at 15 and 30 minutes, 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours following study medication application.If a maximum value occurred at more than one timepoint Tmax is defined as the first timepoint with this value. |
| AUCBL for PpIX | 0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours post-dose | The area under the concentration time-curve assuming the baseline observed plasma concentration existed from time 0 to tlast. |
| AUCt for PpIX | 0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours post-dose | The area under the observed plasma concentration time-curve from time 0 to the last quantifiable plasma concentration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypopigmentation | Baseline | HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas |
| Erythema | Baseline | Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema |
| Edema | Baseline | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area |
| Stinging/Burning | Baseline | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable |
| Scaling and Dryness | Baseline | SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling |
| Scaling and Dryness at Visit 4 | 24 hours after PDT | SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling |
| OOZING/VESICULATION/CRUSTING | Baseline | OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above |
| Hyperpigmentation | Baseline | HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ALA-PDT 20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2 | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | ALA-PDT |
|---|---|
| Age, Continuous | 65.6 years STANDARD_DEVIATION 7.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 14 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 1 / 14 |
Outcome results
Primary
AUCBL for PpIX
The area under the concentration time-curve assuming the baseline observed plasma concentration existed from time 0 to tlast.
Time frame: 0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours post-dose
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| ALA-PDT | AUCBL for PpIX | 77.34 ng*hr/mL | Geometric Coefficient of Variation 98.04 |
Primary
AUCt
AUCt is the area under the baseline corrected plasma concentration-time profile up to the last quantifiable/non-negative plasma concentration
Time frame: 0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24 hours post-dose
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| ALA-PDT | AUCt | 182.1 ng*hr/mL | Geometric Coefficient of Variation 111.6 |
Primary
AUCt/AUCBL for PpIX
The ratio of AUCt to AUCBL for PpIX
Time frame: 0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours post-dose
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| ALA-PDT | AUCt/AUCBL for PpIX | 0.9956 ratio |
Primary
AUCt for PpIX
The area under the observed plasma concentration time-curve from time 0 to the last quantifiable plasma concentration.
Time frame: 0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours post-dose
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| ALA-PDT | AUCt for PpIX | 77.00 ng*hr/mL | Geometric Coefficient of Variation 59.16 |
Primary
Maximum Baseline Corrected Plasma Concentration (Cmax) for ALA
Maximum baseline corrected plasma concentration (Cmax) for ALA over the 24 hour sampling time period. Blood samples were taken before ALA application and at 15 and 30 minutes, 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours following study medication application.
Time frame: 2 days
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| ALA-PDT | Maximum Baseline Corrected Plasma Concentration (Cmax) for ALA | 39.05 ng/mL | Geometric Coefficient of Variation 319.7 |
Primary
Maximum Baseline Corrected Plasma Concentration (Cmax) for PpIX
Maximum baseline corrected plasma concentration (Cmax) for PpIX over the 48 hour sampling time period. Blood samples were taken before ALA application and at 15 and 30 minutes, 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours following study medication application.
Time frame: 2 days
Population: For 50% of the subjects, more than 50% of the PpIX plasma concentrations following topical application of ALA HCI were less than the predose plasma concentration. Therefore, negative values were set to 0 to evaluate median baseline corrected plasma concentration.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ALA-PDT | Maximum Baseline Corrected Plasma Concentration (Cmax) for PpIX | 0.735 ng/mL |
Primary
The Terminal Exponential Half-life (T1/2,z) for ALA
The terminal slope was calculated by linear least squares regression of the log plasma concentration-time data. The terminal exponential half-life (T1/2,z) will be calculated as 0.693 divided by the absolute value of slope.
Time frame: 2 days
Population: T1/2,z could not be determined in 11 subjects
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| ALA-PDT | The Terminal Exponential Half-life (T1/2,z) for ALA | 5.386 hours | Geometric Coefficient of Variation 253.7 |
Primary
Time at Which Cmax is Attained (Tmax) for ALA
Time of the maximum baseline corrected plasma concentration for ALA measured at at 15 and 30 minutes, 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours following study medication application.If a maximum value occurred at more than one timepoint Tmax is defined as the first timepoint with this value.
Time frame: 2 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ALA-PDT | Time at Which Cmax is Attained (Tmax) for ALA | 2 hours |
Primary
Time at Which Cmax is Attained (Tmax) for PpIX
Time of the maximum baseline corrected plasma concentration for PpIX measured at at 15 and 30 minutes, 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours following study medication application.If a maximum value occurred at more than one timepoint Tmax is defined as the first timepoint with this value.
Time frame: 2 days
Population: One subject had tmax that could not be determined.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ALA-PDT | Time at Which Cmax is Attained (Tmax) for PpIX | 12 hours |
Secondary
Edema
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time frame: Baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA-PDT | Edema | Grade 0 | 14 Participants |
| ALA-PDT | Edema | Grade 1 | 0 Participants |
| ALA-PDT | Edema | Grade 2 | 0 Participants |
| ALA-PDT | Edema | Grade 3 | 0 Participants |
| ALA-PDT | Edema | Grade 4 | 0 Participants |
Secondary
Edema
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time frame: Week 4
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA-PDT | Edema | Grade 0 | 14 Participants |
| ALA-PDT | Edema | Grade 1 | 0 Participants |
| ALA-PDT | Edema | Grade 2 | 0 Participants |
| ALA-PDT | Edema | Grade 3 | 0 Participants |
| ALA-PDT | Edema | Grade 4 | 0 Participants |
Secondary
Edema
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time frame: 24 hours after PDT
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA-PDT | Edema | Grade 0 | 8 Participants |
| ALA-PDT | Edema | Grade 1 | 3 Participants |
| ALA-PDT | Edema | Grade 2 | 3 Participants |
| ALA-PDT | Edema | Grade 3 | 0 Participants |
| ALA-PDT | Edema | Grade 4 | 0 Participants |
Secondary
Edema
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time frame: 5 Minutes after PDT
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA-PDT | Edema | Grade 0 | 8 Participants |
| ALA-PDT | Edema | Grade 1 | 5 Participants |
| ALA-PDT | Edema | Grade 2 | 1 Participants |
| ALA-PDT | Edema | Grade 3 | 0 Participants |
| ALA-PDT | Edema | Grade 4 | 0 Participants |
Secondary
Erythema
Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time frame: 24 hours after PDT
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA-PDT | Erythema | Grade 0 | 0 Participants |
| ALA-PDT | Erythema | Grade 1 | 3 Participants |
| ALA-PDT | Erythema | Grade 2 | 4 Participants |
| ALA-PDT | Erythema | Grade 3 | 7 Participants |
| ALA-PDT | Erythema | Grade 4 | 0 Participants |
Secondary
Erythema
Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time frame: Baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA-PDT | Erythema | Grade 0 | 11 Participants |
| ALA-PDT | Erythema | Grade 1 | 1 Participants |
| ALA-PDT | Erythema | Grade 2 | 2 Participants |
| ALA-PDT | Erythema | Grade 3 | 0 Participants |
| ALA-PDT | Erythema | Grade 4 | 0 Participants |
Secondary
Erythema
Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time frame: 5 Minutes after PDT
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA-PDT | Erythema | Grade 0 | 4 Participants |
| ALA-PDT | Erythema | Grade 1 | 2 Participants |
| ALA-PDT | Erythema | Grade 2 | 5 Participants |
| ALA-PDT | Erythema | Grade 3 | 3 Participants |
| ALA-PDT | Erythema | Grade 4 | 0 Participants |
Secondary
Erythema
Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time frame: Week 4
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA-PDT | Erythema | Grade 4 | 0 Participants |
| ALA-PDT | Erythema | Grade 0 | 7 Participants |
| ALA-PDT | Erythema | Grade 1 | 6 Participants |
| ALA-PDT | Erythema | Grade 2 | 1 Participants |
| ALA-PDT | Erythema | Grade 3 | 0 Participants |
Secondary
Hyperpigmentation
HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Time frame: Week 4
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA-PDT | Hyperpigmentation | Grade 3 | 0 Participants |
| ALA-PDT | Hyperpigmentation | Grade 4 | 0 Participants |
| ALA-PDT | Hyperpigmentation | Grade 0 | 7 Participants |
| ALA-PDT | Hyperpigmentation | Grade 1 | 6 Participants |
| ALA-PDT | Hyperpigmentation | Grade 2 | 1 Participants |
Secondary
Hyperpigmentation
HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Time frame: 24 hours after PDT
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA-PDT | Hyperpigmentation | Grade 0 | 7 Participants |
| ALA-PDT | Hyperpigmentation | Grade 1 | 6 Participants |
| ALA-PDT | Hyperpigmentation | Grade 2 | 1 Participants |
| ALA-PDT | Hyperpigmentation | Grade 3 | 0 Participants |
| ALA-PDT | Hyperpigmentation | Grade 4 | 0 Participants |
Secondary
Hyperpigmentation
HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Time frame: Baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA-PDT | Hyperpigmentation | Grade 0 | 6 Participants |
| ALA-PDT | Hyperpigmentation | Grade 3 | 0 Participants |
| ALA-PDT | Hyperpigmentation | Grade 4 | 0 Participants |
| ALA-PDT | Hyperpigmentation | Grade 1 | 7 Participants |
| ALA-PDT | Hyperpigmentation | Grade 2 | 1 Participants |
Secondary
Hypopigmentation
HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Time frame: 24 hours after PDT
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA-PDT | Hypopigmentation | Grade 0 | 8 Participants |
| ALA-PDT | Hypopigmentation | Grade 1 | 6 Participants |
| ALA-PDT | Hypopigmentation | Grade 2 | 0 Participants |
| ALA-PDT | Hypopigmentation | Grade 3 | 0 Participants |
| ALA-PDT | Hypopigmentation | Grade 4 | 0 Participants |
Secondary
Hypopigmentation
HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Time frame: Week 4
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA-PDT | Hypopigmentation | Grade 0 | 8 Participants |
| ALA-PDT | Hypopigmentation | Grade 1 | 6 Participants |
| ALA-PDT | Hypopigmentation | Grade 2 | 0 Participants |
| ALA-PDT | Hypopigmentation | Grade 3 | 0 Participants |
| ALA-PDT | Hypopigmentation | Grade 4 | 0 Participants |
Secondary
Hypopigmentation
HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Time frame: Baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA-PDT | Hypopigmentation | Grade 0 | 8 Participants |
| ALA-PDT | Hypopigmentation | Grade 1 | 6 Participants |
| ALA-PDT | Hypopigmentation | Grade 2 | 0 Participants |
| ALA-PDT | Hypopigmentation | Grade 3 | 0 Participants |
| ALA-PDT | Hypopigmentation | Grade 4 | 0 Participants |
Secondary
OOZING/VESICULATION/CRUSTING
OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Time frame: 24 hours after PDT
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA-PDT | OOZING/VESICULATION/CRUSTING | Grade 0 | 13 Participants |
| ALA-PDT | OOZING/VESICULATION/CRUSTING | Grade 1 | 1 Participants |
| ALA-PDT | OOZING/VESICULATION/CRUSTING | Grade 2 | 0 Participants |
| ALA-PDT | OOZING/VESICULATION/CRUSTING | Grade 3 | 0 Participants |
| ALA-PDT | OOZING/VESICULATION/CRUSTING | Grade 4 | 0 Participants |
Secondary
OOZING/VESICULATION/CRUSTING
OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Time frame: Week 4
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA-PDT | OOZING/VESICULATION/CRUSTING | Grade 0 | 14 Participants |
| ALA-PDT | OOZING/VESICULATION/CRUSTING | Grade 1 | 0 Participants |
| ALA-PDT | OOZING/VESICULATION/CRUSTING | Grade 2 | 0 Participants |
| ALA-PDT | OOZING/VESICULATION/CRUSTING | Grade 3 | 0 Participants |
| ALA-PDT | OOZING/VESICULATION/CRUSTING | Grade 4 | 0 Participants |
Secondary
OOZING/VESICULATION/CRUSTING
OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Time frame: Baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA-PDT | OOZING/VESICULATION/CRUSTING | Grade 0 | 14 Participants |
| ALA-PDT | OOZING/VESICULATION/CRUSTING | Grade 1 | 0 Participants |
| ALA-PDT | OOZING/VESICULATION/CRUSTING | Grade 2 | 0 Participants |
| ALA-PDT | OOZING/VESICULATION/CRUSTING | Grade 3 | 0 Participants |
| ALA-PDT | OOZING/VESICULATION/CRUSTING | Grade 4 | 0 Participants |
Secondary
Scaling and Dryness
SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Time frame: Baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA-PDT | Scaling and Dryness | Grade 0 | 12 Participants |
| ALA-PDT | Scaling and Dryness | Grade 1 | 2 Participants |
| ALA-PDT | Scaling and Dryness | Grade 2 | 0 Participants |
| ALA-PDT | Scaling and Dryness | Grade 3 | 0 Participants |
| ALA-PDT | Scaling and Dryness | Grade 4 | 0 Participants |
Secondary
Scaling and Dryness
SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Time frame: Week 4
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA-PDT | Scaling and Dryness | Grade 0 | 9 Participants |
| ALA-PDT | Scaling and Dryness | Grade 1 | 5 Participants |
| ALA-PDT | Scaling and Dryness | Grade 2 | 0 Participants |
| ALA-PDT | Scaling and Dryness | Grade 3 | 0 Participants |
| ALA-PDT | Scaling and Dryness | Grade 4 | 0 Participants |
Secondary
Scaling and Dryness at Visit 4
SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Time frame: 24 hours after PDT
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA-PDT | Scaling and Dryness at Visit 4 | Grade 0 | 9 Participants |
| ALA-PDT | Scaling and Dryness at Visit 4 | Grade 1 | 3 Participants |
| ALA-PDT | Scaling and Dryness at Visit 4 | Grade 2 | 1 Participants |
| ALA-PDT | Scaling and Dryness at Visit 4 | Grade 3 | 1 Participants |
| ALA-PDT | Scaling and Dryness at Visit 4 | Grade 4 | 0 Participants |
Secondary
Stinging/Burning
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: Baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA-PDT | Stinging/Burning | Grade 0 | 13 Participants |
| ALA-PDT | Stinging/Burning | Grade 1 | 1 Participants |
| ALA-PDT | Stinging/Burning | Grade 2 | 0 Participants |
| ALA-PDT | Stinging/Burning | Grade 3 | 0 Participants |
Secondary
Stinging/Burning
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: 24 hours after PDT
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA-PDT | Stinging/Burning | g | 10 Participants |
| ALA-PDT | Stinging/Burning | Grade 1 | 4 Participants |
| ALA-PDT | Stinging/Burning | Grade 2 | 0 Participants |
| ALA-PDT | Stinging/Burning | Grade 3 | 0 Participants |
Secondary
Stinging/Burning
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: 5 Minutes after photodynamic therapy
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA-PDT | Stinging/Burning | Grade 0 | 6 Participants |
| ALA-PDT | Stinging/Burning | Grade 1 | 5 Participants |
| ALA-PDT | Stinging/Burning | Grade 2 | 3 Participants |
| ALA-PDT | Stinging/Burning | Grade 3 | 0 Participants |
Secondary
Stinging/Burning
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: Week 4
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA-PDT | Stinging/Burning | Grade 0 | 13 Participants |
| ALA-PDT | Stinging/Burning | Grade 1 | 1 Participants |
| ALA-PDT | Stinging/Burning | Grade 2 | 0 Participants |
| ALA-PDT | Stinging/Burning | Grade 3 | 0 Participants |
Secondary
Stinging/Burning
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: Intraprocedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALA-PDT | Stinging/Burning | Grade 0 | 0 Participants |
| ALA-PDT | Stinging/Burning | Grade 1 | 6 Participants |
| ALA-PDT | Stinging/Burning | Grade 2 | 8 Participants |
| ALA-PDT | Stinging/Burning | Grade 3 | 0 Participants |