Back to resultsControlled Study of the Occurrence of Actinic Keratosis on the Face After Cryotherapy + Aminolevulinic Acid (ALA) Photodynamic Therapy
Primary Purpose
Actinic Keratosis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Aminolevulinic Acid
Topical Solution Vehicle
BLU-U
Cryotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Actinic Keratosis focused on measuring Actinic Keratosis
Eligibility Criteria
Inclusion Criteria:
- Four to fifteen AKs on the face
- histologically confirmed presence of abnormal architecture and satellite atypical keratinocytes in the epidermis, in clinically normal tissue samples of photodamaged skin adjacent to AKs
- at least one previously treated nonmelanoma skin cancer (NMSC) on the head and/or neck area within the past five years
Exclusion Criteria:
- Pregnancy
- history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis
- lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the Treatment Area
- skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy
- Subject is immunosuppressed
- unsuccessful outcome from previous ALA-PDT therapy
- currently enrolled in an investigational drug or device study
- has received an investigational drug or been treated with an investigational device within 30 days prior to the initiation of treatment
- known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol)
- has an active herpes simplex infection OR a history of 2 or more outbreaks within the past 12 months, on the face
use of the following topical preparations on the extremity to be treated:
- Keratolytics including urea (greater than 5%), alpha hydroxyacids [e.g.glycolic acid, lactic acid, etc. greater than 5%], salicylic acid (greater than 2%) within 2 days
- Retinoids, including tazarotene, adapalene, tretinoin, within 4 weeks
- Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-fluorouracil (5-FU), diclofenac, ingenol mebutate, imiquimod or other topical treatments for AK within 8 weeks
- use of systemic retinoid therapy within 6 months
Sites / Locations
- UCSD Dermatology
- Therapeutics Clinical Research
- Altman Dermatology Associates
- Shideler Clinical Research Center
- Sadick Research Group
- Tennessee Clinical Research Center
- Suzanne Bruce and Associates, P.A.,The Center for Skin Research
- Virginia Clinical Research, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Experimental
Arm Label
ALA X3
VEH
ALA X2
Arm Description
Cryotherapy followed by 3 aminolevulinic acid + blue light (BLU-U) treatments
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.
Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Proportion of Subjects With 0 AKs
Normalized based on number of lesions present at Baseline
Subject Satisfaction Score
Subject satisfaction score
= Excellent (very satisfied)
= Good (moderately satisfied)
= Fair (slightly satisfied)
= Poor (not satisfied at all) Unknown
Proportion of Subjects With 0 AKs
Normalized based on number of lesions present at Baseline
Proportion of Subjects With 0 AKs
Normalized based on number of lesions present at Baseline
Proportion of Subjects With 0 AKs
Normalized based on number of lesions present at Baseline
Proportion of Subjects With 0 AKs
Normalized based on number of lesions present at Baseline
Recurrence Rate
Recurrence rate of all lesions that were complete responses following on-study cryotherapy (at Visit 3/Baseline).
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
Full Information
NCT ID
NCT02239679
First Posted
September 10, 2014
Last Updated
July 27, 2018
Sponsor
DUSA Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02239679
Brief Title
Controlled Study of the Occurrence of Actinic Keratosis on the Face After Cryotherapy + Aminolevulinic Acid (ALA) Photodynamic Therapy
Official Title
A Phase 2 Study Comparing the Occurrence of Actinic Keratoses on the Face in High-Risk Individuals After Cryotherapy + Photodynamic Therapy With Levulan Topical Solution + Blue Light Versus Cryotherapy + Vehicle Topical Solution + Blue Light
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DUSA Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if Levulan photodynamic therapy (PDT) is safe and effective in the treatment of actinic keratoses (AK) on the face, following treatment with liquid nitrogen cryotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis
Keywords
Actinic Keratosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
166 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ALA X3
Arm Type
Experimental
Arm Description
Cryotherapy followed by 3 aminolevulinic acid + blue light (BLU-U) treatments
Arm Title
VEH
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
ALA X2
Arm Type
Experimental
Arm Description
Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments
Intervention Type
Drug
Intervention Name(s)
Aminolevulinic Acid
Other Intervention Name(s)
Levulan Kerastick, ALA
Intervention Description
20% ALA applied to face for one hour prior to 10 J/cm2 blue light
Intervention Type
Drug
Intervention Name(s)
Topical Solution Vehicle
Intervention Description
Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face one hour prior to 10 J/cm2 blue light
Intervention Type
Device
Intervention Name(s)
BLU-U
Other Intervention Name(s)
BLU-U Blue Light Photodynamic Therapy Illuminator
Intervention Description
10 J/cm2 blue light delivered at 10 mW/cm2
Intervention Type
Procedure
Intervention Name(s)
Cryotherapy
Other Intervention Name(s)
Liquid Nitrogen
Intervention Description
Liquid nitrogen cryotherapy by standard of care method to all visible/palpable actinic keratosis (AK) lesions at screening.
Primary Outcome Measure Information:
Title
Total Number of AKs in Treatment Area
Description
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.
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Proportion of Subjects With 0 AKs
Description
Normalized based on number of lesions present at Baseline
Time Frame
Week 4
Title
Subject Satisfaction Score
Description
Subject satisfaction score
= Excellent (very satisfied)
= Good (moderately satisfied)
= Fair (slightly satisfied)
= Poor (not satisfied at all) Unknown
Time Frame
Week 52
Title
Proportion of Subjects With 0 AKs
Description
Normalized based on number of lesions present at Baseline
Time Frame
Week 12
Title
Proportion of Subjects With 0 AKs
Description
Normalized based on number of lesions present at Baseline
Time Frame
Week 24
Title
Proportion of Subjects With 0 AKs
Description
Normalized based on number of lesions present at Baseline
Time Frame
Week 36
Title
Proportion of Subjects With 0 AKs
Description
Normalized based on number of lesions present at Baseline
Time Frame
Week 52
Title
Recurrence Rate
Description
Recurrence rate of all lesions that were complete responses following on-study cryotherapy (at Visit 3/Baseline).
Time Frame
Week 52
Title
Duration of Response
Description
Duration of response is the elapsed number of weeks from the Baseline visit until a lesion recurred or Week 52, whichever comes first
Time Frame
within 52 weeks after Baseline
Other Pre-specified Outcome Measures:
Title
Hyperpigmentation
Description
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
Screening
Title
Hyperpigmentation
Description
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
Title
Hyperpigmentation
Description
HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Time Frame
24-48 hours after photodynamic therapy (PDT) #1
Title
Hyperpigmentation
Description
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
4 Weeks after PDT #1
Title
Hyperpigmentation
Description
HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Time Frame
12 Weeks after PDT #1
Title
Hyperpigmentation
Description
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 Weeks after PDT #1
Title
Hyperpigmentation
Description
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
36 Weeks after PDT #1
Title
Hyperpigmentation
Description
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
52 Weeks after PDT #1
Title
Hypopigmentation
Description
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
Time Frame
Screening
Title
Hypopigmentation
Description
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
Time Frame
Baseline
Title
Hypopigmentation
Description
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
Time Frame
24-48 hours after PDT #1
Title
Hypopigmentation
Description
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
Time Frame
4 Weeks after PDT #1
Title
Hypopigmentation
Description
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
Time Frame
12 Weeks after PDT #1
Title
Hypopigmentation
Description
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
Time Frame
24 Weeks after PDT #1
Title
Hypopigmentation
Description
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
Time Frame
36 Weeks after PDT #1
Title
Hypopigmentation
Description
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
Time Frame
52 Weeks after PDT #1
Title
Erythema
Description
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
Screening
Title
Erythema
Description
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
Title
Erythema
Description
Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time Frame
5 minutes after PDT #1
Title
Erythema
Description
Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time Frame
24-48 hours after PDT #1
Title
Erythema
Description
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
4 Weeks after PDT #1
Title
Erythema
Description
Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time Frame
12 Weeks after PDT #1
Title
Erythema
Description
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 Weeks after PDT #1
Title
Erythema
Description
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
36 Weeks after PDT #1
Title
Erythema
Description
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
52 Weeks after PDT #1
Title
Edema
Description
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
Screening
Title
Edema
Description
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
Title
Edema
Description
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time Frame
5 minutes after PDT #1
Title
Edema
Description
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time Frame
24-48 hours after PDT #1
Title
Edema
Description
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
4 Weeks after PDT #1
Title
Edema
Description
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time Frame
12 Weeks after PDT #1
Title
Edema
Description
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 weeks after PDT #1
Title
Edema
Description
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
36 Weeks after PDT #1
Title
Edema
Description
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
52 Weeks after PDT #1
Title
Stinging/Burning
Description
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
Screening
Title
Stinging/Burning
Description
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
Title
Stinging/Burning
Description
Immediately after PDT, the most intensive, acute perception of Stinging/Burning DURING treatment will be recorded.
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time Frame
During PDT #1
Title
Stinging/Burning
Description
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time Frame
5 minutes after PDT #1
Title
Stinging/Burning
Description
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time Frame
24-48 hours after PDT #1
Title
Stinging/Burning
Description
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
4 Weeks after PDT #1
Title
Stinging/Burning
Description
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time Frame
12 Weeks after PDT #1
Title
Stinging/Burning
Description
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 Weeks after PDT #1
Title
Stinging/Burning
Description
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
36 Weeks after PDT #1
Title
Stinging/Burning
Description
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
52 Weeks after PDT #1
Title
Scaling & Dryness
Description
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
Screening
Title
Scaling & Dryness
Description
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
Title
Scaling & Dryness
Description
SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Time Frame
24-48 hours after PDT #1
Title
Scaling & Dryness
Description
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
4 Weeks after PDT #1
Title
Scaling & Dryness
Description
SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Time Frame
12 Weeks after PDT #1
Title
Scaling & Dryness
Description
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 Weeks after PDT #1
Title
Scaling & Dryness
Description
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
36 Weeks after PDT #1
Title
Scaling & Dryness
Description
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
52 Weeks after PDT #1
Title
Oozing/Vesiculation/Crusting
Description
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
Screening
Title
Oozing/Vesiculation/Crusting
Description
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
Title
Oozing/Vesiculation/Crusting
Description
OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Time Frame
24-48 hours after PDT #1
Title
Oozing/Vesiculation/Crusting
Description
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
4 Weeks after PDT #1
Title
Oozing/Vesiculation/Crusting
Description
OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Time Frame
12 Weeks after PDT #1
Title
Oozing/Vesiculation/Crusting
Description
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 Weeks after PDT #1
Title
Oozing/Vesiculation/Crusting
Description
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
36 Weeks after PDT #1
Title
Oozing/Vesiculation/Crusting
Description
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
52 Weeks after PDT #1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Four to fifteen AKs on the face
histologically confirmed presence of abnormal architecture and satellite atypical keratinocytes in the epidermis, in clinically normal tissue samples of photodamaged skin adjacent to AKs
at least one previously treated nonmelanoma skin cancer (NMSC) on the head and/or neck area within the past five years
Exclusion Criteria:
Pregnancy
history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis
lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the Treatment Area
skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy
Subject is immunosuppressed
unsuccessful outcome from previous ALA-PDT therapy
currently enrolled in an investigational drug or device study
has received an investigational drug or been treated with an investigational device within 30 days prior to the initiation of treatment
known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol)
has an active herpes simplex infection OR a history of 2 or more outbreaks within the past 12 months, on the face
use of the following topical preparations on the extremity to be treated:
Keratolytics including urea (greater than 5%), alpha hydroxyacids [e.g.glycolic acid, lactic acid, etc. greater than 5%], salicylic acid (greater than 2%) within 2 days
Retinoids, including tazarotene, adapalene, tretinoin, within 4 weeks
Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-fluorouracil (5-FU), diclofenac, ingenol mebutate, imiquimod or other topical treatments for AK within 8 weeks
use of systemic retinoid therapy within 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart Marcus, MD, PhD
Organizational Affiliation
DUSA Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
UCSD Dermatology
City
San Diego
State/Province
California
ZIP/Postal Code
92122
Country
United States
Facility Name
Therapeutics Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Altman Dermatology Associates
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Shideler Clinical Research Center
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
Sadick Research Group
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Tennessee Clinical Research Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
Suzanne Bruce and Associates, P.A.,The Center for Skin Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
Virginia Clinical Research, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Controlled Study of the Occurrence of Actinic Keratosis on the Face After Cryotherapy + Aminolevulinic Acid (ALA) Photodynamic Therapy
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