Controlled Study of the Occurrence of Actinic Keratosis on the Face After Cryotherapy + Aminolevulinic Acid (ALA) Photodynamic Therapy

Phase 2

Completed

Interventions: Drug: Aminolevulinic Acid
Drug: Topical Solution Vehicle
Device: BLU-U
Procedure: Cryotherapy

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
ALA X2	BLU-U	Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments
ALA X3	Aminolevulinic Acid	Cryotherapy followed by 3 aminolevulinic acid + blue light (BLU-U) treatments
ALA X2	Cryotherapy	Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments
ALA X3	Cryotherapy	Cryotherapy followed by 3 aminolevulinic acid + blue light (BLU-U) treatments
VEH	BLU-U	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.
ALA X3	BLU-U	Cryotherapy followed by 3 aminolevulinic acid + blue light (BLU-U) treatments
ALA X2	Aminolevulinic Acid	Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments
VEH	Topical Solution Vehicle	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.
VEH	Cryotherapy	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.

Primary Outcome Measures

Name	Time	Method
Total Number of AKs in Treatment Area	Week 52	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

Name	Time	Method
Proportion of Subjects With 0 AKs	Week 52	Normalized based on number of lesions present at Baseline
Subject Satisfaction Score	Week 52	Subject satisfaction score 1. = Excellent (very satisfied) 2. = Good (moderately satisfied) 3. = Fair (slightly satisfied) 4. = Poor (not satisfied at all) Unknown
Recurrence Rate	Week 52	Recurrence rate of all lesions that were complete responses following on-study cryotherapy (at Visit 3/Baseline).
Duration of Response	within 52 weeks after Baseline	Duration of response is the elapsed number of weeks from the Baseline visit until a lesion recurred or Week 52, whichever comes first

Locations (8): UCSD Dermatology
🇺🇸
San Diego, California, United States
Sadick Research Group
🇺🇸
New York, New York, United States
Shideler Clinical Research Center
🇺🇸
Carmel, Indiana, United States
Therapeutics Clinical Research
🇺🇸
San Diego, California, United States
Altman Dermatology Associates
🇺🇸
Arlington Heights, Illinois, United States
Tennessee Clinical Research Center
🇺🇸
Nashville, Tennessee, United States
Suzanne Bruce and Associates, P.A.,The Center for Skin Research
🇺🇸
Houston, Texas, United States
Virginia Clinical Research, Inc.
🇺🇸
Norfolk, Virginia, United States