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

Dusa Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Actinic Keratosis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02239679

CP0109

Details and patient eligibility

About

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.

Enrollment: 166 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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166 participants in 3 patient groups, including a placebo group

ALA X3

Experimental group

Description:

Cryotherapy followed by 3 aminolevulinic acid + blue light (BLU-U) treatments

Treatment:

Procedure: Cryotherapy

Device: BLU-U

Drug: Aminolevulinic Acid

VEH

Placebo Comparator group

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.

Treatment:

Procedure: Cryotherapy

Drug: Topical Solution Vehicle

Device: BLU-U

ALA X2

Experimental group

Description:

Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments

Treatment:

Procedure: Cryotherapy

Device: BLU-U

Drug: Aminolevulinic Acid