Safety and Efficacy Study of Photodynamic Therapy With Levulan Kerastick + Blue Light for Actinic Keratoses on the Upper Extremities

Dusa Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Actinic Keratosis

Treatments: Device: Blue Light Photodynamic Therapy Illuminator (BLU-U); Drug: Aminolevulinic Acid (ALA); Drug: Topical Solution Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT02137785

CP0108

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 on the upper arms and hands

Enrollment: 269 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Four to fifteen Grade 1/2 actinic keratosis lesions (AKs) on one upper extremity

Exclusion criteria

• Pregnancy

• grade 3 and/or atypical >1cm AKs within Treatment Area

• 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)

• 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 of initiation of treatment.
  • Cryotherapy within 2 weeks of initiation of treatment
  • Retinoids, including tazarotene, adapalene, tretinoin, within 4 weeks of initiation of treatment.
  • Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, ingenol mebutate, 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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269 participants in 2 patient groups, including a placebo group

ALA

Experimental group

Treatment:

Device: Blue Light Photodynamic Therapy Illuminator (BLU-U)

Drug: Aminolevulinic Acid (ALA)

Vehicle

Placebo Comparator group

Treatment:

Device: Blue Light Photodynamic Therapy Illuminator (BLU-U)

Drug: Topical Solution Vehicle