Short-incubation Levulan Photodynamic Therapy Versus Vehicle for Face/Scalp Actinic Keratosis (AK)

Dusa Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Actinic Keratosis

Treatments: Device: Blue Light Treatment; Drug: broad area ALA 3-hour incubation; Drug: Vehicle PDT; Drug: Broad Area ALA 1-hour incubation; Drug: Spot ALA 2 hour incubation; Drug: Broad Area ALA 2 hour incubation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01475955

CP0105

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 keratosis when applied to broad areas on the face and scalp for 1, 2 and 3 hours.

Enrollment: 235 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 6-20 Grade 1/2 AKs on the face or scalp
• a history of AK therapy within the treatment area at least twice in the two years prior to study entry

Exclusion criteria

• Pregnancy

• Grade 3 AKs or atypical AKs (e.g., AK > 1 cm2 in size) within the Treatment Area

• lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the Treatment Area

• plans to be exposed to artificial tanning devices or excessive sunlight during the trial

• Subject is immunosuppressed

• unsuccessful outcome from previous ALA-PDT therapy

• history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis

• skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy

• skin pathology or condition that could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy

• any condition which would make it unsafe for the subject to participate in this research study

• 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)

• Subject has;

  • an active herpes simplex infection OR
  • a history of 2 or more outbreaks within the past 12 months, in the Treatment Area

• 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.
  • Two or more ALA PDT treatments in the past 6 months

• 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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235 participants in 5 patient groups, including a placebo group

Broad Area ALA 1-hour incubation

Experimental group

Description:

Broad Area ALA 1-hour incubation

Treatment:

Drug: Broad Area ALA 1-hour incubation

Device: Blue Light Treatment

Broad Area ALA 2-hour incubation

Experimental group

Description:

Broad Area ALA 2-hour incubation

Treatment:

Drug: Broad Area ALA 2 hour incubation

Device: Blue Light Treatment

Broad Area ALA 3-hour incubation

Experimental group

Description:

Broad Area ALA 3-hour incubation

Treatment:

Drug: broad area ALA 3-hour incubation

Device: Blue Light Treatment

Spot ALA 2-hour incubation

Experimental group

Description:

Spot ALA 2-hour incubation

Treatment:

Drug: Spot ALA 2 hour incubation

Device: Blue Light Treatment

Vehicle PDT

Placebo Comparator group

Description:

VEH group will be randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH will be considered a single treatment group.

Treatment:

Drug: Vehicle PDT

Device: Blue Light Treatment