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

A Phase II Study of Photodynamic Therapy With LEVULAN® Topical Solution + Blue Light Versus LEVULAN® Topical Solution Vehicle + Blue Light Using Spot and Broad Area Application and Incubation Times of 1, 2 and 3 Hours for the Treatment of Multiple Actinic Keratoses on the Face or Scalp

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.

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.