Overview

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

Status:
Completed
Trial end date:
2012-11-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
DUSA Pharmaceuticals, Inc.
Treatments:
Aminolevulinic Acid
Criteria
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.