Photodynamic Therapy With Levulan® Topical Solution And Blue Light +/- Topical Retinoid Pre-Treatment In The Treatment Of Dorsal Hand/Forearm Actinic Keratoses
Subjects will be randomized such that their RIGHT dorsal hand/forearm will receive one of
the following two treatments with the subject's LEFT dorsal hand/forearm receiving the other
treatment; Treatment 1 will include pre-treatment of the dorsal hand/forearm with Tazorac
0.1% gel BID for one week, followed by ALA applied to the entire dorsal hand/forearm 60
minutes prior to BLUE light treatment for 16 minutes 40 seconds Treatment 2 will have ALA
applied to the entire dorsal hand/forearm and occluded for 60 minutes prior to BLUE light
treatment for 16 minutes 40 secondsNote: ALA will be applied to individual dorsal
hand/forearm actinic keratoses (AK) lesions followed by broad area application over the
entire dorsal hand/forearm surface. The treatment area on the side NOT pre-treated with
Tazorac will then be occluded using plastic wrap for 60 minutes. The treatment area of the
dorsal hand/forearm is defined as the extensor surface of the hand/forearm between the elbow
and the base of the fingers (the fingers are NOT included in the treatment area).
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Change in lesion counts in 25 cm2 Target Area relative to Baseline. Tolerability of treatment, local and systemic adverse events.
12 weeks
Yes
Barry Galitzer, MD
Principal Investigator
Roger H. Stewart MD PA
United States: Institutional Review Board
INV-0901
NCT01053000
January 2010
November 2010
Name | Location |
---|---|
Roger Stewart MD PA | Fort Lauderdale, Florida 33308 |