Phase IIB Randomized, Double-Blinded, Placebo Controlled Study to Evaluate the Safety and Efficacy of Topical Difluoromethylornithine (DFMO) With and Without a Topical Corticosteroid Cream (Triamcinolone 0.1%) in the Therapy of Actinic Keratoses (AK) on the Forearms

Inclusion Criteria

DISEASE CHARACTERISTICS: Diagnosis of actinic keratosis At least 3 clinically visible
lesions on each lower posterior forearm Lesions must be discrete and quantifiable No prior
or concurrent skin cancer on forearms Prior skin cancer (other than melanoma) on an area
other than the forearms allowed unless chronic recurrent lesions indicate
immunosuppression Concurrent skin cancer on an area other than the forearms allowed if
active lesion previously excised

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life
expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not
specified Other: No serious concurrent illness No immunosuppression due to medication or
disease No invasive cancer (including melanoma) within the past 5 years Not pregnant or
nursing Negative pregnancy test Fertile patients must use effective contraception at least
28 days prior to and during study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 5 years
since prior systemic chemotherapy At least 6 months since prior fluorouracil (5-FU) to
forearms Prior or concurrent 5-FU to the face allowed Endocrine therapy: Not specified
Radiotherapy: Not specified Surgery: See Disease Characteristics Other: At least 30 days
since prior megadoses of vitamins (e.g., more than 400 IU of vitamin E, 200 micrograms of
selenium, or 1 g of vitamin C per day or more than the tolerable upper limits of any other
supplement) At least 6 months since prior tretinoin to forearms Prior or concurrent
tretinoin to the face allowed No concurrent mega-doses of vitamins No other concurrent
investigational drug or device