Topical Perillyl Alcohol in Treating Patients With Sun Damaged Skin and Actinic Keratoses

DISEASE CHARACTERISTICS:

• Resident of Pima or adjoining Southern Arizona county
• Patients outside of Pima County are also eligible
• Sun damaged skin as judged by the study physician and quantifiable, clinically diagnosed, and visible actinic keratoses (AK) on both dorsal forearms, with at least two AK on each arm
• AK lesions must not be clustered, confluent, or too numerous to count accurately
• Presence of AK on sites other than the test area allowed
• No significant inflammation or irritation of the skin of the upper extremities that is not clinically diagnosed as sun damage or AK
• Patients must agree to limit sun exposure as much as possible and may continue their normal pattern of sunscreen use

PATIENT CHARACTERISTICS:

Inclusion criteria

• Females must not be of childbearing potential, and therefore must be post-menopausal or surgically sterile by hysterectomy
• Not pregnant or nursing

Exclusion criteria

• Concurrent skin malignancy or disorder of the upper extremities
• Patients with Squamous cell carcinoma or basal cell carcinoma in an area other than the test area are eligible upon excision of the Squamous cell carcinoma or basal cell carcinoma
• Patients who are immunosuppressed by virtue of medication or disease
• Serious concurrent illness that could interfere with study regimen
• Invasive cancer within the past 5 years

PRIOR CONCURRENT THERAPY:

• At least 30 days since prior topical medications to the skin of the upper extremities except for emollients or sunscreens
• At least 30 days since prior and no concurrent mega-doses of vitamins, defined as any of the following:
• More than 5 times the recommended daily allowance
• More than 5 capsules of multivitamins
• 400 IU of vitamin E
• 200 μg of selenium
• 1 gm of vitamin C
• At least 6 months since prior and no concurrent therapy for squamous cell carcinoma (SCC) or basal cell carcinoma (BCC) anywhere in the test area (i.e., the forearms or hands)
• Treatment for Squamous cell carcinoma or basal cell carcinoma on sites other than the test area is allowed
• At least 4 weeks since prior surgical biopsy, surgical excision, or cryotherapy for AK in the test area and the sites must have healed
• At least 6 months since prior topical treatment (e.g., 5-fluorouracil or imiquimod) for AK
• No concurrent therapy that may interfere with clinical evaluations
• No concurrent topical drug treatment (e.g., retinoids, aminolevulinic acid, diclofenac sodium, imiquimod, or fluorouracil) to any area of skin, including test area
• No concurrent enrollment in another clinical trial
• No concurrent topical citrus peel or consumption of citrus peel
• No chemotherapy for cancer within the past 5 years