Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Men and women with the presence of actinic keratoses

Women who have had surgical sterilization or are post-menopausal (absence of menses for at least one year) are eligible. Women of child-bearing potential who are non-pregnant and non-nursing, and willing to avoid pregnancy during the course of the study and during the menstrual cycle following completion of their participation in the study are eligible. (Adequate contraception is defined as regular use of, diaphragm with condoms, IUD with condoms, or systemic contraceptives - if used for at least three months prior to enrollment in the study). A negative pregnancy test is required at entry into the study
Able to refrain from the use of all other topical medications to the facial area during the treatment period
Considered reliable and capable of understanding their responsibility and role in the study
Have provided written informed consent

Exclusion Criteria:

History of allergy or hypersensitivity to 5-fluorouracil

Known dihydropyrimidine dehydrogenase (DPD) enzyme deficiency
Clinical evidence of severe, uncontrolled auto-immune, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, pulmonary or renal disease
Dermatologic conditions if present on the face such as: atopic dermatitis, basal cell carcinoma, eczema, psoriasis, rosacea, squamous cell carcinoma, or albinism
Positive urine pregnancy test in women of child-bearing potential
Inability to use adequate birth control measures for women of child-bearing potential, as defined above
Serious psychological illness
Significant history (within the past year) of alcohol or drug abuse
Participation in any clinical research study during the 30 day period preceding study initiation
Medical history which, based on the clinical judgment of the investigator, implies an unlikelihood of successful completion of the study
Treatment for actinic keratosis or skin cancer in the previous 28 days with the following: topical 5 fluorouracil, cryodestruction (liquid nitrogen spray), curettage (scraping of pre-cancer or skin cancers), surgical removal of skin cancer, photodynamic therapy, surgical excision, topical diclofenac (Solaraze), topical imiquimod (Aldara), topical retinoids if used for actinic keratosis or other treatments for actinic keratoses
Application of 1) chemical peel, 2) dermabrasion, 3) laser abrasion, 4) PUVA (psoralen plus ultraviolet A) therapy, or 5) UVB therapy to the face or bald scalp within six months prior to randomization
Use of sun lamps or sun tanning beds or booths during the 2 weeks prior to first application until Day 42 visit
Any oral (systemic steroids) or topical corticosteroids within 1 month of study entry, except for subjects on chronic low dose corticosteroids less than 5 mg daily for greater than 1 year
Use within 1 month of any immunomodulators like interferon, or cytotoxic drugs
Prior treatment with systemic 5-fluorouracil or systemic cancer therapy within 6 months of study entry
Subjects with lesions suspicious for squamous cell carcinoma