Fluorouracil Cream 0.5% for Actinic Keratoses on Multiple Body Sites: An 18-Month Open-Label Study

• Published in: Cutis (New York, N.Y.) Vol. 85; no. 5; pp. 267 - 273
• Main Authors: STOUGH, Dow, BUCKO, Alicia D, VAMVAKIAS, George, RAFAL, Elyse S, DAVIS, Steven A
• Format: Journal Article
• Language: English
• Published: Plainview, NY Quadrant HealthCom 01-05-2010
• Subjects: Administration, Topical; Adult; Aged; Aged, 80 and over; Antimetabolites, Antineoplastic - therapeutic use; Biological and medical sciences; Dermatology; Female; Fluorouracil - therapeutic use; Follow-Up Studies; Humans; Keratosis, Actinic - drug therapy; Male; Medical sciences; Middle Aged; Prospective Studies; Antineoplastic agent; Multiple; Dermatology; Cream; Fluorouracil; Keratosis
• ISSN: 0011-4162; 2326-6929

This prospective 18-month, open-label, multicenter study assessed the long-term safety and efficacy of fluorouracil cream 0.5% in 277 participants with multiple actinic keratoses (AKs) on the face/anterior scalp and other body sites. Two treatment/observation cycles were separated by 12 months. During treatment cycle 1 (TC1), all participants were treated with fluorouracil cream 0.5% for 4 weeks with 4-week follow-up. Twelve months later, all participants were assessed for treatment cycle 2 (TC2); participants with face/anterior scalp AKs (N = 98) were re-treated with fluorouracil cream 0.5% for 4 weeks with 4-week follow-up. Only 4 participants (7.4%) experienced a treatment-related adverse event (AE) that was not an application site reaction or eye irritation. No unexpected AEs were reported; most were mild or moderate. After TC1 (week 8), the number of AK lesions was significantly reduced on the face/anterior scalp and all other treated body sites (P < .0001). Clearance rates were 30.5% (hands), 39.8% (face/anterior scalp), and 79.1% (lips). After TC2 (week 60), face/anterior scalp AKs were significantly reduced (P < .0001) and the clearance rate was 33.3%. This study indicates that fluorouracil cream 0.5% with a patented microsponge delivery system was well-tolerated and effective in treating and preventing recurrence of AK lesions up to 18 months after initial treatment.