Fluorouracil cream 0.5% for the treatment of actinic keratoses on the face and anterior scalp: interim results of an 18-month open-label study.

OBJECTIVE

This study further assessed the long-term safety and efficacy of fluorouracil cream 0.5% in patients with multiple actinic keratosis (AK) on the face/anterior scalp and other body sites.

DESIGN/SETTING: This 18-month, prospective, open-label, multicenter study comprised two treatment cycles separated by 12 months. Cycle 1 included treatment of AK lesions on the face, anterior scalp, posterior scalp, ears, neck, lips, arms, and/or hands. Once-daily fluorouracil cream 0.5% was applied for four weeks as tolerated, followed by four weeks of follow-up in each treatment cycle.

PARTICIPANTS

Adults (N=277) with five or more visible and/or palpable AK lesions on the face/anterior scalp and five or more lesions on the posterior scalp, ears, neck, lips, arms, and/or hands were enrolled.

MEASUREMENTS

Main outcome measures included adverse events (AEs) and reduction/clearance of AK lesions on the face/anterior scalp after four weeks of treatment.

RESULTS

RESULTS for treatment of AK lesions on the face/anterior scalp for Cycle 1 are reported. All 277 patients were treated during Cycle 1. Besides anticipated application-site reactions (67.9% and 19.1% of patients experiencing mild-to-moderate and severe events, respectively) and eye irritation, overall incidence of treatment-emergent AEs was low. No individual AE appeared in greater than four percent of patients. At the end of Cycle 1, significant reductions were noted in lesion counts on the face/anterior scalp (84.8%; P<0.0001). Clearance rate for lesions on the face and anterior scalp was 39.8 percent at eight weeks.

CONCLUSION

RESULTS indicate that fluorouracil cream 0.5% is safe and effective for patients with multiple AK lesions on the face/anterior scalp.