ORLANDO Once-daily application of topical fluorouracil cream 0.5% for 4 weeks significantly reduced the number of visible and palpable actinic keratosis lesions on the posterior scalp, ears, neck, lips, arms, and hands by 8 weeks in an open-label, multicenter study of 277 patients.
The effect of the cream was greatest for AK lesions on the lips, ears, and neck. By week 8, 79% of patients with AK lesions on the lips, 62% of patients with AK lesions on the ears, and 65% of patients with AK lesions on the neck, achieved total clearance of their lesions, Dr. Dow Stough reported in a poster at the annual meeting of the American Society of Dermatologic Surgery.
Almost half (48%) of patients were clear of lesions on the posterior scalp, 37% of patients were clear of lesions on the arms, and 31% were clear on the hands. Fourteen percent of patients experienced clearance of AK lesions on all designated treatment areas, wrote Dr. Stough of Burke Pharmaceutical Research and the University of Arkansas, Hot Springs, and his associates.
These results were accomplished with a low incidence of treatment-emergent adverse events, aside from expected application site reactions and eye irritation, according to the investigators.
Topical fluorouracil cream 0.5% is a lower concentration of topical 5-fluourouracil, which has long been used to treat actinic keratoses.
The formulation was developed by Dermik Laboratories, which sponsored the study, and is applied to the AK lesions via the patented Microsponge technology, which permits its controlled release. It is currently approved by the Food and Drug Administration for the treatment of multiple AKs on the face and anterior scalp.
The study was conducted at 25 centers throughout the United States. Patients had at least five lesions on the face or anterior scalp, and at least five lesions on the posterior scalp, ears, neck, lips, arms, or hands. Their mean age was 67 years and 81% were men.
The efficacy and safety of fluorouracil cream 0.5% on facial and anterior scalp AK lesions have already been shown in two randomized, double-blind, vehicle-controlled phase III trials (Cutis 2002;70:3359; Cutis 2002;70[2 suppl]:229). The results of this subanalysis are about the effects of fluorouracil cream 0.5% on AK lesions on sites other than the face, the investigators explained.
Fluorouracil cream 0.5% was applied by the patient to designated lesions once a day for up to 4 weeks, as tolerated. Four weeks after the last application, the patients returned for a follow-up assessment.
There were statistically significant percentage decreases from baseline in the number of AK lesions at the 8-week assessment (P less than .0001). AK lesions decreased by 77% on the lips, 80% on the ears, 79% on the neck, 63% on the arms, 56% on the hands, and 77% on the posterior scalp, Dr. Stough and his associates reported.
The most common adverse event was skin irritation. Symptoms included dryness, erythema, burning, erosion, pruritus, edema, and pain at the application site, they noted.
Patients also reported experiencing symptoms of eye irritation, which included watering, burning, itching, sensitivity, and stinging. One patient was discontinued from the study because of moderate conjunctivitis, and one patient was discontinued because of pancreatitis, which was unrelated to the treatment medication.
Dr. Stough disclosed that his travel expenses to the ASDS annual meeting were funded by Dermik Laboratories.