RELIEF OF PRURITUS IN PATIENTS WITH ATOPIC-DERMATITIS AFTER TREATMENTWITH TOPICAL DOXEPIN CREAM

Background: Atopic dermatitis is associated with severe pruritus for w hich effective topical treatment is lacking. As a potent H-1 and H-2 a ntagonist, the antipruritic effect of topical doxepin was first demons trated in histamine-induced itch in nonatopic volunteers. Objective: T he current study was undertaken to compare the efficacy and safety of topical 5% doxepin cream in relieving pruritus associated with atopic dermatitis. Methods: A total of 270 patients with atopic dermatitis wh o had daily moderate to severe pruritus for at least 1 week were enrol led in the double-blind, vehicle-controlled, multicenter study. Treatm ent was randomly assigned: 5% doxepin cream or vehicle cream was appli ed twice on the day of the baseline visit and four times daily for the remainder of the 7-day trial. Results: Relief of pruritus was achieve d in 85% of doxepin-treated patients and 57%, of vehicle-treated patie nts by day 7; a majority of these positive responses occurred during t he first 24 hours. Pruritus severity scores demonstrated significantly greater improvement with topical doxepin at each study visit (p < 0.0 1). Visual analogue scales for pruritus severity and pruritus relief s howed similar improvement in the doxepin-treated group. At each of thr ee visits, the physician's global evaluation for relief of pruritus al so showed significant improve ment in the doxepin treatment group (p < 0.01). The physician's global evaluations of eczema significantly fav ored topical doxepin on day 7 (p < 0.01). Nineteen patients withdrew f rom the study because of adverse effects (doxepin, n = 16; vehicle, n = 3). The most commonly reported were localized stinging or burning (d oxepin group, n = 39; vehicle group, n = 34) and drowsiness (doxepin g roup, n = 37; vehicle group, n = 3), all of which decreased in fre- qu ency and severity over time. Conclusion: Topical doxepin is effective in reducing pruritus in patients with atopic dermatitis. It has an app arent short-term low risk of major side effects or sensitization.