DOXEPIN CREAM RELIEVES ECZEMA-ASSOCIATED PRURITUS WITHIN 15 MINUTES AND IS NOT ACCOMPANIED BY A RISK OF REBOUND UPON DISCONTINUATION

Doxepin hydrochloride 5% cream has been previously demonstrated to be effective for relief of pruritus associated with atopic dermatitis and simplex chronicus. In these studies, no evaluations prior to 12 h aft er the first application, or following discontinuation of topical doxe pin therapy, were performed. The current study was done to investigate the onset of action of topical 5% doxepin cream and to ascertain whet her discontinuance of doxepin therapy is associated with 'rebound' wor sening of pruritus. A total of 120 patients with atopic dermatitis or lichen simplex chronicus with moderate to severe pruritus were treated with 5% doxepin cream in a single-blind treatment period (days 0 to 7 ) followed by a double-blind treatment period (days 7 to 14) in which patients were randomized to receive either doxepin or vehicle cream to evaluate the effects of cessation of active therapy. Pruritus evaluat ions performed 15 min following application of doxepin cream demonstra ted significant antipruritic activity compared with baseline as measur ed by visual analogue scales of pruritus severity (P<0.001) and prurit us relief (P<0.001). Of the 120 patients, 75% reported reductions in p ruritus severity in just 15 min and 84% reported such reductions by 12 0 min following doxepin cream application. Decreasing pruritus severit y and increasing pruritus relief continued significantly through day 7 . A statistically significant (P<0.001) improvement in both the prurit us severity rating and the physician's global evaluation of pruritus r elief was present on day 7 and continued to day 14 compared with basel ine in both treatment groups. Eczema severity was significantly improv ed on both days 7 and 14 in all treatment groups compared with baselin e (P<0.001), with significant continued improvement in the doxepin gro up on day 14 compared with day 7 (P=0.011). Adverse experiences were p redominantly mild to moderate in severity and decreased throughout the study. Within 15 min of application, topically applied 5% doxepin cre am provided significant antipruritic activity in patients with atopic dermatitis and lichen simplex chronicus. After completing a 7-day trea tment period, it was possible to replace active treatment with an emol lient without a rebound effect being observed.