[Clinical evaluation of a topical doxepin cream [5%] in treatment of eczema]

ABSTRACT

Eczema is one of the most common pruritic skin disorders for which various treatments are used to relieve the symptoms. There are several reports about the efficacy and in part safety of topical doxepin in the treatment of pruritic dermal diseases. However, lack of a suitable topical preparation from this drug in our country persuaded us to design the present trial. A randomized, double blind, placebo controlled and multi- central clinical trial was carried out in Isfahan during the years of 1383-84 by using 60 volunteers and both the drug and placebo were given QID for 8 days. The efficacy, side effects and their relevance to sex and age of subjects were assessed before, during and after the treatment. The data were analyzed using non-parametric tests including Mann-Whitney, Wilcoxon, and Kendall Tau where appropriate. Results indicated that doxepin cream effectively reduced disease symptoms including pruritus [75.5%], inflammation [43.8%] skin dryness [37.5%] exudates [59.5%], lichenification [41.5%], and eczema [41.5%] after the course of treatment [the day of 8]. Same results were obtained by using placebo. Stinging as an adverse effect was occurred in both the drug [30%] and placebo [27%] groups. Although there was no significant difference between the two groups, it can be concluded that doxepin cream [5%] is effective in depressing the signs and symptoms of pruritic skin disorders. A larger clinical trial is needed to evaluate the efficacy and safety of the product more precisely