THE ANTIPRURITIC EFFECT OF 5-PERCENT DOXEPIN CREAM IN PATIENTS WITH ECZEMATOUS DERMATITIS

Background cmd Design: Eczematous dermatitis is commonly characterized by intense pruritus. Current treatment modalities for this condition, regardless of its cause, are primarily directed at blunting the cutan eous inflammatory response and thereby providing relief of pruritus. T o expand on our previous findings in atopic dermatitis, the present mu lticenter double-blind trial was conducted to evaluate the safety and antipruritic efficacy of 5% doxepin hydrochloride cream in patients wi th lichen simplex chronicus (n=136); nummular eczema (n=87), or contac t dermatitis (n=86). A total of 309 patients with moderate to severe p ruritus were randomly assigned to apply either doxepin cream (n=154) o r vehicle cream (n=155) to eczematous areas four times per day for a p eriod of 7 days. Efficacy was assessed using a pruritus severity ratin g scale, a Physician's Global Evaluation for pruritus relief, and a Vi sual Analogue Scale for pruritus relief. Results: Twenty-four hours af ter initiation of treatment, and continuing throughout the remainder o f the study, patients treated with doxepin cream experienced significa ntly greater pruritus relief than did vehicle-treated patients as dete rmined by all efficacy parameters (P<.002). Sixty percent of doxepin-t reated patients experienced pruritus relief within 24 hours. The respo nse rate increased to 84% by conclusion of the study. As judged by sig nificant changes (P less than or equal to.05) occurring in at least on e assessment of efficacy, doxepin cream provided pruritus relief in al l forms of eczematous dermatitis that were examined. The study medicat ion was well tolerated. The two most common adverse effects, stinging at the site of application and drowsiness, were usually transient and mild to moderate in severity. Conclusion: Topical application of doxep in provides significant antipruritic activity with a favorable safety- profile, suggesting a role for doxepin cream in the symptomatic treatm ent of pruritus associated with eczematous dermatitis.