Arch Dermatol
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Randomized Controlled Trial Multicenter Study Clinical Trial
The antipruritic effect of 5% doxepin cream in patients with eczematous dermatitis. Doxepin Study Group.
Eczematous dermatitis is commonly characterized by intense pruritus. Current treatment modalities for this condition, regardless of its cause, are primarily directed at blunting the cutaneous inflammatory response and thereby providing relief of pruritus. To expand on our previous findings in atopic dermatitis, the present multicenter double-blind trial was conducted to evaluate the safety and antipruritic efficacy of 5% doxepin hydrochloride cream in patients with lichen simplex chronicus (n = 136), nummular eczema (n = 87), or contact dermatitis (n = 86). A total of 309 patients with moderate to severe pruritus were randomly assigned to apply either doxepin cream (n = 154) or vehicle cream (n = 155) to eczematous areas four times per day for a period of 7 days. Efficacy was assessed using a pruritus severity rating scale, a Physician's Global Evaluation for pruritus relief, and a Visual Analogue Scale for pruritus relief. ⋯ Topical application of doxepin provides significant antipruritic activity with a favorable safety profile, suggesting a role for doxepin cream in the symptomatic treatment of pruritus associated with eczematous dermatitis.