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Miltefosine versus clobetasol in mastocytosis: Controlled study

A 2-week, randomized, double-blind, placebo-controlled, parallel-group trial of topical miltefosine (a raft modulator), topical clobetasol or vehicle evaluated their efficacy and safety in 39 mastocytosis patients. The treatments were applied b.i.d. on three distinct test areas over 2 weeks. The primary efficacy endpoint was the change of a composite score denoting the severity of wheals, erythema and itching after elicitation of Darier's sign. Miltefosine but not clobetasol decreased the itching subscore versus placebo (P = 0.044); however neither agent decreased any other symptom or the composite score significantly versus placebo. Clobetasol significantly decreased wheal volume (P = 0.025 vs. placebo) and decreased the number of mast cells in the upper dermis (P ...