科研之友
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摘要
Background Efficacy and tolerance should be considered in topical treatments of chronicle affections with impaired skin barrier function such as ichthyosis. Objectives To demonstrate the efficacy of Dexeryl (R) in reducing severity of ichthyosis. Methods A prospective, multicentre, randomized, placebo controlled study was performed with patients under 18 years suffering from a non-bullous form of ichthyosis. A double-blind period using Dexeryl (R) (an emollient cream containing glycerol 15% and paraffin 10%) or placebo (its vehicle) during 4 weeks followed by an open label period with all patients treated by Dexeryl (R) for 8 weeks. Improvement of ichthyosis was assessed by cutaneous xerosis evolution (SRRC score): the percentage of patients with 50% reduction of the SRRC score at D28 was the primary criterion. The assessment of pruritus [visual analogue scale (VAS)], global evaluation and safety were secondary. Results The percentage of patients with at least 50% reduction of SRRC score at D28 was significantly higher in Dexeryl (R) group (60.3%) vs. vehicle group (43.5%; P = 0.008). Reduction of pruritus on VAS was significantly higher at D28 with Dexeryl (R) (-2.16) compared to that in placebo (-1.49), P < 0.05. The improvement continues through the open label period: at D84 we observed -2.5 of SRRC score in the Dexeryl (R) group vs.-1.8 for the group previously treated by vehicle. Investigators found Dexeryl (R) efficacy as satisfying for about 80% of treated patients vs. 50% with vehicle. Concerning safety, most of the adverse events were not related to treatment. Conclusions Dexeryl (R) showed a significant improvement of xerosis and related symptoms in children with ichthyosis and was well tolerated.
- 出版日期2012-8
