Association of glycerol and paraffin in the treatment of ichthyosis in children: An international, multicentric, randomized, controlled, double-blind study

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® 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® (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® 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® group (60.3%) vs. vehicle group (43.5%; P = 0.008). Reduction of pruritus on VAS was significantly higher at D28 with Dexeryl® (-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® group vs.-1.8 for the group previously treated by vehicle. Investigators found Dexeryl® 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® showed a significant improvement of xerosis and related symptoms in children with ichthyosis and was well tolerated.