title: Association of glycerol and paraffin in the treatment of ichthyosis in children: an international, multicentric, randomized, controlled, double-blind study.
abstract: BACKGROUND
  Efficacy and tolerance should be considered in topical treatments of chronicle affections with impaired skin barrier function such as ichthyosis.
  
  
  OBJECTIVE
  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.
authors: Dermatology Department, Saint-Louis Hospital, Paris, France. claudine.blanchet-bardon@sls.aphp.fr
authors: C
authors: C
authors: Blanchet-Bardon
authors: G
authors: G
authors: Tadini
authors: M
authors: M
authors: Machado Matos
authors: A
authors: A
authors: Delarue
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D005990:Glycerol / Q000627:therapeutic use*; D006801:Humans; D007057:Ichthyosis / Q000188:drug therapy*; D008297:Male; D010232:Paraffin / Q000627:therapeutic use*
chemical_list: D010232:Paraffin; D005990:Glycerol