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

C. Blanchet-Bardon, G. Tadini, M. MacHado Matos, A. Delarue

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Abstract

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.

Original languageEnglish
Pages (from-to)1014-1019
Number of pages6
JournalJournal of the European Academy of Dermatology and Venereology
Volume26
Issue number8
DOIs
Publication statusPublished - Aug 2012

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Ichthyosis
Double-Blind Method
Paraffin
Glycerol
Placebos
Pruritus
Visual Analog Scale
Emollients
Therapeutics
Safety
Skin
Research Personnel

ASJC Scopus subject areas

  • Dermatology
  • Infectious Diseases

Cite this

@article{0086c0112ff841c1be60112a98928865,
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. Objectives To demonstrate the efficacy of Dexeryl{\circledR} 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{\circledR} (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{\circledR} 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{\circledR} group (60.3{\%}) vs. vehicle group (43.5{\%}; P = 0.008). Reduction of pruritus on VAS was significantly higher at D28 with Dexeryl{\circledR} (-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{\circledR} group vs.-1.8 for the group previously treated by vehicle. Investigators found Dexeryl{\circledR} 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{\circledR} showed a significant improvement of xerosis and related symptoms in children with ichthyosis and was well tolerated.",
author = "C. Blanchet-Bardon and G. Tadini and {MacHado Matos}, M. and A. Delarue",
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T1 - Association of glycerol and paraffin in the treatment of ichthyosis in children

T2 - An international, multicentric, randomized, controlled, double-blind study

AU - Blanchet-Bardon, C.

AU - Tadini, G.

AU - MacHado Matos, M.

AU - Delarue, A.

PY - 2012/8

Y1 - 2012/8

N2 - 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.

AB - 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.

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