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 language | English |
|---|---|
| Pages (from-to) | 1014-1019 |
| Number of pages | 6 |
| Journal | Journal of the European Academy of Dermatology and Venereology |
| Volume | 26 |
| Issue number | 8 |
| DOIs | |
| Publication status | Published - Aug 2012 |
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ASJC Scopus subject areas
- Dermatology
- Infectious Diseases
Cite this
Association of glycerol and paraffin in the treatment of ichthyosis in children : An international, multicentric, randomized, controlled, double-blind study. / Blanchet-Bardon, C.; Tadini, G.; MacHado Matos, M.; Delarue, A.
In: Journal of the European Academy of Dermatology and Venereology, Vol. 26, No. 8, 08.2012, p. 1014-1019.Research output: Contribution to journal › Article
}
TY - JOUR
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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UR - http://www.scopus.com/inward/citedby.url?scp=84864280587&partnerID=8YFLogxK
U2 - 10.1111/j.1468-3083.2011.04304.x
DO - 10.1111/j.1468-3083.2011.04304.x
M3 - Article
C2 - 22118417
AN - SCOPUS:84864280587
VL - 26
SP - 1014
EP - 1019
JO - Journal of the European Academy of Dermatology and Venereology
JF - Journal of the European Academy of Dermatology and Venereology
SN - 0926-9959
IS - 8
ER -