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Lack of efficacy of topical furfuryl palmitate in pediatric atopic dermatitis: a randomized double-blind study
S Tripodi1, A Di Rienzo Businco, V Panetta
1Pediatric Allergology Unit, S. Pertini Hospital, Rome, Italy. salvatore.tripodi@gmail.com
Insights
A new antioxidant, furfuryl palmitate, was tested for childhood atopic dermatitis. Basic emollient cream showed better efficacy than the antioxidant-enriched version, though both improved symptoms.
Area of Science:
- Dermatology
- Pediatrics
- Pharmacology
Background:
- Atopic dermatitis is a prevalent childhood skin condition.
- Current treatments include topical steroids, calcineurin inhibitors, and emollients.
- Topical antioxidants represent a novel therapeutic avenue for pediatric atopic dermatitis.
Purpose of the Study:
- To assess the efficacy and tolerability of furfuryl palmitate, a new antioxidant molecule.
- To compare a basic emollient cream with the same cream fortified with furfuryl palmitate in treating pediatric atopic dermatitis.
Main Methods:
- A multicenter, randomized, double-blind, vehicle-controlled study.
- Sixty children received basic emollient cream; 57 received emollient cream with furfuryl palmitate.
- Treatment duration was two weeks, with efficacy measured by the SCORAD index.
Main Results:
- Both treatments significantly reduced atopic dermatitis symptoms (SCORAD index) within 14 days.
- The basic emollient cream demonstrated higher efficacy in per-protocol and intention-to-treat analyses (70% vs. 29% success).
- Pediatricians and parents perceived the basic cream as more effective; tolerability was comparable between groups.
Conclusions:
- Both furfuryl palmitate-enriched and basic emollient creams were effective for pediatric atopic dermatitis.
- The basic emollient cream exhibited superior clinical efficacy compared to the formulation containing furfuryl palmitate.
Introduction:
Atopic dermatitis is a common disease in children. It is usually treated with topical steroids and/or calcineurin inhibitors in association with emollients but topical antioxidants have been recently introduced as a therapeutic option for children. The aim of this study was to evaluate the efficacy and tolerability of furfuryl palmitate, a new antioxidant molecule, in a multicenter, randomized, double-blind, vehicle-controlled study.
Patients And Methods:
Children with atopic dermatitis were randomized into 2 groups treated for 2 weeks. One group of children (n = 60) was treated with a basic emollient cream and the other (n = 57) was treated with the same cream enriched with furfuryl palmitate.
Results:
In both groups, there was a significant reduction (P < .001) in atopic dermatitis-measured using the SCORAD index-after 14 days. The reduction in the per-protocol analysis was higher for the basic cream. Treatment success was defined as a reduction of 20% or more in the SCORAD index from baseline to day 14. Patients who used treatment not permitted by the protocol were also considered treatment failures. The intention-to-treat analysis showed 70% positive results for the basic treatment and 29% for the treatment containing furfuryl palmitate (P < .0001) with a number needed to treat of 2.4 (95% confidence interval, 1.6-4.6). The emollient cream without furfuryl palmitate was observed to be more efficacious by pediatricians and parents, and no differences were reported between the 2 products in terms of tolerability.
Conclusions:
Both products proved to be efficacious in treating atopic dermatitis in children, but the emollient cream not containing furfuryl palmitate showed better clinical efficacy.
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