Lack of efficacy of topical furfuryl palmitate in pediatric atopic dermatitis: a randomized double-blind study.
BACKGROUND
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.


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.
Tripodi
S
S
Pediatric Allergology Unit, S. Pertini Hospital, Rome, Italy. salvatore.tripodi@gmail.com
Di Rienzo Businco
A
A
Panetta
V
V
Pingitore
G
G
Volterrani
A
A
Frediani
T
T
Pelosi
S
S
Miceli Sopo
S
S
D000279:Administration, Cutaneous; D002648:Child; D002675:Child, Preschool; D003876:Dermatitis, Atopic / Q000188:drug therapy*; D004311:Double-Blind Method; D004643:Emollients / Q000008:administration & dosage*; D005260:Female; D005663:Furans / Q000008:administration & dosage*; D006801:Humans; D007223:Infant; D008297:Male; D010168:Palmitates / Q000008:administration & dosage*; D016896:Treatment Outcome
D004643:Emollients; D005663:Furans; D010168:Palmitates; C470048:furfuryl palmitate