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Original Article


Lack of Efficacy of Topical Furfuryl Palmitate in Pediatric Atopic Dermatitis: A Randomized Double-Blind Study


S Tripodi,1 A Di Rienzo Businco,1 V Panetta,2 G Pingitore,3 A Volterrani,4 T Frediani,5 S Pelosi,6 S Miceli Sopo7

1 Pediatric Allergology Unit, “S. Pertini” Hospital,Rome, Italy
2 Medical Statistics & Information Technology, AFaR, Fatebenefratelli Association for Research, Isola Tiberina, Rome, Italy
3 Pediatric Department “G.B. Grassi” Hospital, Rome, Italy
4 Allergology Unit, “Nuova Regina Margherita” Hospital, Rome, Italy
5 Pediatric Department, “La Sapienza” University, Rome, Italy
6 TPS production, Rome, Italy
7 Pediatric Department, “A. Gemelli” Hospital, Rome, Italy

J Investig Allergol Clin Immunol 2009; Vol. 19(3): 204-209



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, doubleblind, 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 signifi cant 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.

Key words: Atopic dermatitis. Children. Furfuryl palmitate. Topical administration.