title: A double-blind, placebo-controlled pilot study to estimate the efficacy and tolerability of a nonsteroidal cream for the treatment of cradle cap (seborrheic dermatitis).
abstract: This study was a multicenter, double-blind, placebo-controlled, parallel-group pilot study of efficacy and tolerability of a nonsteroidal cream (Promiseb® Topical Cream; Promius Pharma, LLC, Bridgewater, NJ) for treatment of cradle cap when applied topically twice daily for up to 14 days in 42 pediatric subjects. Both treatments were similarly effective in reducing disease severity, as measured by success with Investigator's Global Assessment scores at day 7 or end of treatment, with 96% of subjects achieving success in the nonsteroidal cream group and 92% of subjects achieving success in the placebo cream group. Both treatments resulted in significant reductions from baseline in terms of erythema, crusting, scaling, and oiliness (P<.05), with no significant difference between treatments. There was a significant difference (P=.03) between treatment groups for percent reduction in scaling at the end of treatment, with a 90% reduction in the nonsteroidal cream group compared with a 58% reduction in the placebo cream group. All subjects in both groups had an overall safety score of excellent, and there were no adverse events related to treatment for either group.
authors: University of Medicine and Dentistry, University Hospital Clinical Research Center, Newark, NJ, USA.
authors: Elmer
authors: E
authors: David
authors: Hanan
authors: H
authors: Tanuos
authors: Timothy
authors: T
authors: Sullivan
authors: Albert
authors: A
authors: Yan
authors: Leon H
authors: LH
authors: Kircik
mesh_terms: D000287:Administration, Topical; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage; D000935:Antifungal Agents / Q000008:administration & dosage; D002648:Child; D002675:Child, Preschool; D012628:Dermatitis, Seborrheic / Q000188:drug therapy* / Q000473:pathology; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004643:Emollients / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D008297:Male; D010865:Pilot Projects; D012536:Scalp Dermatoses / Q000188:drug therapy* / Q000473:pathology; D012720:Severity of Illness Index; D063465:Skin Cream / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D000935:Antifungal Agents; D003879:Dermatologic Agents; D004643:Emollients