title: Efficacy and safety of an over-the-counter 1% colloidal oatmeal cream in the management of mild to moderate atopic dermatitis in children: a double-blind, randomized, active-controlled study.
abstract: OBJECTIVE
  The purpose of this study is to evaluate the efficacy and safety of an over-the-counter (OTC) 1% colloidal oatmeal cream versus a prescription barrier cream in children with mild-to-moderate atopic dermatitis (AD).
  
  
  METHODS
  Eligible patients (6 months-18 years) were randomized to OTC or prescription cream. Eczema Area and Severity Index (EASI) scores, Investigator's Global Atopic Dermatitis Assessment (IGADA) scores, patients' and/or caregivers' assessment of itch using 10-cm visual analog scale (VAS) on day 0, weeks 1, 2, and 3 were assessed. The intention to treat (ITT) and per protocol (PP) populations were analyzed.
  
  
  RESULTS
  Ninety patients (mean [SD] age, 8.1 [4] years; boys, 45.6%; African American, 54.4%) were randomized (OTC cream, 45; prescription cream, 45). At week 3, EASI scores showed that the OTC cream was non-inferior (non-inferiority margin = 1.5) to the prescription cream (adjusted mean change [95% CI] from baseline: ITT, 0.18 [-0.35, 0.70]; PP, 0.14 [-0.42, 0.70]). IGADA (adjusted mean between group difference, 0.106 [-0.130, 0.341]) and VAS itch (0.103 [-0.831, 1.038]) scores improved in both groups. No safety issues were identified.
  
  
  CONCLUSIONS
  OTC 1% oatmeal cream was equally effective and safe as the prescription barrier cream for the symptomatic treatment of mild-to-moderate AD in children.
  
  
  BACKGROUND
  NCT01326910.
authors.affiliation: a Research & Development Clinical Research , Johnson & Johnson Consumer Inc , Skillman , NJ , USA.
authors.forename: Toni Anne
authors.initials: TA
authors.lastname: Lisante
authors.affiliation: a Research & Development Clinical Research , Johnson & Johnson Consumer Inc , Skillman , NJ , USA.
authors.forename: Chris
authors.initials: C
authors.lastname: Nuñez
authors.affiliation: b Research & Development Biostatistics , Johnson & Johnson Consumer Inc , Skillman , NJ , USA.
authors.forename: Paul
authors.initials: P
authors.lastname: Zhang
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D003102:Colloids / Q000737:chemistry; D003876:Dermatitis, Atopic / Q000188:drug therapy* / Q000473:pathology; D004311:Double-Blind Method; D004485:Eczema / Q000473:pathology; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D004366:Nonprescription Drugs; D009824:Ointments / Q000009:adverse effects / Q000737:chemistry / Q000627:therapeutic use*; D011537:Pruritus / Q000209:etiology; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D003102:Colloids; D004366:Nonprescription Drugs; D009824:Ointments
keywords: Atopic dermatitis; mild to moderate; oatmeal cream; over-the-counter; prescription barrier cream; quality-of-life