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

J Dermatolog Treat. 2017 Nov;28(7):659-667. doi: 10.1080/09546634.2017.1303569. Epub 2017 Apr 2.

Abstract

Purpose: 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).

Materials and 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.

Conclusion: 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.

Trial registration number: NCT01326910.

Keywords: Atopic dermatitis; mild to moderate; oatmeal cream; over-the-counter; prescription barrier cream; quality-of-life.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Child
  • Child, Preschool
  • Colloids / chemistry
  • Dermatitis, Atopic / drug therapy*
  • Dermatitis, Atopic / pathology
  • Double-Blind Method
  • Eczema / pathology
  • Female
  • Humans
  • Infant
  • Male
  • Nonprescription Drugs
  • Ointments / adverse effects
  • Ointments / chemistry
  • Ointments / therapeutic use*
  • Pruritus / etiology
  • Severity of Illness Index
  • Treatment Outcome

Substances

  • Colloids
  • Nonprescription Drugs
  • Ointments

Associated data

  • ClinicalTrials.gov/NCT01326910