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

Autor:	Paul Zhang, Toni Anne Lisante, Chris Nunez
Rok vydání:	2017
Předmět:	Male medicine.medical_specialty Adolescent medicine.medical_treatment Eczema Barrier cream Nonprescription Drugs Dermatology Severity of Illness Index Dermatitis Atopic Ointments Double blind 030207 dermatology & venereal diseases 03 medical and health sciences 0302 clinical medicine Double-Blind Method medicine Humans Colloids Medical prescription Child skin and connective tissue diseases business.industry Pruritus digestive oral and skin physiology Infant food and beverages Atopic dermatitis medicine.disease Colloidal Oatmeal Cream Treatment Outcome Child Preschool 030220 oncology & carcinogenesis Female Over-the-counter business
Zdroj:	Journal of Dermatological Treatment. 28:659-667
ISSN:	1471-1753 0954-6634 0132-6910
DOI:	10.1080/09546634.2017.1303569
Popis:	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).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.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.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.NCT01326910.
Databáze:	OpenAIRE
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