Human Testing of an Over-the-Counter (OTC) Cream in Children With Eczema

Completed 90 enrolled Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

This three week study will be conducted to determine the safety and efficacy of an over-the-counter (OTC) cream in children with mild to moderate atopic dermatitis.

Timeline

Start: 2011-03
Primary completion: 2011-05
Completion: 2011-06

Outcome

Met primary endpoint

paper At week 3, EASI scores showed that the OTC cream was non-inferior (non-inferiority margin = 1.5) to the prescription cream PMID 28366039 ↗

Publications

Lisante TA, Nunez C, Zhang P. 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	OATMEAL, COLLOIDAL	Unknown	1 %	Topical