An Over-the-Counter Moisturizer Is as Clinically Effective as, and More Cost-Effective Than, Prescription Barrier Creams in the Treatment of Children With Mild-to-Moderate Atopic Dermatitis: A Randomized, Controlled Trial
May 2011 | Volume 10 | Issue 5 | Original Article | 531 | Copyright © May 2011
Drew W. Miller MD, Sarah B. Koch BBA, Brad A. Yentzer MD, Adele R. Clark PA-C, Jenna O'Neill MD, Julie Fountain, Teresa M. Weber PhD, Alan B. Fleischer Jr MD
Departments of Dermatology, Pathology and Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, NC; Beiersdorf Inc., Wilton, CT
Abstract
Background: Atopic dermatitis (AD) is a prevalent skin disorder with significant cost of treatment. Several prescription device moisturizers have been approved by the FDA to treat AD but are significantly more expensive than well-crafted over-the-counter (OTC) moisturizers. No studies have been performed to compare both the clinical efficacy and cost-efficacy of these prescription devices to OTC moisturizers.
Purpose: The purpose of this study is to compare the clinical efficacy and cost-efficacy of a glycyrrhetinic acid-containing barrier repair cream (BRC-Gly, Atopiclair®), a ceramide-dominant barrier repair cream (BRC-Cer, EpiCeram®) and an OTC petroleum-based skin protectant moisturizer (OTC-Pet, Aquaphor Healing Ointment®) as monotherapy for mild-to-moderate AD in children.
Methods: Thirty-nine patients, age 2-17 years, with mild-to-moderate AD were randomized 1:1:1 to receive one of three treatments—BRC-Gly, BRC-Cer or OTC-Pet—with instructions to apply the treatment three times daily for three weeks. Disease
severity and improvement was assessed at baseline and on days 7 and 21.
Results: No statistically significant difference for any efficacy assessment was found between the three groups at each time point. The OTC-Pet was found to be at least 47 times more cost-effective than BRC-Gly or BRC-Cer.
Limitations: The relatively small sample size of 39 subjects was not sufficient to establish OTC-Pet as superior treatment in AD.
Conclusions: OTC-Pet is as effective in treating mild-to-moderate AD as both BRC-Gly and BRC-Cer and is at least 47 times more cost-effective.
Name of registry: II-AF-ATD-Aquaphor, Comparing the Efficacy and Cost-Effectiveness of Aquaphor to Atopiclair and EpiCeram in Children with Mild to Moderate Atopic Dermatitis
Registration Identifier: NCT01093469
J Drugs Dermatol. 2011;10(5):531-537.
INTRODUCTION
Atopic dermatitis (AD) is a chronic, relapsing inflammatory skin disorder which affects 10 to 20 percent of the general population.1-3 Symptoms of AD include dry, scaly and intensely
itchy skin. Estimated direct and indirect costs of AD in the United States range widely, from $364 million to $3.8 billion per year, and this cost is expected to increase in proportion to rising disease prevalence.4
Moisturizers have long been recommended in the management of AD. Moisturizers decrease transepidermal water loss and attract
