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

J Drugs Dermatol. 2011 May;10(5):531-7.

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.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Cutaneous
  • Adolescent
  • Ceramides / administration & dosage
  • Ceramides / economics
  • Ceramides / therapeutic use
  • Child
  • Child, Preschool
  • Cholesterol / administration & dosage
  • Cholesterol / economics
  • Cholesterol / therapeutic use
  • Cost-Benefit Analysis
  • Dermatitis, Atopic / drug therapy*
  • Dermatitis, Atopic / pathology
  • Dermatologic Agents / administration & dosage
  • Dermatologic Agents / economics
  • Dermatologic Agents / therapeutic use*
  • Dietary Fats / administration & dosage
  • Dietary Fats / economics
  • Dietary Fats / therapeutic use
  • Double-Blind Method
  • Drug Combinations
  • Emollients / administration & dosage
  • Emollients / economics
  • Emollients / therapeutic use*
  • Fatty Acids / administration & dosage
  • Fatty Acids / economics
  • Fatty Acids / therapeutic use
  • Female
  • Glycyrrhetinic Acid / administration & dosage
  • Glycyrrhetinic Acid / economics
  • Glycyrrhetinic Acid / therapeutic use
  • Humans
  • Male
  • Nonprescription Drugs / administration & dosage
  • Nonprescription Drugs / economics
  • Nonprescription Drugs / therapeutic use
  • Petrolatum / administration & dosage
  • Petrolatum / economics
  • Petrolatum / therapeutic use
  • Plant Extracts / administration & dosage
  • Plant Extracts / economics
  • Plant Extracts / therapeutic use
  • Prescription Drugs / administration & dosage
  • Prescription Drugs / economics
  • Prescription Drugs / therapeutic use
  • Severity of Illness Index
  • Treatment Outcome

Substances

  • Ceramides
  • Dermatologic Agents
  • Dietary Fats
  • Drug Combinations
  • Emollients
  • EpiCeram
  • Fatty Acids
  • MAS063DP
  • Nonprescription Drugs
  • Plant Extracts
  • Prescription Drugs
  • Petrolatum
  • Cholesterol
  • Glycyrrhetinic Acid

Associated data

  • ClinicalTrials.gov/NCT01093469