Comparing the Efficacy and Cost-Effectiveness of Aquaphor to Atopiclair and EpiCeram in Children With Mild to Moderate Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alan B. Fleischer, Wake Forest University
ClinicalTrials.gov Identifier:
NCT01093469
First received: March 24, 2010
Last updated: January 2, 2013
Last verified: January 2013
  Purpose

The purpose of this study is to compare the efficacy and cost effectiveness of Aquaphor Healing Ointment, Atopiclair and EpiCeram as a monotherapy in mild to moderate AD.

The investigators hypothesize that no statistical difference will exist in the efficacy between an over-the-counter moisturizer, Aquaphor Healing Ointment, compared to prescription devices Atopiclair and EpiCeram in treating mild to moderate AD. Therefore, Aquaphor will be most cost-effective than Atopiclair or EpiCeram.


Condition Intervention
Atopic Dermatitis
Drug: Atopiclair Nonsteroidal Cream
Other: Aquaphor Healing Ointment
Drug: EpiCeram

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: An Investigator Blinded, Randomized, Controlled Study Comparing the Efficacy and Cost-Effectiveness of Aquaphor Healing Ointment, Atopiclair Nonsteroidal Cream (MAS063DP) and EpiCeram Skin Barrier Emulsion in Children With Mild to Moderate Atopic Dermatitis

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Enrollment: 39
Study Start Date: September 2009
Study Completion Date: February 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aquaphor Healing Ointment Other: Aquaphor Healing Ointment
Active Comparator: Atopiclair Nonsteroidal Cream Drug: Atopiclair Nonsteroidal Cream
Other Name: MAS063DP
Active Comparator: EpiCeram Skin Barrier Emulsion Drug: EpiCeram
Other Name: BRC-Cer

Detailed Description:

The primary objective is to compare the efficacy of Aquaphor Healing Ointment, Atopiclair Nonsteroidal Cream and EpiCeram Skin Barrier Emulsion in children with mild to moderate atopic dermatitis. The secondary objective is to compare the cost-effectiveness of these products. A significant difference exists in the cost of these products; therefore, if our hypothesis is proved correct - that Aquaphor will be just as efficacious as the more expensive counterparts Atopiclair and EpiCeram - this could have a significant impact on the overall cost of treating atopic dermatitis.

This is a single center, investigator blinded, randomized, prospective controlled study of subjects with mild to moderate atopic dermatitis. The study is intended to compare the efficacy of Aquaphor Healing Ointment, Atopiclair Nonsteroidal Cream and the EpiCeram Skin Barrier Emulsion used three times a day in treating mild to moderate atopic dermatitis. All subjects will receive active study medication and will return to study center for efficacy and safety assessments at Days 7 and 21. Approximately 50 subjects will be enrolled in order to obtain 39 completed subjects that will be randomized 1:1:1 (13 to receive Aquaphor, 13 to receive Atopiclair and 13 to receive EpiCeram) according to standard randomization tables. Efficacy will be measured through Investigator's Global Assessment, BSA involvement, Investigator Global Assessment of Improvement, Eczema Area and Severity Index and 100-pt Visual Analog Score for pruritis. Subjects will complete a Subject Global Assessment of Improvement and a drug diary to monitor for compliance. Cost benefit analysis will be calculated as cost in dollars for change in outcome according to EASI, BSA and VAS.

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female with mild to moderate atopic dermatitis, 2-17 years of age, that agree to participate and provide written consent (and assent if applicable)
  • Have an investigator Global Assessment of mild to moderate atopic dermatitis (IGA rating of 2-3 in the Investigator Global Assessment)
  • Percentage of overall body surface area of involvement (BSA) must be > 1% and may include facial and intertriginous skin.

Exclusion Criteria:

  • Use within 4 weeks of baseline of systemic anti-inflammatory medication, which may influence study outcome, such as systemic corticosteroids.
  • Application or use within 2 weeks of baseline of topical corticosteroid medications or topical anti-inflammatory medication, which may influence study outcome.
  • Presence of a concurrent medical condition, which is determined by the investigator to potentially interfere with study outcomes or patient assessments.
  • Introduction of any other prescription medication, topical or systemic, for atopic dermatitis while participating int he study (oral antihistamines will be allowed, so long as they are neither initiated nor discontinued during the course of this study)
  • Amount of disease involvement that would require >60gm of cream in a 1 week period
  • Subjects with known allergy or sensitivity to Aquaphor Healing Ointment, Atopiclair or EpiCeram or components therein.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01093469

Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Alan Fleischer, MD Wake Forest University Health Sciences Department of Dermatology
  More Information

No publications provided by Wake Forest School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alan B. Fleischer, Professor of Dermatology, Wake Forest University
ClinicalTrials.gov Identifier: NCT01093469     History of Changes
Other Study ID Numbers: II-AF-ATD-Aquaphor
Study First Received: March 24, 2010
Last Updated: January 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Wake Forest School of Medicine:
Atopic Dermatitis
Wake Forest
Dermatology
Skin
Over-the-counter
Moisturizer
Children

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Decanoic acid
Petrolatum
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Emollients
Dermatologic Agents

ClinicalTrials.gov processed this record on September 30, 2014