Comparing Aquaphor to Atopiclair and EpiCeram in Children With Mild to Moderate Atopic Dermatitis

NCT01093469 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB00009130
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis; Wake Forest; Dermatology; Skin; Over-the-counter; Moisturizer; Children

Outcome Measures

Primary Outcomes (1)

• Investigator Global Assessment of Improvement

  This measures the overall response to treatment and quantifies disease on a 6 point scale from "completely clear" to "worsening of disease".0= Completely clear: except for possible residual hyperpigmentation, 1= Almost clear: very significant clearance (about 90%), 2 = Marked improvement: significant improvement (about 75%), 3= Moderate improvement: intermediate between slight and marked; representing about 50% improvements , 4= Slight improvement: some improvement (about 25%); however, significant disease remaining, 5 = No change from baseline, 6 = Worse

  Day 21

Study Arms (3)

Aquaphor Healing Ointment

EXPERIMENTAL

Aquaphor Healing Ointment three times daily to atopic dermatitis

Other: Aquaphor Healing Ointment

Atopiclair Nonsteroidal Cream

ACTIVE COMPARATOR

Atopiclair Nonsteroidal Cream three times daily to atopic dermatitis

Drug: Atopiclair Nonsteroidal Cream

EpiCream Skin Barrier Emulsion

ACTIVE COMPARATOR

EpiCream Skin Barrier Emulsion three times daily to atopic dermatitis

Drug: EpiCeram

Interventions

Atopiclair Nonsteroidal Cream DRUG

Also known as: MAS063DP

Atopiclair Nonsteroidal Cream

Aquaphor Healing Ointment OTHER

Aquaphor Healing Ointment

EpiCeram DRUG

Also known as: BRC-Cer

EpiCream Skin Barrier Emulsion

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

• Miller DW, Koch SB, Yentzer BA, Clark AR, O'Neill JR, Fountain J, Weber TM, Fleischer AB Jr. 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.

  PMID: 21533301 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

MAS063DP; EpiCeram

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Dr Alan Fleischer
• Organization: Wake Forest

adclark@wakehalth.edu

336-716-3775

Study Officials

• Alan Fleischer, MD

  Wake Forest University Health Sciences Department of Dermatology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2010
• First Posted: March 25, 2010
• Study Start: September 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: February 1, 2010
• Last Updated: September 11, 2018
• Results First Posted: May 18, 2017

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)