Atopic Dermatitis Clinical Trial
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
Verified date | August 2018 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 39 |
Est. completion date | February 2010 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 17 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Wake Forest Baptist Medical Center | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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