Comparing Aquaphor to Atopiclair and EpiCeram in Children With Mild to Moderate Atopic Dermatitis
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|ClinicalTrials.gov Identifier: NCT01093469|
Recruitment Status : Completed
First Posted : March 25, 2010
Results First Posted : May 18, 2017
Last Update Posted : September 11, 2018
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 or disease||Intervention/treatment||Phase|
|Atopic Dermatitis||Drug: Atopiclair Nonsteroidal Cream Other: Aquaphor Healing Ointment Drug: EpiCeram||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||February 2010|
Experimental: Aquaphor Healing Ointment
Aquaphor Healing Ointment three times daily to atopic dermatitis
Other: Aquaphor Healing Ointment
Active Comparator: Atopiclair Nonsteroidal Cream
Atopiclair Nonsteroidal Cream three times daily to atopic dermatitis
Drug: Atopiclair Nonsteroidal Cream
Other Name: MAS063DP
Active Comparator: EpiCream Skin Barrier Emulsion
EpiCream Skin Barrier Emulsion three times daily to atopic dermatitis
Other Name: BRC-Cer
- Investigator Global Assessment of Improvement [ Time Frame: Day 21 ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01093469
|United States, North Carolina|
|Wake Forest Baptist Medical Center|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Alan Fleischer, MD||Wake Forest University Health Sciences Department of Dermatology|