Status and phase
Conditions
Treatments
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
39 participants in 3 patient groups
There are currently no registered sites for this trial.
Start date
Sep 01, 2009 • 15 years ago
End date
Dec 01, 2009 • 15 years ago
Results posted
ViewMay 18, 2017 • 7 years ago
Today
May 04, 2025
Lead Sponsor
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal