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
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.
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.
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