Eczema Clinical Trial
Official title:
A Clinical Trial to Evaluate the Efficacy of an Investigational Nighttime Moisturizing Balm in the Management of Mild to Moderate Atopic Dermatitis in Infants and Toddlers
The purpose of this 3 week study is to test the effectiveness of an over-the-counter (OTC) skin balm in infants and toddlers with mild to moderate dry, itchy skin.
50 infants and toddlers will be enrolled in this study to yield 40 completed subjects, 30
babies in the active treatment group and 10 babies in the positive control group.
Infants and toddlers aged 6 to 47 months inclusive will receive either a prescription or
non-marketed investigational product for the treatment of eczema. Caregivers will be asked
to stop use of prescription eczema treatments one week before the start of the study and
during the study. Caregivers will apply study product to babies as indicated for 14 days to
affected areas.
Subject caregivers will record treatment use in a daily diary and complete questionnaires. A
dermatologist will examine and score the babies eczema and symptoms. Skin moisture levels
will also be tested.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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