Atopic Dermatitis Clinical Trial
Official title:
A Clinical Study to Evaluate the Safety and Efficacy of a Baby Cleanser and a Moisturizer Under the Supervision of Dermatologist and Pediatrician
A Clinical Study to Evaluate the Safety and Efficacy of a Baby Cleanser and a Moisturizer Under the Supervision of Dermatologist and Pediatrician
This single-center clinical trial is being conducted to demonstrate that the Sponsor's
product does not statistically or clinically worsen eczema scores in children aged 6 months
through 7 years after 4 weeks of treatment compared to baseline scores.
Safety and efficacy will be assessed through clinical grading at baseline and week 4.
Efficacy will also be assessed through Corneometer and Tewameter measurements at baseline and
week 4. Microbiome skin swab sampling will be performed at baseline and week 4.
Parents/guardians will complete Patient Oriented Eczema Measure and Family Dermatology
Quality of Life Index at baseline and week 4.
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