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Clinical Trial Summary

A Clinical Study to Evaluate the Safety and Efficacy of a Baby Cleanser and a Moisturizer Under the Supervision of Dermatologist and Pediatrician


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03719742
Study type Interventional
Source Burt's Bees Inc.
Contact
Status Completed
Phase N/A
Start date September 27, 2018
Completion date January 18, 2019

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