NCT03719742

A Clinical Study to Evaluate the Safety and Efficacy of a Baby Cleanser and a Moisturizer

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Burt's Bees Inc. · Industry
• Sex: All
• Age: 6 Months – 7 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
OTHER	Sponsor Test Products	Baby Bee Foaming Cleanser(at least once daily but not more than twice daily), BB Baby Ultra Gentle Lotion (Once immediately after cleansing and again approximately 10-12 hours after cleansing)

Timeline

• Start date: 2018-09-27
• Primary completion: 2019-01-18
• Completion: 2019-01-18
• First posted: 2018-10-25
• Last updated: 2019-04-19

Locations

1 site across 1 country: United States