Clinical Trial to Assess the Effects of Topical Lotions on Changes in the Skin Microbiome and Associations With Itch

Microbiota Clinical Trial

Official title: A Multi-Center, Controlled Clinical Trial to Assess the Effects of Topical Lotions on Changes in the Skin Microbiome and Associations With Itch

Status Completed

Clinical Trial Summary

This was a multi-center, 14-day clinical use study with a 7-day regression period, being conducted to assess the changes in the skin microbiome with two moisturizers in female and male subjects 16-50 years of age with mild to moderate eczema that experienced a recent itch flare up.

Clinical Trial Description

In this study, subjects were divided into two groups, one group was supplied with a test product containing an over-the-counter (OTC) drug monographed ingredient for treatment of eczema. The other group was supplied with a cosmetic test product which is a standard dry skin daily moisturizer. Both groups were also provided with a cosmetic test cleanser to use in place of their normal cleanser. Subjects used the products for 14 days, followed by a 7-day regression period (no product use).

Subjects were assessed at Baseline and at Day 1, Day 3, Day 7, and Day 14 of product use. They were assessed again 7 days after stopping product use. Only the group provided with the test product containing the monograph ingredient for treatment of eczema were assessed for eczema endpoints after the Baseline visit. ;

Related Conditions & MeSH terms

• Microbiota

• NCT number: NCT03673059
• Study type: Interventional
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Status: Completed
• Phase: N/A
• Start date: March 27, 2015
• Completion date: June 13, 2016