Ignite Creation Date:
2024-05-06 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 12:54 PM
Study NCT ID:
NCT03673059
Status:
COMPLETED
Last Update Posted:
2018-09-17
First Post:
2018-08-17
Brief Title:
Clinical Trial to Assess the Effects of Topical Lotions on Changes in the Skin Microbiome and Associations With Itch
Sponsor:
Johnson Johnson Consumer Products Company Division of Johnson Johnson Consumer Companies Inc
Organization:
Johnson Johnson Consumer and Personal Products Worldwide
Study Overview
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
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None