Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2025-12-25 @ 7:25 PM
Study NCT ID:
NCT03386032
Status:
COMPLETED
Last Update Posted:
2020-12-17
First Post:
2017-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
8-Week Atopic Dermatitis (AD) Treatment Study
Sponsor:
Procter and Gamble
Organization:
Study Overview
Official Title:
8-Week Atopic Dermatitis (AD) Treatment Study
Status:
COMPLETED
Status Verified Date:
2020-12
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 is a study to investigate the clinical effectiveness of the Sponsor's experimental cream treatment on eczema as measured by visual grading of SCORAD (scoring of atopic dermatitis).
Detailed Description:
This will be a 9-week, randomized, double blind, parallel comparison study consisting of a 1-week washout phase followed by an 8-week treatment phase. This study will be executed by one clinical research company utilizing two test sites and up to 62 subjects with moderate or severe atopic dermatitis, ages 12-65, will be enrolled. Subjects that are enrolled will be placed on one of three products (e.g. Sponsor's Experimental Cream Treatment, a basic moisturizer, or a positive control - Desonide) and will be required to use the assigned product twice a day for the duration of the 8-week treatment phase.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: