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A Phase 3 Efficacy and Safety Study of Tapinarof for the Treatment of Moderate to Severe Atopic Dermatitis in Children and Adults
This is a double-blind, randomized, vehicle controlled Phase 3 study to evaluate the efficacy and safety of topical tapinarof cream, 1% compared to vehicle control cream in pediatric and adult subjects with atopic dermatitis.
This study is a 8-week double-blind, vehicle-controlled treatment study in which subjects will be randomized to receive tapinarof cream, 1% or vehicle cream once daily for 8 weeks. At the end of the 8-week study treatment, qualified subjects will have the option to enroll in an open-label, long-term extension study for an additional 48 weeks of treatment. Subjects who do not participate in the open-label, long-term extension study will complete a follow-up visit approximately one week after the end of treatment in this study.
Age
2 - No limit years
Sex
ALL
Healthy Volunteers
No
Dermavant Investigative Site
Birmingham, Alabama, United States
Dermavant Investigative Site
Phoenix, Arizona, United States
Dermavant Investigative Site
Bryant, Arkansas, United States
Dermavant Investigative Site
Beverly Hills, California, United States
Dermavant Investigative Site
Fountain Valley, California, United States
Dermavant Investigative Site
Fremont, California, United States
Dermavant Investigative Site
Inglewood, California, United States
Dermavant Investigative Site
Los Angeles, California, United States
Dermavant Investigative Site
Los Angeles, California, United States
Dermavant Investigative Site
Mission Viejo, California, United States
Start Date
September 1, 2021
Primary Completion Date
March 30, 2023
Completion Date
April 7, 2023
Last Updated
September 4, 2025
407
ACTUAL participants
tapinarof cream, 1%
DRUG
Vehicle cream
DRUG
Lead Sponsor
Organon and Co
NCT07262983
NCT06389136
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06342713