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A Phase 3 Efficacy and Safety Study of Tapinarof for the Treatment of Plaque Psoriasis in Adults
This is a randomized, double-blind, vehicle-controlled Phase 3 study to evaluate the efficacy and safety of topical tapinarof cream, 1% once daily for the treatment of plaque psoriasis in adults. Approximately 500 adult subjects with plaque psoriasis will be randomized 2:1 to receive either tapinarof cream, 1% or matching vehicle cream once daily for 12 weeks.
This study is a 12-week double-blind, vehicle-controlled treatment study in which subjects will be randomized to receive tapinarof cream, 1% or vehicle cream once daily for 12 weeks. At the end of the 12-week study treatment, qualified subjects completing the study will have the option to enter a separate open-label, long-term safety and efficacy study for an additional 40 weeks of treatment with tapinarof cream, 1%. Subjects who do not enroll in the open-label long-term study will complete a follow-up visit approximately 4 weeks after end of treatment in this study (at Week 16).
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Dermavant Investigative Site
Birmingham, Alabama, United States
Dermavant Investigative Site
Phoenix, Arizona, United States
Dermavant Investigative Site
Hot Springs, Arkansas, United States
Dermavant Investigative Site
Rogers, Arkansas, United States
Dermavant Investigative Site
Anaheim Hills, California, United States
Dermavant Investigative Site
Fresno, California, United States
Dermavant Investigative Site
Los Angeles, California, United States
Dermavant Investigative Site
Northridge, California, United States
Dermavant Investigative Site
San Diego, California, United States
Dermavant Investigative Site
Santa Ana, California, United States
Start Date
May 21, 2019
Primary Completion Date
May 26, 2020
Completion Date
May 26, 2020
Last Updated
June 12, 2025
510
ACTUAL participants
Tapinarof
DRUG
Vehicle Cream
DRUG
Lead Sponsor
Organon and Co
Collaborators
NCT07116967
NCT07250802
NCT07449702
Data Source & Attribution
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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.
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