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An Open-Label, Long-Term Extension Study to Evaluate the Safety and Efficacy of Tapinarof Cream, 1% in Subjects With Atopic Dermatitis
This is an open-label, long-term multicenter, study to evaluate the safety and efficacy of topical tapinarof cream, 1% in subjects with atopic dermatitis. Subjects in this study have completed treatment in one of two Phase 3 pivotal studies (DMVT-505-3101 or DMVT-505-3102) or completed treatment in the DMVT-505-2104 study, or directly enrolled into this study. This study will consist of up to 48 weeks of treatment and a 1 week safety follow-up period.
At the completion of the Week 8 visit of study DMVT-505-3101 (NCT05014568) or study DMVT-505-3102 (NCT05032859) or the Day 28 visit of study DMVT-505-2104 (NCT05186805) (Day 1 \[Baseline\] in this study), all eligible subjects will be offered enrollment in this open-label long-term extension (OL-LTE) study. Approximately 125 additional pediatric subjects ages 2 to \< 18 years who are not eligible for participation in the Phase 3 pivotal studies (DMVT-505-3101 or DMVT-505-3102) will be enrolled directly into this OL-LTE study. Study visits during the treatment period for all subjects will occur every 4 weeks (± 3 days). The total duration of study participation will be approximately 48 weeks for rollover subjects (Baseline to Final Visit) with a 1-week Safety Follow-up Period and approximately 52 weeks for direct-enrolling subjects (Screening to Final Visit) with a 1-week Safety Follow-up Period.
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
Scottsdale, Arizona, United States
Dermavant Investigative Site
Scottsdale, Arizona, United States
Dermavant Investigative Site
Bryant, Arkansas, United States
Dermavant Investigative Site
Fort Smith, Arkansas, United States
Dermavant Investigative Site
Cerritos, California, United States
Dermavant Investigative Site
Fountain Valley, California, United States
Dermavant Investigative Site
Fremont, California, United States
Dermavant Investigative Site
Huntington Beach, California, United States
Start Date
October 28, 2021
Primary Completion Date
February 29, 2024
Completion Date
March 7, 2024
Last Updated
August 13, 2025
728
ACTUAL participants
Tapinarof cream, 1%
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