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NCT05014568 · ClinicalTrials.gov registry record · Phase 3
Tapinarof for the Treatment of Atopic Dermatitis in Children and Adults
A Phase 3 study of Atopic Dermatitis, sponsored by Organon and.
- Completed
- Registry status
- Phase 3
- Development phase
- 407
- Enrollment target
- 20
- Study locations
NCT05014568: Completed Phase 3 study of Atopic Dermatitis, sponsored by Organon and.
NCT05014568 is a Phase 3 study of Atopic Dermatitis that has completed, run by Organon and. The registered enrollment target is 407 participants, below the 607-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (33% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05014568, a Phase 3 study of Atopic Dermatitis, has completed, sponsored by Organon and.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 407 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
The vIGA-AD is a global assessment of the current state of the disease. It is a static 5-point scale used to grade overall disease severity (scalp excluded), as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting. The vIGA-AD ranges from 0 to 4 and is calculated as Clear (0), Almost clear (1), Mild (2), Moderate (3), and Severe (4). Higher vIGA-AD scores represent more severe disease. Statistics are based on 100
Conditions Studied
Interventions
- DRUG Vehicle cream
- DRUG tapinarof cream, 1%
Study Locations (20)
California
- Dermavant Investigative Site - Beverly Hills
- Dermavant Investigative Site - Fountain Valley
- Dermavant Investigative Site - Fremont
- Dermavant Investigative Site - Inglewood
- Dermavant Investigative Site - Los Angeles
- Dermavant Investigative Site - Los Angeles
- Dermavant Investigative Site - Mission Viejo
- Dermavant Investigative Site - Sacramento
Florida
- Dermavant Investigative Site - Boca Raton
- Dermavant Investigative Site - Boca Raton
- Dermavant Investigative Site - Brandon
- Dermavant Investigative Site - Coral Gables
- Dermavant Investigative Site - Jacksonville
- Dermavant Investigative Site - Margate
- Dermavant Investigative Site - Miami
- Dermavant Investigative Site - Miami Lakes
Alabama
- Dermavant Investigative Site - Birmingham
Arizona
- Dermavant Investigative Site - Phoenix
Arkansas
- Dermavant Investigative Site - Bryant
District of Columbia
- Dermavant Investigative Site - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 407 participants |
| Start Date | 2021-09-01 |
| Est. Completion | 2023-04-07 |
| Phase | Phase 3 |
What the finished NCT05014568 record still lists
NCT05014568 is an interventional study that assigns participants to a tested intervention. The registered 407 participants enrollment target is mid-sized for trials with a published cap, below the 607-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (33% lower).
The record links to 1 condition, with Atopic Dermatitis appearing as the primary indexed condition, and to 2 interventions - of which Vehicle cream is the first listed.
NCT05014568 names 20 study sites across 6 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT05014568 about?
NCT05014568 is a clinical study titled "Tapinarof for the Treatment of 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.
What is the current status of trial NCT05014568?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 407 participants. The study started on 2021-09-01. Estimated completion is 2023-04-07.
What conditions does trial NCT05014568 study?
This clinical trial studies the following conditions: Atopic Dermatitis.
What interventions are being tested in trial NCT05014568?
The interventions under investigation include: Vehicle cream (DRUG), tapinarof cream, 1% (DRUG).
Who is sponsoring clinical trial NCT05014568?
This trial is sponsored by Organon and, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05014568 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Atopic Dermatitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05014568's enrollment target sits among peer trials
407 31st of 150 higher than 120 of 150 other Atopic Dermatitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atopic Dermatitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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