Tapinarof for the Treatment of Atopic Dermatitis in Children and Adults (DMVT-505-3102)
NCT05032859 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 406
Last updated 2025-09-02
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.
Conditions
Interventions
- DRUG
-
tapinarof cream, 1%
applied topically once daily
- DRUG
-
vehicle cream
applied topically once daily
Sponsors & Collaborators
-
Organon and Co
lead INDUSTRY
Principal Investigators
-
Diana Villalobos · Dermavant Sciences, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 2 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-09-23
- Primary Completion
- 2023-02-03
- Completion
- 2023-02-08
- FDA Drug
- Yes
Countries
- United States
- Canada
Study Locations
More Related Trials
-
Dupilumab in Adolescent and Adult Skin of Color Participants: Open-label Moderate-to-severe Eczema Trial
NCT05590585 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Evaluate the Safety and Efficacy of Ruxolitinib Phosphate Cream Applied Topically to Adults With Atopic Dermatitis
NCT03011892 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate the Efficacy and Safety of Oral Difelikefalin as Adjunct Therapy to a Topical Corticosteroid for Moderate to Severe Pruritus in Subjects With Atopic Dermatitis
NCT05387707 ·Status: TERMINATED ·Phase: PHASE3
-
Study of RVT-501 in Adult and Adolescent Subjects With Atopic Dermatitis
NCT02950922 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of Dupilumab in Participants ≥12 to <18 Years of Age, With Moderate-to-severe Atopic Dermatitis
NCT03054428 ·Status: COMPLETED ·Phase: PHASE3
-
Study Evaluating Efficacy and Safety of PF-04965842 and Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis on Background Topical Therapy
NCT03720470 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Efficacy and Safety of 0.1% and 0.03% Tacrolimus Ointment Administered in Adults With Moderate to Severe Atopic Dermatitis
NCT00691145 ·Status: COMPLETED ·Phase: PHASE3
-
Effectiveness and Safety of Lebrikizumab Treatment in Adults and Adolescents With Moderate-to-Severe Atopic Dermatitis
NCT05990725 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
DMT210 Topical Gel in the Treatment of Atopic Dermatitis
NCT02949960 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy of AN2728 Topical Ointment, 2% in Children, Adolescents, and Adults (Aged 2 Years and Older) With Atopic Dermatitis
NCT02118792 ·Status: COMPLETED ·Phase: PHASE3
-
Study Evaluating the Mechanism of Action of PF-04965842 Monotherapy for Moderate-to-severe Atopic Dermatitis
NCT03915496 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Investigate the Efficacy and Safety of Dupilumab Administered With Topical Corticosteroids (TCS) in Participants ≥6 to <12 Years With Severe Atopic Dermatitis (AD)
NCT03345914 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate Efficacy and Safety of PF-04965842 With or Without Topical Medications in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
NCT03422822 ·Status: COMPLETED ·Phase: PHASE3
-
Tofacitinib Ointment For Atopic Dermatitis (Atopic Eczema)
NCT02001181 ·Status: COMPLETED ·Phase: PHASE2
-
A Dose-Finding Study of GSK2894512 Cream in Subjects With Atopic Dermatitis (AD)
NCT02564055 ·Status: COMPLETED ·Phase: PHASE2
-
An Efficacy and Safety Study of Tacrolimus Ointment in Adult Participants With Atopic Dermatitis
NCT01828879 ·Status: COMPLETED ·Phase: PHASE4
-
This Study is to Assess the Efficacy of Difamilast Ointment in Mild to Moderate Atopic Dermatitis(AD)
NCT05608343 ·Status: COMPLETED ·Phase: PHASE3
-
Crisaborole Ointment 2% Skin Biomarker Biopsy Study in Atopic Dermatitis
NCT03233529 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy of AN2728 Topical Ointment, 2% in Children, Adolescents, and Adults (Ages 2 Years and Older) With Atopic Dermatitis
NCT02118766 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Ruxolitinib Cream in Adolescents With Atopic Dermatitis
NCT05456529 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Tolerability Study of Device, RD047-26 for the Treatment of Mild to Moderate Atopic Dermatitis in Adults
NCT01232985 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Assess the Efficacy and Safety of Afimkibart (RO7790121) in Participants With Moderate to Severe Atopic Dermatitis
NCT06863961 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis
NCT03568318 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) With Severe Atopic Dermatitis
NCT00121381 ·Status: COMPLETED ·Phase: PHASE4
-
Study to Evaluate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis
NCT03349060 ·Status: COMPLETED ·Phase: PHASE3