MedDataX Logo

Tapinarof for the Treatment of Atopic Dermatitis in Children and Adults (DMVT-505-3102)

NCT ID: NCT05032859

Last Updated: 2025-09-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

406 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-23

Study Completion Date

2023-02-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Tapinarof for the Treatment of Atopic Dermatitis in Children and Adults

NCT05014568

Atopic Dermatitis
COMPLETED PHASE3

A Study to Investigate Safety and Efficacy of Tapinarof Cream, 1% in Participants Ages 3 Months to < 24 Months With Atopic Dermatitis

NCT07265479

Atopic Dermatitis
RECRUITING PHASE3

Long Term Extension Study of Tapinarof Cream, 1% for Subjects With Atopic Dermatitis

NCT05142774

Atopic Dermatitis
COMPLETED PHASE3

Maximal Use Study of Tapinarof Cream, 1% in Pediatric Subjects With Extensive Atopic Dermatitis

NCT05186805

Atopic Dermatitis
COMPLETED PHASE2

A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis.

NCT05375955

Atopic Dermatitis Plaque Psoriasis
COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atopic Dermatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Following a 30-day screening period, eligible subjects will be randomized at a 2:1 ratio to receive once daily treatment with tapinarof cream, 1% or vehicle cream.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
The investigator, study center staff, subject, and sponsor will be blinded to treatment assignment.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

tapinarof cream

tapinarof cream, 1%, applied topically once daily

Group Type EXPERIMENTAL

tapinarof cream, 1%

Intervention Type DRUG

applied topically once daily

vehicle cream

vehicle cream, applied topically once daily

Group Type PLACEBO_COMPARATOR

vehicle cream

Intervention Type DRUG

applied topically once daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

tapinarof cream, 1%

applied topically once daily

Intervention Type DRUG

vehicle cream

applied topically once daily

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male and female subjects ages 2 and above with clinical diagnosis of AD
* Subject with atopic dermatitis covering ≥5% and ≤ 35% of the BSA
* A vIGA-AD score of ≥3 at screening and baseline
* An EASI score of ≥6 at screening and baseline
* Atopic dermatitis present for at least 6 months for ages 6 years old and above or 3 months for ages 2 to 5 years old
* Female subjects of childbearing potential who are engaging in sexual activity that could lead to pregnancy should use acceptable birth control methods
* Must not be pregnant
* Subject, subject's parent, or legal representative must be capable of giving written informed consent/assent

Exclusion Criteria

* Immunocompromised at screening
* Chronic or acute systemic or superficial infection requiring treatment with systemic antibacterials or antifungals within one week prior to baseline visit
* Significant dermatological or inflammatory condition other than AD that, in the Investigator's opinion, would make it difficult to interpret data or assessments during the study
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.0x the upper limit of normal (ULN).
* Screening total bilirubin \> 1.5x ULN
* Current or chronic history of liver disease
* Current or history of cancer within 5 years except for adequately treated cutaneous basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix
* Subjects who would not be considered suitable for topical therapy
* Use of any prohibited medication or procedure within the indicated period before the baseline visit including other investigational product within 30 days or 5 half-lives of the investigational product (whichever is longer)
* History of or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the Investigator's opinion, may interfere with the subject's participation in the study, interpretation of results, or ability to understand and give informed consent.
* Pregnant or lactating females
* History of sensitivity to the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the -Investigator or Medical Monitor, contraindicates their participation
* Previous known participation in a clinical study with tapinarof (previously known as GSK2894512 and WBI-1001)
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Organon and Co

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Diana Villalobos

Role: STUDY_DIRECTOR

Dermavant Sciences, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dermavant Investigative Site

Birmingham, Alabama, United States

Site Status

Dermavant Investigative Site

Scottsdale, Arizona, United States

Site Status

Dermavant Investigative Site

Scottsdale, Arizona, United States

Site Status

Dermavant Investigative Site

Fort Smith, Arkansas, United States

Site Status

Dermavant Investigative Site

Cerritos, California, United States

Site Status

Dermavant Investigative Site

Huntington Beach, California, United States

Site Status

Dermavant Investigative Site

Lancaster, California, United States

Site Status

Dermavant Investigative Site

Long Beach, California, United States

Site Status

Dermavant Investigative Site

Los Angeles, California, United States

Site Status

Dermavant Investigative Site

San Diego, California, United States

Site Status

Dermavant Investigative Site

San Francisco, California, United States

Site Status

Dermavant Investigative Site

Santa Ana, California, United States

Site Status

Dermavant Investigative Site

Santa Monica, California, United States

Site Status

Dermavant Investigative Site

Boca Raton, Florida, United States

Site Status

Dermavant Investigative Site

Delray Beach, Florida, United States

Site Status

Dermavant Investigative Site

Jacksonville, Florida, United States

Site Status

Dermavant Investigative Site

Miami, Florida, United States

Site Status

Dermavant Investigative Site

Miami, Florida, United States

Site Status

Dermavant Investigative Site

Miami Lakes, Florida, United States

Site Status

Dermavant Investigative Site

Tampa, Florida, United States

Site Status

Dermavant Investigative Site

Snellville, Georgia, United States

Site Status

Dermavant Investigative Site

Evansville, Indiana, United States

Site Status

Dermavant Investigative Site

Overland Park, Kansas, United States

Site Status

Dermavant Investigative Site

Lexington, Kentucky, United States

Site Status

Dermavant Investigative Site

Louisville, Kentucky, United States

Site Status

Dermavant Investigative Site

Baton Rouge, Louisiana, United States

Site Status

Dermavant Investigative Site

Baton Rouge, Louisiana, United States

Site Status

Dermavant Investigative Site

New Orleans, Louisiana, United States

Site Status

Dermavant Investigative Site

Rockville, Maryland, United States

Site Status

Dermavant Investigative Site

Detroit, Michigan, United States

Site Status

Dermavant Investigative Site

Lincoln, Nebraska, United States

Site Status

Dermavant Investigative Site

Omaha, Nebraska, United States

Site Status

Dermavant Investigative Site

Las Vegas, Nevada, United States

Site Status

Dermavant Investigative Site

East Windsor, New Jersey, United States

Site Status

Dermanvant Investigative Site

Brooklyn, New York, United States

Site Status

Dermavant Investigative Site

Watertown, New York, United States

Site Status

Dermavant Investigative Site

Charlotte, North Carolina, United States

Site Status

Dermavant Investigative Site

Dayton, Ohio, United States

Site Status

Dermavant Investigative Site

Mason, Ohio, United States

Site Status

Dermavant Investigative Site

Mayfield Heights, Ohio, United States

Site Status

Dermavant Investigative Site

Tulsa, Oklahoma, United States

Site Status

Dermavant Investigative Site

Medford, Oregon, United States

Site Status

Dermavant Investigative Site

Portland, Oregon, United States

Site Status

Dermavant Investigative Site

Portland, Oregon, United States

Site Status

Dermavant Investigative Site

East Greenwich, Rhode Island, United States

Site Status

Dermavant Investigative Site

Anderson, South Carolina, United States

Site Status

Dermavant Investigative Site

North Charleston, South Carolina, United States

Site Status

Dermavant Investigative Site

Spartanburg, South Carolina, United States

Site Status

Dermavant Investigative Site

Memphis, Tennessee, United States

Site Status

Dermavant Investigative Site

Bellaire, Texas, United States

Site Status

Dermavant Investigative Site

Dripping Springs, Texas, United States

Site Status

Dermavant Investigative Site

Grapevine, Texas, United States

Site Status

Dermavant Investigative Site

Houston, Texas, United States

Site Status

Dermavant Investigative Site

Houston, Texas, United States

Site Status

Dermavant Investigative Site

San Antonio, Texas, United States

Site Status

Dermavant Investigative Site

Webster, Texas, United States

Site Status

Dermavant Investigative Site

Spokane, Washington, United States

Site Status

Dermavant Investigative Site

Surrey, British Columbia, Canada

Site Status

Dermavant Investigative Site

Barrie, Ontario, Canada

Site Status

Dermavant Investigative Site

Markham, Ontario, Canada

Site Status

Dermavant Investigative Site

Waterloo, Ontario, Canada

Site Status

Dermavant Investigative Site

Windsor, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada

References

Explore related publications, articles, or registry entries linked to this study.

Silverberg JI, Eichenfield LF, Hebert AA, Simpson EL, Stein Gold L, Bissonnette R, Papp KA, Browning J, Kwong P, Korman NJ, Brown PM, Rubenstein DS, Piscitelli SC, Somerville MC, Tallman AM, Kircik L. Tapinarof cream 1% once daily: Significant efficacy in the treatment of moderate to severe atopic dermatitis in adults and children down to 2 years of age in the pivotal phase 3 ADORING trials. J Am Acad Dermatol. 2024 Sep;91(3):457-465. doi: 10.1016/j.jaad.2024.05.023. Epub 2024 May 20.

Reference Type RESULT
PMID: 38777187 (View on PubMed)

Alexis AF, Kircik L, Chovatiya R, Rice ZP, Soong W, Bhutani T, Brown PM, Piscitelli SC, Rubenstein DS, Tallman AM, Armstrong AW. Tapinarof Cream for Adults and Children with Atopic Dermatitis-Efficacy by Race and Fitzpatrick Skin Type in Two Phase 3 Randomized Clinical Trials. Dermatol Ther (Heidelb). 2025 Sep;15(9):2667-2682. doi: 10.1007/s13555-025-01489-w. Epub 2025 Jul 22.

Reference Type DERIVED
PMID: 40696240 (View on PubMed)

Gold LS, Bruno MJ, Lewitt GM, Hebert AA. Characteristics and management of follicular events and contact dermatitis in patients using tapinarof cream for the treatment of atopic dermatitis or plaque psoriasis. J Dermatolog Treat. 2025 Dec;36(1):2517388. doi: 10.1080/09546634.2025.2517388. Epub 2025 Jul 2.

Reference Type DERIVED
PMID: 40600584 (View on PubMed)

Gold LS, Del Rosso J, Ehst BD, Zirwas MJ, Green LJ, Brown PM, Rubenstein DS, Piscitelli SC, Tallman AM. Tapinarof cream 1% once daily was well tolerated in adults and children with atopic dermatitis in two phase 3 randomized trials. J Dermatolog Treat. 2025 Dec;36(1):2444489. doi: 10.1080/09546634.2024.2444489. Epub 2025 Jan 12.

Reference Type DERIVED
PMID: 39799945 (View on PubMed)

Simpson EL, Hebert AA, Browning J, Serrao RT, Sofen H, Brown PM, Piscitelli SC, Rubenstein DS, Tallman AM. Tapinarof Improved Outcomes and Sleep for Patients and Families in Two Phase 3 Atopic Dermatitis Trials in Adults and Children. Dermatol Ther (Heidelb). 2025 Jan;15(1):111-124. doi: 10.1007/s13555-024-01318-6. Epub 2025 Jan 7.

Reference Type DERIVED
PMID: 39777610 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DMVT-505-3102

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Dupilumab in Adolescent and Adult Skin of Color Participants: Open-label Moderate-to-severe Eczema Trial
NCT05590585 COMPLETED PHASE4
A Study to Evaluate the Safety and Efficacy of Ruxolitinib Phosphate Cream Applied Topically to Adults With Atopic Dermatitis
NCT03011892 COMPLETED 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 TERMINATED PHASE3
Study of RVT-501 in Adult and Adolescent Subjects With Atopic Dermatitis
NCT02950922 COMPLETED PHASE2
Efficacy and Safety of Dupilumab in Participants ≥12 to <18 Years of Age, With Moderate-to-severe Atopic Dermatitis
NCT03054428 COMPLETED 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 COMPLETED 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 COMPLETED PHASE3
Effectiveness and Safety of Lebrikizumab Treatment in Adults and Adolescents With Moderate-to-Severe Atopic Dermatitis
NCT05990725 ACTIVE_NOT_RECRUITING PHASE3
DMT210 Topical Gel in the Treatment of Atopic Dermatitis
NCT02949960 COMPLETED PHASE2
Safety and Efficacy of AN2728 Topical Ointment, 2% in Children, Adolescents, and Adults (Aged 2 Years and Older) With Atopic Dermatitis
NCT02118792 COMPLETED PHASE3
Study Evaluating the Mechanism of Action of PF-04965842 Monotherapy for Moderate-to-severe Atopic Dermatitis
NCT03915496 COMPLETED 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 COMPLETED 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 COMPLETED PHASE3
Tofacitinib Ointment For Atopic Dermatitis (Atopic Eczema)
NCT02001181 COMPLETED PHASE2
A Dose-Finding Study of GSK2894512 Cream in Subjects With Atopic Dermatitis (AD)
NCT02564055 COMPLETED PHASE2
An Efficacy and Safety Study of Tacrolimus Ointment in Adult Participants With Atopic Dermatitis
NCT01828879 COMPLETED PHASE4
This Study is to Assess the Efficacy of Difamilast Ointment in Mild to Moderate Atopic Dermatitis(AD)
NCT05608343 COMPLETED PHASE3
Crisaborole Ointment 2% Skin Biomarker Biopsy Study in Atopic Dermatitis
NCT03233529 COMPLETED PHASE2
Safety and Efficacy of AN2728 Topical Ointment, 2% in Children, Adolescents, and Adults (Ages 2 Years and Older) With Atopic Dermatitis
NCT02118766 COMPLETED PHASE3
Study of Ruxolitinib Cream in Adolescents With Atopic Dermatitis
NCT05456529 COMPLETED PHASE3
Efficacy and Tolerability Study of Device, RD047-26 for the Treatment of Mild to Moderate Atopic Dermatitis in Adults
NCT01232985 COMPLETED PHASE2
A Study to Assess the Efficacy and Safety of Afimkibart (RO7790121) in Participants With Moderate to Severe Atopic Dermatitis
NCT06863961 RECRUITING PHASE2
A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis
NCT03568318 ACTIVE_NOT_RECRUITING PHASE3
Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) With Severe Atopic Dermatitis
NCT00121381 COMPLETED PHASE4
Study to Evaluate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis
NCT03349060 COMPLETED PHASE3