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

NCT07265479 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: OG0505-3104
• Study Type: interventional
• Target: 187
• Locations: 2 countries
• Sites: 46

Brief Summary

The purpose of this global Phase 3 clinical study is to investigate the safety and efficacy of tapinarof cream, 1% in participants ages 3 months to 23 months (inclusive) with atopic dermatitis.

Conditions

Atopic Dermatitis

Keywords

Pediatric Atopic Dermatitis; Eczema; tapinarof; topical

Outcome Measures

Primary Outcomes (2)

• Percentage of participants who have a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear or almost clear (0 or 1) and a minimum 2-grade Improvement from Baseline to Week 8

  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 reported as Clear (0), Almost clear (1), Mild (2), Moderate (3), and Severe (4). Higher vIGA-AD scores represent more severe disease.

  Baseline to last planned visit in the Double-Blind Period, up to 8 weeks.

• Percentage of participants who enter with or achieve have a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear or almost clear (0 or 1) and a minimum 2-grade Improvement at least once during the Open-Label Period

  The vIGA-AD is a clinical tool for assessing the current state/severity of a subject's atopic dermatitis at a given timepoint.. 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 reported as Clear (0), Almost clear (1), Mild (2), Moderate (3), and Severe (4). Higher vIGA-AD scores represent more severe disease.

  Baseline to the end of the Open-Label Period, up to 56 weeks.

Secondary Outcomes (11)

• Percentage of participants with ≥ 75% improvement in Eczema Area and Severity Index (EASI) Score from Baseline to Week 8.

  Baseline to last planned visit in the Double-Blind Period, up to 8 weeks.

• Mean change in percentage of total body surface area (%BSA) affected from Baseline to Week 8

  Baseline to last planned visit in the Double-Blind Period, up to 8 weeks.

• Percentage of participants with ≥ 90% improvement in Eczema Area and Severity Index (EASI) score from Baseline to Week 8

  Baseline to last planned visit in the Double-Blind Period, up to 8 weeks.

• Number of participants with one or more Treatment Emergent Adverse Events (TEAEs)

  Baseline to last planned visit in the Double-Blind Period, up to 8 weeks

• Number of participants with one or more Treatment Emergent Adverse Events (TEAEs)

  Baseline to the end of the Open-Label Period, up to 56 weeks

Study Arms (2)

Tapinarof cream

EXPERIMENTAL

Tapinarof cream, 1%, applied topically once daily

Drug: Tapinarof cream, 1%

Vehicle cream

PLACEBO COMPARATOR

Vehicle cream is applied topically once daily for up to 8-weeks.

Drug: Vehicle Cream

Interventions

Vehicle Cream DRUG

Applied topically once daily to lesions on participant's skin during the Double-Blind period.

Vehicle cream

Tapinarof cream, 1% DRUG

Tapinarof cream, 1%: Applied topically once daily to lesions on participant's skin during the Double-Blind period. During the Open-Label Period, it will be applied once daily to lesions, as needed.

Also known as: OG-0505, DMVT-505, GSK2894512A, GSK28994512, STI-1001, WBI-1001

Tapinarof cream

Eligibility Criteria

• Age: 3 Months - 23 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants and toddlers born at term (≥37 weeks of gestational age) that are 3 months to \<24 months of age at the Screening visit.
• Clinical diagnosis of atopic dermatitis (AD), AD covering \>5% Body Surface Area (BSA) and validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 2, 3 or 4
• Legal guardian or primary caregiver is willing and able to sign informed consent form before any study-related activities
• Legal guardian or primary caregiver is able and willing to adhere to protocol requirements

You may not qualify if:

• Significant neurological disorder or history of seizure
• Know clinically significant cardiac rhythm or cardiac disorder
• History of sudden infant death in a sibling
• Clinically significant chromosome abnormality
• History of or ongoing serious illness or medical, physical or psychiatric condition(s) that may interfere with the participant's participation
• Diseases that could cause pruritic and/or sleep disruption
• Immunocompromised
• Current chronic or acute infection requiring treatment
• Use of prohibited medication(s) or procedure(s)
• Use of prohibited medications by breastfeeding mother if breastfeeding participant

Sponsors & Collaborators

• Organon and Co: lead

Study Sites (46)

AllerVie Clinical Research

Birmingham, Alabama, 35209, United States

Location

Dermatology Trial Associates

Bryant, Arkansas, 72022, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Integrative Skin Science and Research

Sacramento, California, 95815, United States

Location

Allergy and Asthma Medical Group and Research Center

San Diego, California, 92123, United States

Location

Clinical Trials Research Institute

Thousand Oaks, California, 91320, United States

Location

Clarity Dermatology

Castle Rock, Colorado, 80109, United States

Location

Skin Care Research, LLC.

Boca Raton, Florida, 33486, United States

Location

APEX Clinical Trials

Jacksonville, Florida, 32256, United States

Location

TruDerm Research

Wellington, Florida, 33449, United States

Location

Cleaver Medical Group Dermatology, Inc

Cumming, Georgia, 30040, United States

Location

Ada West Research

Meridian, Idaho, 83646, United States

Location

Endeavor Health Clinical Trials Center

Skokie, Illinois, 60077, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

Location

The Indiana Clinical Trials Center, PC

Plainfield, Indiana, 46168, United States

Location

Equity Medical, LLC

Bowling Green, Kentucky, 42104, United States

Location

Lawrence J Green, MD LLC

Rockville, Maryland, 20850, United States

Location

Oakland Hills Dermatology

Auburn Hills, Michigan, 48326, United States

Location

Minnesota Clinical Study Center

New Brighton, Minnesota, 55112, United States

Location

SKY Integrative Medical Center

Ridgeland, Mississippi, 39157, United States

Location

MediSearch Clinical Trials

Saint Joseph, Missouri, 64506, United States

Location

Skin Cancer and Dermatology Institute

Reno, Nevada, 89509, United States

Location

Forest Hills Dermatology Group

Kew Gardens, New York, 11415, United States

Location

Bobby Buka MD, PC

New York, New York, 10012, United States

Location

Equity Medical, LLC

The Bronx, New York, 10455, United States

Location

The University of North Carolina Dermatology and Skin Cancer Center

Chapel Hill, North Carolina, 27516, United States

Location

Dermatologists of Central States, LLC

Fairborn, Ohio, 45324, United States

Location

Allergy Asthma and Clinical Research Center

Oklahoma City, Oklahoma, 73120, United States

Location

Oregon Dermatology and Research Center

Portland, Oregon, 97210, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

National Allergy and Asthma Research, LLC.

North Charleston, South Carolina, 29420, United States

Location

The University of Texas Health Science Center at Houston

Bellaire, Texas, 77401, United States

Location

Dermatology Treatment and Research Center

Dallas, Texas, 75230, United States

Location

Stryde Research - Epiphany Dermatology

Southlake, Texas, 76092, United States

Location

Dermatology Specialists of Spokane

Spokane, Washington, 99202, United States

Location

Dermatology Research Institute

Calgary, Alberta, T2J 7E1, Canada

Location

CARe Clinic (Central Alberta Research Clinic)

Red Deer, Alberta, T4P 1K4, Canada

Location

Dr. Chih-Ho Hong Medical Inc.

Surrey, British Columbia, V3R 6A7, Canada

Location

Manitoba Allergy Research Inc.

Winnipeg, Manitoba, R3J 0S9, Canada

Location

Maritime Dermatology

Halifax, Nova Scotia, B3K 5R3, Canada

Location

Halton Pediatric Allergy

Burlington, Ontario, L7L 6W6, Canada

Location

Triple A Lab Inc.

Hamilton, Ontario, L8S 1G5, Canada

Location

Allergy Research Canada Inc.

Niagara Falls, Ontario, L2H 1C4, Canada

Location

Dr. Rachel Asiniwasis Medical Professional Corporation

Regina, Saskatchewan, S4V 1R9, Canada

Location

Skinsense Medical Research

Saskatoon, Saskatchewan, S7K 2C1, Canada

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

tapinarof

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Clinical Lead Late-Stage Clinical Development

  Organon and Co

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Following a screening period of up to 30 days, eligible participants will be randomly assigned to one of two groups for up to 8 weeks. During this time-called the Double-Blind Period-2 out of 3 participants will receive the active treatment (tapinarof cream, 1%), while 1 out of 3 will receive a vehicle cream (placebo). Following completion of the Double-blind period, participants will enter the 48-week Open Label Period and will be treated as needed.

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 4, 2025
• Study Start: December 29, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (36); CA (10)