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

August 11, 2026 updated by: Organon and Co

A Randomized, Double-Blind, Vehicle-Controlled (Period 1) and Open-Label (Period 2) Phase 3 Study to Investigate the Safety and Efficacy of Tapinarof Cream, 1% in Pediatric Participants Ages 3 Months to < 24 Months With Atopic Dermatitis

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

187

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2J 7E1
        • Dermatology Research Institute
      • Red Deer, Alberta, Canada, T4P 1K4
        • CARe Clinic (Central Alberta Research Clinic)
    • British Columbia
      • Surrey, British Columbia, Canada, V3R 6A7
        • Dr. Chih-ho Hong Medical Inc.
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3J 0S9
        • Manitoba Allergy Research Inc.
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 5R3
        • Maritime Dermatology
    • Ontario
      • Burlington, Ontario, Canada, L7L 6W6
        • Halton Pediatric Allergy
      • Hamilton, Ontario, Canada, L8S 1G5
        • Triple A Lab Inc.
      • Niagara Falls, Ontario, Canada, L2H 1C4
        • Allergy Research Canada Inc.
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4V 1R9
        • Dr. Rachel Asiniwasis Medical Professional Corporation
      • Saskatoon, Saskatchewan, Canada, S7K 2C1
        • Skinsense Medical Research
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Allervie Clinical Research
    • Arkansas
      • Bryant, Arkansas, United States, 72022
        • Dermatology Trial Associates
    • California
      • Los Angeles, California, United States, 90045
        • Dermatology Research Associates
      • Sacramento, California, United States, 95815
        • Integrative Skin Science and Research
      • San Diego, California, United States, 92123
        • Allergy and Asthma Medical Group and Research Center
      • Thousand Oaks, California, United States, 91320
        • Clinical Trials Research Institute
    • Colorado
      • Castle Rock, Colorado, United States, 80109
        • Clarity Dermatology
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Skin Care Research, LLC.
      • Jacksonville, Florida, United States, 32256
        • APEX Clinical Trials
      • Wellington, Florida, United States, 33449
        • TruDerm Research
    • Georgia
      • Cumming, Georgia, United States, 30040
        • Cleaver Medical Group Dermatology, Inc
    • Idaho
      • Meridian, Idaho, United States, 83646
        • Ada West Research
    • Illinois
      • Skokie, Illinois, United States, 60077
        • Endeavor Health Clinical Trials Center
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Dawes Fretzin Clinical Research Group, LLC
      • Plainfield, Indiana, United States, 46168
        • The Indiana Clinical Trials Center, PC
    • Kentucky
      • Bowling Green, Kentucky, United States, 42104
        • Equity Medical, LLC
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Lawrence J Green, MD LLC
    • Michigan
      • Auburn Hills, Michigan, United States, 48326
        • Oakland Hills Dermatology
    • Minnesota
      • New Brighton, Minnesota, United States, 55112
        • Minnesota Clinical Study Center
    • Mississippi
      • Ridgeland, Mississippi, United States, 39157
        • Sky Integrative Medical Center
    • Missouri
      • Saint Joseph, Missouri, United States, 64506
        • Medisearch Clinical Trials
    • Nevada
      • Reno, Nevada, United States, 89509
        • Skin Cancer and Dermatology Institute
    • New York
      • Kew Gardens, New York, United States, 11415
        • Forest Hills Dermatology Group
      • New York, New York, United States, 10012
        • Bobby Buka MD, PC
      • The Bronx, New York, United States, 10455
        • Equity Medical, LLC
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27516
        • The University of North Carolina Dermatology and Skin Cancer Center
    • Ohio
      • Fairborn, Ohio, United States, 45324
        • Dermatologists of Central States, LLC
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Allergy Asthma and Clinical Research Center
    • Oregon
      • Portland, Oregon, United States, 97210
        • Oregon Dermatology and Research Center
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • North Charleston, South Carolina, United States, 29420
        • National Allergy and Asthma Research, LLC.
    • Texas
      • Bellaire, Texas, United States, 77401
        • The University of Texas Health Science Center at Houston
      • Dallas, Texas, United States, 75230
        • Dermatology Treatment and Research Center
      • Southlake, Texas, United States, 76092
        • Stryde Research - Epiphany Dermatology
    • Washington
      • Spokane, Washington, United States, 99202
        • Dermatology Specialists of Spokane

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tapinarof cream
Tapinarof cream, 1%, applied topically once daily
Drug: Tapinarof cream, 1%
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.
Other Names:
  • DMVT-505
  • OG-0505
  • GSK2894512A
  • GSK28994512
  • STI-1001
  • WBI-1001
Placebo Comparator: Vehicle cream
Vehicle cream is applied topically once daily for up to 8-weeks.
Drug: Vehicle Cream
Applied topically once daily to lesions on participant's skin during the Double-Blind period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks.
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
Time Frame: Baseline to the end of the Open-Label Period, up to 56 weeks.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants with ≥ 75% improvement in Eczema Area and Severity Index (EASI) Score from Baseline to Week 8.
Time Frame: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks.
The EASI is a scoring system that takes into account the overall severity of disease based on lesion severity and the %BSA affected with atopic dermatitis. The EASI is a composite score ranging from 0 -72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the %BSA involved for each body region relative to the whole body. The subject's scalp is excluded from this assessment. A higher EASI score represents more severe disease.
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
Time Frame: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks.
Assessment of %BSA is an estimate of the percentage of total involved skin with atopic dermatitis. Estimates were made using the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumbs together) represented approximately 1% of the total BSA. Body regions are assigned a specific number of handprints with associated percentages (Head and neck = 10% [10 handprints], upper extremities = 20% [20 handprints], trunk (including axillae and groin) = 30% [30 handprints], lower extremities, including buttocks, = 40% [40 handprints]). Estimates of the percent involvement of each body region will be multiplied by the fraction of total body area to obtain the total %BSA involved by region and overall.
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
Time Frame: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks.
Severity Index (EASI) score from Baseline to Week 8 Description: The EASI is a scoring system that takes into account the overall severity of disease based on lesion severity and the extent of percent body surface area affected with atopic dermatitis. The EASI is a composite score ranging from 0 -72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the percent body surface area involved for each body region relative to the whole body. A higher EASI score represents more severe disease.
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)
Time Frame: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks
TEAEs are AEs that started on or after the first dose of study medication.
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)
Time Frame: Baseline to the end of the Open-Label Period, up to 56 weeks
TEAEs are AEs that started on or after the first dose of study medication.
Baseline to the end of the Open-Label Period, up to 56 weeks
Percentage of participants with one or more Treatment Emergent Adverse Events (TEAEs)
Time Frame: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks .
TEAEs are AEs that started on or after the first dose of study medication.
Baseline to last planned visit in the Double-Blind Period, up to 8 weeks .
Percentage of participants with one or more Treatment Emergent Adverse Events (TEAEs)
Time Frame: Baseline to the end of the Open-Label Period, up to 56 weeks.
TEAEs are AEs that started on or after the first dose of study medication.
Baseline to the end of the Open-Label Period, up to 56 weeks.
Investigator-assessed Local Tolerability Scale (LTS) scores by visit (overall)
Time Frame: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks
The LTS measures the presence and overall degree of irritation at the application site(s) using a 5-point scale, where 0 indicates no irritation and 4 very severe irritation.
Baseline to last planned visit in the Double-Blind Period, up to 8 weeks
Investigator-assessed Local Tolerability Scale (LTS) scores by visit (overall)
Time Frame: Beginning of Open-Label to the end of the Open-Label Period, up to 48 weeks.
The LTS measures the presence and overall degree of irritation at the application site(s) using a 5-point scale, where 0 indicates no irritation and 4 very severe irritation.
Beginning of Open-Label to the end of the Open-Label Period, up to 48 weeks.
Investigator-assessed Local Tolerability Scale (LTS) scores by visit (sensitive areas)
Time Frame: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks
The LTS measures the presence and overall degree of irritation at the application site(s) using a 5-point scale, where 0 indicates no irritation and 4 very severe irritation.
Baseline to last planned visit in the Double-Blind Period, up to 8 weeks
Investigator-assessed Local Tolerability Scale (LTS) scores by visit (sensitive areas)
Time Frame: Beginning of Open-Label to the end of the Open-Label Period, up to 48 weeks.
The LTS measures the presence and overall degree of irritation at the application site(s) using a 5-point scale, where 0 indicates no irritation and 4 very severe irritation.
Beginning of Open-Label to the end of the Open-Label Period, up to 48 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Investigators

  • Study Director: Clinical Lead Late-Stage Clinical Development, Organon and Co

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 29, 2025

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

November 21, 2025

First Submitted That Met QC Criteria

December 2, 2025

First Posted (Actual)

December 4, 2025

Study Record Updates

Last Update Posted (Actual)

August 12, 2026

Last Update Submitted That Met QC Criteria

August 11, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OG0505-3104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe