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

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: Recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Tapinarof cream, 1%; Drug: Vehicle Cream

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Clinical Lead Late-Stage Clinical Development; Phone Number: 551-430-6000; Email: studysites@organon.com

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2J 7E1
      • Recruiting
      • Dermatology Research Institute
      • Principal Investigator: Vimal Prajapati
    • Red Deer, Alberta, Canada, T4P 1K4
      • Recruiting
      • CARe Clinic (Central Alberta Research Clinic)
      • Principal Investigator: Isaiah Day
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Recruiting
      • Dr. Chih-ho Hong Medical Inc.
      • Principal Investigator: Chih-Ho Hong
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3J 0S9
      • Recruiting
      • Manitoba Allergy Research Inc.
      • Principal Investigator: Nestor Cisneros
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3K 5R3
      • Recruiting
      • Maritime Dermatology
      • Principal Investigator: Natalie Cunningham
  • Ontario
    • Burlington, Ontario, Canada, L7L 6W6
      • Recruiting
      • Halton Pediatric Allergy
      • Principal Investigator: Mariam Hanna
    • Hamilton, Ontario, Canada, L8S 1G5
      • Recruiting
      • Triple A Lab Inc.
      • Principal Investigator: Jason Ohayon
    • Niagara Falls, Ontario, Canada, L2H 1C4
      • Recruiting
      • Allergy Research Canada Inc.
      • Principal Investigator: Vipul Jain
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4V 1R9
      • Active, not recruiting
      • Dr. Rachel Asiniwasis Medical Professional Corporation
    • Saskatoon, Saskatchewan, Canada, S7K 2C1
      • Recruiting
      • Skinsense Medical Research
      • Principal Investigator: Kirsten Walker
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Recruiting
      • AllerVie Clinical Research
      • Principal Investigator: Weily Soong
  • Arkansas
    • Bryant, Arkansas, United States, 72022
      • Recruiting
      • Dermatology Trial Associates
      • Principal Investigator: Dowling Stough
  • California
    • Los Angeles, California, United States, 90045
      • Recruiting
      • Dermatology Research Associates
      • Principal Investigator: Howard Sofen
    • Sacramento, California, United States, 95815
      • Recruiting
      • Integrative Skin Science and Research
      • Principal Investigator: Raja Sivamani
    • San Diego, California, United States, 92123
      • Recruiting
      • Allergy and Asthma Medical Group and Research Center
      • Principal Investigator: Bob Geng
    • Thousand Oaks, California, United States, 91320
      • Recruiting
      • Clinical Trials Research Institute
      • Principal Investigator: Navid Ezra
  • Colorado
    • Castle Rock, Colorado, United States, 80109
      • Recruiting
      • Clarity Dermatology
      • Principal Investigator: James Daniel Jensen
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Recruiting
      • Skin Care Research, LLC.
      • Principal Investigator: Ann Mazor Reed
    • Jacksonville, Florida, United States, 32256
      • Recruiting
      • APEX Clinical Trials
      • Principal Investigator: Pearl Kwong
    • Wellington, Florida, United States, 33449
      • Recruiting
      • TruDerm Research
      • Principal Investigator: Andleeb Usmani
  • Georgia
    • Cumming, Georgia, United States, 30040
      • Recruiting
      • Cleaver Medical Group Dermatology, Inc
      • Principal Investigator: Weston Waxweiler
  • Idaho
    • Meridian, Idaho, United States, 83646
      • Recruiting
      • Ada West Research
      • Principal Investigator: Elizabeth Swanson
  • Illinois
    • Skokie, Illinois, United States, 60077
      • Recruiting
      • Endeavor Health Clinical Trials Center
      • Principal Investigator: Joel Joyce
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Recruiting
      • Dawes Fretzin Clinical Research Group, LLC
      • Principal Investigator: Kenneth Dawes
    • Plainfield, Indiana, United States, 46168
      • Recruiting
      • The Indiana Clinical Trials Center, PC
      • Principal Investigator: Scott Guenthner
  • Kentucky
    • Bowling Green, Kentucky, United States, 42104
      • Recruiting
      • Equity Medical, LLC
      • Principal Investigator: James Allred
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Recruiting
      • Lawrence J Green, MD LLC
      • Principal Investigator: Lawrence Green
  • Michigan
    • Auburn Hills, Michigan, United States, 48326
      • Recruiting
      • Oakland Hills Dermatology
      • Principal Investigator: Christofer Buatti
  • Minnesota
    • New Brighton, Minnesota, United States, 55112
      • Recruiting
      • Minnesota Clinical Study Center
      • Principal Investigator: Steven Kempers
  • Mississippi
    • Ridgeland, Mississippi, United States, 39157
      • Recruiting
      • SKY Integrative Medical Center
      • Principal Investigator: Jasmine Hollinger
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Recruiting
      • MediSearch Clinical Trials
      • Principal Investigator: MELODY STONE
  • Nevada
    • Reno, Nevada, United States, 89509
      • Recruiting
      • Skin Cancer and Dermatology Institute
      • Principal Investigator: Michael Heaphy
  • New York
    • Kew Gardens, New York, United States, 11415
      • Recruiting
      • Forest Hills Dermatology Group
      • Principal Investigator: Jeffrey Weinberg
    • New York, New York, United States, 10012
      • Recruiting
      • Bobby Buka MD, PC
      • Principal Investigator: Andrew Peranteau
    • The Bronx, New York, United States, 10455
      • Recruiting
      • Equity Medical, LLC
      • Principal Investigator: Alissa McInerney
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27516
      • Recruiting
      • The University of North Carolina Dermatology and Skin Cancer Center
      • Principal Investigator: Donna Culton
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Not yet recruiting
      • Cincinnati Children's Hospital Medical Center
      • Principal Investigator: Kalyani Marathe
    • Fairborn, Ohio, United States, 45324
      • Recruiting
      • Dermatologists of Central States, LLC
      • Principal Investigator: Craig Rohan
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Recruiting
      • Allergy Asthma and Clinical Research Center
      • Principal Investigator: Martha Tarpay
  • Oregon
    • Portland, Oregon, United States, 97239
      • Not yet recruiting
      • Oregon Health & Science University
      • Principal Investigator: Tracy Funk
    • Portland, Oregon, United States, 97210
      • Recruiting
      • Oregon Dermatology and Research Center
      • Principal Investigator: Phoebe Rich
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina
      • Principal Investigator: Lara Wine Lee
    • North Charleston, South Carolina, United States, 29420
      • Recruiting
      • National Allergy and Asthma Research, LLC.
      • Principal Investigator: John Ramey
  • Texas
    • Bellaire, Texas, United States, 77401
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Principal Investigator: Adelaide Hebert
    • Dallas, Texas, United States, 75230
      • Recruiting
      • Dermatology Treatment and Research Center
      • Principal Investigator: Ross Radusky
    • Southlake, Texas, United States, 76092
      • Recruiting
      • Stryde Research - Epiphany Dermatology
      • Principal Investigator: Ronald Todd Plott
  • Washington
    • Spokane, Washington, United States, 99202
      • Recruiting
      • Dermatology Specialists of Spokane
      • Principal Investigator: Katherine Reed

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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 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.	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	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	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)	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)	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)	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)	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)	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)	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)	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)	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

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

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

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): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: topical; Eczema; tapinarof; Pediatric Atopic Dermatitis
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic; Eczema; tapinarof
• 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