NCT07265479SuspendedPhase 3
A Study to Investigate Safety and Efficacy of Tapinarof Cream, 1% in Participants Ages 3 Months to < 24 Months With Atopic Dermatitis
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
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Reason given: As a precaution, study drug dosing is paused due to a PK finding in OG505-3104. No safety signal or change to the established safety or benefit-risk profile has been identified. The Sponsor is further investigating and assessing the data.
Brief summary (registry, in English)
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.
- Status (registry)
- Suspended
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 187 (actual)
- First submitted
- 21 Nov 2025
- Start date
- 29 Dec 2025
- Primary completion date
- Aug 2027
- Lead sponsor
- Organon and Co
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT07265479
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of prohibited medication(s) or procedure(s)
- Use of prohibited medications by breastfeeding mother if breastfeeding participant
Other illness
- Significant neurological disorder or history of seizure
- Know clinically significant cardiac rhythm or cardiac disorder
- History of sudden infant death in a sibling
- 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
- Current chronic or acute infection requiring treatment
Other
- Clinically significant chromosome abnormality
- Immunocompromised
Who the study is looking for
- 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
Age in the registry: 3 months to 23 months · Sex: All · Does not accept healthy volunteers
Sites (46)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Halton Pediatric Allergy | Burlington | Canada | Unknown status |
| Dermatology Research Institute | Calgary | Canada | Unknown status |
| Maritime Dermatology | Halifax | Canada | Unknown status |
| Triple A Lab Inc. | Hamilton | Canada | Unknown status |
| Allergy Research Canada Inc. | Niagara Falls | Canada | Unknown status |
| CARe Clinic (Central Alberta Research Clinic) | Red Deer | Canada | Unknown status |
| Dr. Rachel Asiniwasis Medical Professional Corporation | Regina | Canada | Unknown status |
| Skinsense Medical Research | Saskatoon | Canada | Unknown status |
| Dr Chih-Ho Hong Medical Inc | Surrey | Canada | Unknown status |
| Manitoba Allergy Research Inc. | Winnipeg | Canada | Unknown status |
| Oakland Hills Dermatology | Auburn Hills | United States | Unknown status |
| The University of Texas Health Science Center at Houston | Bellaire | United States | Unknown status |
| AllerVie Clinical Research | Birmingham | United States | Unknown status |
| Skin Care Research, LLC | Boca Raton | United States | Unknown status |
| Equity Medical, LLC | Bowling Green | United States | Unknown status |
| Dermatology Trial Associates | Bryant | United States | Unknown status |
| Clarity Dermatology | Castle Rock | United States | Unknown status |
| The University of North Carolina Dermatology and Skin Cancer Center | Chapel Hill | United States | Unknown status |
| Medical University of South Carolina | Charleston | United States | Unknown status |
| Cleaver Medical Group Dermatology, Inc | Cumming | United States | Unknown status |
| Dermatology Treatment and Research Center | Dallas | United States | Unknown status |
| Dermatologists of Central States LLC | Fairborn | United States | Unknown status |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | United States | Unknown status |
| APEX Clinical Trials | Jacksonville | United States | Unknown status |
| Forest Hills Dermatology Group | Kew Gardens | United States | Unknown status |
| Dermatology Research Associates | Los Angeles | United States | Unknown status |
| Ada West Research | Meridian | United States | Unknown status |
| Minnesota Clinical Study Center | New Brighton | United States | Unknown status |
| Bobby Buka MD, PC | New York | United States | Unknown status |
| National Allergy and Asthma Research, LLC | North Charleston | United States | Unknown status |
| Allergy Asthma and Clinical Research Center | Oklahoma City | United States | Unknown status |
| The Indiana Clinical Trials Center, PC | Plainfield | United States | Unknown status |
| Oregon Dermatology and Research Center | Portland | United States | Unknown status |
| Oregon Health Science University | Portland | United States | Unknown status |
| Skin Cancer and Dermatology Institute | Reno | United States | Unknown status |
| Sky Integrative Medical Center | Ridgeland | United States | Unknown status |
| Lawrence J. Green, MD, LLC | Rockville | United States | Unknown status |
| Integrative Skin Science and Research | Sacramento | United States | Unknown status |
| Medisearch Clinical Trials | Saint Joseph | United States | Unknown status |
| Allergy and Asthma Medical Group and Research Center | San Diego | United States | Unknown status |
| Endeavor Health Clinical Trials Center | Skokie | United States | Unknown status |
| Stryde Research-Epiphany Dermatology | Southlake | United States | Unknown status |
| Dermatology Specialists of Spokane | Spokane | United States | Unknown status |
| Equity Medical, LLC | The Bronx | United States | Unknown status |
| Clinical Trials Research Institute | Thousand Oaks | United States | Unknown status |
| TruDerm Research | Wellington | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.