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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
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

Full criteria on ClinicalTrials.gov

Sites (46)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Halton Pediatric AllergyBurlingtonCanadaUnknown status
Dermatology Research InstituteCalgaryCanadaUnknown status
Maritime DermatologyHalifaxCanadaUnknown status
Triple A Lab Inc.HamiltonCanadaUnknown status
Allergy Research Canada Inc.Niagara FallsCanadaUnknown status
CARe Clinic (Central Alberta Research Clinic)Red DeerCanadaUnknown status
Dr. Rachel Asiniwasis Medical Professional CorporationReginaCanadaUnknown status
Skinsense Medical ResearchSaskatoonCanadaUnknown status
Dr Chih-Ho Hong Medical IncSurreyCanadaUnknown status
Manitoba Allergy Research Inc.WinnipegCanadaUnknown status
Oakland Hills DermatologyAuburn HillsUnited StatesUnknown status
The University of Texas Health Science Center at HoustonBellaireUnited StatesUnknown status
AllerVie Clinical ResearchBirminghamUnited StatesUnknown status
Skin Care Research, LLCBoca RatonUnited StatesUnknown status
Equity Medical, LLCBowling GreenUnited StatesUnknown status
Dermatology Trial AssociatesBryantUnited StatesUnknown status
Clarity DermatologyCastle RockUnited StatesUnknown status
The University of North Carolina Dermatology and Skin Cancer CenterChapel HillUnited StatesUnknown status
Medical University of South CarolinaCharlestonUnited StatesUnknown status
Cleaver Medical Group Dermatology, IncCummingUnited StatesUnknown status
Dermatology Treatment and Research CenterDallasUnited StatesUnknown status
Dermatologists of Central States LLCFairbornUnited StatesUnknown status
Dawes Fretzin Clinical Research Group, LLCIndianapolisUnited StatesUnknown status
APEX Clinical TrialsJacksonvilleUnited StatesUnknown status
Forest Hills Dermatology GroupKew GardensUnited StatesUnknown status
Dermatology Research AssociatesLos AngelesUnited StatesUnknown status
Ada West ResearchMeridianUnited StatesUnknown status
Minnesota Clinical Study CenterNew BrightonUnited StatesUnknown status
Bobby Buka MD, PCNew YorkUnited StatesUnknown status
National Allergy and Asthma Research, LLCNorth CharlestonUnited StatesUnknown status
Allergy Asthma and Clinical Research CenterOklahoma CityUnited StatesUnknown status
The Indiana Clinical Trials Center, PCPlainfieldUnited StatesUnknown status
Oregon Dermatology and Research CenterPortlandUnited StatesUnknown status
Oregon Health Science UniversityPortlandUnited StatesUnknown status
Skin Cancer and Dermatology InstituteRenoUnited StatesUnknown status
Sky Integrative Medical CenterRidgelandUnited StatesUnknown status
Lawrence J. Green, MD, LLCRockvilleUnited StatesUnknown status
Integrative Skin Science and ResearchSacramentoUnited StatesUnknown status
Medisearch Clinical TrialsSaint JosephUnited StatesUnknown status
Allergy and Asthma Medical Group and Research CenterSan DiegoUnited StatesUnknown status
Endeavor Health Clinical Trials CenterSkokieUnited StatesUnknown status
Stryde Research-Epiphany DermatologySouthlakeUnited StatesUnknown status
Dermatology Specialists of SpokaneSpokaneUnited StatesUnknown status
Equity Medical, LLCThe BronxUnited StatesUnknown status
Clinical Trials Research InstituteThousand OaksUnited StatesUnknown status
TruDerm ResearchWellingtonUnited StatesUnknown status

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