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

Study acronym: Adoring
StatusSuspended
PhasePhase 3
Started2025-12-29
View on ClinicalTrials.gov ↗
Why the trial stopped
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.

Amendment history

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
2026-09-30
Trial status changed: Active, Not Recruiting → Suspended
Recruitment suspended: As a precaution, study drug dosing is paused due to a PK finding in OG505-3104. No safety signal or change to the...
Eligibility criteria-74 characters
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 [...] sessment for Atopic Dermatitis (vIGA-AD) score of 2, 3 or 4 * Legal guardian or primary caregiver is willing and able to s [...] n 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 [...] [...]
Secondary endpointsdetails revised at 3 of 11 entries
Study sitesdetails revised at 1 of 46 sites
2026-08-11
Study Status, Study Design, Contacts/Locations v12
Enrollment closed, study ongoing
Primary completion moved earlier: 2028-01 → 2027-08
Completion moved earlier: 2028-01 → 2027-08
Enrollment targetestimated 180→confirmed 187
Study sitesdetails revised at 46 of 46 sites
2026-07-15
Study Status, Contacts/Locations v11
Study sites47→46
2026-06-03
Study Status, Contacts/Locations v10
Study sitesdetails revised at 2 of 47 sites
2026-05-13
Study Status, Contacts/Locations v9
Study sites48→47
Show 7 earlier versions
2026-04-16
Study Status, Contacts/Locations v8
Study sitesdetails revised at 2 of 48 sites
2026-04-01
Study Status, Contacts/Locations v7
Study sites48 entries, revised
Endeavor Health Clinical OperationsTrials Center Oakland Hills Dermatology P.C The University of North Carolina atDermatology Chapeland HillSkin Cancer Center WrightDermatologists Stateof Physicians StrydeCentral ConsultingStates, LLC OriginsStryde Research - Epiphany Dermatology Dr. CentreRachel Asiniwasis Medical Professional Corporation
2026-03-12
Study Status, Contacts/Locations v6
Study sitesdetails revised at 2 of 48 sites
2026-02-20
Study Status, Eligibility, Contacts/Locations v5
Eligibility criteria+48 characters
Inclusion Criteria: Infants and toddlers born at term (≥37 weeks of gestational age) that are 3 months to <24 months (post-natal) of age at the Screening visit. Clinical diagnosis of atopic [...] ia: Significant neurological disorder or history of seizure ClinicallyKnow clinically significant cardiac rhythm or functional cardiac disorder History of sudden infant death in a sibling [...] ication(s) or procedure(s) Use of prohibited medications by breastfeeding mother if breastfeeding participant
Study sitesdetails revised at 5 of 48 sites
2026-02-13
Study Status, Contacts/Locations v4
Study sites49→48
2026-02-05
Study Status, Contacts/Locations v3
Study sitesdetails revised at 14 of 49 sites
2026-01-09
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-12→confirmed 2025-12-29
Study sites1→49
2025-12-02
Original filing
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.
Trial Details
NCT Number NCT07265479
Lead Sponsor Organon and Co
Conditions Atopic Dermatitis
Enrollment 187 participants
Start Date 2025-12-29
Primary Completion 2027-08 (estimated)
Study Completion 2027-08 (estimated)
Updated on ClinicalTrials.gov 2026-10-05