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Study of Tapinarof Cream for Atopic Dermatitis in Infants and Toddlers

This study is looking at how safe and effective Tapinarof cream, 1% is for infants and toddlers aged 3 months to less than 24 months who have atopic dermatitis (eczema). Participants will apply either Tapinarof cream or a vehicle cream (a cream without the active medicine) to their skin once daily. The study aims to see if Tapinarof cream can help clear up eczema or significantly improve it. To join, your child must be between 3 and 23 months old, have a diagnosis of atopic dermatitis covering more than 5% of their body, and have a certain severity of eczema. The study plans to enroll 180 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is a Phase 3 study and plans to enroll 180 participants.
What's involved
Participants will apply cream to their skin once daily during the double-blind period, and then as needed during the open-label period. The double-blind period lasts up to 8 weeks, and the open-label period lasts up to 56 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 56 weeks to assess the cream's effectiveness.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07265479

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

Active, Not Recruiting
PHASE3Ages 3–23InterventionalTreatment
Organon and Co
~187 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:Tapinarof cream, 1%Vehicle Cream

At a glance

Recruiting sites
0 of 46 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over Baseline to last planned visit in the Double-Blind Period, up to 8 weeks.
+1 more outcome measured

Conditions

Atopic Dermatitis

Explore related trials

Atopic Dermatitis

Where it's being run

46 sites across 30 states
California4
Florida3
New York3
Texas3
Ontario3
Indiana2
Oregon2
South Carolina2

Study leadership

  • Clinical Lead Late-Stage Clinical Development · STUDY_DIRECTOR · Organon and Co

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • 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 8Baseline 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.

  • 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 PeriodBaseline 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.