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Tapinarof cream 1% for infants and toddlers 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

Phase 3 Interventional Organon and Co · NCT07265479

This study will test whether tapinarof cream 1% improves eczema in babies and toddlers aged 3 months to under 2 years compared with a matching vehicle cream.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment180 (estimated)
Ages3 Months to 23 Months
SexAll
SponsorOrganon and Co Industry-sponsored
Locations48 sites (Birmingham, Alabama and 47 other locations)
Trial IDNCT07265479 on ClinicalTrials.gov

What this trial studies

This global Phase 3 interventional trial enrolls participants 3 months to <24 months old with atopic dermatitis covering more than 5% body surface area and a vIGA-AD score of 2–4. Eligible children will receive either tapinarof cream 1% or a vehicle cream and will attend regular clinic visits to monitor skin signs, symptoms, and safety. The protocol places particular emphasis on safety monitoring in this very young age group while measuring clinical efficacy outcomes. Organon is the sponsor and the trial is being conducted at multiple dermatology research centers in the United States.

Who should consider this trial

Good fit: Ideal candidates are term-born infants and toddlers aged 3 months to 23 months with a clinical diagnosis of atopic dermatitis affecting >5% BSA and a vIGA-AD score of 2, 3, or 4 whose caregiver can provide consent and follow study procedures.

Not a fit: Children with significant neurological or cardiac disorders, a history of sibling sudden infant death, clinically significant chromosomal abnormalities, other pruritic diseases, or other serious medical conditions are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this could provide a new non-steroidal topical treatment option to reduce inflammation and itching in infants and toddlers with atopic dermatitis.

How similar studies have performed: Tapinarof has shown efficacy in older patients with inflammatory skin diseases and prior adult/older pediatric data supported its development, but testing in infants under two years is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Birmingham, Alabama and 47 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Atopic DermatitisPediatric Atopic DermatitisEczematapinaroftopical
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.