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New cream could soothe eczema in babies as young as 3 months

NCT ID NCT07265479

Symptom relief Sponsor: Organon and Co Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 4 times

Summary

This study tests a cream called tapinarof on babies and toddlers aged 3 to 23 months with eczema (atopic dermatitis). The goal is to see if it can clear or nearly clear their skin rash. About 180 children will take part, and the cream is compared to a placebo (inactive cream) for 8 weeks, followed by an open-label period where everyone gets the real cream.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

187 people

The number who actually took part.

Started

Dec 2025

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 23 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

atopic eczema Eczema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atopic dermatitis

Contacts and locations

Locations

  • APEX Clinical Trials

    Jacksonville, Florida, 32256, United States

  • Ada West Research

    Meridian, Idaho, 83646, United States

  • AllerVie Clinical Research

    Birmingham, Alabama, 35209, United States

  • Allergy Asthma and Clinical Research Center

    Oklahoma City, Oklahoma, 73120, United States

  • Allergy Research Canada Inc.

    Niagara Falls, Ontario, L2H 1C4, Canada

  • Allergy and Asthma Medical Group and Research Center

    San Diego, California, 92123, United States

  • Bobby Buka MD, PC

    New York, New York, 10012, United States

  • CARe Clinic (Central Alberta Research Clinic)

    Red Deer, Alberta, T4P 1K4, Canada

  • Clarity Dermatology

    Castle Rock, Colorado, 80109, United States

  • Cleaver Medical Group Dermatology, Inc

    Cumming, Georgia, 30040, United States

  • Clinical Trials Research Institute

    Thousand Oaks, California, 91320, United States

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46250, United States

  • Dermatologists of Central States, LLC

    Fairborn, Ohio, 45324, United States

  • Dermatology Research Associates

    Los Angeles, California, 90045, United States

  • Dermatology Research Institute

    Calgary, Alberta, T2J 7E1, Canada

  • Dermatology Specialists of Spokane

    Spokane, Washington, 99202, United States

  • Dermatology Treatment and Research Center

    Dallas, Texas, 75230, United States

  • Dermatology Trial Associates

    Bryant, Arkansas, 72022, United States

  • Dr. Chih-Ho Hong Medical Inc.

    Surrey, British Columbia, V3R 6A7, Canada

  • Dr. Rachel Asiniwasis Medical Professional Corporation

    Regina, Saskatchewan, S4V 1R9, Canada

  • Endeavor Health Clinical Trials Center

    Skokie, Illinois, 60077, United States

  • Equity Medical, LLC

    Bowling Green, Kentucky, 42104, United States

  • Equity Medical, LLC

    The Bronx, New York, 10455, United States

  • Forest Hills Dermatology Group

    Kew Gardens, New York, 11415, United States

  • Halton Pediatric Allergy

    Burlington, Ontario, L7L 6W6, Canada

  • Integrative Skin Science and Research

    Sacramento, California, 95815, United States

  • Lawrence J Green, MD LLC

    Rockville, Maryland, 20850, United States

  • Manitoba Allergy Research Inc.

    Winnipeg, Manitoba, R3J 0S9, Canada

  • Maritime Dermatology

    Halifax, Nova Scotia, B3K 5R3, Canada

  • MediSearch Clinical Trials

    Saint Joseph, Missouri, 64506, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Minnesota Clinical Study Center

    New Brighton, Minnesota, 55112, United States

  • National Allergy and Asthma Research, LLC.

    North Charleston, South Carolina, 29420, United States

  • Oakland Hills Dermatology

    Auburn Hills, Michigan, 48326, United States

  • Oregon Dermatology and Research Center

    Portland, Oregon, 97210, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • SKY Integrative Medical Center

    Ridgeland, Mississippi, 39157, United States

  • Skin Cancer and Dermatology Institute

    Reno, Nevada, 89509, United States

  • Skin Care Research, LLC.

    Boca Raton, Florida, 33486, United States

  • Skinsense Medical Research

    Saskatoon, Saskatchewan, S7K 2C1, Canada

  • Stryde Research - Epiphany Dermatology

    Southlake, Texas, 76092, United States

  • The Indiana Clinical Trials Center, PC

    Plainfield, Indiana, 46168, United States

  • The University of North Carolina Dermatology and Skin Cancer Center

    Chapel Hill, North Carolina, 27516, United States

  • The University of Texas Health Science Center at Houston

    Bellaire, Texas, 77401, United States

  • Triple A Lab Inc.

    Hamilton, Ontario, L8S 1G5, Canada

  • TruDerm Research

    Wellington, Florida, 33449, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.