NCT07265479 · Organon and Co
A Study to Investigate Safety and Efficacy of Tapinarof Cream, 1% in Participants Ages 3 Months to < 24 Months With Atopic Dermatitis
(Adoring)
What this study is about
The purpose of this global Phase 3 clinical study is to investigate the safety and effectiveness of tapinarof cream, 1% in participants ages 3 months to 23 months (inclusive) with atopic dermatitis.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Birmingham, Alabama
- Bryant, Arkansas
- Los Angeles, California
- Sacramento, California
- San Diego, California
- Thousand Oaks, California
- Castle Rock, Colorado
- Boca Raton, Florida
- Jacksonville, Florida
- Wellington, Florida
- Cumming, Georgia
- Meridian, Idaho
And 24 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 4, 2026 · Source of record for eligibility and locations