Tapinarof Cream for Atopic Dermatitis

(Adoring Trial)

Overseen By Clinical Lead Late-Stage Clinical Development

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Organon and Co

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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 Is on the Research Team?

Clinical Lead Late-Stage Clinical Development

Principal Investigator

Organon and Co

Are You a Good Fit for This Trial?

This clinical trial is for young children aged between 3 months and less than 24 months who have atopic dermatitis. Specific eligibility details are not provided, but typically participants must meet certain health criteria to be included.

Inclusion Criteria

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

My child is between 3 months and less than 24 months old.

Exclusion Criteria

History of sudden infant death in a sibling

Significant neurological disorder or history of seizure

Use of prohibited medication(s) or procedure(s)

What Are the Treatments Tested in This Trial?

Interventions

• Tapinarof Cream

Trial Overview The study is testing the safety and effectiveness of a cream called Tapinarof at a concentration of 1%. It's being compared with a vehicle cream (a placebo without the active drug) in babies and toddlers with skin inflammation due to atopic dermatitis.

How Is the Trial Designed?

Group I: Tapinarof cream Experimental Treatment 1 Intervention

Tapinarof cream, 1%, applied topically once daily

Group II: Vehicle cream Placebo Group 1 Intervention

Vehicle cream is applied topically once daily for up to 8-weeks.

Who Is Running the Clinical Trial?

Organon and Co

Lead Sponsor

Trials

492

Recruited

1,733,000+

Juan Camilo Arjona Ferreira

Organon and Co

Chief Medical Officer since 2023

MD

Kevin Ali

Organon and Co

Chief Executive Officer since 2021

MBA from Santa Clara University, BA from the University of California, Berkeley