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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age3-23
SponsorOrganon and Co

About 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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Tapinarof cream, 1%
  • Vehicle Cream

Treatment groups

180 Participants
are divided into 2 treatment groups

Sponsors and collaborators