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

Organon

Status and phase: Enrolling; Phase 3

Conditions: Atopic Dermatitis

Treatments: Drug: Vehicle Cream; Drug: Tapinarof cream, 1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT07265479

OG0505-3104

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 3 to 23 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infants and toddlers 3 months to <24 months (post-natal) 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
• Clinically significant cardiac rhythm or functional 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 mother if breastfeeding participant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 2 patient groups, including a placebo group

Tapinarof cream

Experimental group

Description:

Tapinarof cream, 1%, applied topically once daily

Treatment:

Drug: Tapinarof cream, 1%

Vehicle cream

Placebo Comparator group

Description:

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

Treatment:

Drug: Vehicle Cream