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

Purpose

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.

Condition

  • Atopic Dermatitis

Eligibility

Eligible Ages
Between 3 Months and 23 Months
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Following a screening period of up to 30 days, eligible participants will be randomly assigned to one of two groups for up to 8 weeks. During this time-called the Double-Blind Period-2 out of 3 participants will receive the active treatment (tapinarof cream, 1%), while 1 out of 3 will receive a vehicle cream (placebo). Following completion of the Double-blind period, participants will enter the 48-week Open Label Period and will be treated as needed.
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Tapinarof cream 		Tapinarof cream, 1%, applied topically once daily
  • Drug: Tapinarof cream, 1%
    Tapinarof cream, 1%: Applied topically once daily to lesions on participant's skin during the Double-Blind period. During the Open-Label Period, it will be applied once daily to lesions, as needed.
    Other names:
    • OG-0505
    • DMVT-505
    • GSK2894512A
    • GSK28994512
    • STI-1001
    • WBI-1001
Placebo Comparator
Vehicle cream 		Vehicle cream is applied topically once daily for up to 8-weeks.
  • Drug: Vehicle Cream
    Applied topically once daily to lesions on participant's skin during the Double-Blind period.

Recruiting Locations

AllerVie Clinical Research
Birmingham 4049979, Alabama 4829764 35209

Dermatology Trial Associates
Bryant 4103448, Arkansas 4099753 72022

Dermatology Research Associates
Los Angeles 5368361, California 5332921 90045

Integrative Skin Science and Research
Sacramento 5389489, California 5332921 95815

Allergy and Asthma Medical Group and Research Center
San Diego 5391811, California 5332921 92123

Clinical Trials Research Institute
Thousand Oaks 5402405, California 5332921 91320

Clarity Dermatology
Castle Rock 5416329, Colorado 5417618 80109

Skin Care Research, LLC.
Boca Raton 4148411, Florida 4155751 33486

APEX Clinical Trials
Jacksonville 4160021, Florida 4155751 32256

TruDerm Research
Wellington 4177703, Florida 4155751 33449

Cleaver Medical Group Dermatology, Inc
Cumming 4190396, Georgia 4197000 30040

Ada West Research
Meridian 5600685, Idaho 5596512 83646

The Indiana Clinical Trials Center, PC
Plainfield 4263108, Indiana 4921868 46168

Equity Medical, LLC
Bowling Green 4285268, Kentucky 6254925 42104

Lawrence J Green, MD LLC
Rockville 4367175, Maryland 4361885 20850

Oakland Hills Dermatology P.C
Auburn Hills 4984565, Michigan 5001836 48326

Minnesota Clinical Study Center
New Brighton 5039080, Minnesota 5037779 55112

SKY Integrative Medical Center
Ridgeland 4443296, Mississippi 4436296 39157

MediSearch Clinical Trials
Saint Joseph 4407010, Missouri 4398678 64506

Skin Cancer and Dermatology Institute
Reno 5511077, Nevada 5509151 89509

Forest Hills Dermatology Group
Kew Gardens 5123344, New York 5128638 11415

Bobby Buka MD, PC
New York 5128581, New York 5128638 10038

Equity Medical, LLC
The Bronx 5110266, New York 5128638 10455

Wright State Physicians
Fairborn 4511263, Ohio 5165418 45324

Allergy Asthma and Clinical Research Center
Oklahoma City 4544349, Oklahoma 4544379 73120

Oregon Dermatology and Research Center
Portland 5746545, Oregon 5744337 97210

Medical University of South Carolina
Charleston 4574324, South Carolina 4597040 29425

National Allergy and Asthma Research, LLC.
North Charleston 4589387, South Carolina 4597040 29420

Dermatology Treatment and Research Center
Dallas 4684888, Texas 4736286 75230

Stryde Consulting, LLC
Southlake 4733313, Texas 4736286 75093

Dermatology Specialists of Spokane
Spokane 5811696, Washington 5815135 99202

More Details

Status
Recruiting
Sponsor
Organon and Co

Study Contact

Clinical Lead Late-Stage Clinical Development
551-430-6000
studysites@organon.com