A Study to Investigate Safety and Efficacy of Tapinarof Cream, 1% in Participants Ages 3 Months to < 24 Months With Atopic Dermatitis
Phase 3 – large-scale trial before approval
Conditions:
Atopic Dermatitis
Sponsor: Organon and Co
trial.available_in:
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Overview
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
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
Interventions
Tapinarof cream, 1%
DRUG
Vehicle Cream
DRUG
Locations
48
Canada (10)
Halton Pediatric Allergy
Burlington , Ontario
Dermatology Research Institute
Calgary , Alberta
Maritime Dermatology
Halifax , Nova Scotia
Triple A Lab Inc.
Hamilton , Ontario
Allergy Research Canada Inc.
Niagara Falls , Ontario
CARe Clinic (Central Alberta Research Clinic)
Red Deer , Alberta
Dr. Rachel Asiniwasis Medical Professional Corporation
Regina , Saskatchewan
ACTIVE_NOT_RECRUITING
Skinsense Medical Research
Saskatoon , Saskatchewan
Dr. Chih-ho Hong Medical Inc.
Surrey , British Columbia
Manitoba Allergy Research Inc.
Winnipeg , Manitoba
United States (38)
Oakland Hills Dermatology
Auburn Hills , Michigan
The University of Texas Health Science Center at Houston
Bellaire , Texas
AllerVie Clinical Research
Birmingham , Alabama
Skin Care Research, LLC.
Boca Raton , Florida
Equity Medical, LLC
Bowling Green , Kentucky
Dermatology Trial Associates
Bryant , Arkansas
Clarity Dermatology
Castle Rock , Colorado
The University of North Carolina Dermatology and Skin Cancer Center
Chapel Hill , North Carolina
NOT_YET_RECRUITING
Medical University of South Carolina
Charleston , South Carolina
Northwestern University
Chicago , Illinois
NOT_YET_RECRUITING
Cincinnati Children's Hospital Medical Center
Cincinnati , Ohio
NOT_YET_RECRUITING
Cleaver Medical Group Dermatology, Inc
Cumming , Georgia
Dermatology Treatment and Research Center
Dallas , Texas
Dermatologists of Central States, LLC
Fairborn , Ohio
Dawes Fretzin Clinical Research Group, LLC
Indianapolis , Indiana
APEX Clinical Trials
Jacksonville , Florida
Forest Hills Dermatology Group
Kew Gardens , New York
Dermatology Research Associates
Los Angeles , California
Ada West Research
Meridian , Idaho
Minnesota Clinical Study Center
New Brighton , Minnesota
Bobby Buka MD, PC
New York , New York
National Allergy and Asthma Research, LLC.
North Charleston , South Carolina
Allergy Asthma and Clinical Research Center
Oklahoma City , Oklahoma
The Indiana Clinical Trials Center, PC
Plainfield , Indiana
Oregon Dermatology and Research Center
Portland , Oregon
Oregon Health & Science University
Portland , Oregon
NOT_YET_RECRUITING
Skin Cancer and Dermatology Institute
Reno , Nevada
SKY Integrative Medical Center
Ridgeland , Mississippi
Lawrence J Green, MD LLC
Rockville , Maryland
Integrative Skin Science and Research
Sacramento , California
MediSearch Clinical Trials
Saint Joseph , Missouri
Allergy and Asthma Medical Group and Research Center
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