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

Atopic Dermatitis

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.

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Participation Requirements

  • Sex:

    ALL
  • Eligible Ages:

    0 to 2

Participation Criteria

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

Study Location

Manitoba Allergy Research Inc.
Manitoba Allergy Research Inc.
Winnipeg, Manitoba
Canada

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Allergy Research Canada Inc.
Allergy Research Canada Inc.
Niagara Falls, Ontario
Canada

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Dr. Chih-ho Hong Medical Inc.
Dr. Chih-ho Hong Medical Inc.
Surrey, British Columbia
Canada

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Triple A Lab Inc.
Triple A Lab Inc.
Hamilton, Ontario
Canada

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CARe Clinic (Central Alberta Research Clinic)
CARe Clinic (Central Alberta Research Clinic)
Red Deer, Alberta
Canada

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Halton Pediatric Allergy
Halton Pediatric Allergy
Burlington, Ontario
Canada

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Skinsense Medical Research
Skinsense Medical Research
Saskatoon, Saskatchewan
Canada

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Dermatology Research Institute
Dermatology Research Institute
Calgary, Alberta
Canada

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Maritime Dermatology
Maritime Dermatology
Halifax, Nova Scotia
Canada

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Origins Dermatology Centre
Origins Dermatology Centre
Regina, Saskatchewan
Canada

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Study Sponsored By
Organon and Co
Participants Required
More Information
Study ID: NCT07265479