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

Last updated:
2026-07-25
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View trial details

Overview

Official protocol title:

A RANDOMIZED, DOUBLE-BLIND, VEHICLE-CONTROLLED (PERIOD 1) AND OPEN-LABEL (PERIOD 2) PHASE 3 STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF TAPINAROF CREAM, 1% IN PEDIATRIC PARTICIPANTS AGES 3 MONTHS TO < 24 MONTHS WITH ATOPIC DERMATITIS

Intervention/treatment:
TAPINAROF (OG-0505)
Medical condition:
ATOPIC DERMATITIS
Protocol code:
OG0505-3104
Control number:
300592
Status:
Recruiting
Approved:
September 04, 2025
Trial phase:
Phase 3
For more information:
ClinicalTrials.gov - NCT07265479
This is an external link. The information is not authorized by the Government of Canada.

Eligibility

Sex: ALL
Age
3 Months to 23 Months
Accepts healthy volunteers: No

Contacts and locations

Contact
Name
Clinical Lead Late-Stage Clinical Development
Role
CONTACT
Phone:
551-430-6000
Sponsor
ORGANON LLC

Locations

Alberta

CARe Clinic (Central Alberta Research Clinic)
Red Deer, Alberta, T4P 1K4
RECRUITING
Name
Isaiah Day
Role
PRINCIPAL_INVESTIGATOR
Dermatology Research Institute
Calgary, Alberta, T2J 7E1
RECRUITING
Name
Vimal Prajapati
Role
PRINCIPAL_INVESTIGATOR

British Columbia

Dr. Chih-Ho Hong Medical Inc.
Surrey, British Columbia, V3R 6A7
RECRUITING
Name
Chih-Ho Hong
Role
PRINCIPAL_INVESTIGATOR

Manitoba

Manitoba Allergy Research Inc.
Winnipeg, Manitoba, R3J 0S9
RECRUITING
Name
Nestor Cisneros
Role
PRINCIPAL_INVESTIGATOR

Nova Scotia

Maritime Dermatology
Halifax, Nova Scotia, B3K 5R3
RECRUITING
Name
Natalie Cunningham
Role
PRINCIPAL_INVESTIGATOR

Ontario

Allergy Research Canada Inc.
Niagara Falls, Ontario, L2H 1C4
RECRUITING
Name
Vipul Jain
Role
PRINCIPAL_INVESTIGATOR
Halton Pediatric Allergy
Burlington, Ontario, L7L 6W6
RECRUITING
Name
Mariam Hanna
Role
PRINCIPAL_INVESTIGATOR
Triple A Lab Inc.
Hamilton, Ontario, L8S 1G5
RECRUITING
Name
Jason Ohayon
Role
PRINCIPAL_INVESTIGATOR

Saskatchewan

Dr. Rachel Asiniwasis Medical Professional Corporation
Regina, Saskatchewan, S4V 1R9
RECRUITING
Name
Rachel Asiniwasis
Role
PRINCIPAL_INVESTIGATOR
Skinsense Medical Research
Saskatoon, Saskatchewan, S7K 2C1
RECRUITING
Name
Kirsten Walker
Role
PRINCIPAL_INVESTIGATOR
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