Status:
COMPLETED
Maximal Use Study of Tapinarof Cream, 1% in Pediatric Subjects With Extensive Atopic Dermatitis
Lead Sponsor:
Organon and Co
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
2-17 years
Phase:
PHASE2
Brief Summary
This is an open-label, multicenter study to evaluate the systemic exposure and safety of topical tapinarof cream, 1% under conditions of maximal use in pediatric subjects with atopic dermatitis
Detailed Description
This is a 4-week open-label study in which subjects will be assigned to receive tapinarof cream, 1% once daily for 4 weeks. At the end of the 4-week study treatment, qualified subjects will have the o...
Eligibility Criteria
Inclusion
- Male and female subjects age 2 to 17 with a confirmed clinical diagnosis of atopic dermatitis and present for at least 6 months for ages 6-17 years old, 3 months for ages 2-5 years old
- BSA involvement ≥ 25% for subjects ages 12-17 years old, or ≥ 35% for subjects ages 2-11 years old, suitable for topical therapy.
- vIGA-AD score of ≥ 3 at screening and baseline (pre-dose)
- Female subjects of child bearing potential who are engaging in sexual activity that could lead to pregnancy agree to follow the specified contraceptive guidance throughout the study
- Capable of giving written informed consent
- Negative pregnancy test at Baseline (Day 1)
Exclusion
- Immunocompromised at screening
- Chronic or acute systemic or superficial infection requiring treatment with systemic antibacterials or antifungals within one week prior to baseline visit
- Significant dermatological or inflammatory condition other than AD that, in the Investigator's opinion, would make it difficult to interpret data or assessments during the study
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.0x the upper limit of normal (ULN).
- Screening total bilirubin \> 1.5x ULN
- Current or chronic history of liver disease
- Current or history of cancer within 5 years except for adequately treated cutaneous basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix
- Subjects who would not be considered suitable for topical therapy
- Use of any prohibited medication or procedure within the indicated period before the baseline visit including other investigational product within 30 days or 5 half-lives of the investigational product (whichever is longer)
- History of or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the Investigator's opinion, may interfere with the subject's participation in the study, interpretation of results, or ability to understand and give informed consent.
- Pregnant or lactating females
- History of sensitivity to the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the -Investigator or Medical Monitor, contraindicates their participation
- Previous known participation in a clinical study with tapinarof (previously known as GSK2894512 and WBI-1001)
Key Trial Info
Start Date :
November 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2022
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05186805
Start Date
November 15 2021
End Date
August 24 2022
Last Update
September 5 2025
Active Locations (10)
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1
Dermavant Investigative Site
Thousand Oaks, California, United States, 91320
2
Dermavant Investigative Site
Centennial, Colorado, United States, 80112
3
Dermavant Investigative Site
Coral Gables, Florida, United States, 33146
4
Dermavant Investigative Site
Hialeah, Florida, United States, 33016