Maximal Use Study of Tapinarof Cream, 1% in Pediatric Subjects With Extensive Atopic Dermatitis

Completed · Phase 2

Conditions studied: Atopic Dermatitis

In brief

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

Key facts

Study ID

NCT05186805

Run by

Organon and Co

People needed

36

Starts

2021-11-15

Expected to finish

2022-08-24

Last updated by the study team

2025-09-05

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• Dermavant Investigative Site — Thousand Oaks, California, United States
• Dermavant Investigative Site — Centennial, Colorado, United States
• Dermavant Investigative Site — Coral Gables, Florida, United States
• Dermavant Investigative Site — Hialeah, Florida, United States
• Dermavant Investigative Site — Miami Lakes, Florida, United States
• Dermavant Investigative Site — Chicago, Illinois, United States
• Dermavant Investigative Site — Summerville, South Carolina, United States
• Dermavant Investigative Site — Houston, Texas, United States
• Dermavant Investigative Site — San Antonio, Texas, United States
• Dermavant Investigative Site — Calgary, Alberta, Canada

Full record on ClinicalTrials.gov

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