Tapinarof for the Treatment of Atopic Dermatitis in Children and Adults

Completed · Phase 3

Conditions studied: Atopic Dermatitis

In brief

This is a double-blind, randomized, vehicle controlled Phase 3 study to evaluate the efficacy and safety of topical tapinarof cream, 1% compared to vehicle control cream in pediatric and adult subjects with atopic dermatitis.

Key facts

Study ID

NCT05014568

Run by

Organon and Co

People needed

407

Starts

2021-09-01

Expected to finish

2023-04-07

Last updated by the study team

2025-09-04

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female subjects ages 2 and above with clinical diagnosis of AD
• Subject with atopic dermatitis covering ≥5% and ≤ 35% of the BSA
• A vIGA-AD score of ≥3 at screening and baseline
• An EASI score of ≥6 at screening and baseline
• Atopic dermatitis present for at least 6 months for ages 6 years old and above or 3 months for ages 2 to 5 years old
• Female subjects of childbearing potential who are engaging in sexual activity that could lead to pregnancy should use acceptable birth control methods
• Must not be pregnant
• Subject, subject's parent, or legal representative must be capable of giving written informed consent/assent

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 — Phoenix, Arizona, United States
• Dermavant Investigative Site — Bryant, Arkansas, United States
• Dermavant Investigative Site — Beverly Hills, California, United States
• Dermavant Investigative Site — Fountain Valley, California, United States
• Dermavant Investigative Site — Fremont, California, United States
• Dermavant Investigative Site — Inglewood, California, United States
• Dermavant Investigative Site — Los Angeles, California, United States
• Dermavant Investigative Site — Los Angeles, California, United States
• Dermavant Investigative Site — Mission Viejo, California, United States
• Dermavant Investigative Site — Sacramento, California, United States
• Dermavant Investigative Site — Washington D.C., District of Columbia, United States
• Dermavant Investigative Site — Boca Raton, Florida, United States
• Dermavant Investigative Site — Boca Raton, Florida, United States
• Dermavant Investigative Site — Brandon, Florida, United States
• Dermavant Investigative Site — Coral Gables, Florida, United States
• Dermavant Investigative Site — Jacksonville, Florida, United States
• Dermavant Investigative Site — Margate, Florida, United States
• Dermavant Investigative Site — Miami, Florida, United States
• Dermavant Investigative Site — Miami Lakes, Florida, United States
• Dermavant Investigative Site — Orlando, Florida, United States
• Dermavant Investigative Site — Pinellas Park, Florida, United States
• Dermavant Investigative Site — Sweetwater, Florida, United States
• Dermavant Investigative Site — Tampa, Florida, United States
• Dermavant Investigative Site — Marietta, Georgia, United States
• Dermavant Investigative Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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