Individuals aged 2 years and older with a clinical diagnosis of atopic dermatitis (AD), may qualify to participate. Must have moderate to severe disease, with AD covering 5 – 35% body surface area (excluding the scalp). AD present for at least 6 months for ages 6 years old and above or 3 months for ages 2 to 5 years old, is also required.
Participants will receive investigational topical medication (active study drug) or placebo, via a cream. Study medication and study-related procedures will be provided at no cost. Reimbursement for study-related expenses may be provided.
Study participation will last about 13 weeks and involve about 7 visits to the study centre, plus 2 phone visits.
The following information is from ClinicalTrials.gov
Last Update Posted: October 02, 2022
Dermavant Sciences GmbH
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.
Condition or Disease:
Intervention/Treatment:Drug: tapinarof cream, 1%
Ages Eligible for Study:
2 Years and older (Child)
Sexes Eligible for Study:
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
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)
Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.