Tapinarof for the Treatment of Atopic Dermatitis in Children and Adults

Inclusion Criteria:

• 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 3months for ages 2 to 5 years old

• Female subjects of childbearing potential who are engaging in sexual activity thatcould 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 writteninformed consent/assent

Exclusion Criteria:

• Immunocompromised at screening

• Chronic or acute systemic or superficial infection requiring treatment with systemicantibacterials or antifungals within one week prior to baseline visit

• Significant dermatological or inflammatory condition other than AD that, in theInvestigator's opinion, would make it difficult to interpret data or assessmentsduring the study

• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.0x the upperlimit 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 cutaneousbasal 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 thebaseline visit including other investigational product within 30 days or 5half-lives of the investigational product (whichever is longer)

• History of or ongoing serious illness or medical, physical, or psychiatriccondition(s) that, in the Investigator's opinion, may interfere with the subject'sparticipation in the study, interpretation of results, or ability to understand andgive informed consent.

• Pregnant or lactating females

• History of sensitivity to the study medications, or components thereof or a historyof drug or other allergy that, in the opinion of the Investigator or MedicalMonitor, contraindicates their participation

• Previous known participation in a clinical study with tapinarof (previously known asGSK2894512 and WBI-1001)