NCT05014568.
| Study characteristics | |
| Methods | Trial design: randomised, double‐blind study Trial registration number: NCT05014568 Country: US and Canada Outpatient or hospital: not reported Date trial conducted: from 2021 Duration of trial participation: 8 weeks Inclusion criteria: · Male or female aged 2 and above with AD · AD ≥ 5% and ≤ 35% of the BSA · vIGA‐AD score of ≥ 3 · An EASI score of ≥ 6 at screening and baseline · AD present for at least 6 months for ages 6 years old and above or 3 months for ages 2 to 5 years old · Female of childbearing potential who are engaging in sexual activity that could lead to pregnancy should use acceptable birth control methods and must not be pregnant. Exclusion criteria: · Immunocompromised · Chronic or acute systemic or superficial infection requiring treatment with systemic antibacterials or antifungals · Laboratory values outside defined criteria · Current or chronic history of liver disease OR of cancer within 5 years except for adequately treated cutaneous basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix · History of or ongoing serious illness or medical, physical, or psychiatric condition(s) that may interfere with the subject's participation in the study · Pregnant or lactating females · History of sensitivity to the study medications, or a history of drug or other allergy · Previous known participation in a clinical study with tapinarof Additional design details: none |
| Participants | Total number randomised: 407 Number of withdrawals: not reported Notes: none |
| Interventions | Run‐in details: 30‐day screening period ‐ no details on what this entailed Intervention: tapinarof 1% cream used once daily for 56 days · Concurrent treatment: not reported · Other key information: none Comparator: vehicle cream used once daily for 56 days · Concurrent treatment: not reported · Other key information: none Concurrent treatments received alongside both intervention and comparator: not reported Notes: none |
| Outcomes | · IGA · EASI · BSA · Pruritus score |
| Notes | Funding source: Dermavant Sciences GmbH Declarations of interest: not declared Original language of publication: English Other: none |