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NCT05680740
A Study to Investigate Efficacy and Safety of VTAMA (Tapinarof) Cream, 1% in Intertriginous Plaque Psoriasis
Conditions: Psoriasis
Sex: All
Ages: 18 Years – N/A
Phase: PHASE4
Enrollment: 30
Sponsor: Dermavant Sciences, Inc.
Location: United States
Summary
This is an open-label, multi-center study to evaluate the efficacy and safety of VTAMA (tapinarof) cream, 1% in adults with intertriginous psoriasis
Eligibility Criteria
Inclusion Criteria:18 years of age or older, at the time of signing the informed consentParticipants with clinical diagnosis of plaque psoriasis, including lesion(s) in intertriginous area(s) and stable disease in intertriginous areas for at least 3 months prior to the studyAn iPGA score of 2 (mild), 3 (moderate), or 4 (severe) at screening and baselineFemale 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 studyNegative pregnancy test at Baseline (Day 1)Capable of giving written informed consentExclusion Criteria:Diagnosis of a type of psoriasis other than plaque psoriasisAny sign of infection of any of the psoriatic lesionsConcurrent significant dermatologic or inflammatory condition other than plaque psoriasis that, in the Investigator's opinion, would make it difficult to interpret data or assessments during the studyHistory of or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the Investigator's opinion, may interfere with participation in the study and ability to understand and give informed consentHistory of sensitivity to the study product, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates participation in the studyPrevious known participation in a clinical study with tapinarof (previously known as GSK2894512 and WBI-1001); previous or current use of VTAMA® (Tapinarof) Cream 1%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)UV light therapy or prolonged exposure to natural or artificial sources of UV radiation (e.g., phototherapy, tanning beds/booths, or therapeutic sunbathing) within 4 weeks prior to the Baseline
Source: ClinicalTrials.gov (NCT05680740). StuddyBuddy aggregates publicly available trial information.