A Study to Investigate Efficacy and Safety of VTAMA (Tapinarof) Cream, 1% in Intertriginous Plaque Psoriasis

Phase 4

Completed

Brief 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

Detailed Description: This is an open-label study in which participants will be assigned to receive VTAMA (tapinarof) cream, 1% once daily for 12 weeks. Study participants will have a follow-up period of 1 week. The study duration will be up to 17 weeks.

Recruitment & Eligibility

Inclusion Criteria

18 years of age or older, at the time of signing the informed consent
Participants 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 study
An iPGA score of 2 (mild), 3 (moderate), or 4 (severe) at screening and baseline
Female 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 study
Negative pregnancy test at Baseline (Day 1)
Capable of giving written informed consent

Exclusion Criteria

Diagnosis of a type of psoriasis other than plaque psoriasis
Any sign of infection of any of the psoriatic lesions
Concurrent 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 study
History 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 consent
History 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 study
Previous 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

Arm && Interventions

Group	Intervention	Description
VTAMA® (tapinarof) Cream 1%	VTAMA® (tapinarof) Cream 1%	VTAMA® (tapinarof) Cream 1% applied topically once daily

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Achieve an Intertriginous PGA (iPGA) Score of Clear (0) or Almost Clear (1) With a ≥ 2-grade Improvement	from Baseline to Week 12	Intertriginous Physician Global Assessment (iPGA) is a clinical tool for assessing the current state/severity of a subject's psoriasis in the intertriginous areas at a given timepoint. It is a static 5-point assessment of plaque qualities on the clinical characteristics of erythema, scaling, and plaque thickness/elevation within the intertriginous areas. The iPGA ranges from 0 to 4, and is calculated as Clear (0), Almost Clear (1), Mild (2), Moderate (3), and Severe (4). Higher iPGA scores represent more severe disease.

Secondary Outcome Measures

Name	Time	Method
Time to Achieve an iPGA Score of 0 or 1 With a ≥ 2 Grade Improvement	from Baseline to Week 12	Intertriginous Physician Global Assessment (iPGA) is a clinical tool for assessing the current state/severity of a subject's psoriasis in the intertriginous areas at a given timepoint. It is a static 5-point assessment of plaque qualities on the clinical characteristics of erythema, scaling, and plaque thickness/elevation within the intertriginous areas. The iPGA ranges from 0 to 4, and is calculated as Clear (0), Almost Clear (1), Mild (2), Moderate (3), and Severe (4). Higher iPGA scores represent more severe disease.