Clinical trial NCT05680740: A Study to Investigate Efficacy and Safety of VTAMA (Tapinarof) Cream, 1% in Intertriginous Plaque Psoriasis
Official title: A Phase 4, Open-label, Study to Investigate the Efficacy and Safety of VTAMA® (Tapinarof) Cream 1% in the Treatment of Plaque Psoriasis in Intertriginous Areas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis
Keywords: Tapinarof
Plaque psoriasis
Adult
Phase 4
Topical
Open-label
Efficacy
Safety
Psoriasis
Intertriginous Psoriasis
Inverse Psoriasis
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2023-01-11
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Who Achieve an Intertriginous PGA (iPGA) Score of Clear (0) or Almost Clear (1) With a ≥ 2-grade Improvement
timeFrame: from Baseline to Week 12
Secondary outcomes:
measure: Time to Achieve an iPGA Score of 0 or 1 With a ≥ 2 Grade Improvement
timeFrame: from Baseline to Week 12
Other outcomes:
Locations:
city: Fort Smith
country: United States
facility: Dermavant Investigative Site
state: Arkansas
city: Los Angeles
country: United States
facility: Dermavant Investigative Site
state: California
city: Boca Raton
country: United States
facility: Dermavant Investigative Site
state: Florida
city: Margate
country: United States
facility: Dermavant Investigative Site
state: Florida
city: Plainfield
country: United States
facility: Dermavant Investigative Site
state: Indiana
city: Houston
country: United States
facility: Dermavant Investigative Site
state: Texas
city: Webster
country: United States
facility: Dermavant Investigative Site
state: Texas
Study officials:
References: