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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05680740
• Other study ID #: DMVT-505-4001
• Status: Completed
• Phase: Phase 4
• Start date: January 12, 2023
• Est. completion date: May 25, 2023

Study information

• Verified date: September 2023
• Source: Dermavant Sciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 25, 2023
• Est. primary completion date: May 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• VTAMA® (tapinarof) Cream 1%
VTAMA® (tapinarof) Cream 1% applied topically once daily

Locations

Country	Name	City	State
United States	Dermavant Investigative Site	Boca Raton	Florida
United States	Dermavant Investigative Site	Fort Smith	Arkansas
United States	Dermavant Investigative Site	Houston	Texas
United States	Dermavant Investigative Site	Los Angeles	California
United States	Dermavant Investigative Site	Margate	Florida
United States	Dermavant Investigative Site	Plainfield	Indiana
United States	Dermavant Investigative Site	Webster	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Dermavant Sciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants who achieve an intertriginous PGA (iPGA) score of clear (0) or almost clear (1) with a = 2-grade improvement	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.	from Baseline to Week 12
Secondary	Time to achieve an iPGA score of 0 or 1 with a = 2 grade improvement	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.	from Baseline to Week 12