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

NCT05680740 | Completed Phase 4 Results FDA Drug

• 1 other identifier: DMVT-505-4001
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 7

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

Conditions

Psoriasis

Keywords

Tapinarof; Plaque psoriasis; Adult; Phase 4; Topical; Open-label; Efficacy; Safety; Psoriasis; Intertriginous Psoriasis; Inverse Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Time to Achieve an iPGA Score of 0 or 1 With a ≥ 2 Grade Improvement

  from Baseline to Week 12

Study Arms (1)

VTAMA® (tapinarof) Cream 1%

EXPERIMENTAL

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

Drug: VTAMA® (tapinarof) Cream 1%

Interventions

VTAMA® (tapinarof) Cream 1% DRUG

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

Also known as: DMVT-505

VTAMA® (tapinarof) Cream 1%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

Study Sites (7)

Dermavant Investigative Site

Fort Smith, Arkansas, 72916, United States

Location

Dermavant Investigative Site

Los Angeles, California, 90045, United States

Location

Dermavant Investigative Site

Boca Raton, Florida, 33431, United States

Location

Dermavant Investigative Site

Margate, Florida, 33063, United States

Location

Dermavant Investigative Site

Plainfield, Indiana, 46168, United States

Location

Dermavant Investigative Site

Houston, Texas, 77004, United States

Location

Dermavant Investigative Site

Webster, Texas, 77598, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

tapinarof

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Clinical Lead, Late-Stage Clinical Development
• Organization: Organon and Co

pdrl@organon.com

551-430-6000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2022
• First Posted: January 11, 2023
• Study Start: December 27, 2022
• Primary Completion: May 18, 2023
• Study Completion: May 25, 2023
• Last Updated: June 12, 2025
• Results First Posted: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)