A Study to Investigate Efficacy and Safety of VTAMA® (Tapinarof) Cream, 1% in Plaque Psoriasis in the Head and Neck Region

NCT05789576 | Completed Phase 4 Results FDA Drug

• 1 other identifier: DMVT-505-4002
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 10

Brief Summary

This is an open-label, multi-center study to evaluate the efficacy and safety of VTAMA (tapinarof) cream, 1% in adults with plaque psoriasis occurring in the head and neck region

Conditions

Psoriasis

Keywords

Tapinarof; Plaque Psoriasis; Scalp Psoriasis; Psoriasis; Phase 4; Topical; Open-label; Efficacy; Safety; Adult; Face Psoriasis; Neck Psoriasis; Psoriatic conditions

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieve a Target Lesion Physician Global Assessment (PGA) Score in the Head and Neck Region of Clear (0) or Almost Clear (1) With a ≥ 2-grade Improvement

  Physician Global Assessment (PGA) is a clinical tool for assessing the current state/severity of a participant's psoriasis in a target lesion of the head and neck region 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 head and neck region. The PGA ranges from 0 to 4, and is assessed as Clear (0), Almost Clear (1), Mild (2), Moderate (3), and Severe (4). Higher PGA scores represent more severe disease.

  from Baseline to Week 12

Secondary Outcomes (1)

• Time to Achieve a Target Lesion PGA Score of Clear (0) or Almost Clear (1) With a ≥ 2-grade Improvement

  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 the head and neck region and stable disease in the head and neck region for at least 3 months prior to the study
• Participant has a plaque psoriasis lesion in the head and neck region that is suitable for evaluation as the target lesion and has a PGA (target lesion) 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 (10)

Dermavant Investigative Site

Macon, Georgia, 31217, United States

Location

Dermavant Investigative Site

Chicago, Illinois, 60602, United States

Location

Dermavant Investigative Sites

Rockville, Maryland, 20850, United States

Location

Dermavant Investigative Site

Auburn Hills, Michigan, 48326, United States

Location

Dermavant Investigative Site

Detroit, Michigan, 48202, United States

Location

Dermavant Investigative Site

Las Vegas, Nevada, 89144, United States

Location

Dermavant Investigative Site

Portsmouth, New Hampshire, 03801, United States

Location

Dermavant Investigative Site

Kew Gardens, New York, 11415, United States

Location

Dermavant Investigative Site

Marion, Ohio, 43302, United States

Location

Dermavant Investigative Site

Arlington, Texas, 76014, 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: March 14, 2023
• First Posted: March 29, 2023
• Study Start: March 13, 2023
• Primary Completion: June 30, 2023
• Study Completion: July 19, 2023
• Last Updated: June 12, 2025
• Results First Posted: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)