Loading clinical trials...

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

COMPLETEDPHASE4

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

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

NCT05680740•Organon and Co

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (7)

Dermavant Investigative Site

Fort Smith, Arkansas, United States

Dermavant Investigative Site

Los Angeles, California, United States

Dermavant Investigative Site

Boca Raton, Florida, United States

Dermavant Investigative Site

Margate, Florida, United States

Dermavant Investigative Site

Plainfield, Indiana, United States

Dermavant Investigative Site

Houston, Texas, United States

Dermavant Investigative Site

Webster, Texas, United States

Key Dates

Start Date

December 27, 2022

Primary Completion Date

May 18, 2023

Completion Date

May 25, 2023

Last Updated

June 12, 2025

Enrollment

ACTUAL participants

Conditions

Psoriasis

Interventions

VTAMA® (tapinarof) Cream 1%

DRUG

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

NCT07449234

Psoriasis

View study

RECRUITINGPHASE3

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967

Plaque Psoriasis

View study

RECRUITINGPHASE3

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

NCT07250802

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments