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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05680740
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Dermavant Sciences, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Victoria Butners
Principal Investigator Affiliation Dermavant Sciences, Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Additional Details

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.

Arms & Interventions

Arms

Experimental: VTAMA® (tapinarof) Cream 1%

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

Interventions

Drug: - VTAMA® (tapinarof) Cream 1%

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Dermavant Investigative Site, Fort Smith, Arkansas

Status

Not yet recruiting

Address

Dermavant Investigative Site

Fort Smith, Arkansas, 72916

Site Contact

Dermavant Clinical Trials

dermavantclinicaltrials@dermavant.com

480-666-0844

Dermavant Investigative Site, Los Angeles, California

Status

Not yet recruiting

Address

Dermavant Investigative Site

Los Angeles, California, 90045

Site Contact

Dermavant Clinical Trials

dermavantclinicaltrials@dermavant.com

480-666-0844

Dermavant Investigative Site, Boca Raton, Florida

Status

Not yet recruiting

Address

Dermavant Investigative Site

Boca Raton, Florida, 33431

Site Contact

Dermavant Clinical Trials

dermavantclinicaltrials@dermavant.com

480-666-0844

Dermavant Investigative Site, Margate, Florida

Status

Not yet recruiting

Address

Dermavant Investigative Site

Margate, Florida, 33063

Site Contact

Dermavant Clinical Trials

dermavantclinicaltrials@dermavant.com

480-666-0844

Dermavant Investigative Site, Plainfield, Indiana

Status

Not yet recruiting

Address

Dermavant Investigative Site

Plainfield, Indiana, 46168

Site Contact

Dermavant Clinical Trials

dermavantclinicaltrials@dermavant.com

480-666-0844

Dermavant Investigative Site, Houston, Texas

Status

Not yet recruiting

Address

Dermavant Investigative Site

Houston, Texas, 77004

Site Contact

Dermavant Clinical Trials

dermavantclinicaltrials@dermavant.com

480-666-0844

Dermavant Investigative Site, Webster, Texas

Status

Recruiting

Address

Dermavant Investigative Site

Webster, Texas, 77598

Site Contact

Dermavant Clinical Trials

dermavantclinicaltrials@dermavant.com

480-666-0844

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