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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05680740
Recruitment Status : Active, not recruiting
First Posted : January 11, 2023
Last Update Posted : April 14, 2023
Sponsor:
Information provided by (Responsible Party):
Dermavant Sciences, Inc.

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

Condition or disease Intervention/treatment Phase
Psoriasis Drug: VTAMA® (tapinarof) Cream 1% Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 27, 2022
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Tapinarof

Arm Intervention/treatment
Experimental: VTAMA® (tapinarof) Cream 1%
VTAMA® (tapinarof) Cream 1% applied topically once daily
Drug: VTAMA® (tapinarof) Cream 1%
VTAMA® (tapinarof) Cream 1% applied topically once daily
Other Name: DMVT-505




Primary Outcome Measures :
  1. Percentage of participants who achieve an intertriginous PGA (iPGA) score of clear (0) or almost clear (1) with a ≥ 2-grade improvement [ Time Frame: from Baseline to Week 12 ]
    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.


Secondary Outcome Measures :
  1. Time to achieve an iPGA score of 0 or 1 with a ≥ 2 grade improvement [ Time Frame: from Baseline to Week 12 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05680740


Locations
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United States, Arkansas
Dermavant Investigative Site
Fort Smith, Arkansas, United States, 72916
United States, California
Dermavant Investigative Site
Los Angeles, California, United States, 90045
United States, Florida
Dermavant Investigative Site
Boca Raton, Florida, United States, 33431
Dermavant Investigative Site
Margate, Florida, United States, 33063
United States, Indiana
Dermavant Investigative Site
Plainfield, Indiana, United States, 46168
United States, Texas
Dermavant Investigative Site
Houston, Texas, United States, 77004
Dermavant Investigative Site
Webster, Texas, United States, 77598
Sponsors and Collaborators
Dermavant Sciences, Inc.
Investigators
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Study Director: Victoria Butners Dermavant Sciences, Inc.
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Responsible Party: Dermavant Sciences, Inc.
ClinicalTrials.gov Identifier: NCT05680740    
Other Study ID Numbers: DMVT-505-4001
First Posted: January 11, 2023    Key Record Dates
Last Update Posted: April 14, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dermavant Sciences, Inc.:
Tapinarof
Plaque psoriasis
Adult
Phase 4
Topical
Open-label
Efficacy
Safety
Psoriasis
Intertriginous Psoriasis
Inverse Psoriasis
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases