A Study to Investigate Efficacy and Safety of VTAMA (Tapinarof) Cream, 1% in Intertriginous Plaque Psoriasis
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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
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Condition or disease | Intervention/treatment | Phase |
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Psoriasis | Drug: VTAMA® (tapinarof) Cream 1% | Phase 4 |
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 |

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

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

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
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 |
Study Director: | Victoria Butners | Dermavant Sciences, Inc. |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Tapinarof Plaque psoriasis Adult Phase 4 Topical Open-label |
Efficacy Safety Psoriasis Intertriginous Psoriasis Inverse Psoriasis |
Psoriasis Skin Diseases, Papulosquamous Skin Diseases |