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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-27

Study Completion Date

2023-05-25

Brief Summary

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

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Detailed Description

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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.

Conditions

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Psoriasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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VTAMA® (tapinarof) Cream 1%

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

Group Type EXPERIMENTAL

VTAMA® (tapinarof) Cream 1%

Intervention Type DRUG

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

Interventions

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VTAMA® (tapinarof) Cream 1%

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

Intervention Type DRUG

Other Intervention Names

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DMVT-505

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No