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Topical Agent
A Study to Investigate Efficacy and Safety of VTAMA (Tapinarof) Cream, 1% in Intertriginous Plaque Psoriasis
Phase 4
Waitlist Available
Research Sponsored by Dermavant Sciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to week 12
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial tests a special cream called VTAMA (tapinarof) on adults with a type of psoriasis that affects skin folds. Participants will use the cream once daily for a few months. The cream helps by calming the skin's immune response, reducing redness and scaling. Tapinarof cream, also known as VTAMA, is a newly approved topical agent for treating plaque psoriasis and has shown promising results in clinical trials.
Eligible Conditions
- Psoriasis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to week 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants Who Achieve an Intertriginous PGA (iPGA) Score of Clear (0) or Almost Clear (1) With a ≥ 2-grade Improvement
Secondary study objectives
Time to Achieve an iPGA Score of 0 or 1 With a ≥ 2 Grade Improvement
Side effects data
From 2023 Phase 4 trial • 34 Patients • NCT0568074024%
Folliculitis
9%
Dermatitis contact
6%
Basal cell carcinoma
3%
Pancreatitis acute
3%
Ischaemic stroke
100%
80%
60%
40%
20%
0%
Study treatment Arm
VTAMA® (Tapinarof) Cream 1%
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: VTAMA® (tapinarof) Cream 1%Experimental Treatment1 Intervention
VTAMA® (tapinarof) Cream 1% applied topically once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VTAMA® (tapinarof) Cream 1%
2022
Completed Phase 4
~40
Find a Location
Who is running the clinical trial?
Dermavant Sciences, Inc.Lead Sponsor
8 Previous Clinical Trials
1,754 Total Patients Enrolled
3 Trials studying Psoriasis
171 Patients Enrolled for Psoriasis
Victoria ButnersStudy DirectorDermavant Sciences, Inc.
3 Previous Clinical Trials
1,788 Total Patients Enrolled
3 Trials studying Psoriasis
1,788 Patients Enrolled for Psoriasis