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Topical Therapy
Tapinarof Cream for Plaque Psoriasis
Phase 3
Recruiting
Research Sponsored by Teva Pharmaceuticals USA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Males and non-pregnant, non-lactating females aged ≥18 at the time of signing the informed consent
A Physician's Global Assessment (PGA) score of 2 (mild), 3 (moderate) or 4 (severe) at screening and baseline
Must not have
Current diagnosis of unstable forms of psoriasis (other than plaque variant) in the treatment area, including guttate, erythrodermic, exfoliative or pustular psoriasis
Females who are pregnant, breast feeding, or who wish to become pregnant during the study period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Pivotal Trial
Summary
This trial aims to see if a new cream called Tapinarof Cream 1% is as safe and effective as a reference cream called VTAMA® and a placebo cream in treating plaque psoriasis.
Who is the study for?
This trial is for individuals with plaque psoriasis. Specific eligibility details are not provided, but typically participants must have a certain severity of psoriasis and be in good general health.
What is being tested?
The study is testing the effectiveness and safety of Tapinarof Cream 1% against VTAMA® (also Tapinarof Cream 1%) and a placebo cream to see if they are clinically equivalent in treating plaque psoriasis.
What are the potential side effects?
While specific side effects aren't listed, topical treatments like Tapinarof may cause skin irritation, redness, itching or burning at the application site. Systemic side effects are less common.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am an adult over 18 and if female, not pregnant or breastfeeding.
Select...
My doctor rates my condition as mild, moderate, or severe.
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I am not pregnant or breastfeeding, confirmed by a sensitive pregnancy test.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have unstable psoriasis types like guttate or pustular in the treatment area.
Select...
I am not pregnant, breastfeeding, nor planning to become pregnant during the study.
Select...
I haven't had chemotherapy, radiation, or cancer drugs in the last 3 months.
Select...
I am unable or unwilling to give informed consent.
Select...
I am currently on immunosuppressive therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Primary Endpoint
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Test: Tapinarof Cream 1%Experimental Treatment1 Intervention
Tapinarof Cream 1%, Apply a thin layer once daily to psoriatic affected areas for 84 days.
Group II: VTAMA®Active Control1 Intervention
(Tapinarof) Cream 1%, Apply a thin layer once daily to psoriatic affected areas for 84 days.
Group III: Vehicle ProductPlacebo Group1 Intervention
Vehicle of the Test Product, Cream, Apply a thin layer once daily to psoriatic affected areas for 84 days.
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Who is running the clinical trial?
Teva Pharmaceuticals USALead Sponsor
231 Previous Clinical Trials
188,208 Total Patients Enrolled
Teva Pharmaceuticals, Inc.Industry Sponsor
1 Previous Clinical Trials
807 Total Patients Enrolled