Tapinarof Cream for Plaque Psoriasis
Trial Summary
What is the purpose of this trial?
To compare the safety and efficacy of the test (Tapinarof Cream 1%), placebo (vehicle cream) and reference VTAMA® (Tapinarof Cream 1%) treatments to demonstrate clinical equivalence in patients with plaque psoriasis.
Will I have to stop taking my current medications?
Yes, you will need to stop using certain medications before joining the trial. Specifically, you must stop using topical anti-psoriatic drugs, topical corticosteroids, and immunosuppressive drugs at least two weeks before starting the trial. Additionally, you should not have used systemic steroids, antibiotics, or other systemic treatments for psoriasis within one month before the trial.
What data supports the effectiveness of the drug Tapinarof Cream 1% for treating plaque psoriasis?
Tapinarof Cream 1% has shown promising results in clinical trials, with 35.4% and 40.2% of patients achieving significant improvement compared to 6.0% and 6.3% in the placebo group. Additionally, a high rate of complete disease clearance was observed, with 40.9% of patients achieving clear skin.12345
Is Tapinarof Cream 1% safe for human use?
Tapinarof Cream 1% has been shown to be generally safe in humans, with common side effects including mild to moderate folliculitis (inflammation of hair follicles), contact dermatitis (skin irritation), and headache. These side effects were mostly localized to the application site and led to low discontinuation rates in clinical trials.13467
What makes Tapinarof Cream unique for treating plaque psoriasis?
Tapinarof Cream 1% is unique because it is a non-steroidal topical treatment that works by activating aryl hydrocarbon receptors, which help regulate the immune response and maintain skin balance. It is applied once daily and has shown significant efficacy in clinical trials, with some patients experiencing complete disease clearance and a remittive effect lasting about four months after stopping the treatment.12358
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants apply a thin layer of Tapinarof Cream 1% or placebo once daily to psoriatic affected areas
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Tapinarof Cream 1%
Tapinarof Cream 1% is already approved in United States for the following indications:
- plaque psoriasis in adults
- atopic dermatitis in adults and pediatric patients 2 years of age and older
Find a Clinic Near You
Who Is Running the Clinical Trial?
Teva Pharmaceuticals USA
Lead Sponsor
Dr. Eric A. Hughes
Teva Pharmaceuticals USA
Chief Medical Officer since 2022
MD and PhD from Yale School of Medicine
Richard Francis
Teva Pharmaceuticals USA
Chief Executive Officer since 2023
BSc in Biochemistry from Imperial College London
Teva Pharmaceuticals, Inc.
Industry Sponsor