Betamethasone vs. Tapinarof for Psoriasis
Trial Summary
What is the purpose of this trial?
The purpose of this prospective study is to evaluate the degree of post-inflammatory pigmentation alteration on legs of study subjects treated with two different psoriasis treatments. Betamethasone dipropionate 0.05% cream is a high potency steroid that is commonly used to alleviate the inflammation of psoriasis. Tapinarof is another medication approved for psoriasis; tapinarof activates aryl hydrocarbon receptors to downregulate inflammatory cytokines (such as interleukin \[IL\]-17) which play a large role in psoriasis. Study subjects will be randomized to receive one of these medications and will be followed to monitor for PIPA. Photographs will be taken to help evaluate visual changes. The Taylor Hyperpigmentation scale will be used to grade the area and severity of hyperpigmentation and hypopigmentation; severity of erythema, burning, peeling, and dryness will also be recorded. This will allow us to understand the effects of two standard-of-care psoriasis medications to better treat patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it requires that you have been stable on other therapies, like biologics, for at least 3 months before joining.
What data supports the effectiveness of the drug Tapinarof for treating psoriasis?
Tapinarof cream 1% has shown promising results in treating plaque psoriasis, with 35.4% and 40.2% of patients achieving primary efficacy endpoints in clinical trials, compared to only 6.0% and 6.3% in the control group. Additionally, a high rate of complete disease clearance was observed, with 40.9% of patients achieving clear skin, and improvements exceeding treatment goals set by the National Psoriasis Foundation.12345
Is Tapinarof cream safe for treating psoriasis?
Tapinarof cream has been shown to be generally safe for treating psoriasis, with common side effects including mild to moderate folliculitis (inflammation of hair follicles), contact dermatitis (skin irritation), and headache. These side effects were mostly mild and localized to the application site.23456
How does the drug Tapinarof differ from other psoriasis treatments?
Tapinarof is unique because it is a novel topical drug that works by activating aryl hydrocarbon receptors, which help regulate the immune response and maintain skin balance. Unlike traditional treatments like corticosteroids, Tapinarof offers a new mechanism of action and has shown promising results in clinical trials for plaque psoriasis.12346
Research Team
Steven Feldman, MD, PhD
Principal Investigator
Wake Forest University Health Sciences
Eligibility Criteria
This trial is for adults over 18 with a certain skin type (Fitzpatrick skin type 3 or higher) who have been diagnosed with psoriasis. They must be stable on other treatments like biologics for at least three months before the study starts. People without this diagnosis or those with pigmentary changes that could affect outcome assessment cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to receive either betamethasone dipropionate 0.05% cream or 1% tapinarof cream applied once daily to both legs until clear or up to 12 weeks
Follow-up
Participants are monitored for PIPA and other after-treatment effects
Treatment Details
Interventions
- Betamethasone dipropionate 0.05% cream
- Tapinarof
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor
Dermavant Sciences, Inc.
Industry Sponsor