What Is Tapinarof?
Tapinarof is an FDA-approved medication for plaque psoriasis. It is a topical aryl hydrocarbon receptor (AhR) agonist. This means it works by activating the AhR pathway in the skin, which helps to reduce inflammation and normalize skin cell growth. By modulating these pathways, tapinarof aims to alleviate symptoms associated with inflammatory skin conditions.
While approved for plaque psoriasis, tapinarof is also being investigated in clinical trials for other inflammatory skin conditions. These include atopic dermatitis, other forms of psoriasis, palmoplantar keratoderma, and cutaneous lupus erythematosus. The drug is primarily studied as a topical cream applied directly to affected skin areas.
Uses and Conditions Under Study
Tapinarof is being studied for its potential to treat several inflammatory skin conditions, with a focus on its anti-inflammatory properties.
- Psoriasis: Tapinarof is extensively studied for various forms of psoriasis, including plaque psoriasis (6 trials), general psoriasis (4 trials), plaque type psoriasis (1 trial), and psoriasis identified by ICD10 Code L40.9 (1 trial). Psoriasis is a chronic autoimmune condition that causes rapid skin cell buildup, leading to thick, red, scaly patches. Tapinarof's mechanism as an AhR agonist helps to reduce the inflammation and abnormal cell growth characteristic of psoriasis. A specific form, palmoplantar keratoderma (1 trial), which affects the palms and soles, is also under investigation, with the aim to improve quality of life by stopping disease advancement. In total, 13 trials are exploring tapinarof for psoriasis-related conditions.
- Atopic Dermatitis: This chronic inflammatory skin condition, commonly known as eczema, causes dry, itchy, and inflamed skin. Tapinarof is being evaluated in 6 trials for atopic dermatitis. Its ability to modulate immune responses and reduce inflammation may offer relief for patients experiencing the symptoms of eczema.
- Cutaneous Lupus Erythematosus: This condition involves lupus affecting the skin, leading to rashes and lesions. Tapinarof is being investigated in 1 trial for cutaneous lupus erythematosus. Researchers hypothesize that its topical application could inhibit lupus-causing T cells, potentially leading to an improvement in skin lesions.
Dosing
Tapinarof is primarily studied as a topical cream for application to the skin. The most common strength investigated is 1% tapinarof cream, often referred to by its brand name, Vtama®.
In clinical trials, tapinarof cream is typically applied topically to the affected areas of the skin. The usual dosing regimen involves applying a thin layer of the cream once daily. For example, some studies specify application to lesions once daily, while others mention self-application to affected areas of the face once daily in the evening for a set period, such as 84 consecutive days. This once-daily application aims to deliver the medication directly to the site of inflammation and abnormal skin cell activity.
Side Effects
The provided clinical trial data does not contain specific adverse event frequencies for Tapinarof with placebo comparisons, which are necessary to report side effects as percentages. Therefore, a detailed list of common side effects and their rates cannot be presented here.
Clinical Trial Results
Plaque Psoriasis
Two pivotal studies, NCT03956355 and NCT03983980, evaluated Tapinarof cream for plaque psoriasis over 12 weeks.
In the first study (NCT03956355), 35.4% of patients treated with Tapinarof achieved a Physician Global Assessment (PGA) score of clear or almost clear with at least a 2-grade improvement, compared to 6.0% of patients using a vehicle cream. Additionally, 36.1% of patients on Tapinarof saw a 75% or greater improvement in their Psoriasis Area and Severity Index (PASI 75) score, compared to 10.2% on vehicle. The average affected body surface area (%BSA)
Currently Recruiting Trials
Clinical trials are currently investigating Tapinarof for several conditions, exploring its potential benefits for patients. These studies aim to understand how safe and effective Tapinarof is across different age groups and skin conditions. One ongoing global Phase 3 study, NCT07265479, is evaluating Tapinarof cream, 1% for atopic dermatitis in very young participants. This study is recruiting approximately 180 children aged 3 months to 23 months (inclusive) to assess the safety and efficacy of the cream for this common skin condition. Another trial, NCT06561321, to evaluate the safety and efficacy of Tapinarof in adults with palmoplantar keratoderma, a condition causing thickening of the skin on the palms and soles. This study is recruiting 6 adults. Additionally, Wake Forest University Health Sciences is conducting a Phase 2/Phase 3 study, NCT05981118, comparing Tapinarof with betamethasone dipropionate 0.05% cream for post-inflammatory pigment alteration after psoriasis treatment. This study seeks to enroll 40 participants to evaluate pigmentation changes on the legs following treatment.Where to Participate
Clinical trials for Tapinarof are actively recruiting across a wide geographic area, offering opportunities for participation in many locations. Currently, there are 39 study sites located in 38 cities across 24 states. Some of the top locations with recruiting sites include:- Indianapolis, Indiana (2 sites)
- Portland, Oregon (2 sites)
- Los Angeles, California (1 site)
- Sacramento, California (1 site)
- San Diego, California (1 site)
- Thousand Oaks, California (1 site)
- Castle Rock, Colorado (1 site)
- Boca Raton, Florida (1 site)
- Jacksonville, Florida (1 site)
- Wellington, Florida (1 site)