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Clinical Trial Data for Use of Tapinarof in AD


Raj Chovatiya, MD, PhD, and Adelaide A. Hebert, MD, FAAD, review clinical trial data for tapinarof cream, 1% in the treatment of AD.

This is a video synopsis/summary of a panel discussion involving Raj Chovatiya, MD, PhD, and Adelaide A. Hebert, MD, FAAD.

The discussion centers on the recent presentation of data from phase 3 trials of the drug tapinarof cream 1%, focusing on its efficacy in treating moderate to severe atopic dermatitis in adults and children as young as 2 years old. The data was presented at the European Academy of Dermatology and Neurology as a late-breaking abstract.

The drug, identified as an aryl hydrocarbon agonist, has been studied for various inflammatory diseases, emphasizing its therapeutic potential for conditions affecting different body surfaces, such as the lungs, guts, and skin. The discussion highlights the need for rapid-acting treatments for moderate to severe patients, addressing the urgency of improving their conditions.

The medical professional stresses the drawbacks of topical corticosteroids commonly used in treating atopic dermatitis, citing issues like pigmentation, adverse events, and especially concerns about systemic absorption in children. Tapinarof cream 1% is presented as a well-tolerated, non-steroidal alternative with no restrictions on duration, usage, or application sites.

The study's design is briefly outlined, emphasizing the significance of a once-daily application for moderate to severe atopic dermatitis, which reduces the burden on patients and parents. The 2 concomitant studies in the United States involved over 400 patients, aged 2 years and older, with a 2:1 randomization comparing tapinarof to a vehicle formulation. The eight-week study allowed patients to transition to a long-term safety study, contributing to patient retention in the clinical trial.

Primary and secondary endpoints of the study are discussed, with a focus on the validated investigators global assessment for atopic dermatitis. Treatment success is defined by reaching clear or almost clear status with at least a two-grade improvement from baseline by week eight. Key secondary endpoints include a 75% improvement in the Eczema Area and Severity Index (EASI) score and a reduction in itch severity for patients 12 years and older. Safety considerations, including the assessment of treatment-related adverse events, are also highlighted as integral components of the study.

Video synopsis is AI-generated and reviewed by Dermatology Times editorial staff.

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