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Tapinarof cream safe, effective for plaque psoriasis in intertriginous areas
Vtama (tapinarof) cream is efficacious, safe, and well tolerated for the treatment of plaque psoriasis in sensitive intertriginous areas, according to a study presented at the annual Fall Clinical Dermatology Conference, held from Oct. 19 to 22 in Las Vegas.
In a phase 4 clinical trial, Howard Sofen, M.D., of Dermatology Research Associates in Los Angeles, and colleagues evaluated tapinarof cream, 1 percent, for the once-daily treatment of intertriginous plaque psoriasis among 34 adults.
The researchers found that 82.8 percent of participants achieved an intertriginous Physician Global Assessment (iPGA) score of 0 (clear) or 1 (almost clear) and ≥2-grade improvement from baseline at week 12, the primary end point of the study. Two-thirds of participants (65.5 percent) achieved complete disease clearance (iPGA score of 0) at week 12, with a median time to complete disease clearance of eight weeks. Rapid onset of efficacy was seen with iPGA as early as week 2 and with a median time to iPGA success of six weeks, the secondary end point of the study. By week 4, half of patients achieved itch relief (a clinically meaningful ≥4-point improvement in Peak Pruritus-Numeric Rating Scale score), which increased to 75 percent at week 12. No new safety signals were detected, and the most common adverse reactions included folliculitis, nasopharyngitis, contact dermatitis, headache, pruritus, and influenza.
"The results of this phase 4 study are meaningful because patients that entered this study had suffered with extensive disease, many over 10 years duration. While the rates of disease clearance are impressive, the fast onset of Vtama cream and associated itch relief are particularly noteworthy," Sofen said in a statement. "These data, combined with those of previous studies, further indicate that Vtama cream is a safe and effective treatment for adult patients with intertriginous plaque psoriasis."
The study was funded by Dermavant, the manufacturer of tapinarof.
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