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Investigational Cream Promising for Atopic Dermatitis

In phase IIb trial, success rates were higher with TRPV1 antagonist than with vehicle cream


MONDAY, Jan. 14, 2019 (Pharmacist's Briefing) -- Topical application of a transient receptor potential vanilloid subfamily, member 1 (TRPV1) antagonist may be an effective and safe treatment for patients with mild-to-moderate atopic dermatitis (AD), according to a phase IIb study published online Jan. 8 in the British Journal of Dermatology.

Y.W. Lee, from Konkuk University School of Medicine in Seoul, South Korea, and colleagues assessed the clinical efficacy and safety of PAC-14028, a TRPV1 antagonist, via topical application in 194 patients with mild-to-moderate AD. Participants were randomly assigned to receive either PAC-14028 cream 0.1 percent, 0.3 percent, or 1 percent or vehicle cream twice daily for eight weeks.

The researchers found that Investigator's Global Assessment (IGA) success rates at week 8 were 14.58 percent for vehicle cream, 42.55 percent for 0.1 percent PAC-14028 cream, 38.3 percent for 0.3 percent PAC-14028 cream, and 57.45 percent for 1 percent PAC-14028 cream. Statistically significant differences were noted between the vehicle and treatment groups in the IGA success rates with two-grade improvement in particular. In addition, there was a trend toward improvement in the Scoring of Atopic Dermatitis index, Eczema Area and Severity Index 75/90, sleep disturbance score, and pruritus visual analogue scale. The researchers reported no significant safety issues.

"PAC-14028 cream is a promising new treatment option for patients with mild-to-moderate AD based on the favorable tolerability profile and the improved efficacy in treating AD observed in the present study," the authors write.

Several authors disclosed financial ties to pharmaceutical and personal care companies, including AmorePacific Corp., which manufactures PAC-14028 and funded the study.

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