New Delhi: In response to the proposal submitted by Pure and Cure Healthcare, the Subject Expert Committee (SEC) on Dermatology and Allergy, functioning under the Central Drugs Standard Control Organisation (CDSCO), has recommended several revisions to the Phase III clinical trial protocol for Tapinarof Cream 1% w/w.

This came after the firm sought permission to manufacture and market Tapinarof Cream 1% and presented its Phase III clinical trial protocol titled “A Multicenter, Randomized, Double-Blind, Active-Controlled Phase III Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Inflammatory Biomarker Modulation of Tapinarof 1% Cream Compared to Calcipotriol 0.005% Cream for the topical treatment of plaque psoriasis in adult patients” (Protocol ID: VRL-CT-25-041, Version 1.0

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