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 dated 28 July 2025).
Tapinarof is a therapeutic aryl hydrocarbon receptor-modulating agent (TAMA) indicated for the treatment of adult psoriasis. Tapinarof is a novel, first-in-class, small-molecule AhR agonist that is indicated for the treatment of adult psoriasis. It is available as a topical cream to be applied to the affected area once daily. Tapiranof was first discovered as a metabolite (3,5-dihydroxy-4-isopropylstilbene) produced in Photorhabdus luminescens, a gram-negative bacillus that lives symbiotically with the Heterorhabditis nematodes.
During the SEC meeting held on 08 October 2025, the expert panel reviewed the submission in detail. Following deliberation, the committee made the following observations:
1) Not to include very severe patients of plaque psoriasis and to revise the inclusion criteria accordingly.
2) A washout period should be defined for severe patients who are already on treatment with other drugs, and ethical considerations of the same should be justified.
3) The firm has not mentioned any concomitant medication (like moisturizer).
4) The age of the patients should be revised to 18-60 years.
5) Quantity of application should be defined by fingertip unit (FTU).
Accordingly, the expert panel suggested that the firm should submit the revised protocol for further review by the committee.
