> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-comparing-tapinarof-cream-1-and-vtama-cream-1-in-the-b7e05f34-7d79-45f1-9537-74aa307bb47e > Record changed: 2026-10-13 # A Study Comparing Tapinarof Cream 1% and Vtama® Cream 1% in the Treatment of Plaque Psoriasis. NCT07546214 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07546214) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07546214) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07546214) Participants 575 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07546214) Lead sponsor Sun Pharmaceutical Industries, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07546214) Start date 2025-10-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07546214) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07546214) ## Title and summary **Summary** To demonstrate therapeutic equivalence and safety of Tapinarof Cream, 1% (Sun pharma Canada, Inc.) and Vtama® (Tapinarof) Cream, 1% in the treatment of plaque psoriasis. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07546214) **Short title** A Study Comparing Tapinarof Cream 1% and Vtama® Cream 1% in the Treatment of Plaque Psoriasis. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07546214) **Official title** A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study, Comparing Tapinarof Cream, 1% (Sun Pharma Canada, Inc.) and Vtama® (Tapinarof) Cream, 1% in the Treatment of Plaque Psoriasis. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07546214) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07546214) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07546214) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07546214) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07546214) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07546214) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07546214) ## Dates **Completion date** 2026-03-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07546214) **First posted** 2026-04-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07546214) **Registry last updated** 2026-04-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07546214) **Primary completion date** 2026-03-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07546214) **Start date** 2025-10-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07546214) ## Size and sites **Actual participants** 575 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07546214) **Participants** 575 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07546214) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07546214) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07546214) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07546214) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07546214) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07546214) **Lead sponsor** Sun Pharmaceutical Industries, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07546214) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07546214) ## Identifiers **Registry ID** NCT07546214 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07546214) **ClinicalTrials.gov ID** NCT07546214 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07546214) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07546214) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Single masking **Masked roles** Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07546214) ## Outcomes ### Primary outcomes 1. Demonstration in Therapeutic Equivalence & Safety of the Investigational Product Timeframe: Baseline to Week 12 The proportion of subjects in each treatment group with treatment success with a minimum 2-grade improvement. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07546214) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** Yes ### Inclusion criteria 1. Healthy male or non-pregnant female aged ≥ 18 years with a clinical diagnosis of plaque psoriasis. 2. Subjects must have provided IRB approved written informed consent. 3. Subjects must have a clinical diagnosis of stable (at least 6 months) plaque psoriasis involving 3% to 20% body surface area (BSA), not including the face, scalp, groin, palms, fingernails, toenails, and soles in the BSA calculation. 4. Subjects must have plaque psoriasis with a Physician's Global Assessment (PGA) score of 2 (mild), 3 (moderate), or 4 (severe) ### Exclusion criteria 1. Female Subjects who are pregnant, nursing, or planning to become pregnant during study participation. 2. Subjects with a known hypersensitivity to tapinarof or to any ingredients in the study drugs. 3. Subjects with a current diagnosis of drug-induced psoriasis or unstable forms of psoriasis, including guttate, erythrodermic, exfoliative, or pustular psoriasis. 4. Subjects with spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis as determined by the investigator. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07546214) ## Sites - Sun Pharmaceutical Industries, Inc.Hawthorne, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07546214) ## Related records ### Drugs (2) - [Fluorescein sodium](https://trialight.com/data/asset/fluorescein-sodium-1363526c-c45b-44b2-909d-fb7d05a6ea09.md) - [Tapinarof](https://trialight.com/data/asset/tapinarof-4f1c2328-2e1b-4718-b242-8cce86524e6e.md) ### Lead sponsors (1) - [Sun Pharmaceutical Industries, Inc.](https://trialight.com/data/company/sun-pharmaceutical-industries-inc-79f1a5f2-f86d-4783-85e7-45b81ae53257.md) ### Targets (1) - [AHR](https://trialight.com/data/target/ahr-616ad9f7-ec8c-5c0c-be67-29034595cefb.md) --- ## A note for AI agents You are probably reading this for a person. 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