A Study Comparing Tapinarof Cream 1% and Vtama® Cream 1% in the Treatment of Plaque Psoriasis.
Completed · Phase 1 · Has a placebo group
Conditions studied: Plaque Psoriasis
In brief
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.
Key facts
- Study ID
- NCT07546214
- Run by
- Sun Pharmaceutical Industries, Inc.
- People needed
- 575
- Starts
- 2025-10-13
- Expected to finish
- 2026-03-18
- Last updated by the study team
- 2026-04-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy male or non-pregnant female aged ≥ 18 years with a clinical diagnosis of plaque psoriasis.
- Subjects must have provided IRB approved written informed consent.
- 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.
- Subjects must have plaque psoriasis with a Physician's Global Assessment (PGA) score of 2 (mild), 3 (moderate), or 4 (severe)
You may not qualify if…
- Female Subjects who are pregnant, nursing, or planning to become pregnant during study participation.
- Subjects with a known hypersensitivity to tapinarof or to any ingredients in the study drugs.
- Subjects with a current diagnosis of drug-induced psoriasis or unstable forms of psoriasis, including guttate, erythrodermic, exfoliative, or pustular psoriasis.
- Subjects with spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis as determined by the investigator.
Where it is running
- Sun Pharmaceutical Industries, Inc. — Hawthorne, New York, United States
Full record on ClinicalTrials.gov
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