CompletedPhase 1

A Study Comparing Tapinarof Cream 1% and Vtama® Cream 1% in the Treatment of Plaque Psoriasis.

United States575 participantsStarted 2025-10-13

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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)

Exclusion criteria

✕. 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.

What they're measuring

Demonstration in Therapeutic Equivalence & Safety of the Investigational Product

Timeframe: Baseline to Week 12

Trial details

NCT IDNCT07546214

SponsorSun Pharmaceutical Industries, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-18

View on ClinicalTrials.gov More Plaque Psoriasis trials