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Completed

NCT Number: NCT07546214

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

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.

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Key information

Conditions

Plaque Psoriasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sun Pharmaceutical Industries, Inc.

Hawthorne, New York, 10532, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tapinarof cream, 1%

Drug

The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days.

Other names: Test Product

Vtama® (Tapinarof) Cream, 1%

Drug

The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days.

Other names: Reference Product

Placebo Control

Drug

The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days.

Other names: Vehicle of the test product

Primary outcomes

  1. Demonstration in Therapeutic Equivalence & Safety of the Investigational Product

    Time frame: Baseline to Week 12

    The proportion of subjects in each treatment group with treatment success with a minimum 2-grade improvement.

Sponsors and collaborators

Lead sponsor

Sun Pharmaceutical Industries, Inc.

Industry

Registry information

Official study 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.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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