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

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.

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.

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: Tapinarof Cream, 1%; Drug: Vtama® (Tapinarof) Cream, 1%; Drug: Placebo Control

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 575
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Hawthorne, New York, United States, 10532
      • Sun Pharmaceutical Industries, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tapinarof Cream, 1%; The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days.	Drug: Tapinarof Cream, 1%; 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
Active Comparator: Vtama® (Tapinarof) Cream, 1%; The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days.	Drug: Vtama® (Tapinarof) Cream, 1%; 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 Comparator: Placebo Control; The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days.	Drug: Placebo Control; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demonstration in Therapeutic Equivalence & Safety of the Investigational Product	The proportion of subjects in each treatment group with treatment success with a minimum 2-grade improvement.	Baseline to Week 12

Collaborators and Investigators

• Sponsor: Sun Pharmaceutical Industries, Inc.
• Investigators: Study Director: Natalie Yantovskiy, Sun Pharmaceuticals Industries, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2025
• Primary Completion (Actual): March 18, 2026
• Study Completion (Actual): March 18, 2026

Study Registration Dates

• First Submitted: April 15, 2026
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: tapinarof
• Other Study ID Numbers: TPNC-2412

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes