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

NCT07546214 | Completed Phase 1 FDA Drug

• 1 other identifier: TPNC-2412
• Study Type: interventional
• Target: 575
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Tapinarof Cream, 1%

EXPERIMENTAL

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%

Vtama® (Tapinarof) Cream, 1%

ACTIVE COMPARATOR

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%

Placebo Control

PLACEBO COMPARATOR

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

Interventions

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.

Also known as: Test Product

Tapinarof Cream, 1%

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.

Also known as: Reference Product

Vtama® (Tapinarof) Cream, 1%

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.

Also known as: Vehicle of the test product

Placebo Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Sun Pharmaceutical Industries, Inc.: lead

Study Sites (1)

Sun Pharmaceutical Industries, Inc.

Hawthorne, New York, 10532, United States

Location

MeSH Terms

Interventions

tapinarof

Study Officials

• Natalie Yantovskiy

  Sun Pharmaceuticals Industries, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 22, 2026
• Study Start: October 13, 2025
• Primary Completion: March 18, 2026
• Study Completion: March 18, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)