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

Conditions

• Plaque Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

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.
• 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.
• 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.

Study Details

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 Dates

Start date

Oct 13, 2025

Status verified

Apr 2026

Primary completion

Mar 18, 2026

Completion

Mar 18, 2026

Study Design

Enrollment

575 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.
• 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.
• 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.

Primary Outcome Measure

Demonstration in Therapeutic Equivalence & Safety of the Investigational Product [ Time Frame: Baseline to Week 12 ]

Locations (1)

Find similar trials in Hawthorne, NY

Related Studies

• A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe Plaque Psoriasis
  PHASE3 · Recruiting · Bristol-Myers Squibb · Birmingham, Alabama
• Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)
  PHASE3 · Recruiting · Bristol-Myers Squibb · Birmingham, Alabama
• Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
  PHASE2 · Recruiting · Oruka Therapeutics, Inc. · Phoenix, Arizona
• An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis
  PHASE2 · Recruiting · Oruka Therapeutics, Inc. · Fountain Valley, California