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

NCT07546214
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Phase
Phase 1
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Recruitment status
Completed
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Participants
575
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Lead sponsor
Sun Pharmaceutical Industries, Inc.
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Start date
2025-10-13
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Number of sites
1
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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.
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Short title
A Study Comparing Tapinarof Cream 1% and Vtama® Cream 1% in the Treatment of Plaque Psoriasis.
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Official 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.
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 1
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Study type
Interventional
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Completion date
2026-03-18
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First posted
2026-04-22
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Registry last updated
2026-04-22
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Primary completion date
2026-03-18
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Start date
2025-10-13
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Actual participants
575
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Participants
575
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Participant count basis
Actual
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Protocol amendments
0
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Number of sites
1
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Sun Pharmaceutical Industries, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07546214
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ClinicalTrials.gov ID
NCT07546214
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Single masking
Masked roles
Investigators
Sources for study design
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  1. Demonstration in Therapeutic Equivalence & Safety of the Investigational Product

    Timeframe: Baseline to Week 12

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

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
Yes

  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)

  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.
Sources for eligibility
clinicaltrials.gov

  • Sun Pharmaceutical Industries, Inc.Hawthorne, United States
Sources for sites
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Targets (1)