Plaque PsoriasisPhase 1NCT07546214
A Study Comparing Tapinarof Cream 1% and Vtama® Cream 1% in the Treatment of Plaque Psoriasis.
A Phase 1 study testing Tapinarof Cream, 1% and Vtama® (Tapinarof) Cream, 1% in people with Plaque Psoriasis, run by Sun Pharmaceutical Industries, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Tapinarof Cream, 1% and Vtama® (Tapinarof) Cream, 1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 575 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2025to 18 Mar 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sun Pharmaceutical Industries, Inc.
Hawthorne, New York, 10532
About this study
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.
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.
Read the 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.
- Conditions
- Plaque Psoriasis
- Being tested
- Tapinarof Cream, 1%, Vtama® (Tapinarof) Cream, 1%, Placebo Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tapinarof Cream, 1%Drug
Also called Test Product
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
Also called Reference Product
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 ControlDrug
Also called Vehicle of the test product
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start13 Oct 2025
- Primary completion18 Mar 2026
- Study completion18 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 575 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Natalie Yantovskiy, Study director, Sun Pharmaceuticals Industries, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07546214
- Sponsor's protocol ID
- TPNC-2412
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07546214
- Acronym / sponsor ID
- TPNC-2412
- Conditions
- Plaque Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 575 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- 18 Mar 2026 (actual)
- Study completion
- 18 Mar 2026 (actual)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tapinarof Cream, 1% | Experimental | 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. |
| Vtama® (Tapinarof) Cream, 1% | Active comparator | 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. |
| Placebo Control | Placebo comparator | Drug: Placebo ControlThe investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tapinarof Cream, 1%Also: Test ProductThe 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%Also: Reference ProductThe 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 ControlAlso: Vehicle of the test productThe 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 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalie Yantovskiy study director
Sun Pharmaceuticals Industries, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tapinarof Cream, 1% and Vtama® (Tapinarof) Cream, 1% in people with Plaque Psoriasis, run by Sun Pharmaceutical Industries, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstration in Therapeutic Equivalence & Safety of the Investigational Product (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.