Plaque Type PsorisisPhase 3NCT06742957
Study Comparing Tapinarof Cream 1% To VTAMA ® (Tapinarof Cream 1%) In the Treatment of Plaque Psoriasis
A Phase 3 study testing Tapinarof Cream 1% and VTAMA® in people with Plaque Type Psorisis, run by Teva Pharmaceuticals USA at 26 sites in United States.
Trial summary
To compare the safety and efficacy of the test (Tapinarof Cream 1%), placebo (vehicle cream) and reference VTAMA® (Tapinarof Cream 1%) treatments to demonstrate clinical equivalence in patients with 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 Type Psorisis
- What is being tested?
- Tapinarof Cream 1% and VTAMA®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 560 participants
- Where
- 26 sitesUnited States
- Study dates
- 17 Dec 2024to 12 Nov 2025
- Phase
- Phase 3
- 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
- Signed ICF indicating that the patient understands the purpose of, and procedures required for the study and is willing to participate in the study.
- Males and non-pregnant, non-lactating females aged ≥18 at the time of signing the informed consent.
- Patients with clinical diagnosis of chronic plaque psoriasis and stable disease for at least 6 months prior to the study.
- Body surface area (BSA) involvement ≥ 3% and ≤ 20% (the patient's face, scalp, groins, palms and soles should be excluded from the percent of total BSA (%BSA) calculations).
- A Physician's Global Assessment (PGA) score of 2 (mild), 3 (moderate) or 4 (severe) at screening and baseline.
- Female patients of childbearing potential (*WOCBP) must not be pregnant or lactating at the time of screening/baseline visit as documented by a negative urine pregnancy test with a sensitivity to at least 25 mIU/ml hCG:
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- Female patients of childbearing potential (WOCBP) are defined as sexually mature women without prior hysterectomy, or who have had any evidence of menses in the past 12 months. However, women who have been amenorrheic for the past 12 or more months are still considered to be of childbearing potential, if the amenorrhea is possibly due to other causes, including prior chemotherapy, anti- estrogens, or ovarian suppression. Postmenopausal women (defined as women who have been amenorrheic for at least 12 consecutive months, in the appropriate age group, without other known or suspected primary cause) or women who have been sterilized surgically or who are otherwise proven sterile (i.e., total hysterectomy, or bilateral oophorectomy with surgery at least 4 weeks prior to randomization) are not considered WOCBP. Patients who have undergone tubal ligation are NOT considered as surgically sterile.
- Female patients of childbearing potential must be willing to use an acceptable form of birth control during the study from the day of the first dose administration to 30 days after the last administration of study drug.
- For the purposes of this study the following are considered acceptable methods of birth control: oral or injectable contraceptives, contraceptive patches, medroxyprogesterone acetate (ex. Depo-Provera®) with stabilized use for at least 3 months, vaginal contraceptive (ex. etonogestrel/ethinyl estradiol vaginal ring (ex. NuvaRing®), contraceptive implant with etonogestrel or equivalent, double barrier methods, (e.g. condom and spermicide), intrauterine device (IUD), true abstinence (if in line with patient's lifestyle).
- Patients on hormonal contraception must be stabilized on the same type for at least three months prior to enrollment in the study and must not change the method during the study. A sterile sexual partner is not considered an adequate form of birth control.
- If a patient who was abstinent becomes sexually active during the study, a second acceptable method of birth control should be used and documented.
- Willing and able to adhere to the lifestyle restrictions specified in this protocol.
- Patients must be in good health and free from any clinically significant disease, which may interfere with the evaluation of plaque psoriasis or the administration of the investigative product.
- Patients must be willing to refrain from using all other topical plaque psoriasis products during the 12-week treatment period, other than the investigational product.
Who cannot join
- Known allergies, hypersensitivity, or intolerance to any of the ingredients of study treatment interventions, or components/ excipients thereof (refer to the prescribing information of VTAMA®), or drug or other allergy that, in the opinion of the investigator, contraindicates participation in the study.
- Current diagnosis of unstable forms of psoriasis (other than plaque variant) in the treatment area, including guttate, erythrodermic, exfoliative or pustular psoriasis.
- Patients with other inflammatory skin disease in the treatment area that may confound the evaluation of the plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis, and or any others in the opinion of the Investigator).
- Presence of pigmentation, extensive scarring, or pigmented lesions in the treatment areas, which could interfere with the rating of efficacy parameters.
- Patients with current immunosuppression.
- Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation (eg, phototherapy, tanning booths, or therapeutic sunbathing), laser therapy, tattoos removal, skin wraps or exfoliant techniques or Fraxel within 4 weeks prior to the baseline visit and/or plans to have such exposures during the study which could potentially impact the patient's psoriasis (as determined by the Investigator).
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- Use of biological treatments for psoriasis within the last 6 months of the baseline evaluation.
- Patients that have been treated with systemic steroids, systemic antibiotics, systemic anti-psoriatic treatment (i.e., methotrexate, cyclosporine, hydroxyurea), PUVA therapy, ultraviolet- B Therapy or systemic anti-inflammatory agents within 1 month or within 5 half-lives (whichever is longer) before Baseline.
- Use of any of the following therapies within two weeks prior to baseline:
- topical anti-psoriatic drugs (e.g., salicylic acid, anthralin, coal tar, calcipotriene, tazarotene)
- topical corticosteroids
- immunosuppressive drugs (e.g., tacrolimus, pimecrolimus)
- topical retinoids
- Received an investigational intervention within 30 days or 5 half-lives prior to the first dose of study intervention, whichever is longer.
- Documented medical history of uncontrolled, clinically significant intercurrent medical condition(s) (i.e., chronic infectious disease, system disorder, organ disorder, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, renal disease, severe psychiatric condition, etc.) for which, in the opinion of the investigator, participation would not be in the best interest of the patient (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
- Employees of the Investigator or research center or their immediate family members.
- Females who are pregnant, breast feeding, or who wish to become pregnant during the study period.
- Patients who have received chemotherapy or radiation therapy and/or anti-neoplastic agents within 3 months prior to screening/baseline.
- Patients who are unable or unwilling to give informed consent.
- Patients, who in the opinion of the Investigator, would be non-compliant with the requirements of the study protocol.
- Patients who consume excessive amounts of alcohol (greater than two drinks per day) or use drugs of abuse (including, but not limited to, cannabinoids, cocaine and barbiturates) within one year prior to screening.
- Patients who have been previously enrolled in this study.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Site 12101
Bryant, Arkansas, 72022
Site 12108
Chicago, Illinois, 60614
Site 12106
Clarksville, Indiana, 47129
Site 12103
College Station, Texas, 77845
Site 12110
Dublin, California, 94568
Site 12112
Dublin, California, 94568
Site 12118
El Paso, Texas, 79925
Site 12115
Fort Lauderdale, Florida, 33308
Site 12102
Fremont, California, 94538
Site 12122
Greenwich, Connecticut, 06831
Site 12117
Houston, Texas, 77070
Site 12119
Huntington Beach, California, 92647
Site 12109
Las Vegas, Nevada, 89121
Site 12105
Louisville, Kentucky, 40241
Site 12123
Merrillville, Indiana, 46410
Site 12104
Miami, Florida, 33144
Site 12116
Miami, Florida, 33146
Site 12113
Miami, Florida, 33175
Site 12114
Miramar, Florida, 33027
Site 12120
Northridge, California, 91325
Site 12111
Pomona, California, 91767
Site 12126
Portland, Oregon, 97210
Site 12121
Rolling Meadows, Illinois, 60008
Site 12107
Scottsdale, Arizona, 85260
Site 12125
Upper Saint Clair, Pennsylvania, 15241
12127
Woodbury, New York, 11797
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site, Clinical Study to Evaluate the Therapeutic Equivalence of Tapinarof Cream 1% (Teva Pharmaceuticals, Inc.) With VTAMA® Tapinarof (Tapinarof) Cream 1% (Dermavant Sciences, Inc.) in Adult Patients With Plaque Psoriasis
To compare the safety and efficacy of the test (Tapinarof Cream 1%), placebo (vehicle cream) and reference VTAMA® (Tapinarof Cream 1%) treatments to demonstrate clinical equivalence in patients with plaque psoriasis.
Read the detailed description
To compare the safety of Test, Reference, and Placebo treatments in patients with Plaque Psoriasis. Patients in this randomized, double-blind, three-arm, placebo controlled, parallel-design, multi-site study will be randomly assigned in a 2:2:1 ratio to treatment with the test product, reference product or placebo control, respectively.
- Conditions
- Plaque Type Psorisis
- Being tested
- Tapinarof Cream 1%, VTAMA®, Placebo
- Keywords
- Dermatologic Agents, Skin Diseases, Plaque Psoriasis, Tapinarof, Adult, Phase 3, Topical, Double-Blind, Safety, Efficacy, Skin Diseases, Papulosquamous
- Medical subject headings
- Skin Diseases, Skin Diseases, Papulosquamous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tapinarof Cream 1%Drug
Cream
VTAMA®Drug
Cream
PlaceboDrug
Cream
| Study group | Role | What they receive |
|---|---|---|
| Test: Tapinarof Cream 1% | Experimental | Tapinarof Cream 1%, Apply a thin layer once daily to psoriatic affected areas for 84 days. Receives: Drug: Tapinarof Cream 1% |
| VTAMA® | Active comparator | (Tapinarof) Cream 1%, Apply a thin layer once daily to psoriatic affected areas for 84 days. Receives: Drug: VTAMA® |
| Vehicle Product | Placebo comparator | Vehicle of the Test Product, Cream, Apply a thin layer once daily to psoriatic affected areas for 84 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary change in the Physician Global Assessment (PGA)
Proportion of patients with treatment success (defined as a Physician Global Assessment (PGA) score of clear (0) or almost clear (1) with a minimum 2-grade improvement from baseline at the end of treatment (Week 12; Study Day 84):
Score of (0) Clear: No signs of psoriasis; post-inflammatory hyperpigmentation may be present
Score of (1) Almost Clear: No thickening; normal to pink coloration; no to minimal focal scaling
Score of (2) Mild: Just detectable to mild thickening; pink to light red coloration; predominantly fine scaling
Score of (3) Moderate: Clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable erythema; moderate scaling
Score of (4) Severe: Severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start17 Dec 2024
- Primary completion7 Oct 2025
- Study completion12 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque Type PsorisisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 560 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Pharmaceuticals USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Teva Pharmaceuticals, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742957
- Sponsor's protocol ID
- 72336004
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2024
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site, Clinical Study to Evaluate the Therapeutic Equivalence of Tapinarof Cream 1% (Teva Pharmaceuticals, Inc.) With VTAMA® Tapinarof (Tapinarof) Cream 1% (Dermavant Sciences, Inc.) in Adult Patients With Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT06742957
- Acronym / sponsor ID
- 72336004
- Conditions
- Plaque Type Psorisis
- Keywords
- Dermatologic Agents, Skin Diseases, Plaque Psoriasis, Tapinarof, Adult, Phase 3, Topical, Double-Blind
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 560 participants (actual)
- Lead sponsor
- Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
- Collaborators
- Teva Pharmaceuticals, Inc.
- Study start
- 17 Dec 2024 (actual)
- Primary completion
- 7 Oct 2025 (actual)
- Study completion
- 12 Nov 2025 (actual)
- First posted
- 19 Dec 2024 (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 compare the safety and efficacy of the test (Tapinarof Cream 1%), placebo (vehicle cream) and reference VTAMA® (Tapinarof Cream 1%) treatments to demonstrate clinical equivalence in patients with plaque psoriasis.
Detailed description
To compare the safety of Test, Reference, and Placebo treatments in patients with Plaque Psoriasis. Patients in this randomized, double-blind, three-arm, placebo controlled, parallel-design, multi-site study will be randomly assigned in a 2:2:1 ratio to treatment with the test product, reference product or placebo control, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test: Tapinarof Cream 1% | Experimental | Drug: Tapinarof Cream 1%Tapinarof Cream 1%, Apply a thin layer once daily to psoriatic affected areas for 84 days. |
| VTAMA® | Active comparator | Drug: VTAMA®(Tapinarof) Cream 1%, Apply a thin layer once daily to psoriatic affected areas for 84 days. |
| Vehicle Product | Placebo comparator | Drug: PlaceboVehicle of the Test Product, Cream, Apply a thin layer once daily to psoriatic affected areas for 84 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Signed ICF indicating that the patient understands the purpose of, and procedures required for the study and is willing to participate in the study.
- Males and non-pregnant, non-lactating females aged ≥18 at the time of signing the informed consent.
- Patients with clinical diagnosis of chronic plaque psoriasis and stable disease for at least 6 months prior to the study.
- Body surface area (BSA) involvement ≥ 3% and ≤ 20% (the patient's face, scalp, groins, palms and soles should be excluded from the percent of total BSA (%BSA) calculations).
- A Physician's Global Assessment (PGA) score of 2 (mild), 3 (moderate) or 4 (severe) at screening and baseline.
Key exclusion criteria (22 listed)
- Known allergies, hypersensitivity, or intolerance to any of the ingredients of study treatment interventions, or components/ excipients thereof (refer to the prescribing information of VTAMA®), or drug or other allergy that, in the opinion of the investigator, contraindicates participation in the study.
- Current diagnosis of unstable forms of psoriasis (other than plaque variant) in the treatment area, including guttate, erythrodermic, exfoliative or pustular psoriasis.
- Patients with other inflammatory skin disease in the treatment area that may confound the evaluation of the plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis, and or any others in the opinion of the Investigator).
- Presence of pigmentation, extensive scarring, or pigmented lesions in the treatment areas, which could interfere with the rating of efficacy parameters.
- Patients with current immunosuppression.
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%Cream | Drug | Test: Tapinarof Cream 1% |
| VTAMA®Cream | Drug | VTAMA® |
| PlaceboCream | Drug | Vehicle Product |
Primary outcome
Primary change in the Physician Global Assessment (PGA)
Time frame: 12 Weeks
Proportion of patients with treatment success (defined as a Physician Global Assessment (PGA) score of clear (0) or almost clear (1) with a minimum 2-grade improvement from baseline at the end of treatment (Week 12; Study Day 84): Score of (0) Clear: No signs of psoriasis; post-inflammatory hyperpigmentation may be present Score of (1) Almost Clear: No thickening; normal to pink coloration; no to minimal focal scaling Score of (2) Mild: Just detectable to mild thickening; pink to light red coloration; predominantly fine scaling Score of (3) Moderate: Clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable erythema; moderate scaling Score of (4) Severe: Severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions
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 17 Dec 2025.
- FDA Drug and Device ResourcesLink provided by the sponsor.
- Office of Generic Drugs, Center for Drug Evaluation and Research. Draft Guidance on Tapinarof (PSG\_215272) \[Internet\]. Silver Spring, MD: U.S. Food and Drug Administration; 2023 \[cited 2024 May 10\].Link provided by the sponsor.
- VTAMA (Tapinarof) cream, 1%, for topical use \[US Prescribing Information\] \[Internet\]. Long Beach, CA: Dermavant Sciences Inc.; 2023 \[cited 2024 May 16\].Link provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tapinarof Cream 1% and VTAMA® in people with Plaque Type Psorisis, run by Teva Pharmaceuticals USA at 26 sites 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 14 inclusion and 22 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 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Primary change in the Physician Global Assessment (PGA) (time frame: 12 Weeks). 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 17 Dec 2025.