Trials Sponsors Conditions Drugs Pricing

Conditions

Keywords

Dermatologic AgentsSkin DiseasesPlaque PsoriasisTapinarofAdultPhase 3TopicalDouble-BlindSafetyEfficacySkin Diseases, Papulosquamous

Outcome Measures

Primary Outcomes (1)

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
12 Weeks

Study Arms (3)

Test: Tapinarof Cream 1%

EXPERIMENTAL

Tapinarof Cream 1%, Apply a thin layer once daily to psoriatic affected areas for 84 days.

Drug: Tapinarof Cream 1%

VTAMA®

ACTIVE COMPARATOR

(Tapinarof) Cream 1%, Apply a thin layer once daily to psoriatic affected areas for 84 days.

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.

Interventions

Tapinarof Cream 1%Drug

Cream

Test: Tapinarof Cream 1%

VTAMA®Drug

Cream

VTAMA®

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

Teva Pharmaceuticals, Inc.
Industrycollaborator
Teva Pharmaceuticals USA
Industrylead

Study Sites (26)

Site 12107

Scottsdale, Arizona, 85260, United States

Site 12101

Bryant, Arkansas, 72022, United States

Site 12110

Dublin, California, 94568, United States

Site 12112

Dublin, California, 94568, United States

Site 12102

Fremont, California, 94538, United States

Site 12119

Huntington Beach, California, 92647, United States

Site 12120

Northridge, California, 91325, United States

MeSH Terms

Conditions

Skin DiseasesSkin Diseases, Papulosquamous

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Enrollment

560 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 16, 2024

First Posted

December 19, 2024

Study Start

December 17, 2024

Actual (reported)

You may not qualify if:

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).
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.
+7 more criteria

Study Comparing Tapinarof Cream 1% To VTAMA ® (Tapinarof Cream 1%) In the Treatment of Plaque Psoriasis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (3)

Test: Tapinarof Cream 1%

VTAMA®

Vehicle Product

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (26)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (3)

Test: Tapinarof Cream 1%

VTAMA®

Vehicle Product

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (26)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations