Plaque Psoriasis
Conditions
Brief 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.
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.
Interventions
The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days.
DRUGVtama® (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.
DRUGPlacebo 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.
Sponsors
Sun Pharmaceutical Industries, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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)
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demonstration in Therapeutic Equivalence & Safety of the Investigational Product | Baseline to Week 12 | The proportion of subjects in each treatment group with treatment success with a minimum 2-grade improvement. |
Countries
United States
Contacts
STUDY_DIRECTORNatalie Yantovskiy
Sun Pharmaceuticals Industries, Inc.
Outcome results
None listed