Health Condition 1: L40- Psoriasis
Conditions
Interventions
Intervention1: Tapinarof cream 1%: (dose) once daily for 12 weeks
Control Intervention1: VTAMA® (Tapinarof cream 1%,): (dose) once daily for 12 weeks
Sponsors
Mylan Laboratories Ltd
Cliantha Research Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or non-pregnant, non-lactating females aged between 18 to 75 years with a clinical diagnosis of stable (at least 6 months) plaque psoriasis involving 3 to 20% body surface area (BSA) 2. A PGA score of 2 (mild), 3 (moderate), or 4 (severe) 3. Female participants should have been postmenopausal for at least 1 year
Exclusion criteria
Exclusion criteria: 1. Females who are pregnant, breast feeding, or who wish to become pregnant during the trial period. 2. Current diagnosis of unstable forms of psoriasis 3. Other inflammatory skin disease in the treatment area that may confound the evaluation of the plaque psoriasis 4. Current immunosuppression 5. Concurrent conditions or history of other inflammatory, infectious and immunocompromised diseases 6. Current or chronic history of liver disease, known hepatic or biliary abnormalities 7. Current or a history of cancer within 5 years, 8. Presence of pigmentation, extensive scarring, or pigmented lesions in the treatment areas 9. History of hypersensitivity to any component of the test product or reference listed drug. 10. A history of or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the Investigatorâ??s opinion, may interfere with the participants participation in the trial and ability to understand and give informed consent. 11.Planned surgery or hospitalization (anticipated to last > 72 hours) during the trial. 12.Any other medical condition that, in the opinion of the Investigator, renders the participants unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the participant. 13. Clinically significant abnormalities in ECG or Screening laboratory parameters 14. Non-cooperation with clinical trial staff.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants 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.Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the body sites and size of treatment area. To assess the safety and tolerability of trial treatments by reported adverse events. Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactMr Devesh Verma
Cliantha Research Limited
Outcome results
None listed