Health Condition 1: L40- Psoriasis
Conditions
Interventions
Intervention1: Tapinarof cream 1%: (dose) once daily for 12 weeks
Control Intervention1: VTAMA (Tapinarof cream 1%, Dermavant Sciences Inc.)
: (dose) once daily for 12 weeks
Sponsors
Encube Ethicals Private Limited
Cliantha Research Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or non-pregnant, non-lactating female aged between 18 to 75 years with a clinical diagnosis of stable plaque psoriasis for at least 6 months prior to the study. 2. BSA involvement greater than or equals to 3 percent and less than or equals to 20 percent (the participants face, scalp, groin, palms and soles should be excluded from the percent of total BSA (percent BSA) calculations) to determine trial participants eligibility. 3. A PGA score for plaque psoriasis of 2 (mild), 3 (moderate) or 4 (severe) at screening and baseline visit. 4. Female participant with postmenopausal status (spontaneous amenorrhea for at least 12 consecutive months) OR surgically sterilized OR female of child bearing potential with a negative pregnancy test must use acceptable methods of contraception throughout the study period and until 4 weeks after the last dose of investigational product. 5. Participant must be willing to refrain from using all other topical plaque psoriasis products during the 12-week treatment period, other than the investigational product. 6. Participant willing to provide written informed consent. 7. Participant willing and able to comply with the procedures and requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Female who is pregnant, breast-feeding, or who wish to become pregnant during the study period. 2. Current diagnosis of unstable forms of psoriasis in the treatment area, including guttate, erythrodermic, exfoliative or pustular psoriasis. 3. Any sign of infection of any of the psoriatic lesions. 4. 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). 5. Presence of pigmentation, extensive scarring, or pigmented lesions in the treatment areas, which could interfere with the rating of efficacy parameters. 6. History of psoriasis unresponsive to topical treatments and/or biologic treatments. 7. History of hypersensitivity to any component of the test product or reference listed drug. 8. Current immunosuppression 9. Concurrent or medical history of uncontrolled, clinically significant intercurrent medical condition(s): a. Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome) or medical history of positive human immunodeficiency virus (HIV) antibody b. Chronic or acute systemic infection requiring treatment with systemic antibiotics, antivirals, antiparasitic, antiprotozoals, or antifungals within 4 weeks prior to the baseline visit. c. Acute active bacterial, fungal, or viral (herpes simplex, herpes zoster, chicken pox) skin infection within 1 week prior to the baseline visit. d. Significant dermatologic or inflammatory condition other than plaque psoriasis that, in the Investigators opinion, would make it difficult to interpret data or assessments during the study. e. System disorder, organ disorder, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, renal disease, severe psychiatric condition, etc. which in the opinion of the investigator, would interfere with optimal participation in the study or produce significant risk to the participant. 10. Use within one month or within 5 half-lives (whichever is longer) prior to baseline of: a) Systemic steroids b) Systemic antibiotics c) Systemic antipsoriatic treatment d) Vitamin D3 and analogs (greater than 5000 IU/day), retinoids (eg, acitretin, isotretinoin), or adrenocorticotropic hormone analogs e) Psoralen plus ultraviolet A (PUVA) therapy f) Ultraviolet B (UVB) therapy g) Systemic anti-inflammatory agents h) Any systemic immunosuppressive or immunomodulating agents 11. Use of any of the following therapies within two weeks prior to baseline: a) Topical anti-psoriatic drugs (e.g., salicylic acid, anthralin, coal tar, calcipotriene, tazarotene) b) Topical corticosteroids c) Topical immunosuppressive drugs (e.g., tacrolimus, pimecrolimus) d) Topical retinoids 12. Clinically significant abnormalities in ECG or Screening laboratory parameters. 13. Participant who has received chemotherapy or radiation therapy and/or anti-neoplastic agents within 3 months prior to screening/baseline. 14. Use of biological treatments for psoriasis within the last 6 months of the baseline evaluation. 15. Within 2 weeks of immunizations with a live viral component; drugs known to possibly worsen psoriasis, such as beta blockers (e.g. propranolol), lithium, iodides, angiotensin converting enzyme inhibitors, and indomethacin, u
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint is the 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 to the end of treatment (Week12).Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Body sites and size of treatment area. 2. Proportion of participants with greater than or equals to 75 percent (PASI75) improvement in Psoriasis Area and Severity Index (PASI) from baseline at Week 12Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactMr Devesh Verma
Cliantha Research Limited
Outcome results
None listed