Health Condition 1: L400- Psoriasis vulgaris
Conditions
Interventions
Intervention1: TAPINAROF CREAM 1%: Once daily application to affected areas for 12 weeks
Control Intervention1: PLACEBO OF TAPINAROF CREAM 1%: Once daily application to affected areas for 12 weeks
Sponsors
M/s. Optimus Pharma Private Limited (Sekhmet Pharmaventures)
Ms Optimus Pharma Private Limited Sekhmet Pharmaventures
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either gender, aged 18 to 65 years (both inclusive) and ready to give written informed consent to participate in the study. 2. Clinical diagnosis of chronic plaque psoriasis and stable disease for at least 6 months prior to the study. 3. Body surface area involvement more than equal to 3 percent and less than equal to 20 percent (the patients scalp, palms, groin, fingernails, toenails, and soles should be excluded from the %BSA calculations). 4. A PGA score of 2 (mild), 3 (moderate) or 4 (severe) at screening and baseline (pre-randomization) 5. Women of childbearing potential must have a negative urine pregnancy test prior to study entry. 6. Patients and their female partners of childbearing potential should agree to use contraceptive measures throughout the study and for at least 2 months after end of treatment.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to the drug components (study drug or excipient) used during the study. 2. Pregnant or lactating women. 3. Patients with non plaque forms of psoriasis (erythrodermic, guttate or pustular psoriasis). 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. Concurrent conditions or history of other diseases a) Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome) or medical history of positive human immunodeficiency virus (HIV) antibody at Screening visit. b) Chronic or acute systemic infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to the Screening visit. c) Acute active bacterial, fungal, or viral (herpes simplex, herpes zoster, chicken pox) skin infection within 1 week prior to the Screening visit. d) Significant dermatologic or inflammatory condition other than plaque psoriasis that, in the Investigator s opinion, would make it difficult to interpret data or assessments during the study. 7. Use of any of the following medication within the indicated period before the Screening visit a) Minimum of 5 half-lives for biologic agents- eg, 12 months for rituximab; 8 months for ustekinumab; 5 months for secukinumab; 12 weeks for golimumab; 10 weeks for ixekizumab; 8 weeks for infliximab, adalimumab, or alefacept; and 4 weeks for etanercept. b) 4 weeks for systemic treatments: cyclosporin, interferon, methotrexate, apremilast, tofacitinib, mycophenolate, thioguanine, hydroxyurea, sirolimus, azathioprine, other systemic immunosuppressive or immunomodulating agents, fumaric acid derivatives, vitamin D3 and analogs (more than 5000 IU^day), retinoids (eg, acitretin, isotretinoin), psoralens, corticosteroids, or adrenocorticotropic hormone analogs. c) 2 weeks for immunizations with a live viral component, drugs known to possibly worsen psoriasis, such as beta-blockers (eg, propranolol), lithium, iodides, angiotensin-converting enzyme inhibitors, and indomethacin, unless on a stable dose for more than 12 weeks. d) With the exception of non-medicated emollients, 2 weeks for topical treatments including corticosteroids, antihistamines, immunomodulators, anthralin (dithranol), Vitamin D derivatives (eg, calcipotriene, calcipotriol), retinoids (Note: 4 weeks for tazarotene), or coal tar. 8. Patients with active systemic infection that required oral, intramuscular, or intravenous administration of antibiotics, antifungal or antiviral agents within 4 weeks of Day 1. 9. Patients have used topical therapy within 2 weeks of randomization or systemic therapy or phototherapy (i.e., UVB, PUVA) for psoriasis within 28 days of randomization. 10. Patients with active substance abuse or a history of substance abuse within 6 months prior to Screening. 11. Current or a history of cancer within 5 years except for adequately treated skin basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix (surgical excision or electrodessication and curettage). 12. Concurrent skin lesions in the treatment area that, in t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who achieve a Physician Global Assessment (PGA) score of clear (0) or almost clear (1) with a minimum 2-grade improvement from Baseline.Timepoint: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with more than 50 percent improvement in Psoriasis Area and Severity Index from Baseline.Timepoint: Week 12;Proportion of patients with more than 75 percent improvement in Psoriasis Area and Severity Index from Baseline.Timepoint: Week 12;Proportion of patients with more than 90 percent improvement in Psoriasis Area and Severity Index from Baseline.Timepoint: Week 12;Change in Peak Pruritus-Numeric Rating Scale (Peak Pruritus-NRS) fromTimepoint: Week 12;Change over time in psoriasis impact on daily activities, as measured by the Dermatology Life Quality Index (DLQI) total and individual dimension scoresTimepoint: Week 12;Change over time in psoriasis symptoms, as measured by the Psoriasis Symptom Diary (PSD)Timepoint: Week 12;Change over time in physical component score and mental component score, as measured by the Short Form-36 (SF-36) questionnaireTimepoint: Week 12;Incidence of TEAEs and SAEsTimepoint: Throughout the study | — |
Countries
India
Contacts
Public ContactMr K Naresh
Insignia Clinical Services Pvt. Ltd.
Outcome results
None listed