Health Condition 1: null- Patients with mild to moderate plaque psoriasis (psoriasis vulgaris). Health Condition 2: L400- Psoriasis vulgaris
Conditions
Interventions
Intervention1: Calcipotriol/AKVANO
50 μg/g cutaneous solution: Applied twice daily treatment with approx. 3 mg/cm2 which is obtained by
spraying an area of approximately 15 cm2. Total duration of the
Sponsors
Cadila Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients (Non-pregnant) aged 18 to 65 years having either Fitzpatrick skin type Iâ??III or IVâ??VI. 2. Diagnosis of plaque psoriasis by a dermatologist with lesions on arms, legs or trunk. 3. Patients with stable plaque psoriasis for 6 months, mild to moderate form on Physicianâ??s global assessment (PGA), Body Surface Area (BSA) involvement of 5-10% (both included) and PASI >= 5. 4. Patients must be willing to provide written informed consent. 5. Patients must be willing and able to understand and can comply with study requirements, apply the medication as instructed and be able to complete the study.
Exclusion criteria
Exclusion criteria: 1.Predominantly palmo-plantar, flexural, scalp and nail location of psoriasis. 2.Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis. 3.Pregnant, nursing Female patient. 4.Women of childbearing potential must use reliable forms of contraception. 5.Patient with any uncontrolled systemic disease. A potential patient in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study. 6.Patient with positive serology tests like HIV, HCV & HBsAg. 7.Patient with presence of any skin disease that might interfere with the diagnosis or evaluation of the test medications. 8.Patient with condition or situation, which may put him/her at significant risk, may confound study results, or may interfere significantly with participation in the study. 9.Patient with spontaneously improving or rapidly deteriorating plaque psoriasis. 10.Use of systemic agents such as oral retinoids, methotrexate, cyclosporine or systemic corticosteroids within four weeks prior to screening. 11.Use of biologic agents such as alefacept, infliximab, efalizumab, adalimumab, etanercept, certolizumab, golimumab, ustekinumab or secukinumab within four weeks prior to study entry. 12.Use of topical drugs that might alter the course of psoriasis or has received ultraviolet B treatment within two weeks prior to study entry. Use of phototherapy with psoralen ultraviolet A treatment within four weeks prior to study entry. 13.Patient with a known sensitivity to any of the study treatments and/or their components. 14.Patient who anticipates a need to use other topical or systemic therapy that might alter course of psoriasis and need for surgery or hospitalization during the study. 15.Participation in other clinical study within 30 days prior to entering the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in Psoriasis Area and Severity Index (PASI) from baseline to the end of treatment. The main assessment will be the severity of psoriasis as measured by comparison of PASI between baseline and at the end of treatment i.e. 8 weeks.Timepoint: Between baseline and at the end of treatment i.e. 8 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events.Timepoint: During entire study period.;Change in irritation & itching.Timepoint: From baseline to 2, 4 and 8 weeks of treatment by 10 point VAS scale.;Proportion of patients that have reached PGA 0 or 1.Timepoint: At 2, 4 and 8 weeks of treatment.;Proportion of patients with greater than 50 % reduction in PASI Score (PASI50).Timepoint: From baseline to 2, 4 and 8 weeks of treatment.;Proportion of patients with greater than 75 % reduction in PASI Score (PASI75).Timepoint: From baseline to 2, 4 and 8 weeks of treatment, respectively. | — |
Countries
India
Contacts
Public ContactDr Hardik Brahmbhatt
Cadila Pharmaceuticals Limited
Outcome results
None listed