Health Condition 1: L400- Psoriasis vulgaris
Conditions
Interventions
Intervention1: Topical formulation of cyclosporine: Standard amount of topical formulation will be applied once daily over healthy skin or lesion area in psoriasis patients (up to 2 weeks in patients)
Sponsors
Dr Ashish Kakkar
Eligibility
Inclusion criteria
Inclusion criteria: They should meet the morphological and dermatological criteria of stable plaque psoriasis. Patients willing to use appropriate method of contraception as per investigatorâ??s discretion throughout the study. Those who provide written informed consent.
Exclusion criteria
Exclusion criteria: Reduced kidney function o Inadequately controlled blood pressure o Current or history of malignancy o Current infectious disease o Pregnant, or lactating females. o Those with other skin diseases that in the opinion of the investigator, can interfere with the study assessments. o Those receiving systemic/ topical immunosuppressive therapy o Patients who are immunodeficient (Primary or secondary) o Known hypersensitivity to cyclosporine gel or its ingredients o Patients who have undergone major surgery in last six months. o Known history or ongoing drug or alcohol abuse in the past six months or any history of convulsions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic evaluation of topical cyclosporinTimepoint: 168 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Predictive biomarkers for treatment responseTimepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactDr Ashish Kakkar
Postgraduate Institute of Medical Education and Research
Outcome results
None listed