Health Condition 1: L400- Psoriasis vulgaris
Conditions
Interventions
Intervention1: Topical Cyclosporine formulation: 2% concentration, once daily, topical for 12 weeks
Control Intervention1: Coaltar: 5% concentration, once daily, topical for 12 weeks
Sponsors
PGIMER Chandigarh
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 18 years or older 2. Fulfilling the criteria of stable plaque psoriasis with bilaterally symmetrical plaques measuring less than equal to 100 cm sq of the body surface area with the PASI score less than equal to 10. 3. Both male and female patients willing to use appropriate method of contraception as per investigator s discretion throughout the study. 4. Willing to provide informed consent
Exclusion criteria
Exclusion criteria: 1. Impaired kidney function 2. Uncontrolled hypertension 3. Past or present malignancy 4. Current infection 5. Female patient who is breastfeeding, pregnant, or who is planning a pregnancy during the study. 6. Patient has evidence of erythrodermic, pustular, predominantly guttate psoriasis, or drug-induced psoriasis 7. Subject has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments. 8. Concomitant immunosuppressive therapy. 9. Primary or secondary immunodeficiency 10. Known hypersensitivity to drug or its ingredients. 12. Subject has had a major surgery within 8 weeks prior to baseline (Day 0) or has a surgery planned during the study. 13. Subject has any clinically significant medical condition or physical/laboratory abnormality that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results. 14. Receiving drugs which have known pharmacological interactions with cyclosporine 15. Known alcohol or drug abuse in the last 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in PASI score from baseline to 12 weeksTimepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean percentage change in PASI score Timepoint: 2 weeks, 4 weeks, 8 weeks and 12 weeks;Proportion of patients achieving PASI 75Timepoint: 12 weeks;Change in Physician Global AssessmentTimepoint: 12 weeks;Change in the Dermatology Life Quality IndexTimepoint: 12 weeks;Safety AssessmentsTimepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactDr Ashish Kakkar
Postgraduate Institute of Medical Education and Research
Outcome results
None listed