Health Condition 1: L400- Psoriasis vulgaris
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Well defined nonindurated dry erythematous lesions with scaling A minimum PASI score of 12.0 at screening Psoriasis covering = 10% of total BSA Dermatology life quality index (DLQI) score at least 4 Duration of disease at least 6 months Plaque psoriasis clinically stable for at least 3 months prior to screening Body weight = 100 kg
Exclusion criteria
Exclusion criteria: Guttate, erythrodermic, or pustular psoriasis Clinically significant psoriasis flare during screening or at the time of enrolment History of any secondary skin infection Pregnancy or lactation Patients undergoing treatment for chronic illness Diabetes mellitus, Cardiovascular diseases, Tuberculosis, Hypertension etc Patient with a history of alcohol or drug abuse Candidate who had been previously treated (e.g., cyclosporine, corticosteroids, methotrexate)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| No significant variation in the haematological, biochemical parameters. PASI Score: Response status at the end will be determined as follows: Responder: Any subject whose PASI score decreased = 50% from day 0 to day 46 and day 91. Partial responder: Any subject whose PASI score decreased = 30% but 50% from day 0 to day 46 and day 91. Non-responder: Any subject whose PASI score decreased 30% from day 0 to day 46 and 91st day. Timepoint: 0th day to 46th and 91st day | — |
Secondary
| Measure | Time frame |
|---|---|
| Dermatology Life Quality Index: Any subjects whose DLQI score increase 4 points and above. Mode of action can be simulated Timepoint: 0th day to 46th and 91st day | — |
Countries
India
Contacts
Siddha Regional Research Institute