Health Condition 1: L400- Psoriasis vulgaris
Conditions
Interventions
Intervention1: Apremilast: Day 1: 10mg AM
Day 2: 10mg AM, 10 mg PM
Day 3: 10mg AM, 20 mg PM
Day 4: 20mg AM, 20 mg PM
Day 5: 20mg AM, 30 mg PM
Day 6: 30mg AM, 30 mg PM
30mg twice a day from day 7 until
Sponsors
Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1.Both male and female patients aged >= 18 years and 2.Diagnosis of chronic plaque psoriasis for at least 6 months prior to Screening. 3.Patients who are ready to give written informed consent, which includes a commitment to comply with all requirements, specified in the study protocol, among others a negative urine pregnancy test in the case of women of childbearing age. 4.Patients who the study staff deems reliable and mentally competent to carry out the study.
Exclusion criteria
Exclusion criteria: 1.Pregnant or nursing females. 2.Patients with known hypersensitivity to the study drugs. 3.Patients with immunosuppressive disease. 4.Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the Investigator(s) could affect the subjectâ??s safety or interfere with the study assessments. 5.Any history of or concomitant medical condition that in the opinion of the Investigator(s) would compromise the subjectâ??s ability to safely complete the study. 6.History of drug or alcohol dependency or abuse within approximately the last 2 years. 7.Currently enrolled in another clinical study or used any investigational drug or device within 28 days preceding informed consent or were scheduled to participate in another clinical study that involved an investigational product or investigational drug during the course of this study. 8.Any patient whom the investigator judged to be inappropriate for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.The incidences of treatment emergent adverse events (TEAEs), treatment related AEs and AEs/SAEs 2.Number of patients who prematurely discontinued Apremilast due to adverse eventTimepoint: Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change in dryness of from baseline. 2.Change in scaling from baseline.Timepoint: Week 4;1.Percentage of Participants Who Achieved at Least a 75% Improvement (Response) in the Psoriasis Area and Severity Index (PASI)-75 From Baseline. 2.Percentage of Participants Who Achieved at Least a 50% Improvement (Response) in the Psoriasis Area and Severity Index (PASI)-50 From Baseline. 3.Percent Change from Baseline in the Affected Body Surface Area (BSA). 4.Percent change in Psoriasis disability index (PDI) from baseline.Timepoint: Week 16;5.Change in erythema from baseline. 6.Change in dryness of from baseline. 7.Change in scaling from baseline.Timepoint: Week 16 | — |
Countries
India
Contacts
Public ContactDr Vishalakshi Viswanath
Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital
Outcome results
None listed