Health Condition 1: L400- Psoriasis vulgaris
Conditions
Interventions
Intervention1: ORAL APREMILAST: Oral apremilast 30 mg twice a day is given to chronic plaque psoriasis patients for 3 months
Control Intervention1: ORAL ROFLUMILAST: Oral roflumilast 500 microgram onc
Sponsors
Dr Shubhi Kalchuri
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with moderate to severe chronic plaque psoriasis. 2. Patients more than 18 years of age. 3. PASI more than equal to 5.
Exclusion criteria
Exclusion criteria: 1. Patients with history of hypersensitivity to apremilast or roflumilast present. 2. Pregnant and lactating. 3. Patients with severe immunological disease, tuberculosis, hepatitis, heart failure (NYHA III-IV), liver failure (Child-Pugh B C). 4. Patients with current or previous malignancy. 5. Patient with severe psychiatric illness like depression, anxiety, etc 6. Patients currently treated with theophylline, phenobarbital, carbamazepine, phenytoin or other drugs which can interact with apremilast and roflumilast. 7. any psychitric illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective: To compare the efficacy of oral apremilast and roflumilast for treatment of moderate to severe chronic plaque psoriasis for patients more than 18 of age. Timepoint: Every 1 month followup for 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objective: 1. To compare the safety of oral apremilast & roflumilast for treatment of moderate to severe chronic plaque psoriasis for patients more than 18 of age. 2. To compare the changes in metabolic parameters like weight, abdominal girth & triglyceride levels between roflumilast & apremilast groups in moderate to severe chronic plaque psoriasis Timepoint: Every 1 month followup for 3 months | — |
Countries
India
Contacts
Public ContactDr Shubhi Kalchuri
Jawaharlal Nehru Medical College
Outcome results
None listed