Health Condition 1: L400- Psoriasis vulgaris
Conditions
Interventions
Intervention1: Apremilast: Patients will receive tablet apremilast 20 mg twice daily (if weight is more than 20 and less than 50 kg) and 30 mg twice daily (if weight is more than or equal to 50 kg), a
Sponsors
Postgraduate Institute of Medical Education and Research
Eligibility
Inclusion criteria
Inclusion criteria: Patient diagnosed to be a case of plaque psoriasis. Patients with PASI score 5 or more Body surface area 10 percent or more DLQI OR CDLQI 5 or more, or involving high impact areas like palmoplantar psoriasis, genital psoriasis, face or head involvement at the time of screening Patients with minimal or no response after an adequate trial of topical therapy. The parent and the child should be willing to comply with the daily or weekly medication and follow-up visits
Exclusion criteria
Exclusion criteria: Patients on topical treatment for psoriasis in the past two weeks or on systemic treatment for the last four weeks. Patients who have used NB-UVB or PUVA in the last 2 weeks. Patients with active moderate to severe psoriatic arthritis who would require systemic therapy beyond what is needed for psoriasis. Body weight less than 20 kg. Patients with known contraindications to Methotrexate or Apremilast, like pregnant and lactating females ,severe anaemia, leucopenia less than 3000 per mm3, thrombocytopenia less than 100000 per microlitres , deranged renal function tests , deranged liver function tests and hypersensitivity to the drug Patients with pre-existing malignancy, thromboembolic events, heart disease, or severe neurological disease Patients who are not willing to participate in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who achieve PASI 75Timepoint: at the end of 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in PASI from baselineTimepoint: at the end of 16 weeks;Change in CDLQI or DLQI from baselineTimepoint: at the end of 16 weeks | — |
Countries
India
Contacts
Public ContactDr Sunil Dogra
Postgraduate Institute of Medical Education and Research
Outcome results
None listed