Health Condition 1: L408- Other psoriasis
Conditions
Interventions
Intervention1: APREMILAST: APREMILAST 30 MG BD ORALLY AFTER THE UP TITRATION SCHEDULE WILL BE GIVEN IN PATIENTS OF PALMOPLANTAR PSORIASIS TILL PATIENT ACHIEVES M-PPPASI 75% OR 16 WEEKS WHICHEVER IS EA
Sponsors
SOUFILA K T
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with moderate to severe Palmoplantar psoriasis, not associated with psoriasis elsewhere on the body for a duration of > 6 months. (patients having more than 50% of a single palmar or plantar surface involved and/or DLQI >6)(29). 2. Individuals of either gender with age between 18-65 years. 3. Patients with minimal response ( <25% improvement) after adequate trial of topical therapy.
Exclusion criteria
Exclusion criteria: 1. Patients with hepatic/ renal disease/pulmonary fibrosis or cardiac diseases. 2. Severe anaemia, leucopenia or thrombocytopenia. 3. Active infectious disease or immune system deficiency including AIDS. 4. Patients with neuropsychiatric illness. 5. Pregnant or lactating women. 6. Significant abnormalities in LFT(serum bilirubin, AST, ALT, and ALP > 1.5 times the upper limit of normal), viral hepatitis or cirrhosis. 7. H/o excessive alcohol consumption. 8. H/o intolerance/hypersensitivity to apremilast and/or methotrexate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.decrease in both modified palmoplantar psoriasis area and severity index(m-PPPASI) and dermatology life quality index(DLQI) in each group. 2.compare percentage of individuals in each group achieving m-pppasi 75 and time to achieve the same. 3.compare the safety and tolerability of each drug by regular evaluation of clinical and biochemical parameters.Timepoint: regular assesment at week 2,4,8,12 and 16. follow up visit 4 weeks after stopping treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| evaluate the factors predicting response in each group.factors assessed will be age,gender,duration of disease,obesity,metabolic syndrome,morphology of the lesions (hyperkeratoticLpustular),smoking,alcohol intake,initial disease severity.Timepoint: week 0, week 16 | — |
Countries
India
Contacts
Public ContactSOUFILA K T
Post Graduate Institute of Medical Education and Research
Outcome results
None listed