Health Condition 1: L408- Other psoriasis
Conditions
Interventions
Intervention1: Apremilast: Day 1: 10 mg in AM, no evening dose
Day 2: 10 mg AM and PM
Day 3: 10 mg AM and 20 mg PM
Day 4: 20 mg AM and PM
Day 5: 20 mg AM and 30 mg PM
Day 6 and 7: 30 mg AM and PM
Sponsors
Mitali Wagh
Eligibility
Inclusion criteria
Inclusion criteria: i. Patients of moderate to severe palmoplantar psoriasis (as diagnosed by the dermatologist)fulfilling one of the following criteria: 1)mPPPASI score >=12 2)Palmoplantar surface area involvement > 10% 3)Physician Global Assessment Scale score 3 or 4
Exclusion criteria
Exclusion criteria: i. Systemic therapy(conventional or biologics)within 12 weeks prior to randomization ii. Use of active topical agents for psoriasis within 2 weeks iii. Pregnant and lactating women & women of reproductive age group who are not practicing a reliable method of contraception iv. Psoriatic arthritis, pustular psoriasis v. Any other dermatological disease vi. Impaired Renal, hepatic function or abnormal CBC vii. Patients on the following drugs: β blockers, Aspirin,Chloroquine, Lithium viii. Patients suffering from any other chronic/systemic disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in mPPPASI score (modified Palmoplantar Psoriasis Area and Severity Index)Timepoint: after 1.5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving sPGA(Static physician global assessment) score of 0 (clear) or 1 (almost clear)Timepoint: At the end of 16 weeks;Proportion of patients attaining mPPPASI 75 (modified Palmoplantar Psoriasis Area and Severity Index)Timepoint: At the end of 16 weeks;Proportion of patients showing atleast5-point reduction in DLQI(Dermatology life quality index) from baselineTimepoint: At the end of 16 weeks | — |
Countries
India
Contacts
Public ContactMitali Shivaji Wagh
Government Medical College, Nagpur
Outcome results
None listed