Comparison of efficacy and tolerability of two drugs named apremilast and methotrexate in patients of moderate to severe palmoplantar psoriasis
- Conditions
- Health Condition 1: L408- Other psoriasis
- Registration Number
- CTRI/2020/05/025198
- Lead Sponsor
- Mitali Wagh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 41
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in mPPPASI score (modified Palmoplantar Psoriasis Area and Severity Index)Timepoint: after 1.5 years
- Secondary Outcome Measures
Name Time Method 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