Comparison of the effectiveness of two medicines namely Methotrexate and Apremilast in patients with a skin disease called psoriasis

Not Applicable

Not yet recruiting

• Conditions: Psoriasis vulgaris,

• Registration Number: CTRI/2019/04/018854
• Lead Sponsor: Yenepoya Medical College

Brief Summary

The study desigin is Quasi experimental study. Primary objective of the study will be to compare the efficacy of Methotrexate and Apremilast in patients with Psoriasis and to compare the adverse effects associated with both the drugs. Patients diagnosed with psoriasis attending the Dermatology OPD in Yenepoya Medical College Hospital, Mangalore will be enrolled for the study. Eligible patients with Psoriasis will be treated with Methotrexate or Apremilast. Outcome will be measured at the end of treatment.  Clinical evaluation will be done for every patients.Psoriasis area severity index (PASI) will be calcilated. Blood investigations like complete blood picture, Liver function test will be done in all subjects as required for treatment. Every alternative patient will be put on either Methotrexate or Apremilast. Methotrexate will be given 7.5 mg/week orally with requisite clinical and laboratory monitoring. Weekly monitoring for first month or as required. Apremilast will be given 30 mg BID orally. Initially dose will be titrated from 10 mg/ day with gradually increasing to 30 mg BID over a week. Patient will be evaluated every month for 4 months. Patient is not supposed to use any topical treatment other than emollients during study time.This study will highlight the advantages of the less commonly used drug for treatment of psoriasis. Apremilast does not require frequent monitoring compared to Methotrexate and improves the quality of life in patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-05
• Last Update Posted: 2019-04-26

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• •All patients visiting the Dermatology OPD diagnosed to have Psoriasis who needs systemic therapy.
• •Patients requiring and willing to undergo treatment with Methotrexate or Apremilast.

Exclusion Criteria

• 1.Patients who have taken systemic therapy in past three months or topical treatment or phototherapy in past 2 weeks 2.Who are lesser than 18 years of age.
• 3.Pregnant or those having any serious illness contraindicating systemic therapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the efficacy of Methotrexate and Apremilast	4 months

Secondary Outcome Measures

Name	Time	Method
To compare the side effects of Methotrexate and Apremilast	4 months

Trial Locations

Locations (1)

Yenepoya Medical College Hospital; 🇮🇳 Kannada, KARNATAKA, India

Yenepoya Medical College Hospital

🇮🇳Kannada, KARNATAKA, India

Dr Maqbool SAEP

Principal investigator

8281141777

mak7891@gmail.com