METHOTREXATE VERSUS APREMILAST IN THE TREATMENT OF PLAQUE PSORIASIS

Phase 4

Not yet recruiting

• Conditions: Psoriasis vulgaris,

• Registration Number: CTRI/2023/03/051052
• Lead Sponsor: Trish Larissa Miranda

Brief Summary

This study is a randomised,participant blinded,parallel group,single centre trial to compare the efficacy of Methotrexate and Apremilast in the treatment of moderate to severe plaque psoriasis.In one group of 21 patients ,tablet Methotrexate will be given as 7.5mg weekly in 3 divided doses whereas in the other group of 21 patients, tablet Apremilast will be started at a dose of 10mg and titrated to maximum of 30mg twice daily upto 16 weeks.Assesment will be done by Psoriasis Area severity Index(PASI) score at baseline,week 4, week 8, week 12 and week 16 where PASI 0,PASI 1,PASI2,PASI3 and PASI 4 are calculated respectively.The efficacy of Methotrexate and Apremilast will be compared using PASI 75 that is time taken for 75% or more reduction in psoriasis lesions from baseline lesions.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-03-23
• Study Start: 2023-03-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• 1)Male and female patients above 18 years with plaque psoriasis.
• 2)Involvement of 20% or more of body surface area with plaque psoriasis.

Exclusion Criteria

• 1)Pregnancy 2)Lactating women.
• 3)Immunosuppressed individuals 4)Patients with pustular psoriasis.
• 5)Patients with erythrodermic psoriasis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Outcome name-Psoriasis Area Severity Index(PASI) based on the following parameters:-	Week 0-Baseline | Week 4 | Week 8 | Week 12 | Week 16
1. Erythema	Week 0-Baseline | Week 4 | Week 8 | Week 12 | Week 16
2. Induration	Week 0-Baseline | Week 4 | Week 8 | Week 12 | Week 16
3. Desquamation or scaling	Week 0-Baseline | Week 4 | Week 8 | Week 12 | Week 16

Secondary Outcome Measures

Name	Time	Method
PASI-75-To compare the efficacy of Methotrexate and Apremilast by comparing their PASI-75 scores that is time taken for 75% or more reduction of psoriasis lesions from baseline lesions.	Not fixed,depending on the time taken to show 75% or more improvement from baseline lesions for each of the 2 drugs separately.

Trial Locations

Locations (1)

Mahatma Gandhi Mission Medical College and Hospital, Aurangabad; 🇮🇳 Aurangabad, MAHARASHTRA, India

Mahatma Gandhi Mission Medical College and Hospital, Aurangabad

🇮🇳Aurangabad, MAHARASHTRA, India

Trish Larissa Miranda

Principal investigator

9975083164

larissatrish@gmail.com