A study to assess the effects of Apremilast and Methotrexate in the treatment of patients with psoriasis

Not yet recruiting

• Conditions: Psoriasis vulgaris,

• Registration Number: CTRI/2019/01/017362
• Lead Sponsor: RATHIPRIYADHARSHINI R

Brief Summary

Psoriasis is a common, chronic inflammatory,immune mediated, hyperproliferative condition affecting primarily the skin. It is associated with significant reduction in the quality of life. There are several modalities of treatment available but none is satisfactory in acheiving significant clearance of lesions. Apremilast is the new orally active Phosphodiestrase-4 inhibitor found to be effective in treatment of psoriasis with negligible adverse effects and also eithout any need for rotine monitoring of blood parameters. Methotrexate is a well-known drug in the treatment of psoriasis for years. Eventhough there is reduction in the morbidity, it is associated with frequent side effects and patient dissatisfaction. This study is to evaluate the efficacy and safety of Apremilast in our setting and to compare the same with the conventionally used Methotrexate in the treatment of Chronic Plaque Psoriasis.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-01-28
• Study Start: 2019-04-02

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Those With chronic plaque psoriasis involving >10%BSA Those who sign the written consent form prior to participation in the study.

Exclusion Criteria

pregnancy lactation abnormalities in LFT,RFT,CBC hypertension and diabetes active tuberculosis/ HIV infection Hypersensitivity to the drugs Those on immunosuppresive medications.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in PASI[Psoriasis Area and Severity Index] more than 75% from baseline	12 weeks

Secondary Outcome Measures

Name	Time	Method
Improvement in PASI[ PsoriasisArea and Severity Index]	3 weeks,9 weeks

Trial Locations

Locations (1)

Chettinad hospital and research institute; 🇮🇳 Kancheepuram, TAMIL NADU, India

Chettinad hospital and research institute

🇮🇳Kancheepuram, TAMIL NADU, India

RATHIPRIYADHARSHINI

Principal investigator

8870705609

rathiii5893@gmail.com