A CLINICAL TRIAL TO STUDY THE EFFECTS OF TWO DRUGS, APREMILAST AND METHOTREXATE IN PATIENTS WITH PSORIASIS OF PALMS AND SOLES.

Phase 3

Completed

• Conditions: Health Condition 1: L408- Other psoriasis

• Registration Number: CTRI/2019/06/019830
• Lead Sponsor: SOUFILA K T

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-06-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 84

Inclusion Criteria

1. Patients with moderate to severe Palmoplantar psoriasis, not associated with psoriasis elsewhere on the body for

a duration of > 6 months. (patients having more than 50% of a single palmar or plantar surface involved and/or DLQI >6)(29).

2. Individuals of either gender with age between 18-65 years.

3. Patients with minimal response ( <25% improvement) after adequate trial of topical therapy.

Exclusion Criteria

1. Patients with hepatic/ renal disease/pulmonary fibrosis or cardiac diseases.

2. Severe anaemia, leucopenia or thrombocytopenia.

3. Active infectious disease or immune system deficiency including AIDS.

4. Patients with neuropsychiatric illness.

5. Pregnant or lactating women.

6. Significant abnormalities in LFT(serum bilirubin, AST, ALT, and

ALP > 1.5 times the upper limit of normal), viral hepatitis or cirrhosis.

7. H/o excessive alcohol consumption.

8. H/o intolerance/hypersensitivity to apremilast and/or methotrexate.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.decrease in both modified palmoplantar psoriasis area and severity index(m-PPPASI) and dermatology life quality index(DLQI) in each group. <br/ ><br>2.compare percentage of individuals in each group achieving m-pppasi 75 and time to achieve the same. <br/ ><br>3.compare the safety and tolerability of each drug by regular evaluation of clinical and biochemical parameters.Timepoint: regular assesment at week 2,4,8,12 and 16. follow up visit 4 weeks after stopping treatment.

Secondary Outcome Measures

Name	Time	Method
evaluate the factors predicting response in each group.factors assessed will be age,gender,duration of disease,obesity,metabolic syndrome,morphology of the lesions (hyperkeratoticLpustular),smoking,alcohol intake,initial disease severity.Timepoint: week 0, week 16