Efficacy and Safety of Apremilast in Psoriasis

September 5, 2023 updated by: Ghurki Trust and Teaching Hospital

Efficacy and Safety of Apremilast in Patients With Moderate to Severe Chronic Plaque Psoriasis

Psoriasis is a long standing inflammatory, autoinflammatory disease linked with many comorbidities. Patients with moderate to severe plaque psoriasis can be managed with topical as well as systemic medications. FDA approved Apremilast as first drug to be taken orally in cases of psoriasis in mid 1990's. Currently, according to researchers best knowledge no study has been done on use of Apremilast in Pakistan. It has recently become available here. Keeping in view all the benefits of this drug, a study has been planned to check its effectiveness and safety 30mg twice a day, in patients with moderate to severe chronic plaque psoriasis based on Psoriasis area and severity index and Body surface area assessments in our population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Ghurki Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed patients of chronic plaque psoriasis
  • patients applicant for oral or parenteral treatments and for light therapy
  • patients not responding to topical treatments

Exclusion Criteria:

  • Patients who show hypersensitive reactions to apremilast to any of its inactive component
  • Pregnancy
  • Lactating mothers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Apremilast 30 mg twice daily
Drug: Apremilast 30mg
Apremilast 30mg twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Psoriasis area and severity index
Time Frame: 16 weeks
16 weeks
body surface area
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ghurki Trust and Teaching Hospital

Investigators

  • Study Director: Prof. Dr. Haroon Nabi, Professor Department of Dermatology LMDC
  • Principal Investigator: Dr. Saira Muaaz, Department of Dermatology Ghurki Hospital
  • Study Chair: Dr. Hira Tariq, Senior Registrar Department of Dermatology Services Hospital
  • Study Chair: Dr. Sumera Hanif, Senior Registrar Department of Dermatology LMDC
  • Study Chair: Dr. Talat Akbar, Associate Professor, Dermatology, LMDC
  • Study Chair: Prof. Dr. Faria Asad, Head of Department Dermatology SIMS/ Services Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2022

Primary Completion (Actual)

July 10, 2023

Study Completion (Actual)

August 10, 2023

Study Registration Dates

First Submitted

September 5, 2023

First Submitted That Met QC Criteria

September 5, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 5, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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