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Efficacy and Safety of Apremilast in Psoriasis

Sponsor
Ghurki Trust and Teaching Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT06032858
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
17.1
Actual Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Apremilast 30mg
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Apremilast in Patients With Moderate to Severe Chronic Plaque Psoriasis
Actual Study Start Date :
Mar 6, 2022
Actual Primary Completion Date :
Jul 10, 2023
Actual Study Completion Date :
Aug 10, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Apremilast 30 mg twice daily

Drug: Apremilast 30mg
Apremilast 30mg twice daily

Outcome Measures

Primary Outcome Measures

  1. Psoriasis area and severity index [16 weeks]

  2. body surface area [16 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 59 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ghurki Hospital Lahore Punjab Pakistan 54000

Sponsors and Collaborators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ghurki Trust and Teaching Hospital
ClinicalTrials.gov Identifier:
NCT06032858
Other Study ID Numbers:
  • D6
First Posted:
Sep 13, 2023
Last Update Posted:
Sep 13, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Psoriasis
Apremilast

Study Results

No Results Posted as of Sep 13, 2023