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Clinical Trials/NCT06032858
NCT06032858CompletedPhase 4

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

Ghurki Trust and Teaching Hospital1 site in 1 country30 target enrollmentStarted: March 6, 2022Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Psoriasis area and severity index

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 59 Years (Adult)
Sex
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

Arms & Interventions

Apremilast 30 mg twice daily

Experimental

Intervention: Apremilast 30mg (Drug)

Outcomes

Primary Outcomes

Psoriasis area and severity index

Time Frame: 16 weeks

body surface area

Time Frame: 16 weeks

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Ghurki Trust and Teaching Hospital
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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