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OpenTrials
Completed

NCT Number: NCT06032858

Efficacy and Safety of Apremilast in 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.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ghurki Hospital

Lahore, Punjab Province, 54000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apremilast 30mg

Drug

Apremilast 30mg twice daily

Primary outcomes

  1. Psoriasis area and severity index

    Time frame: 16 weeks

  2. body surface area

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

Ghurki Trust and Teaching Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 13, 2023
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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