Efficacy and Safety of Apremilast in Psoriasis

NCT ID: NCT06032858

Last Updated: 2023-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-06

Study Completion Date

2023-08-10

Brief Summary

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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.

Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Apremilast 30 mg twice daily

Group Type EXPERIMENTAL

Apremilast 30mg

Intervention Type DRUG

Apremilast 30mg twice daily

Interventions

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Apremilast 30mg

Apremilast 30mg twice daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ghurki Trust and Teaching Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prof. Dr. Haroon Nabi

Role: STUDY_DIRECTOR

Professor Department of Dermatology LMDC

Dr. Saira Muaaz

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology Ghurki Hospital

Dr. Hira Tariq

Role: STUDY_CHAIR

Senior Registrar Department of Dermatology Services Hospital

Dr. Sumera Hanif

Role: STUDY_CHAIR

Senior Registrar Department of Dermatology LMDC

Dr. Talat Akbar

Role: STUDY_CHAIR

Associate Professor, Dermatology, LMDC

Prof. Dr. Faria Asad

Role: STUDY_CHAIR

Head of Department Dermatology SIMS/ Services Hospital

Locations

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Ghurki Hospital

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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Schafer P. Apremilast mechanism of action and application to psoriasis and psoriatic arthritis. Biochem Pharmacol. 2012 Jun 15;83(12):1583-90. doi: 10.1016/j.bcp.2012.01.001. Epub 2012 Jan 10.

Reference Type BACKGROUND
PMID: 22257911 (View on PubMed)

Crowley J, Thaci D, Joly P, Peris K, Papp KA, Goncalves J, Day RM, Chen R, Shah K, Ferrandiz C, Cather JC. Long-term safety and tolerability of apremilast in patients with psoriasis: Pooled safety analysis for >/=156 weeks from 2 phase 3, randomized, controlled trials (ESTEEM 1 and 2). J Am Acad Dermatol. 2017 Aug;77(2):310-317.e1. doi: 10.1016/j.jaad.2017.01.052. Epub 2017 Apr 14.

Reference Type BACKGROUND
PMID: 28416342 (View on PubMed)

Other Identifiers

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D6

Identifier Type: -

Identifier Source: org_study_id

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