Efficacy of Oral Apremilast in the Treatment of Alopecia Areata at the Tertiary Care Hospital, Karachi.

NCT ID: NCT05926882

Last Updated: 2023-07-03

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

2022-08-01

Study Completion Date

2023-06-20

Brief Summary

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Alopecia areata (AA) is a disease characterized by hair cycle dysfunction and the presence of peribulbar and perifollicular mononuclear cell infiltrate.1 The majority of patients report the rapid onset of one or several well-defined, usually round, 1 to 4 cm areas of scalp hair loss. A common feature is the presence of "exclamation-mark" hairs that are broken and short hairs that taper proximally.

Commonly used treatment modalities are steroids (intra-lesional, topical or systemic), contact immunotherapy, anthraline, minoxidil, calcineurine inhibitors, topical retinoids, systemic immune modulating agents, photo-chemotherapy, dermatography wigs and hypnotherapy etc Apremilast is a newer drug. It is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4), this may be effective treatment for a variety of inflammatory skin disorders such as alopecia areata.

Detailed Description

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Due to its increasing prevalence and lack of local data on its long term management, the investigators designed current study On Efficacy of Oral Apremilast in Alopecia areata in-order to evaluate its effectiveness.

Conditions

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Alopecia Areata

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 tablet

Patients will be given Oral Apremilast 30 mg twice daily after 05 days initial titration dose. The effect of treatment will be evaluated using photographs of the patients before and after the study and clinical evaluation of patients.

Group Type EXPERIMENTAL

Apremilast 30mg

Intervention Type DRUG

Patients will be given Oral Apremilast 30 mg twice daily after 05 days titration dose.

Interventions

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Apremilast 30mg

Patients will be given Oral Apremilast 30 mg twice daily after 05 days titration dose.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Either gender.
* Age 20-70 years.

Exclusion Criteria

* Patients with history of connective tissue disorder, vasculitis, seropositive and seronegative arthritis
* Patients with history of psoriasis.
* Patients excluded from the study will be patients having history of previous treatments with some systemic agents
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jinnah Postgraduate Medical Centre

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. Parisa Sanawar

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nazia Jabeen, FCPS

Role: PRINCIPAL_INVESTIGATOR

JPMC

Khadija Asadullah, FCPS

Role: PRINCIPAL_INVESTIGATOR

JPMC

Faiza Inam, FCPS

Role: PRINCIPAL_INVESTIGATOR

JPMC

Locations

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JPMC

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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NO.F.2-81/2022-GENL/321/JPMC

Identifier Type: -

Identifier Source: org_study_id

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