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

Study Overview
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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.

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

Conditions
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Alopecia Areata

Intervention / Treatment
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* Drug: Apremilast 30mg


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apremilast tablet<br>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. | Drug: Apremilast 30mg<br>* Patients will be given Oral Apremilast 30 mg twice daily after 05 days titration dose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Oral Apremilast in the treatment of Alopecia Areata at the Tertiary Care Hospital, Karachi | Efficacy of Oral Apremilast for 12 weeks in alopecia areata will be assessed by using SALT score ( Severity of Alopecia Tool). The SALT score is computed by measuring the percentage of hair loss in each of 4 areas of the scalp-vertex (40%), right profile (18%), left profile (18%), and posterior (24%)-and adding the total to achieve a composite score | It will be assessed upto 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean difference of Salt score before and after the treatment | SALT score difference before and after the treatment will be measured | it will be assessed upto 12 weeks |