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

Phase 4

Completed

• Conditions: Alopecia Areata
• Interventions: Drug: Apremilast 30mg

• Registration Number: NCT05926882
• Lead Sponsor: Jinnah Postgraduate Medical Centre

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-08-01
• Study First Submitted: 2023-03-22
• Status Verified: 2023-06
• Primary Completion: 2023-06-20
• Study Completion: 2023-06-20
• Study First Submitted QC: 2023-06-23
• Last Update Submitted: 2023-06-23
• Study First Posted: 2023-07-03
• Last Update Posted: 2023-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Apremilast tablet	Apremilast 30mg	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.

Primary Outcome Measures

Name	Time	Method
Efficacy of Oral Apremilast in the treatment of Alopecia Areata at the Tertiary Care Hospital, Karachi	It will be assessed upto 12 weeks	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

Secondary Outcome Measures

Name	Time	Method
Mean difference of Salt score before and after the treatment	it will be assessed upto 12 weeks	SALT score difference before and after the treatment will be measured

Trial Locations

Locations (1)

JPMC; 🇵🇰 Karachi, Sindh, Pakistan