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

Alopecia Areata Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05926882
• Other study ID #: NO.F.2-81/2022-GENL/321/JPMC
• Status: Completed
• Phase: Phase 4
• Start date: August 1, 2022
• Est. completion date: June 20, 2023

Study information

• Verified date: June 2023
• Source: Jinnah Postgraduate Medical Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 20, 2023
• Est. primary completion date: June 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

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

Locations

Country	Name	City	State
Pakistan	JPMC	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Jinnah Postgraduate Medical Centre

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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