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

Sponsor

Jinnah Postgraduate Medical Centre (Other)

Overall Status

Completed

CT.gov ID

NCT05926882

Collaborator

(none)

Enrollment

Location

Arm

10.6

Actual Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alopecia Areata	Drug: Apremilast 30mg	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2022

Actual Primary Completion Date :

Jun 20, 2023

Actual Study Completion Date :

Jun 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Apremilast 30mg Patients will be given Oral Apremilast 30 mg twice daily after 05 days titration dose.

Arm

Intervention/Treatment

Experimental: 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.

Drug: Apremilast 30mg

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	JPMC	Karachi	Sindh	Pakistan

Sponsors and Collaborators

Jinnah Postgraduate Medical Centre

Investigators

Principal Investigator: Nazia Jabeen, FCPS, JPMC
Principal Investigator: Khadija Asadullah, FCPS, JPMC
Principal Investigator: Faiza Inam, FCPS, JPMC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Parisa Sanawar, Principal Investigator, Jinnah Postgraduate Medical Centre

ClinicalTrials.gov Identifier:

NCT05926882

Other Study ID Numbers:

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

First Posted:

Jul 3, 2023

Last Update Posted:

Jul 3, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Alopecia

Alopecia Areata

Apremilast

Study Results

No Results Posted as of Jul 3, 2023