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

NCT05926882 | Completed Phase 4

• 1 other identifier: NO.F.2-81/2022-GENL/321/JPMC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mean difference of Salt score before and after the treatment

  it will be assessed upto 12 weeks

Study Arms (1)

Apremilast tablet

EXPERIMENTAL

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

Interventions

Apremilast 30mg DRUG

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

Apremilast tablet

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Either gender.
• Age 20-70 years.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jinnah Postgraduate Medical Centre: lead

Study Sites (1)

JPMC

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Alopecia Areata

Interventions

apremilast

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Nazia Jabeen, FCPS

  JPMC

  PRINCIPAL INVESTIGATOR

• Khadija Asadullah, FCPS

  JPMC

  PRINCIPAL INVESTIGATOR

• Faiza Inam, FCPS

  JPMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: July 3, 2023
• Study Start: August 1, 2022
• Primary Completion: June 20, 2023
• Study Completion: June 20, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Locations

PA (1)