Back to resultsEfficacy of Oral Apremilast in the Treatment of Alopecia Areata at the Tertiary Care Hospital, Karachi.
Primary Purpose
Alopecia Areata
Status
Completed
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Apremilast 30mg
Sponsored by
About this trial
This is an interventional treatment trial for Alopecia Areata
Eligibility Criteria
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
Sites / Locations
- JPMC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Apremilast tablet
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Mean difference of Salt score before and after the treatment
SALT score difference before and after the treatment will be measured
Full Information
NCT ID
NCT05926882
First Posted
March 22, 2023
Last Updated
June 23, 2023
Sponsor
Jinnah Postgraduate Medical Centre
1. Study Identification
Unique Protocol Identification Number
NCT05926882
Brief Title
Efficacy of Oral Apremilast in the Treatment of Alopecia Areata at the Tertiary Care Hospital, Karachi.
Official Title
Efficacy of Oral Apremilast in the Treatment of Alopecia Areata at the Tertiary Care Hospital, Karachi.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
June 20, 2023 (Actual)
Study Completion Date
June 20, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinnah Postgraduate Medical Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Apremilast tablet
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Apremilast 30mg
Intervention Description
Patients will be given Oral Apremilast 30 mg twice daily after 05 days titration dose.
Primary Outcome Measure Information:
Title
Efficacy of Oral Apremilast in the treatment of Alopecia Areata at the Tertiary Care Hospital, Karachi
Description
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
Time Frame
It will be assessed upto 12 weeks
Secondary Outcome Measure Information:
Title
Mean difference of Salt score before and after the treatment
Description
SALT score difference before and after the treatment will be measured
Time Frame
it will be assessed upto 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nazia Jabeen, FCPS
Organizational Affiliation
JPMC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Khadija Asadullah, FCPS
Organizational Affiliation
JPMC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Faiza Inam, FCPS
Organizational Affiliation
JPMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
JPMC
City
Karachi
State/Province
Sindh
Country
Pakistan
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Oral Apremilast in the Treatment of Alopecia Areata at the Tertiary Care Hospital, Karachi.
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