To Compare the Efficacy of Weekly Azathioprine Pulse Versus Betamethasone Oral Mini-Pulse in the Treatment of Moderate to Severe Alopecia Areata

NCT ID: NCT06786689

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2023-09-30

Brief Summary

Alopecia areata (AA) is an autoimmune condition characterized by non-scarring hair loss, ranging from minor patches to complete baldness. Given the variable effectiveness of existing treatments, this study aimed to compare the efficacy of weekly Azathioprine pulse (WAP) therapy against Betamethasone oral mini-pulse (BOMP) therapy in managing moderate to severe AA.

Detailed Description

Alopecia areata (AA) is an autoimmune disorder characterized by non-scarring, solitary, or multiple circular or oval patches of hair loss on scalp or other hear bearing areas. These patches often feature "exclamation mark hairs" near their leading edges. It effects all demographics irrespective of age, sex, and ethnicity. Clinically, Alopecia areata can be categorized in various forms depending on extent of involvement, such as patchy hair loss on the scalp, Alopecia Totalis (complete scalp hair loss), or Alopecia Universalis (complete scalp and body hair loss), or less commonly, as band-like hair loss on specific regions of the scalp.

Given the uncertain pathogenesis and course of the disease, the effectiveness of treatment modalities remains unpredictable. Effective treatment must address both the clinical efficacy and safety. Previous studies have reported variable safety profiles, remission, and relapse rates for weekly Azathioprine pulse therapy versus Betamethasone oral mini-pulse therapy, particularly when compared to placebo. However, direct comparisons, especially within our local demographic, are notably lacking. Therefore, this study aimed to bridge the existing gap in literature by offering a comparative evaluation of these therapies in the management of moderate to severe alopecia areata.

Conditions

Alopecia Areata; Alopecia Areata(AA)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Weekly Azathioprine Pulse Therapy (Group A)

single dose of Tab. Azathioprine 300 mg once weekly

Group Type: ACTIVE_COMPARATOR

Azathioprine (AZA)

Intervention Type: DRUG

weekly single dose of tab azathioprine 300mg

Betamethasone Oral Mini Pulse (Group B)

Tab. Betamethasone 5mg for 2 consecutive days weekly for 3 months

Group Type: ACTIVE_COMPARATOR

Betamethasone

Intervention Type: DRUG

oral Betamethsone 5mg for 2 consecutive days weekly

Interventions

Azathioprine (AZA)

weekly single dose of tab azathioprine 300mg

Intervention Type: DRUG

Betamethasone

oral Betamethsone 5mg for 2 consecutive days weekly

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• aged 16-60 years
• scalp area involvement of ≥ 15% by Alopecia Areata

Exclusion Criteria

• used topical and intralesional treatment within last 1 month,
• received systemic therapy or phototherapy within last three months,
• anemia, leukocytosis, leukopenia, thrombocytopenia, deranged renal and liver function test
• pregnant an lactating females
• patients with contraindications to corticosteroids or Azathioprine

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheikh Zayed Medical College

OTHER_GOV

Sponsor Role: lead

Responsible Party

Kainat usman

Post Graduate Resident in Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sheikh Zayed Medical College/Hospital

Rahimyarkhan, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

Sheikh-ZMC/H

Identifier Type: -

Identifier Source: org_study_id