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

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

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.

Study Overview

• Status: Completed
• Conditions: Alopecia Areata; Alopecia Areata(AA)
• Intervention / Treatment: Drug: Azathioprine (AZA); Drug: Betamethasone

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Rahimyarkhan, Punjab, Pakistan, 62400
      • Sheikh Zayed Medical college/hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Weekly Azathioprine Pulse Therapy (Group A); single dose of Tab. Azathioprine 300 mg once weekly	Drug: Azathioprine (AZA); weekly single dose of tab azathioprine 300mg
Active Comparator: Betamethasone Oral Mini Pulse (Group B); Tab. Betamethasone 5mg for 2 consecutive days weekly for 3 months	Drug: Betamethasone; oral Betamethsone 5mg for 2 consecutive days weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of Alopecia Tool (SALT) score	photographs of the standard four views of the scalp were captured at initial and follow-up appointments using a 50-megapixel Mobile camera under consistent lighting conditions. The Severity of Alopecia Tool (SALT) score was determined by dividing the scalp into four sections according to their surface areas: the top at 40%, the back at 24%, and each side (left and right) at 18%. The SALT score calculation involved the sum of the percentage of hair loss from the left side (0.18) plus the right side (0.18), the vertex (0.40), and the back (0.24). SALT scores were evaluated at baseline, 12 weeks post-treatment initiation, and 3 months after completion of treatment. Treatment response was determined by using the formula: Percentage of hair regrowth= (SALT score at baseline - SALT score at follow-up) x100 / SALT score at baseline. Treatment response was further divided into 4 categories: Poor response (<25% hair growth improvement from baseline), Moderate response (26-50% improvement), Goo	Clinical Assessment will be done monthly for 6 months

Collaborators and Investigators

• Sponsor: Sheikh Zayed Medical College

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: January 16, 2025
• First Submitted That Met QC Criteria: January 16, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 16, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: azathioprine; pulse therapy; alopeica areata; oral betamethasone
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Skin Diseases; Hypotrichosis; Hair Diseases; Alopecia Areata; Alopecia; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Respiratory System Agents; Anti-Asthmatic Agents; Betamethasone; Azathioprine
• Other Study ID Numbers: Sheikh-ZMC/H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No