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

NCT06786689 | Completed Phase 2 DMC

• 1 other identifier: Sheikh-ZMC/H
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Alopecia Areata; Alopecia Areata(AA)

Keywords

alopeica areata; azathioprine; oral betamethasone; pulse therapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Weekly Azathioprine Pulse Therapy (Group A)

ACTIVE COMPARATOR

single dose of Tab. Azathioprine 300 mg once weekly

Drug: Azathioprine (AZA)

Betamethasone Oral Mini Pulse (Group B)

ACTIVE COMPARATOR

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

Drug: Betamethasone

Interventions

Azathioprine (AZA) DRUG

weekly single dose of tab azathioprine 300mg

Weekly Azathioprine Pulse Therapy (Group A)

Betamethasone DRUG

oral Betamethsone 5mg for 2 consecutive days weekly

Betamethasone Oral Mini Pulse (Group B)

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheikh Zayed Medical College: lead

Study Sites (1)

Sheikh Zayed Medical College/Hospital

Rahimyarkhan, Punjab Province, 62400, Pakistan

Location

MeSH Terms

Conditions

Alopecia Areata

Interventions

Azathioprine; Betamethasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Thionucleosides; Sulfur Compounds; Organic Chemicals; Mercaptopurine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Graduate Resident in Dermatology

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 22, 2025
• Study Start: March 1, 2023
• Primary Completion: May 31, 2023
• Study Completion: September 30, 2023
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)