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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06786689
Enrollment
60
Registered
2025-01-22
Start date
2023-03-01
Completion date
2023-09-30
Last updated
2025-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alopecia Areata, Alopecia Areata(AA)

Keywords

alopeica areata, azathioprine, oral betamethasone, pulse therapy

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.

Interventions

weekly single dose of tab azathioprine 300mg

DRUGBetamethasone

oral Betamethsone 5mg for 2 consecutive days weekly

Sponsors

Sheikh Zayed Medical College
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Severity of Alopecia Tool (SALT) scoreClinical Assessment will be done monthly for 6 monthsphotographs 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

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026