Clinical trial NCT06786689: To Compare the Efficacy of Weekly Azathioprine Pulse Versus Betamethasone Oral Mini-Pulse in the Treatment of Moderate to Severe Alopecia Areata
Official title: Comparing the Efficacy of Weekly Azathioprine Pulse Versus Betamethasone Oral Mini-Pulse in the Treatment of Moderate to Severe Alopecia Areata
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alopecia Areata
Alopecia Areata(AA)
Keywords: alopeica areata
azathioprine
oral betamethasone
pulse therapy
Lead sponsor: Sheikh Zayed Medical College
Sponsor class: OTHER_GOV
First posted: 2025-01-22
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Severity of Alopecia Tool (SALT) score
timeFrame: Clinical Assessment will be done monthly for 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rahimyarkhan
country: Pakistan
facility: Sheikh Zayed Medical College/Hospital
state: Punjab
Study officials:
References: