Alopecia AreataPhase 2NCT06786689
To Compare the Efficacy of Weekly Azathioprine Pulse Versus Betamethasone Oral Mini-Pulse in the Treatment of Moderate to Severe Alopecia Areata
A Phase 2 study testing Azathioprine (AZA) and Betamethasone in people with Alopecia Areata and Alopecia Areata(AA), run by Sheikh Zayed Medical College at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Alopecia Areata, Alopecia Areata(AA)
- What is being tested?
- Azathioprine (AZA) and Betamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2023to 30 Sep 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- aged 16-60 years
- scalp area involvement of ≥ 15% by Alopecia Areata
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Sheikh Zayed Medical College/Hospital
Rahimyarkhan, Punjab Province, 62400
About this study
Official title: 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.
Read the 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)
- Being tested
- Azathioprine (AZA), Betamethasone
- Keywords
- alopeica areata, azathioprine, oral betamethasone, pulse therapy
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azathioprine (AZA)Drug
weekly single dose of tab azathioprine 300mg
BetamethasoneDrug
oral Betamethsone 5mg for 2 consecutive days weekly
| Study group | Role | What they receive |
|---|---|---|
| Weekly Azathioprine Pulse Therapy (Group A) | Active comparator | single dose of Tab. Azathioprine 300 mg once weekly Receives: Drug: Azathioprine (AZA) |
| Betamethasone Oral Mini Pulse (Group B) | Active comparator | Tab. Betamethasone 5mg for 2 consecutive days weekly for 3 months Receives: Drug: Betamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Clinical Assessment will be done monthly for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start1 Mar 2023
- Primary completion31 May 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheikh Zayed Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kainat usman, Sheikh Zayed Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786689
- Sponsor's protocol ID
- Sheikh-ZMC/H
- Status last verified
- Jan 2025
- First submitted
- 16 Jan 2025
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of Weekly Azathioprine Pulse Versus Betamethasone Oral Mini-Pulse in the Treatment of Moderate to Severe Alopecia Areata
- ClinicalTrials.gov ID
- NCT06786689
- Acronym / sponsor ID
- Sheikh-ZMC/H
- Conditions
- Alopecia Areata, Alopecia Areata(AA)
- Keywords
- alopeica areata, azathioprine, oral betamethasone, pulse therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sheikh Zayed Medical CollegeOther government
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weekly Azathioprine Pulse Therapy (Group A) | Active comparator | Drug: Azathioprine (AZA)single dose of Tab. Azathioprine 300 mg once weekly |
| Betamethasone Oral Mini Pulse (Group B) | Active comparator | Drug: BetamethasoneTab. Betamethasone 5mg for 2 consecutive days weekly for 3 months |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- aged 16-60 years
- scalp area involvement of ≥ 15% by Alopecia Areata
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azathioprine (AZA)weekly single dose of tab azathioprine 300mg | Drug | Weekly Azathioprine Pulse Therapy (Group A) |
| Betamethasoneoral Betamethsone 5mg for 2 consecutive days weekly | Drug | Betamethasone Oral Mini Pulse (Group B) |
Primary outcome
Severity of Alopecia Tool (SALT) score
Time frame: Clinical Assessment will be done monthly for 6 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Azathioprine (AZA) and Betamethasone in people with Alopecia Areata and Alopecia Areata(AA), run by Sheikh Zayed Medical College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of Alopecia Tool (SALT) score (time frame: Clinical Assessment will be done monthly for 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.