Alopecia AreataPhase 4NCT07926711
Comparative Effectiveness of Intralesional Injection of Triamcinolone Acetonide vs. Microneedling With Local Application of Triamcinolone Acetonide in the Treatment of Alopecia Areata
A Phase 4 study testing Triamcinolone acetonide and Microneedling with topical triamcinolone acetonide in people with Alopecia Areata, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
Brief Summary The goal of this clinical trial is to learn which treatment works better for people with alopecia areata, a condition that causes patchy hair loss. The study will compare two commonly used treatments to see which one leads to better hair regrowth and fewer side effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Triamcinolone acetonide and Microneedling with topical triamcinolone acetonide
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2026to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female participants aged 18 years and above
- Clinically diagnosed alopecia areata involving 25 percent or less of the scalp surface area
- Disease duration of up to 12 months
- Willingness to participate in the study and provide written informed consent
Who cannot join
- Extensive alopecia areata involving more than 25 percent of the scalp, alopecia totalis, or alopecia universalis
- Scarring alopecia or active scalp infection
- History of keloid formation or abnormal wound healing
- Pregnant or lactating women
- Use of systemic or topical immunosuppressive therapy within the last 4 weeks
- Known hypersensitivity to triamcinolone acetonide or local anesthetics
- Presence of uncontrolled autoimmune disorders that may affect treatment response
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Dow University Hospital, Ojha Campus
Karachi, Sindh, 12345
About this study
Brief Summary
The goal of this clinical trial is to learn which treatment works better for people with alopecia areata, a condition that causes patchy hair loss. The study will compare two commonly used treatments to see which one leads to better hair regrowth and fewer side effects.
Read more
The main questions this study aims to answer are:
Does injecting triamcinolone acetonide into the skin lead to better hair regrowth than microneedling with topical triamcinolone acetonide?
Are there any side effects linked to these treatments?
Researchers will compare two groups of participants. One group will receive intralesional injections of triamcinolone acetonide. The other group will receive microneedling followed by the local application of triamcinolone acetonide. The results will be compared to see which treatment works better for alopecia areata.
Participants will:
Be examined by the research team to confirm the diagnosis of alopecia areata
Receive one of the two treatments as part of the study
Attend follow-up visits so researchers can check hair regrowth and monitor for side effects
Read the detailed description
Alopecia areata is a common autoimmune condition characterized by non-scarring hair loss. Intralesional corticosteroid injection is a widely used treatment; however, alternative methods such as microneedling with topical corticosteroids are increasingly being explored to improve outcomes and reduce treatment-related discomfort.
This randomized clinical trial is designed to compare the effectiveness and safety of intralesional injection of triamcinolone acetonide versus microneedling with local application of triamcinolone acetonide in the treatment of alopecia areata. Eligible participants diagnosed with alopecia areata will be enrolled after obtaining informed consent.
Participants will be allocated into two treatment groups. One group will receive intralesional injections of triamcinolone acetonide according to standard clinical practice. The second group will undergo microneedling followed by topical application of triamcinolone acetonide. Treatments will be administered at predefined intervals as outlined in the approved study protocol.
Clinical assessment will be performed at baseline and during follow-up visits to evaluate hair regrowth and treatment response. Participants will also be monitored for local and systemic adverse effects throughout the study period. The findings of this study aim to provide comparative evidence on the efficacy and safety of these two commonly used treatment modalities for alopecia areata.
- Conditions
- Alopecia Areata
- Being tested
- Triamcinolone acetonide, Microneedling with topical triamcinolone acetonide
- Keywords
- Alopecia areata, intralesional triamcinolone, microneedling, topical triamcinolone, randomized controlled trial, hair loss
- Medical subject headings
- Alopecia Areata, Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone acetonideDrug
Triamcinolone acetonide will be administered as intralesional injections into the affected scalp areas at four-week intervals, according to standard clinical practice.
Microneedling with topical triamcinolone acetonideProcedure or surgery
Microneedling will be performed on the affected scalp areas followed by local application of triamcinolone acetonide at four-week intervals.
| Study group | Role | What they receive |
|---|---|---|
| Intralesional Triamcinolone Acetonide | Experimental | Participants in this arm will receive intralesional injections of triamcinolone acetonide into the affected scalp areas at four-week intervals, according to standard clinical practice. Receives: Drug: Triamcinolone acetonide; Procedure: Microneedling with topical triamcinolone acetonide |
| Microneedling with Topical Triamcinolone Acetonide | Experimental | Participants in this arm will undergo microneedling of the affected scalp areas followed by local application of triamcinolone acetonide at four-week intervals. Receives: Drug: Triamcinolone acetonide; Procedure: Microneedling with topical triamcinolone acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair regrowth
Hair regrowth will be assessed by the percentage change in the Severity of Alopecia Tool (SALT) score from baseline.
Measured: 12 weeks
Secondary outcomes (2)
treatment success
Treatment success will be defined as a 50 percent or greater reduction in the Severity of Alopecia Tool (SALT) score compared to baseline.
Measured: 12 weeks
Treatment-related adverse effects
Local adverse effects including pain, erythema, bleeding, infection, skin atrophy, telangiectasia, and pigmentary changes will be recorded during the study period.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2026
- Study start1 Jan 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two parallel treatment groups and will receive only one of the study interventions.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07926711
- Sponsor's protocol ID
- IRB-4379/DUHS/Approval/2025/20
- Status last verified
- Nov 2026
- First submitted
- 3 Nov 2026
- Last updated
- 9 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because this is an investigator-initiated academic study, and no formal data-sharing plan has been approved.
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Intralesional Injection of Triamcinolone Acetonide vs. Microneedling With Local Application of Triamcinolone Acetonide in the Treatment of Alopecia Areata
- ClinicalTrials.gov ID
- NCT07926711
- Acronym / sponsor ID
- IRB-4379/DUHS/Approval/2025/20
- Conditions
- Alopecia Areata
- Keywords
- Alopecia areata, intralesional triamcinolone, microneedling, topical triamcinolone, randomized controlled trial, hair loss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 Nov 2026 (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.
Brief Summary
The goal of this clinical trial is to learn which treatment works better for people with alopecia areata, a condition that causes patchy hair loss. The study will compare two commonly used treatments to see which one leads to better hair regrowth and fewer side effects.
The main questions this study aims to answer are:
Does injecting triamcinolone acetonide into the skin lead to better hair regrowth than microneedling with topical triamcinolone acetonide?
Are there any side effects linked to these treatments?
Researchers will compare two groups of participants. One group will receive intralesional injections of triamcinolone acetonide. The other group will receive microneedling followed by the local application of triamcinolone acetonide. The results will be compared to see which treatment works better for alopecia areata.
Participants will:
Be examined by the research team to confirm the diagnosis of alopecia areata
Receive one of the two treatments as part of the study
Attend follow-up visits so researchers can check hair regrowth and monitor for side effects
Detailed description
Alopecia areata is a common autoimmune condition characterized by non-scarring hair loss. Intralesional corticosteroid injection is a widely used treatment; however, alternative methods such as microneedling with topical corticosteroids are increasingly being explored to improve outcomes and reduce treatment-related discomfort.
This randomized clinical trial is designed to compare the effectiveness and safety of intralesional injection of triamcinolone acetonide versus microneedling with local application of triamcinolone acetonide in the treatment of alopecia areata. Eligible participants diagnosed with alopecia areata will be enrolled after obtaining informed consent.
Participants will be allocated into two treatment groups. One group will receive intralesional injections of triamcinolone acetonide according to standard clinical practice. The second group will undergo microneedling followed by topical application of triamcinolone acetonide. Treatments will be administered at predefined intervals as outlined in the approved study protocol.
Clinical assessment will be performed at baseline and during follow-up visits to evaluate hair regrowth and treatment response. Participants will also be monitored for local and systemic adverse effects throughout the study period. The findings of this study aim to provide comparative evidence on the efficacy and safety of these two commonly used treatment modalities for alopecia areata.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel treatment groups and will receive only one of the study interventions.
| Arm | Type | Receives |
|---|---|---|
| Intralesional Triamcinolone Acetonide | Experimental | Drug: Triamcinolone acetonide, Procedure: Microneedling with topical triamcinolone acetonideParticipants in this arm will receive intralesional injections of triamcinolone acetonide into the affected scalp areas at four-week intervals, according to standard clinical practice. |
| Microneedling with Topical Triamcinolone Acetonide | Experimental | Drug: Triamcinolone acetonide, Procedure: Microneedling with topical triamcinolone acetonideParticipants in this arm will undergo microneedling of the affected scalp areas followed by local application of triamcinolone acetonide at four-week intervals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female participants aged 18 years and above
- Clinically diagnosed alopecia areata involving 25 percent or less of the scalp surface area
- Disease duration of up to 12 months
- Willingness to participate in the study and provide written informed consent
Key exclusion criteria (7 listed)
- Extensive alopecia areata involving more than 25 percent of the scalp, alopecia totalis, or alopecia universalis
- Scarring alopecia or active scalp infection
- History of keloid formation or abnormal wound healing
- Pregnant or lactating women
- Use of systemic or topical immunosuppressive therapy within the last 4 weeks
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 |
|---|---|---|
| Triamcinolone acetonideTriamcinolone acetonide will be administered as intralesional injections into the affected scalp areas at four-week intervals, according to standard clinical practice. | Drug | Intralesional Triamcinolone Acetonide, Microneedling with Topical Triamcinolone Acetonide |
| Microneedling with topical triamcinolone acetonideMicroneedling will be performed on the affected scalp areas followed by local application of triamcinolone acetonide at four-week intervals. | Procedure or surgery | Intralesional Triamcinolone Acetonide, Microneedling with Topical Triamcinolone Acetonide |
Primary outcome
Hair regrowth
Time frame: 12 weeks
Hair regrowth will be assessed by the percentage change in the Severity of Alopecia Tool (SALT) score from baseline.
2 secondary outcomes
treatment success
Time frame: 12 weeks
Treatment-related adverse effects
Time frame: Up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because this is an investigator-initiated academic study, and no formal data-sharing plan has been approved.
Related trials for Alopecia Areata
Recruiting
Efficacy and Safety of Two Hair Supplements in Men With Androgenic Alopecia
Androgenic Alopecia, Healthy Adult Male
Active, not recruitingObservational study
Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib
Alopecia Areata
RecruitingPhase 2
Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata
Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (Apeced), Alopecia Areata
Active, not recruitingPhase 3
A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata
Severe Alopecia Areata
Not yet recruitingPhase 3
Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
Androgenetic Alopecia, Androgenetic Alopecia (AGA)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Triamcinolone acetonide and Microneedling with topical triamcinolone acetonide in people with Alopecia Areata, run by Dow University of Health Sciences 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 9 Nov 2026. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Hafsa HAFSA, MBBS, FCPS (IN PROCESS) (92-332-38229341, hafsawaqas1997@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hair regrowth (time frame: 12 weeks). 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 9 Nov 2026.