Comparative Effectiveness of Intralesional Injection of Triamcinolone Acetonide vs. Microneedling With Local Application of Triamcinolone Acetonide in the Treatment of Alopecia Areata

November 3, 2026 updated by: Dow University of Health Sciences

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
276

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 12345
        • Recruiting
        • Dow University Hospital, Ojha Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intralesional Triamcinolone Acetonide

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.
Drug: Triamcinolone acetonide

Triamcinolone acetonide will be administered as intralesional injections into the affected scalp areas at four-week intervals, according to standard clinical practice.

Procedure: Microneedling with topical triamcinolone acetonide

Microneedling will be performed on the affected scalp areas followed by local application of triamcinolone acetonide at four-week intervals.
Experimental: Microneedling with Topical Triamcinolone Acetonide

Participants in this arm will undergo microneedling of the affected scalp areas followed by local application of triamcinolone acetonide at four-week intervals.
Drug: Triamcinolone acetonide

Triamcinolone acetonide will be administered as intralesional injections into the affected scalp areas at four-week intervals, according to standard clinical practice.

Procedure: Microneedling with topical triamcinolone acetonide

Microneedling will be performed on the affected scalp areas followed by local application of triamcinolone acetonide at four-week intervals.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
treatment success
Time Frame: 12 weeks

Treatment success will be defined as a 50 percent or greater reduction in the Severity of Alopecia Tool (SALT) score compared to baseline.
12 weeks
Treatment-related adverse effects
Time Frame: Up to 12 weeks

Local adverse effects including pain, erythema, bleeding, infection, skin atrophy, telangiectasia, and pigmentary changes will be recorded during the study period.
Up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dow University of Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-4379/DUHS/Approval/2025/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared because this is an investigator-initiated academic study, and no formal data-sharing plan has been approved.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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