Comparative Effectiveness of Intralesional Injection of Triamcinolone Acetonide vs. Microneedling With Local Application of Triamcinolone Acetonide in the Treatment of Alopecia Areata
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
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Dr Hafsa HAFSA, MBBS, FCPS (IN PROCESS)
- Phone Number: 92-332-38229341
- Email: hafsawaqas1997@gmail.com
Study Locations
-
-
Sindh
-
Karachi, Sindh, Pakistan, 12345
- Recruiting
- Dow University Hospital, Ojha Campus
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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. |
Triamcinolone acetonide will be administered as intralesional injections into the affected scalp areas at four-week intervals, according to standard clinical practice. 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. |
Triamcinolone acetonide will be administered as intralesional injections into the affected scalp areas at four-week intervals, according to standard clinical practice. 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
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
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathological Conditions, Anatomical
- Skin Diseases
- Hypotrichosis
- Hair Diseases
- Pathological Conditions, Signs and Symptoms
- Skin and Connective Tissue Diseases
- Alopecia Areata
- Alopecia
- Therapeutics
- Punctures
- Complementary Therapies
- Physical Therapy Modalities
- Polycyclic Compounds
- Triamcinolone
- Pregnadienes
- Pregnanes
- Steroids
- Fused-Ring Compounds
- Steroids, Fluorinated
- Rehabilitation
- Triamcinolone Acetonide
- Percutaneous Collagen Induction
Other Study ID Numbers
- IRB-4379/DUHS/Approval/2025/20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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
Studies a U.S. FDA-regulated device product
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.