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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 4
Kontakter og lokationer
Studiekontakt
- Navn: Dr Hafsa HAFSA, MBBS, FCPS (IN PROCESS)
- Telefonnummer: 92-332-38229341
- E-mail: hafsawaqas1997@gmail.com
Studiesteder
-
-
Sindh
-
Karachi, Sindh, Pakistan, 12345
- Rekruttering
- Dow University Hospital, Ojha Campus
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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. |
|
Eksperimentel: 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Hair regrowth
Tidsramme: 12 weeks
|
Hair regrowth will be assessed by the percentage change in the Severity of Alopecia Tool (SALT) score from baseline. |
12 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
treatment success
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske Tilstande, Anatomiske
- Hudsygdomme
- Hypotrikose
- Hårsygdomme
- Patologiske tilstande, tegn og symptomer
- Hud- og bindevævssygdomme
- Alopecia areata
- Alopeci
- Terapeutik
- Punkteringer
- Komplementære terapier
- Fysioterapimodaliteter
- Polycykliske forbindelser
- Triamcinolon
- Gravidier
- Graviditet
- Steroider
- SMUSED-RING-forbindelser
- Steroider, fluoreret
- Rehabilitering
- Triamcinolonacetonid
- Perkutan kollageninduktion
Andre undersøgelses-id-numre
- IRB-4379/DUHS/Approval/2025/20
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Individual participant data will not be shared because this is an investigator-initiated academic study, and no formal data-sharing plan has been approved.
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