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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 4
Contactos e Locais
Contato de estudo
- Nome: Dr Hafsa HAFSA, MBBS, FCPS (IN PROCESS)
- Número de telefone: 92-332-38229341
- E-mail: hafsawaqas1997@gmail.com
Locais de estudo
-
-
Sindh
-
Karachi, Sindh, Paquistão, 12345
- Recrutamento
- Dow University Hospital, Ojha Campus
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Hair regrowth
Prazo: 12 weeks
|
Hair regrowth will be assessed by the percentage change in the Severity of Alopecia Tool (SALT) score from baseline. |
12 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
treatment success
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Condições Patológicas, Anatômicas
- Doenças de pele
- Hipotricose
- Doenças do cabelo
- Condições Patológicas, Sinais e Sintomas
- Doenças da Pele e do Tecido Conjuntivo
- Alopecia areata
- Alopecia
- Terapêutica
- Perfurações
- Terapias complementares
- Modalidades de fisioterapia
- Compostos policíclicos
- Triamcinolona
- Pregada
- Pregnas
- Esteróides
- Compostos de anel fundido
- Esteróides, fluorados
- Reabilitação
- Acetonido de triancinolona
- Indução percutânea de colágeno
Outros números de identificação do estudo
- IRB-4379/DUHS/Approval/2025/20
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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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