Fractional CO2 Laser vs Dermabrasion With 5-Fluorouracil for Acquired Leukoderma
Fractional Co2 Laser vs Dermabrasion 5-Flurouracil Delivery in Acquired Leukoderma: A Comparative Study
This randomized controlled prospective single-blinded comparative clinical study aims to compare the efficacy and safety of fractional carbon dioxide (CO2) laser therapy versus mechanical dermabrasion, both combined with topical 5-fluorouracil, in the treatment of acquired non-vitiligo leukoderma. The study will evaluate repigmentation, clinical improvement, patient satisfaction, and treatment-related adverse effects.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
'Non-vitiligo leukoderma represents a heterogeneous group of acquired hypopigmentary disorders that may occur following burns, inflammatory dermatoses, trauma, or other cutaneous insults. Treatment can be challenging because of altered skin architecture, scar formation, and impaired melanocyte function or availability.
This randomized controlled prospective single-blinded comparative clinical study will include 16 patients with acquired non-vitiligo leukoderma recruited from the outpatient clinic of Al-Azhar University Hospital (Assiut). Eligible lesions will be treated using either fractional carbon dioxide (CO2) laser therapy followed by topical 5-fluorouracil or mechanical dermabrasion followed by topical 5-fluorouracil. Random allocation will be performed using a computer-generated random allocation sequence.
Fractional CO2 laser sessions will be performed at 4-6-week intervals, with a total of 3-4 sessions. Mechanical dermabrasion will be performed until pinpoint bleeding appears, followed immediately by topical 5-fluorouracil application, with a total of 3-4 sessions. Similar post-procedure care will be provided.
Treatment outcomes will be assessed using objective and subjective measures, including the Vancouver Scar Scale, Vitiligo Analysis by Computer Assisted Grid (VACAG), assessment of treatment-related adverse effects, physician assessment of clinical improvement using the Mean Improvement Score by Physician (MISP), standardized clinical photography, and patient satisfaction using a 10-point visual analogue scale. Adverse effects such as infection, scarring, Koebner phenomenon, aggravation of depigmentation, pain, burning sensation, erythema, and edema will be documented.
The study will be conducted after approval by the local Ethics Committee of the Faculty of Medicine, Al-Azhar University, Assiut. Written and verbal informed consent will be obtained from participating patients, and privacy of the collected data will be maintained.'
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Walaa Ashraf Sayed
- Número de telefone: MBBS
- E-mail: walaaashraf464@yahoo.com
Locais de estudo
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Asyut Governorate
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Asyut, Asyut Governorate, Egito, 71511
- Faculty of medicine, Al-Azhar University Assuit
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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:
- Patients receiving topical treatment will be required to undergo a two-week washout period.
- No sex predilection.
- Cooperative patients.
- Patients with non-vitiligo leukoderma, including post-burn leukoderma, post-inflammatory hypopigmentation, and stable hypopigmented scar.
Exclusion Criteria:
- Vitiligo leukoderma.
- History of bleeding disorder or current anticoagulant therapy.
- Pregnancy or lactation.
- Keloid scarring or hypertrophic scars.
- Unrealistic expectations.
- Laser therapy within one month prior to enrollment.
- Koebnerization.
- Photosensitivity.
- Seizure disorders.
- Active dermatosis or active bacterial, viral, or fungal cutaneous infection within the treatment area.
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: Fractional CO2 Laser + 5-Fluorouracil
Patients will receive fractional carbon dioxide (CO2) laser therapy followed by topical 5-fluorouracil. Laser parameters will be adjusted according to the site and size of the lesions. Treatment sessions will be performed at 4-6-week intervals for a total of 3-4 sessions. Post-procedure care will include topical antibiotic ointment and emollients. |
Fractional carbon dioxide (CO2) laser therapy followed by topical 5-fluorouracil application. Laser parameters will be adjusted according to lesion size and site. Topical 5-fluorouracil applied immediately after fractional CO2 laser or dermabrasion according to the assigned study arm. |
|
Comparador Ativo: Dermabrasion + 5-Fluorouracil
Patients will undergo mechanical dermabrasion using manual or motor-driven dermabrasion until the appearance of pinpoint bleeding, followed immediately by topical 5-fluorouracil application. A total of 3-4 sessions will be performed. Similar post-procedure care will be provided. � |
Topical 5-fluorouracil applied immediately after fractional CO2 laser or dermabrasion according to the assigned study arm. Mechanical dermabrasion using manual or motor-driven dermabrasion followed immediately by topical 5-fluorouracil application. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Degree of Repigmentation
Prazo: At baseline and 6 months after treatment
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Repigmentation will be assessed by two blinded dermatologists using the Mean Improvement Score by Physician (MISP), based on a 5-grade scale: grade 1, <25% improvement; grade 2, 25-49%; grade 3, 50-74%; grade 4, >75-99%; and grade 5, 100% complete repigmentation. |
At baseline and 6 months after treatment
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
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
Termos MeSH relevantes adicionais
- Doenças de pele
- Distúrbios de Pigmentação
- Doenças da Pele e do Tecido Conjuntivo
- Vitiligo
- Hipopigmentação
- Compostos heterocíclicos, 1 anel
- Compostos heterocíclicos
- Terapêutica
- Procedimentos cirúrgicos, operatórios
- Pirimidinas
- Uracil
- Pirimidinonas
- Procedimentos de cirurgia plástica
- Técnicas cosméticas
- Procedimentos Cirúrgicos Dermatológicos
- Fluorouracila
- Dermoabrasão
Outros números de identificação do estudo
- MSC/AZ.AST./DVA021/9/245/4/26
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 with other researchers.
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