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siRNA Microneedle Patches for Ear Keloid Post-Surgical Scars (SILK)

1 de julho de 2026 atualizado por: Ong Kim Yao

Small Interfering RNA (siRNA) Microneedle Patches on the Appearance of Ear Keloid Post-Surgical Scars: A Randomised Controlled Clinical Trial

The goal of this clinical trial is to evaluate whether small interfering RNA (siRNA) microneedle patches can improve the scar appearances of ear keloids treated with surgery. The main questions it aims to answer are:

  • Do siRNA microneedle patches improve post-surgical scar appearance?
  • Do siRNA microneedle patches improve keloid-related symptoms, recurrence, usability, and tolerability?

Researchers will compare standard treatment with CO₂ laser surgery followed by steroid injection with and without siRNA microneedle patches to see if the patches work to improve scar appearance.

Participants will:

  • Undergo CO₂ laser ablation of an ear keloid.
  • Be randomly assigned to receive steroid injections alone every month for four doses, or to receive both steroid injections and siRNA microneedle patches.
  • Visit the clinic at regular intervals for check ups and tests including photography.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

158

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Cingapura
      • Singapore, Cingapura, 308205
        • National Skin Centre
        • Contato:
          • Research Coordinator
          • Número de telefone: +6563506666
        • Investigador principal:
          • Suzanne Wei Na Cheng
        • Subinvestigador:
          • Hong Liang Tey
        • Subinvestigador:
          • Shan Sophie Carrie Cai
        • Subinvestigador:
          • Yisheng Wong
        • Subinvestigador:
          • Woo Chiao Tay
        • Subinvestigador:
          • Xiahong Zhao
        • Subinvestigador:
          • Kim Yao Ong

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • ≥21 years old
  • Not pregnant, breastfeeding or lactating
  • Able to give consent to participate in trial
  • Keloid affecting any part of the ear

  • One keloid recruited per patient

    • For patients with bilateral earlobe keloids, only one earlobe keloid will be recruited (either left or right)
    • For patients with both anterior and posterior earlobe keloid on a single ear, only one side will be recruited (either anterior or posterior)
    • For patients with multiple keloids on a single ear (e.g. both earlobe and helix), only one keloid will be recruited (i.e. earlobe or helix)
  • Keloid must have protruded and extended beyond the margin of the initial injury
  • Keloid base maximally 2cm in diameter
  • Patients who will not undergo additional ear piercing or surgical procedures during the follow-up period

Exclusion Criteria:

  • Pregnant, breastfeeding or lactating
  • Age <21 years old or unable to provide consent (e.g. from cognitive impairment)
  • Keloid anywhere else on the body apart from ear
  • Keloid base more than 2cm in diameter
  • Known allergy to any of the following: local anaesthetics, triamcinolone, siRNA microneedle patches, plasters, mepilex silver foam dressing, both penicillin and macrolide antibiotics
  • Participants assessed to be uncooperative or unable to self-administer the interventions

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: CO2 laser surgery followed by intralesional steroid injection
In the active comparator arm, participants are first treated with CO2 laser surgery of the ear keloid. The first dose of intralesional steroid injection is given immediately to the wound bed post-surgery, followed by subsequent doses of intralesional steroid injection administered at monthly intervals for four doses in total.
Medicamento: Intralesional Triamcinolone 40 mg/mL
Intralesional triamcinolone 40mg/ml injection. The first dose is given immediately to the wound bed post-surgery, then at monthly intervals for four doses in total.
Procedimento: Carbon Dioxide (CO2) Laser Surgery
Carbon Dioxide (CO2) laser ablation of the ear keloid will be performed, followed by intralesional corticosteroid injections alone (active comparator arm) or with siRNA microneedle patches (experimental arm)
Experimental: CO2 laser surgery followed by intralesional steroids and siRNA microneedle patches
In the experimental arm, participants are first treated with CO2 laser surgery of the ear keloid. The first dose of intralesional steroid injection is given immediately to the wound bed post-surgery, followed by subsequent doses of intralesional steroid injection administered at monthly intervals for four doses in total. In addition, participants will apply siRNA microneedle patches for 10 hours per day for 90 days in total except on days where intralesional steroid injection is given to permit healing at puncture site.
Medicamento: Intralesional Triamcinolone 40 mg/mL
Intralesional triamcinolone 40mg/ml injection. The first dose is given immediately to the wound bed post-surgery, then at monthly intervals for four doses in total.
Medicamento: Small interfering RNA (siRNA) Microneedle Patches

Silencing or small interfering RNA (siRNA) are used to alter the expression of transforming growth factor secreted protein acidic and cysteine-rich (SPARC), a key mediator of wound fibrosis and keloid scar formation. Conjugating siRNA targeting SPARC mRNA with tyramine-modified gelatin to form a positively-charged nanoplex can help to enable siRNA protection against rapid in-vivo degradation, promoting uptake into fibroblasts via endocytosis, and enhacing targeted cellular delivery of the siRNA. These siRNA nanoplexes targeting SPARC mRNA are embedded in the tips of hyaluronic acid dissolvable microneedles (siRNA microneedles) to enhance transcutaneous drug delivery.

In this study, participants in the experimental arm will apply siRNA microneedle patches daily for 10 hours a day in between monthly doses of intralesional corticosteroid injection for 90 days in total.

Procedimento: Carbon Dioxide (CO2) Laser Surgery
Carbon Dioxide (CO2) laser ablation of the ear keloid will be performed, followed by intralesional corticosteroid injections alone (active comparator arm) or with siRNA microneedle patches (experimental arm)

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Post-surgical scar appearance measured using the Vancouver Scar Scale (VSS) score
Prazo: Visits at Day 0 (CO2 laser surgery), Day 15, Day 30, Day 60, Day 90, Day 120, Day 180, Day 270, Day 360 (through study completion)
The Vancouver Scar Scale (VSS) is a validated clinician-reported instrument that is a measure of scar severity comprising 4 domains assessing scar appearance and physical characteristics. The scale evaluates Vascularity (from 0 to 3), Pigmentation (from 0 to 2), Pliability (from 0 to 5) and Height (from 0 to 3). Each domain is assigned an individual score and combined to provide a total scar severity score ranging from 0 to 13, with higher values representing greater scar severity and poorer scar appearance. Changes in score over time may be used to assess response to treatment, with reductions in score representing clinical improvement. Score at baseline (post-surgical scar immediately post CO2 laser surgery) and at each review visit will be compared.
Visits at Day 0 (CO2 laser surgery), Day 15, Day 30, Day 60, Day 90, Day 120, Day 180, Day 270, Day 360 (through study completion)
Post-surgical scar appearance measured using Scar Cosmesis Assessment and Rating (SCAR) scale
Prazo: Visits at Day 0 (CO2 laser surgery), Day 15, Day 30, Day 60, Day 90, Day 120, Day 180, Day 270, Day 360 (through study completion)
The Scar Cosmesis Assessment and Rating (SCAR) scale is a validated clinician-reported instrument that is a measure of post-surgical scar quality comprising multiple domains assessing scar appearance, symptoms, and overall cosmetic outcome. The scale evaluates Scar Spread (from 0 to 4), Erythema (from 0 to 3), Dyspigmentation (from 0 to 2), Track or suture marks (from 0 to 1), Hypertrophy or atrophy (from 0 to 3), Overall impression (from 0 to 1), and patient rated bothersome itch and pain over the preceding 24 hours (Yes or No). Individual domain scores are combined to provide a total assessment of scar severity and cosmesis, with higher values representing poorer scar appearance and greater symptom burden. Changes in score over time may be used to assess response to treatment, with reductions in score representing clinical improvement. Score at baseline (post-surgical scar immediately post CO2 laser surgery) and at each review visit will be compared.
Visits at Day 0 (CO2 laser surgery), Day 15, Day 30, Day 60, Day 90, Day 120, Day 180, Day 270, Day 360 (through study completion)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change from baseline on the Detroit Keloid Scale
Prazo: Visits at Recruitment (before treatment), Day 0 (CO2 laser surgery), Day 15, Day 30, Day 60, Day 90, Day 120, Day 180, Day 270, Day 360 (through study completion)
The Detroit Keloid Scale (DKS) is a validated, clinician- and patient-reported instrument to assess the severity and treatment response of keloids. It is designed specifically for keloid scars and evaluates both objective scar characteristics and patient symptoms. The DKS has two components - the Observer Keloid Assessment (clinician-reported domains of location, height and surface area) and Patient Keloid Questionnaire (patient-reported domains of pruritus, pain, contracture/limitation to range of motion and quality of life). Scores from each domain are combined to provide a total assessment of keloid severity, with higher values representing greater disease severity and symptom burden. Changes in score over time may be used to assess response to treatment, with reductions in score representing clinical improvement. Score at baseline and at each review visit will be compared.
Visits at Recruitment (before treatment), Day 0 (CO2 laser surgery), Day 15, Day 30, Day 60, Day 90, Day 120, Day 180, Day 270, Day 360 (through study completion)
Presence of recurrence
Prazo: At first detection of recurrence on any review visits (up to 1 year follow up, through study completion)
Keloid recurrence will be defined by Height score of at least 1 on the Observer Keloid Assessment of the DKS. The keloid wound bed will be flat post-CO2 laser surgery and increase in height is taken to be an early marker of keloid recurrence.
At first detection of recurrence on any review visits (up to 1 year follow up, through study completion)
Recurrence rate
Prazo: At first detection of recurrence on any review visits (up to 1 year follow up, through study completion)
The recurrence rate in each arm will be measured. It is calculated as the number of patients with keloid recurrence divided by the total number of patients in the treatment arm.
At first detection of recurrence on any review visits (up to 1 year follow up, through study completion)
Adverse effects
Prazo: Visits at Day 0 (CO2 laser surgery), Day 15, Day 30, Day 60, Day 90, Day 120, Day 180, Day 270, Day 360 (through study completion)
Patients will be monitored for any adverse effects from the CO2 laser surgery, intralesional corticosteroid injections and/or the siRNA microneedle patches, such as but not limited to - dyspigmentation, skin atrophy, telangiectasia, edema, infection, contact dermatitis, ulceration, necrosis.
Visits at Day 0 (CO2 laser surgery), Day 15, Day 30, Day 60, Day 90, Day 120, Day 180, Day 270, Day 360 (through study completion)
Patient-reported usability of siRNA microneedle patches (for patients in experimental arm only)
Prazo: Visits at Day 60, Day 90, Day 120 (review visits while patients in experimental arm are being treated with microneedle patches)
Patients in the experimental arm who will receive the siRNA microneedle patches will fill in a questionnaire on the usability of the siRNA microneedle patches. The questionnaire evaluates 1) degree of acceptability of microneedle patches (four options of very acceptable, acceptable fair or not acceptable), 2) whether patients will use the microneedles patch again in the future to treat any future post-surgcial scars (Yes/No response, with further open ended elaboration), and 3) areas of improvement to suggest if any (optional open ended).
Visits at Day 60, Day 90, Day 120 (review visits while patients in experimental arm are being treated with microneedle patches)
Time to recurrence (for patients with ear keloid recurrence)
Prazo: From day of CO2 laser surgery to day of first detection of keloid recurrence (up to 1 year follow up, through study completion)
For patients with recurrent ear keloid, time to ear keloid recurrence will be measured. It is calculated as the time from CO2 laser surgery (denoted as day 0) to time of first detection of keloid recurrence in days.
From day of CO2 laser surgery to day of first detection of keloid recurrence (up to 1 year follow up, through study completion)
Secondary rescue treatment (for patients with ear keloid recurrence)
Prazo: Visits at Day 15, Day 30, Day 60, Day 90, Day 120, Day 180, Day 270, Day 360 visits, starting from first detection of recurrence (through study completion)
For patients with recurrent ear keloid, secondary rescue treatment will be measured in terms of treatment modality offered (such as repeat CO2 laser surgery, intralesional steroid injection) and response (resolution, partial response, no response).
Visits at Day 15, Day 30, Day 60, Day 90, Day 120, Day 180, Day 270, Day 360 visits, starting from first detection of recurrence (through study completion)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Ong Kim Yao

Colaboradores

National Healthcare Group, Singapore

Investigadores

  • Investigador principal: Suzanne Wei Na Cheng, National Skin Centre

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de junho de 2026

Conclusão Primária (Estimado)

1 de dezembro de 2027

Conclusão do estudo (Estimado)

1 de dezembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

13 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

13 de maio de 2026

Primeira postagem (Real)

19 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

6 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

1 de julho de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • NHG Health DSRB Ref 2025-1631

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Prazo de Compartilhamento de IPD

De-identified individual participant data will be made available beginning 12 months following publication of the primary study results and ending 3 years thereafter.

Critérios de acesso de compartilhamento IPD

Access to de-identified individual participant data may be granted to qualified researchers for scientifically sound research proposals approved by the study investigators and sponsoring institution. Requests must include a research proposal and statistical analysis plan. Data sharing is subject to applicable institutional, ethical, and regulatory approvals, and a signed data sharing agreement may be required prior to release of data. Data will be provided in a de-identified format through secure institutional channels upon approval of request.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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