siRNA Microneedle Patches for Ear Keloid Post-Surgical Scars

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.
• Процедура 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)
• Препарат 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.

Первичные конечные точки

• Post-surgical scar appearance measured using the Vancouver Scar Scale (VSS) score [Срок оценки: 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 [Срок оценки: 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)]

Вторичные конечные точки (7)

• Change from baseline on the Detroit Keloid Scale [Срок оценки: 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 [Срок оценки: At first detection of recurrence on any review visits (up to 1 year follow up, through study completion)]
• Recurrence rate [Срок оценки: At first detection of recurrence on any review visits (up to 1 year follow up, through study completion)]
• Time to recurrence (for patients with ear keloid recurrence) [Срок оценки: 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) [Срок оценки: 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)]
• Patient-reported usability of siRNA microneedle patches (for patients in experimental arm only) [Срок оценки: Visits at Day 60, Day 90, Day 120 (review visits while patients in experimental arm are being treated with microneedle patches)]
• Adverse effects [Срок оценки: 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)]

Критерии участия

Критерии включения

• ≥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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Сингапур · 1 центр

• National Skin Centre — Singapore

Идентификаторы

NCT: NCT07596628 · NHG Health DSRB Ref 2025-1631

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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