Small Interfering RNA (siRNA) Microneedle Patches on the Appearance of Ear Keloid Post-Surgical Scars: A Randomised Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 158
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Intralesional Triamcinolone 40 mg/mL (Drug)
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.
干预措施: Carbon Dioxide (CO2) Laser Surgery (Procedure)
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.
干预措施: Small interfering RNA (siRNA) Microneedle Patches (Drug)
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.
干预措施: Carbon Dioxide (CO2) Laser Surgery (Procedure)
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.
干预措施: Intralesional Triamcinolone 40 mg/mL (Drug)
结局指标
主要结局
未指定
次要结局
- Patient-reported usability of siRNA microneedle patches (for patients in experimental arm only)(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)(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)(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))
研究者
Ong Kim Yao
Co-Investigator and Internal Medicine Junior Resident
National Skin Centre