siRNA Microneedle Patches for Ear Keloid Post-Surgical Scars (SILK)
2026년 7월 1일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
정황
연구 유형
중재적
등록 (추정된)
158
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Kim Yao Ong
- 전화번호: +6598327799
- 이메일: ongkimyao@gmail.com
연구 장소
-
-
-
Singapore, 싱가포르, 308205
- National Skin Centre
-
연락하다:
- Research Coordinator
- 전화번호: +6563506666
-
수석 연구원:
- Suzanne Wei Na Cheng
-
부수사관:
- Hong Liang Tey
-
부수사관:
- Shan Sophie Carrie Cai
-
부수사관:
- Yisheng Wong
-
부수사관:
- Woo Chiao Tay
-
부수사관:
- Xiahong Zhao
-
부수사관:
- Kim Yao Ong
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: 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.
|
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.
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)
|
|
실험적: 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.
|
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.
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.
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)
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Post-surgical scar appearance measured using the Vancouver Scar Scale (VSS) score
기간: 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
기간: 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)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from baseline on the Detroit Keloid Scale
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Suzanne Wei Na Cheng, National Skin Centre
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 6월 1일
기본 완료 (추정된)
2027년 12월 1일
연구 완료 (추정된)
2027년 12월 1일
연구 등록 날짜
최초 제출
2026년 5월 13일
QC 기준을 충족하는 최초 제출
2026년 5월 13일
처음 게시됨 (실제)
2026년 5월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 6일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 1일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- NHG Health DSRB Ref 2025-1631
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 공유 기간
De-identified individual participant data will be made available beginning 12 months following publication of the primary study results and ending 3 years thereafter.
IPD 공유 액세스 기준
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.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .