siRNA Microneedle Patches for Ear Keloid Post-Surgical Scars (SILK)
2026年7月1日 更新者：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.
調査の概要
状態
まだ募集していません
条件
研究の種類
介入
入学 (推定)
158
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Kim Yao Ong
- 電話番号：+6598327799
- メール：ongkimyao@gmail.com
研究場所
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Singapore、シンガポール、308205
- National Skin Centre
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コンタクト：
- Research Coordinator
- 電話番号：+6563506666
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主任研究者：
- Suzanne Wei Na Cheng
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副調査官：
- Hong Liang Tey
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副調査官：
- Shan Sophie Carrie Cai
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副調査官：
- Yisheng Wong
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副調査官：
- Woo Chiao Tay
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副調査官：
- Xiahong Zhao
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副調査官：
- Kim Yao Ong
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ：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.
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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)
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実験的：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.
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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)
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Post-surgical scar appearance measured using the Vancouver Scar Scale (VSS) score
時間枠：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)
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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.
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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)
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Post-surgical scar appearance measured using Scar Cosmesis Assessment and Rating (SCAR) scale
時間枠：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)
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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.
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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)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from baseline on the Detroit Keloid Scale
時間枠：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)
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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.
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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)
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Presence of recurrence
時間枠：At first detection of recurrence on any review visits (up to 1 year follow up, through study completion)
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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.
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At first detection of recurrence on any review visits (up to 1 year follow up, through study completion)
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Recurrence rate
時間枠：At first detection of recurrence on any review visits (up to 1 year follow up, through study completion)
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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.
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At first detection of recurrence on any review visits (up to 1 year follow up, through study completion)
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Adverse effects
時間枠：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)
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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.
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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)
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Patient-reported usability of siRNA microneedle patches (for patients in experimental arm only)
時間枠：Visits at Day 60, Day 90, Day 120 (review visits while patients in experimental arm are being treated with microneedle patches)
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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).
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Visits at Day 60, Day 90, Day 120 (review visits while patients in experimental arm are being treated with microneedle patches)
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Time to recurrence (for patients with ear keloid recurrence)
時間枠：From day of CO2 laser surgery to day of first detection of keloid recurrence (up to 1 year follow up, through study completion)
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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.
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From day of CO2 laser surgery to day of first detection of keloid recurrence (up to 1 year follow up, through study completion)
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Secondary rescue treatment (for patients with ear keloid recurrence)
時間枠：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)
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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).
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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)
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Suzanne Wei Na Cheng、National Skin Centre
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月1日
一次修了 (推定)
2027年12月1日
研究の完了 (推定)
2027年12月1日
試験登録日
最初に提出
2026年5月13日
QC基準を満たした最初の提出物
2026年5月13日
最初の投稿 (実際)
2026年5月19日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月6日
QC基準を満たした最後の更新が送信されました
2026年7月1日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- NHG Health DSRB Ref 2025-1631
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD 共有時間枠
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 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
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いいえ
米国FDA規制機器製品の研究
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