Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

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

1 lipca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

158

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Singapur
      • Singapore, Singapur, 308205
        • National Skin Centre
        • Kontakt:
          • Research Coordinator
          • Numer telefonu: +6563506666
        • Główny śledczy:
          • Suzanne Wei Na Cheng
        • Pod-śledczy:
          • Hong Liang Tey
        • Pod-śledczy:
          • Shan Sophie Carrie Cai
        • Pod-śledczy:
          • Yisheng Wong
        • Pod-śledczy:
          • Woo Chiao Tay
        • Pod-śledczy:
          • Xiahong Zhao
        • Pod-śledczy:
          • Kim Yao Ong

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: 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.
Lek: 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.
Procedura: 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)
Eksperymentalny: 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.
Lek: 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.
Lek: 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.

Procedura: 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)

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Post-surgical scar appearance measured using the Vancouver Scar Scale (VSS) score
Ramy czasowe: 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
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change from baseline on the Detroit Keloid Scale
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Ong Kim Yao

Współpracownicy

National Healthcare Group, Singapore

Śledczy

  • Główny śledczy: Suzanne Wei Na Cheng, National Skin Centre

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 czerwca 2026

Zakończenie podstawowe (Szacowany)

1 grudnia 2027

Ukończenie studiów (Szacowany)

1 grudnia 2027

Daty rejestracji na studia

Pierwszy przesłany

13 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

13 maja 2026

Pierwszy wysłany (Rzeczywisty)

19 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

6 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

1 lipca 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • NHG Health DSRB Ref 2025-1631

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Ramy czasowe udostępniania 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.

Kryteria dostępu do udostępniania 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.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Subskrybuj