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siRNA Microneedle Patches for Ear Keloid Post-Surgical Scars
Sponsor: Ong Kim Yao
Summary
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.
Official title: Small Interfering RNA (siRNA) Microneedle Patches on the Appearance of Ear Keloid Post-Surgical Scars: A Randomised Controlled Clinical Trial
Key Details
Gender
All
Age Range
21 Years - Any
Study Type
INTERVENTIONAL
Enrollment
158
Start Date
2026-06
Completion Date
2027-12
Last Updated
2026-07-06
Healthy Volunteers
No
Conditions
Interventions
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.
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)
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.
Locations (1)
National Skin Centre
Singapore, Singapore