siRNA Microneedle Patches for Ear Keloid Post-Surgical Scars
Singapore158 participantsStarted 2026-06
Plain-language 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.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Post-surgical scar appearance measured using the Vancouver Scar Scale (VSS) score
Timeframe: 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)
2
Post-surgical scar appearance measured using Scar Cosmesis Assessment and Rating (SCAR) scale
Timeframe: 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)