Keloid of Ear LobePhase 2SILKNCT07596628

siRNA Microneedle Patches for Ear Keloid Post-Surgical Scars

A Phase 2 study testing Small interfering RNA (siRNA) Microneedle Patches, Carbon Dioxide (CO2) Laser Surgery and Intralesional Triamcinolone 40 mg/mL in people with Keloid of Ear Lobe, run by Ong Kim Yao at 1 site in Singapore.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Keloid of Ear Lobe
What is being tested?: Small interfering RNA (siRNA) Microneedle Patches, Carbon Dioxide (CO2) Laser Surgery and Intralesional Triamcinolone 40 mg/mL
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 158 participants
Where: 1 siteSingapore
Study dates: Jun 2026to Dec 2027
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

≥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)

Show all 11Show fewer

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kim Yao Ong contact

+6598327799

ongkimyao@gmail.com

Singapore1 site

National Skin Centre
Singapore, 308205
Research Coordinator, +6563506666
Suzanne Wei Na Cheng

Other trials in Singapore

About this study

Official title: Small Interfering RNA (siRNA) Microneedle Patches on the Appearance of Ear Keloid Post-Surgical Scars: A Randomised Controlled Clinical Trial

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.

Conditions: Keloid of Ear Lobe
Being tested: Small interfering RNA (siRNA) Microneedle Patches, Carbon Dioxide (CO2) Laser Surgery, Intralesional Triamcinolone 40 mg/mL
Keywords: keloid, microneedles, scars, small intefering RNA, RNA, ear, earlobe
Medical subject headings: Keloid, Cicatrix

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Small interfering RNA (siRNA) Microneedle PatchesDrug
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 SurgeryProcedure or 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/mLDrug
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.

Study groups in NCT07596628
Study group	Role	What they receive
CO2 laser surgery followed by intralesional steroid injection	Active comparator	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. Receives: Procedure: Carbon Dioxide (CO2) Laser Surgery; Drug: Intralesional Triamcinolone 40 mg/mL
CO2 laser surgery followed by intralesional steroids and siRNA microneedle patches	Experimental	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. Receives: Drug: Small interfering RNA (siRNA) Microneedle Patches; Procedure: Carbon Dioxide (CO2) Laser Surgery; Drug: Intralesional Triamcinolone 40 mg/mL

What is being measured

The primary outcome is the main question the study is designed to answer.

Post-surgical scar appearance measured using the Vancouver Scar Scale (VSS) score
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.
Measured: 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
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.
Measured: 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)

Secondary outcomes (7)

Change from baseline on the Detroit Keloid Scale
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.
Measured: 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
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.
Measured: At first detection of recurrence on any review visits (up to 1 year follow up, through study completion)
Recurrence rate
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.
Measured: At first detection of recurrence on any review visits (up to 1 year follow up, through study completion)
Time to recurrence (for patients with ear keloid recurrence)
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.
Measured: 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)
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).
Measured: 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)
Patient-reported usability of siRNA microneedle patches (for patients in experimental arm only)
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).
Measured: Visits at Day 60, Day 90, Day 120 (review visits while patients in experimental arm are being treated with microneedle patches)
Adverse effects
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.
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2026Dec 2027

First posted19 May 2026
Study startJun 2026 (estimated)
Primary completionDec 2027 (estimated)
Study completionDec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Keloid of Ear LobeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 158 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07596628
Sponsor's protocol ID: NHG Health DSRB Ref 2025-1631
Acronym: SILK
Status last verified: May 2026
First submitted: 13 May 2026
Last updated: 6 Jul 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Study at a glance

From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Small Interfering RNA (siRNA) Microneedle Patches on the Appearance of Ear Keloid Post-Surgical Scars: A Randomised Controlled Clinical Trial
ClinicalTrials.gov ID: NCT07596628
Acronym / sponsor ID: SILK / NHG Health DSRB Ref 2025-1631
Conditions: Keloid of Ear Lobe
Keywords: keloid, microneedles, scars, small intefering RNA, RNA, ear, earlobe
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 158 participants (estimated)
Lead sponsor: Ong Kim YaoResearch network
Collaborators: National Healthcare Group, Singapore
Study start: Jun 2026 (estimated)
Primary completion: Dec 2027 (estimated)
Study completion: Dec 2027 (estimated)
First posted: 19 May 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
CO2 laser surgery followed by intralesional steroid injection	Active comparator	Procedure: Carbon Dioxide (CO2) Laser Surgery, Drug: Intralesional Triamcinolone 40 mg/mLIn 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.
CO2 laser surgery followed by intralesional steroids and siRNA microneedle patches	Experimental	Drug: Small interfering RNA (siRNA) Microneedle Patches, Procedure: Carbon Dioxide (CO2) Laser Surgery, Drug: Intralesional Triamcinolone 40 mg/mLIn 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.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

≥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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Small interfering RNA (siRNA) Microneedle PatchesSilencing 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.	Drug	CO2 laser surgery followed by intralesional steroids and siRNA microneedle patches
Carbon Dioxide (CO2) Laser SurgeryCarbon 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)	Procedure or surgery	CO2 laser surgery followed by intralesional steroid injection, CO2 laser surgery followed by intralesional steroids and siRNA microneedle patches
Intralesional Triamcinolone 40 mg/mLIntralesional 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.	Drug	CO2 laser surgery followed by intralesional steroid injection, CO2 laser surgery followed by intralesional steroids and siRNA microneedle patches

Primary outcome

Post-surgical scar appearance measured using the Vancouver Scar Scale (VSS) score
Time frame: 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.
Post-surgical scar appearance measured using Scar Cosmesis Assessment and Rating (SCAR) scale
Time frame: 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.

7 secondary outcomes

Change from baseline on the Detroit Keloid Scale
Time frame: 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
Time frame: At first detection of recurrence on any review visits (up to 1 year follow up, through study completion)
Recurrence rate
Time frame: At first detection of recurrence on any review visits (up to 1 year follow up, through study completion)
Time to recurrence (for patients with ear keloid recurrence)
Time frame: 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)
Time frame: 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)
Patient-reported usability of siRNA microneedle patches (for patients in experimental arm only)
Time frame: Visits at Day 60, Day 90, Day 120 (review visits while patients in experimental arm are being treated with microneedle patches)
Adverse effects
Time frame: 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)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
Individual participant dataSharing planned: Yes

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Kim Yao Ong contact

+6598327799

ongkimyao@gmail.com

Suzanne Wei Na Cheng principal investigator

National Skin Centre

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kim Yao Ong (+6598327799, ongkimyao@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-surgical scar appearance measured using the Vancouver Scar Scale (VSS) score (time frame: 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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07596628.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.