siRNA Microneedle Patches for Earlobe Keloid Post-Surgical Scars

NCT07596628 | Not Yet Recruiting Phase 2

• 1 other identifier: NHG Health DSRB Ref 2025-1631
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate whether small interfering RNA (siRNA) microneedle patches can improve the scar appearances of earlobe 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 earlobe 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

Keywords

keloid; microneedles; scars; small intefering RNA; RNA; ear; earlobe

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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

  At first detection of recurrence on any review visits (up to 1 year follow up, through study completion)

• Recurrence rate

  At first detection of recurrence on any review visits (up to 1 year follow up, through study completion)

• Time to recurrence (for patients with earlobe keloid recurrence)

  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 earlobe keloid recurrence)

  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)

Study Arms (2)

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 earlobe 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.

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 earlobe 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.

Drug: Small interfering RNA (siRNA) Microneedle Patches; Procedure: Carbon Dioxide (CO2) Laser Surgery; Drug: Intralesional Triamcinolone 40 mg/mL

Interventions

Small interfering RNA (siRNA) Microneedle Patches DRUG

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.

CO2 laser surgery followed by intralesional steroids and siRNA microneedle patches

Carbon Dioxide (CO2) Laser Surgery PROCEDURE

Carbon Dioxide (CO2) laser ablation of the earlobe keloid will be performed, followed by intralesional corticosteroid injections alone (active comparator arm) or with siRNA microneedle patches (experimental arm)

CO2 laser surgery followed by intralesional steroid injection; CO2 laser surgery followed by intralesional steroids and siRNA microneedle patches

Intralesional Triamcinolone 40 mg/mL DRUG

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.

CO2 laser surgery followed by intralesional steroid injection; CO2 laser surgery followed by intralesional steroids and siRNA microneedle patches

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥21 years old
• Not pregnant, breastfeeding or lactating
• Able to give consent to participate in trial
• Keloid on the earlobe
• 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)
• Keloid must have protruded and extended beyond the margin of the initial injury
• Keloid base maximally 1cm by 1cm in size
• Patients who will not undergo additional ear piercing or surgical procedures during the follow-up period

You may not qualify if:

• Pregnant, breastfeeding or lactating
• Age \<21 years old or unable to provide consent (e.g. from cognitive impairment)
• Keloid anywhere else on the ear apart from earlobe (including helix)
• Keloid base more than 1cm by 1cm in size
• 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

Sponsors & Collaborators

• Ong Kim Yao: lead
• National Healthcare Group, Singapore: collaborator

Study Sites (1)

National Skin Centre

Singapore, 308205, Singapore

Location

MeSH Terms

Conditions

Keloid; Cicatrix

Interventions

RNA, Small Interfering; Carbon Dioxide; Laser Therapy

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RNA, Antisense; Antisense Elements (Genetics); Nucleic Acids, Nucleotides, and Nucleosides; RNA; Nucleic Acids; RNA, Small Untranslated; RNA, Untranslated; Carbon Compounds, Inorganic; Inorganic Chemicals; Gases; Oxides; Oxygen Compounds; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Suzanne Wei Na Cheng

  National Skin Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kim Yao Ong

CONTACT

+6598327799; ongkimyao@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Investigator and Internal Medicine Junior Resident

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 19, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: De-identified individual participant data will be made available beginning 12 months following publication of the primary study results and ending 3 years thereafter.
• Access Criteria: 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.

Locations

SG (1)