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siRNA Microneedle Patches for Earlobe Keloid Post-Surgical Scars

NCT07596628 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2026-05-22

No results posted yet for this study

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

Interventions

DRUG

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.

PROCEDURE

Carbon Dioxide (CO2) Laser Surgery

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)

DRUG

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.

Sponsors & Collaborators

  • National Healthcare Group, Singapore

    collaborator OTHER_GOV

  • Ong Kim Yao

    lead NETWORK

Principal Investigators

  • Suzanne Wei Na Cheng · National Skin Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07596628 on ClinicalTrials.gov