siRNA Microneedle Patches for Ear Keloid Post-Surgical Scars

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

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

Trial sites (1)