siRNA Microneedle Patches for Ear Keloid Post-Surgical Scars

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

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.

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