What is this study trying to find out about post-surgical scars?

This study is comparing two types of microneedle patches containing small interfering RNA (siRNA) to see how they affect the appearance of post-surgical scars. Researchers want to understand if one patch works differently than the other to improve scar healing and appearance. The study is sponsored by the National Skin Centre and involves close monitoring of scar changes over time.

Who may be eligible for this post-surgical scar clinical trial?

Adults aged 21 to 75 who have undergone surgery with an incision into the dermis about two weeks prior and have had their stitches removed may be eligible. Participants must have fully closed wounds and be able to consent and apply the patches themselves. Please review eligibility criteria for more details.

Is there any cost to participate in this post-surgical scar clinical trial?

Study-related care, including the study patches and all trial visits, is provided at no cost. Personal travel or other expenses may vary and are not guaranteed to be covered during the trial.

Actively Recruiting

Phase 2

Age: 21Years - 75Years

All Genders

Healthy Volunteers

ID06138964

Randomized Double-blinded Trial Comparing siSPARC Microneedle Patch Versus siSPARC siLR4A Microneedle Patch on Appearance of Post-surgical Scars

Led by National Skin Centre · Updated on 2024-06-24

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

The trial investigates the effect on appearance of post-surgical scars using two different microneedle patches containing small interfering RNA siRNA. Researchers aim to compare daily application of the siSPARC microneedle patch versus the siSPARC siLR4A microneedle patch in adults aged 21 to 75 who have undergone surgery. This phase 2, randomized, double-blind controlled study is conducted at a single center and sponsored by the National Skin Centre. Participants will apply one of the two microneedle patches daily for 8 weeks, with treatment randomly assigned to each scar site within the same individual. The patches contain short microneedles embedded with hydrolysed RNA designed to target scar tissue. Follow-up visits occur at Day 30 and Day 60 after starting treatment, each lasting about 30 to 60 minutes. During the study, researchers will assess scar elevation using a high-resolution 3D scanner, rate scars with the Vancouver Scar Scale and Scar Cosmesis Assessment and Rating scale, and collect patient-reported pain and itch levels using an 11-point scale. Photographic documentation will be taken at baseline and follow-ups. Safety monitoring includes side effect assessments. The primary outcome measure is scar elevation assessed over one year, with secondary outcomes including scar scale scores, symptom reports, and side effects.

CONDITIONS

Brief Title

Comparing the Effect of siSPARC Microneedle Patch Versus siSPARC+siLR4A Microneedle Patch on Post-surgical Scars

Who Can Participate

Age: 21Years - 75Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Adult aged 21 to 75 years
About 2 weeks (plus or minus 7 days) after surgical operation with incision into the dermis
Post-stitch removal following surgery
Wound closure or union achieved
Able to understand and provide informed consent

You will not qualify if you...

Pregnant or breastfeeding
Wound infection present
Unable or uncooperative to self-administer the patches
Known allergy to patch ingredients including hyaluronic acid, siRNA, glue, or isopropyl alcohol
Unable to personally consent due to cognitive impairment

Research Team

Hong Liang Tey

Delwyn Lim

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