Comparing two types of microneedle patches for improving post-surgical scars
Randomized Intra-individually Controlled Double-blinded Trial Comparing Effect of Small Interfering RNA Against SPARC (siSPARC) Microneedle Patch Versus Small Interfering RNA Against SPARC and IL4-RA (siSPARC + siLR4A) Microneedle Patch on Appearance of Post-surgical Scars
This study is testing two different types of microneedle patches to see which one helps improve the look of scars after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 21 Years to 75 Years |
| Sex | All |
| Sponsor | National Skin Centre Research network |
| Locations | 1 site (Singapore) |
| Trial ID | NCT06138964 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind controlled trial aims to evaluate the effectiveness of two different microneedle patches on the appearance of post-surgical scars over an 8-week period. Participants will be randomly assigned to receive either the siSPARC microneedle patch or a combination of siSPARC and siLR4A microneedle patches. The study will involve high-resolution 3D imaging and various scoring methods to assess scar elevation, cosmesis, and patient-reported outcomes related to pain and itch. A total of at least 50 subjects will be recruited, and follow-up visits will occur at 30 and 60 days post-intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21-75 who are at least two weeks post-surgery with closed wounds.
Not a fit: Patients who are pregnant, have wound infections, or known allergies to the patch ingredients may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel and effective treatment option for improving the appearance of post-surgical scars.
How similar studies have performed: While similar approaches have been explored, this specific combination of microneedle patches is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult * Age 21-75 * 2 weeks (+/- 7 days) after surgical operation with incision into the dermis * Post-stitch removal when stitches were applied * Wound closure/union achieved Exclusion Criteria: * Pregnant or lactating participant * Participants with wound infection * Participants assessed to be uncooperative or unable to self-administer the interventions * Participants with known contact allergy to ingredients in the patch formulation (comprising hyaluronic acid, siRNA and glue) and/or isopropyl alcohol * Participants who are unable to personally consent (for e.g., cognitively impaired)
Where this trial is running
Singapore
- National Skin Centre — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Hong Liang Tey — National Skin Centre
- Study coordinator: Hong Liang Tey
- Email: teyhongliang@ntu.edu.sg
- Phone: 6350 6666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.