Actively Recruiting
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
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 8 weeks
Participants apply the assigned microneedle patch daily on their post-surgical scars for 8 weeks.
1 baseline visit and 2 follow-up visits on Day 30 and Day 60
Trial Site Locations
Total: 1 location
1
National Skin Centre
Singapore, Singapore, 308205
Actively Recruiting
Research Team
H
Hong Liang Tey
D
Delwyn Lim
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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