Comparing the Effect of siSPARC Microneedle Patch Versus siSPARC+siLR4A Microneedle Patch on 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 randomized, double-blind controlled study aims to compare the effect on appearance of post- surgical scars between daily application of siSPARC microneedle patch versus siSPARC + siLR4A microneedle patches. These are patches comprising short microneedles embedded with hydrolysed RNA (siRNAs).

Study Overview

• Status: Recruiting
• Conditions: Wound Heal; Wound; Keloid
• Intervention / Treatment: Drug: siSPARC microneedle patch; Drug: siSPARC + siLR4A microneedle patches

Detailed Description

This is an 8-week, single centre double-blinded intra-individually controlled trial to compare the effect of daily application of siSPARC microneedle patch versus siSPARC + siLR4A microneedle patch on post-surgical scars. At least 50 subjects will be recruited for the study. After the patients have been screened for study eligibility by the study investigators or coordinators, the subjects who have understood and signed the informed consent will be enrolled in the study. Provided a subject satisfies all inclusion criteria and does not fall within exclusion criteria during the screening visit, that subject will be started on the trial during that same visit. Computer-generated randomisation will be performed to determine the randomization of patient population to the siSPARC microneedle patch or siSPARC + siLR4A microneedle patch. Subsequent follow-up visits would be on Day 30 and Day 60. A deviation of +/- 7 days will be accepted during the follow-up. Each study visit will last between 30-60 minutes.

Study investigators and coordinators will be performing the following assessments:

1. High resolution 3D imaging: Scar elevation will be measured using the Space Spider 3D scanner, with a resolution of 0.1 mm and a blue light-emitting diode (LED) light source;
2. Vancouver scar scale (VSS) score;
3. Scar Cosmesis Assessment and Rating (SCAR) scale score from the photographs;
4. Change in patient-reported levels of pain and itch using a 11-point numerical rating scale; and
5. Assessment of side effects (if any). Photographic documentation: Photographic documentation will be performed at baseline and during the specified follow-up examinations. Images will be taken with standardized camera settings and standardized positioning of the subject. These images will be assessed by investigators to assess the change in scar appearance.

The siRNA microneedle patches are not commercially available. These patches have undergone testing with guinea pigs and white rabbits and were ascertained as a 'non-sensitiser' and 'non- irritant', respectively. The patches have also underwent testing to L-929 cells which are adherent cells of mouse fibroblast cell line and found to be 'non-cytotoxic'. This study involves a trial comparing treatment outcomes; there is no investigative work conducted and hence no incidental findings are not anticipated.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Hong Liang Tey; Phone Number: 6350 6666; Email: teyhongliang@ntu.edu.sg
• Study Contact Backup: Name: Delwyn Lim; Phone Number: 6350 6666; Email: delwynlim@Outlook.com

Study Locations

• Singapore
  • Singapore, Singapore, 308205
    • Recruiting
    • National Skin Centre
    • Contact: General National Skin Centre Contact; Phone Number: (65) 6253 4455

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: siSPARC microneedle patch	Drug: siSPARC microneedle patch; siSPARC microneedle patch; Other Names: siSPARC + siLR4A microneedle patch
Experimental: siSPARC + siLR4A microneedle patch	Drug: siSPARC + siLR4A microneedle patches; siSPARC + siLR4A microneedle patch; Other Names: siSPARC + siLR4A microneedle patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of post-surgical scar elevation	To compare the efficacy in reducing post-surgical scar elevation between daily application of siSPARC microneedle patch versus siSPARC + siLR4A microneedle patch. This will be measured using high resolution 3D imaging: scar elevation will be measured using the Space Spider 3D scanner, with a resolution of 0.1 mm and a blue LED light source. The lower the elevation, the better the outcome.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Vancouver Scar Scale (VSS) score	To evaluate the differences in VSS scores between daily application of siSPARC microneedle patch or siSPARC + siLR4A microneedle patch. The total VSS score is based on 4 points: (1) vascularity (on a scale of 0 being normal to 3 being purple); (2) pigmentation (on a scale of 0 being normal, to 2 being hyperpigmentation); (3) pliability (on a scale of 0 being normal to 5 being contractures); and (4) height (on a scale of normal being flat to 3 being >5mm). Higher scores indicate a worse outcome.	1 year
Assessment of Scar Cosmesis Assessment and Rating (SCAR) Scale	Assessment of SCAR Scale performed on photographs. The SCAR Scale is based on 8 points: (1) scar spread (on a scale of 0 being none to near-invisible to 4 being severe); (2) erythema (on a scale of 0 being none to 3 being deep red or purple); (3) dyspigmentation (being either 0 absent or 1 present); (4) track or suture marks (being either 0 absent or 1 present); (5) hypertrophy or atrophy (on a scale of 0 being none to 3 being severe); (6) impression (being either 0 desirable or 1 undesirable); (7) patient reported itch in last 24 hours (being either 0 absent or 1 present); and (8) patient reported pain (being either 0 absent or 1 present). Higher scores indicate a worse outcome.	1 year
Patient-reported levels of pain and itch using a 11-point numerical rating scale	Patient-reported levels of pain and itch using a 11-point numerical rating scale from 0 to 10 (0 being no pain, and 10 being the worst pain). Higher scores indicate a worse outcome.	1 year
Side effects	Patient reported side effects (if any), such as contact dermatitis (if any).	1 year

Collaborators and Investigators

• Sponsor: National Skin Centre
• Investigators: Principal Investigator: Hong Liang Tey, National Skin Centre

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2023
• Primary Completion (Estimated): November 14, 2024
• Study Completion (Estimated): November 14, 2024

Study Registration Dates

• First Submitted: November 9, 2023
• First Submitted That Met QC Criteria: November 17, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): June 24, 2024
• Last Update Submitted That Met QC Criteria: June 20, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 2022/00942

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No