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

NCT06138964 | Recruiting Phase 2

• 1 other identifier: 2022/00942
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Keloid; Wound Heal; Wound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Assessment of Vancouver Scar Scale (VSS) score

  1 year

• Assessment of Scar Cosmesis Assessment and Rating (SCAR) Scale

  1 year

• Patient-reported levels of pain and itch using a 11-point numerical rating scale

  1 year

• Side effects

  1 year

Study Arms (2)

siSPARC microneedle patch

EXPERIMENTAL

siSPARC microneedle patch

Drug: siSPARC microneedle patch

siSPARC + siLR4A microneedle patch

EXPERIMENTAL

siSPARC + siLR4A microneedle patch

Drug: siSPARC + siLR4A microneedle patches

Interventions

siSPARC + siLR4A microneedle patches DRUG

siSPARC + siLR4A microneedle patch

Also known as: siSPARC + siLR4A microneedle patch

siSPARC + siLR4A microneedle patch

siSPARC microneedle patch DRUG

siSPARC microneedle patch

Also known as: siSPARC + siLR4A microneedle patch

siSPARC microneedle patch

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult
• Age 21-75
• weeks (+/- 7 days) after surgical operation with incision into the dermis
• Post-stitch removal when stitches were applied
• Wound closure/union achieved

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Skin Centre: lead

Study Sites (1)

National Skin Centre

Singapore, 308205, Singapore

RECRUITING

MeSH Terms

Conditions

Keloid; Wounds and Injuries

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hong Liang Tey

  National Skin Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hong Liang Tey

CONTACT

6350 6666; teyhongliang@ntu.edu.sg

Delwyn Lim

CONTACT

6350 6666; delwynlim@Outlook.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 18, 2023
• Study Start: November 14, 2023
• Primary Completion: November 14, 2024
• Study Completion: November 14, 2024
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)