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

2022/00942

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 patches comprising short microneedles embedded with hydrolysed RNA (siRNAs) have been classified by Health Science Authority, Singapore, as cosmetic products.

2023-11-14

2024-11-14

2024-11-14

Recruiting

Early phase I

50

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)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

2023-11-18