Comparing the Effect of siSPARC Microneedle Patch Versus siSPARC+siLR4A Microneedle Patch on Post-surgical Scars
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-75
SponsorNational Skin Centre
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adult
Age 21-75
2 weeks (+/- 7 days) after surgical operation with incision into the dermis
Post-stitch removal when stitches were applied
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
siSPARC + siLR4A microneedle patches
DrugsiSPARC + siLR4A microneedle patch
siSPARC microneedle patch
DrugsiSPARC microneedle patch
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: siSPARC microneedle patchExperimental treatment 1 intervention
Group B: siSPARC + siLR4A microneedle patchExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
1 yearSecondary outcomes
1
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.
Time frame
1 year2
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.
Time frame
1 year3
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.
Time frame
1 year4
Side effects
Patient reported side effects (if any), such as contact dermatitis (if any).
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov