Keloid, Wound, Wound Heal
Conditions
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).
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.
Interventions
DRUGsiSPARC + siLR4A microneedle patches
siSPARC + siLR4A microneedle patch
DRUGsiSPARC microneedle patch
siSPARC microneedle patch
Sponsors
National Skin Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of post-surgical scar elevation | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Vancouver Scar Scale (VSS) score | 1 year | 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. |
| Assessment of Scar Cosmesis Assessment and Rating (SCAR) Scale | 1 year | 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. |
| Patient-reported levels of pain and itch using a 11-point numerical rating scale | 1 year | 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. |
| Side effects | 1 year | Patient reported side effects (if any), such as contact dermatitis (if any). |
Countries
Singapore
Contacts
Primary ContactHong Liang Tey
Backup ContactDelwyn Lim
Outcome results
None listed