Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06138964
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2023-11-09
Brief Title:
Comparing the Effect of siSPARC Microneedle Patch Versus siSPARCsiLR4A Microneedle Patch on Post-surgical Scars
Sponsor:
National Skin Centre
Organization:
National Skin Centre
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 01 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 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 01 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None