Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06158867
Status:
RECRUITING
Last Update Posted:
2023-12-11
First Post:
2023-11-28
Brief Title:
Confirmatory Study Assessing the Efficacy and Safety of the AcusMu Microneedle Patch in Treating Periorbital Wrinkles
Sponsor:
AcusMu Medtech Co Ltd
Organization:
AcusMu Medtech Co Ltd
Study Overview
Official Title:
Assessing the Efficacy and Safety of the AcusMu Microneedle Patch in Treating Periorbital Wrinkles and Skin Diseases
Status:
RECRUITING
Status Verified Date:
2023-12
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:
The core objective of this study is to validate the safe and efficacious application of the AcusMu microneedle patch FMD WK to enhance the appearance of periorbital wrinkle
Detailed Description:
This clinical study is a randomized double-blind split-face clinical trial investigating the efficacy of AcusMu FMD WK for the treatment of periorbital wrinkles Participants will attend a study center for a two-week period and undergo a two-week post-treatment follow-up after their final treatment session Each day they will apply one of two test products A micro-needle patches containing active anti-wrinkle ingredients and B placebo patches beneath their eyes The patches will be gently pressed onto the skin for 5-10 seconds and left in place for 2-8 hours continuing this regimen for 14 days Dermatologists will conduct evaluations at four time points during the study on day 0 day 7 day 14 and day 28 2 days from the commencement of the experiment The evaluation process will include the calculation of a Fine Wrinkle Improvement Index specifically designed for assessing under-eye wrinkles to measure improvements Non-invasive skin testing equipment will be employed to measure skin conditions and capture skin images for objective data analysis Wrinkle Index Additionally self-assessment questionnaires will be administered to gather insights into participants perceptions of the efficacy of micro-needle patches with active anti-wrinkle ingredients and placebo patches in improving periorbital wrinkles over the two-week duration
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