NCT06158867

Confirmatory Study: Assessing the Efficacy and Safety of the AcusMu Microneedle Patch in Treating Periorbital Wrinkles

Assessing the Efficacy and Safety of the AcusMu Microneedle Patch in Treating Periorbital Wrinkles and Skin Diseases

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 12 (actual)
• Sponsor: AcusMu Medtech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

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.

Conditions

• Wrinkle

Interventions

Type	Name	Description
DEVICE	FMD WK	micro-needle patches containing active anti-wrinkle ingredients

Timeline

• Start date: 2023-11-24
• Primary completion: 2024-01-26
• Completion: 2024-01-31
• First posted: 2023-12-06
• Last updated: 2024-12-04
• Results posted: 2024-12-04

Locations

1 site across 1 country: Taiwan