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

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

Study Overview

• Status: Completed
• Conditions: Wrinkle
• Intervention / Treatment: Device: FMD WK

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 Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Taipei Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Participants aged 18 to 99, irrespective of race or gender, and diagnosed with mild to moderate periorbital wrinkles by a dermatologist.

Description

Inclusion Criteria:

• Participants aged 18 to 99 (regardless of race or gender).
• Diagnosed with mild or moderate periorbital wrinkles by a dermatologist.

Exclusion Criteria:

• Participants with open wounds or active infections on their skin.
• Individuals involved in other studies that could interfere with this trial.
• Pregnant, breastfeeding, or planning to become pregnant during the trial.
• Those with significant medical conditions such as cancer, liver disease, diabetes, kidney disease, or cardiovascular disorders.
• Individuals who have undergone alternative treatments for periorbital wrinkles in the past six months (e.g., laser therapy, radiofrequency).
• Participants concurrently receiving alternative treatments for periorbital wrinkles.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Placebo
FMD WK	Device: FMD WK; micro-needle patches containing active anti-wrinkle ingredients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants With Improvement in Periorbital Wrinkles From Baseline	This is a half-face trial involving two weeks of treatment followed by a two-week post-treatment follow-up.; Improvements in periorbital wrinkles will be assessed using the Wrinkle Severity Rating Scale (WSRS), which ranges from 0 (no wrinkles) to 5 (severe wrinkles). A lower score indicates an improvement in wrinkle severity.; Each participant's treated half-face serves as the unit of measure. Any decrease in the WSRS score from baseline is counted as an improvement.	Over the course of study completion, an average duration of 4 weeks was observed.
Number of Participants With Adverse Reactions	Evaluate through skin response sheets: erythema, pain, swelling, etc.	Over the course of study completion, an average duration of 4 weeks was observed.

Collaborators and Investigators

• Sponsor: AcusMu Medtech Co., Ltd.
• Collaborators: Taipei Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2023
• Primary Completion (Actual): January 26, 2024
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: November 28, 2023
• First Submitted That Met QC Criteria: November 28, 2023
• First Posted (Actual): December 6, 2023

Study Record Updates

• Last Update Posted (Estimated): December 4, 2024
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Microneedle patch; Anti-wrinkle
• Other Study ID Numbers: 112S0069

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No