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

NCT06158867 | Completed Results DMC

• 1 other identifier: 112S0069
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Wrinkle

Keywords

Microneedle patch; Anti-wrinkle

Outcome Measures

Primary Outcomes (2)

• Proportion of Participants With Improvement in Periorbital Wrinkles From Baseline

  1. This is a half-face trial involving two weeks of treatment followed by a two-week post-treatment follow-up. 2. 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. 3. 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.

Study Arms (2)

FMD WK

Device: FMD WK

Placebo

Interventions

FMD WK DEVICE

micro-needle patches containing active anti-wrinkle ingredients

FMD WK

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AcusMu Medtech Co., Ltd.: lead
• Taipei Medical University Hospital: collaborator

Study Sites (1)

Taipei Medical University Hospital

Taipei, Taiwan

Location

Results Point of Contact

• Title: Dr. Leon Tsung-Ju Lee
• Organization: Taipei Medical University Hospital

TJ.LEE.SKIN@GMAIL.COM

+886-2-27372181

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 6, 2023
• Study Start: November 24, 2023
• Primary Completion: January 26, 2024
• Study Completion: January 31, 2024
• Last Updated: December 4, 2024
• Results First Posted: December 4, 2024

Record last verified: 2024-11

Locations

TW (1)