N/A N=24

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

Wrinkle

Bottom Line

View on ClinicalTrials.gov: NCT06158867 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2024

Primary outcome: Primary: Proportion of Participants With Improvement in Periorbital Wrinkles From Baseline — 10; 2; 8; 2 Participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: FMD WK (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: AcusMu Medtech Co., Ltd.
Primary completion: Jan 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Participants With Improvement in Periorbital Wrinkles From Baseline	10; 2; 8; 2	—
PRIMARY Number of Participants With Adverse Reactions	0; 0	—

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

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06158867). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.