N/A
Completed N=24
Confirmatory Study: Assessing the Efficacy and Safety of the AcusMu Microneedle Patch in Treating Periorbital Wrinkles
Wrinkle
Source: ClinicalTrials.gov NCT06158867 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcomePrimary: Proportion of Participants With Improvement in Periorbital Wrinkles From Baseline — 10; 2; 8; 2 Participants
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
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 | — |
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.
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. Informational only — not medical advice.