Confirmatory Study: Assessing the Efficacy and Safety of the AcusMu Microneedle Patch in Treating… (NCT06158867) | Clinical Trial Compass
CompletedNot Applicable
Confirmatory Study: Assessing the Efficacy and Safety of the AcusMu Microneedle Patch in Treating Periorbital Wrinkles
Taiwan12 participantsStarted 2023-11-24
Plain-language 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
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Participants With Improvement in Periorbital Wrinkles From Baseline
Timeframe: Over the course of study completion, an average duration of 4 weeks was observed.
2
Number of Participants With Adverse Reactions
Timeframe: Over the course of study completion, an average duration of 4 weeks was observed.