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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Assessing the Efficacy and Safety of the AcusMu Microneedle Patch in Treating Periorbital Wrinkles and Skin Diseases

Conditions
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Wrinkle

Intervention / Treatment
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* Device: FMD WK


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| FMD WK<br> | Device: FMD WK<br>* micro-needle patches containing active anti-wrinkle ingredients<br>|
| Placebo<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing the percentage change of the Wrinkle Severity Scale of periorbital wrinkles from baseline | Two weeks of treatment and 2 week follow-up post-treatment Use Wrinkle Severity Scale to assess the percentage improvement of periorbital wrinkles using camera images, with a scale of 0 to 5 | Over the course of study completion, an average duration of 4 weeks was observed. | 
| Assessing the patches' safety on the skin by adverse reactions (erythema, pain, swelling, etc.) | Evaluate through skin response sheets: erythema, pain, swelling, etc. | Over the course of study completion, an average duration of 4 weeks was observed. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anti-wrinkle, Microneedle patch