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

NCT ID: NCT06158867

Last Updated: 2024-12-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-24

Study Completion Date

2024-01-31

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.

Conditions

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Wrinkle

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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FMD WK

FMD WK

Intervention Type DEVICE

micro-needle patches containing active anti-wrinkle ingredients

Placebo

No interventions assigned to this group

Interventions

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FMD WK

micro-needle patches containing active anti-wrinkle ingredients

Intervention Type DEVICE

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taipei Medical University Hospital

OTHER

Sponsor Role collaborator

AcusMu Medtech Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Taipei Medical University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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112S0069

Identifier Type: -

Identifier Source: org_study_id