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

December 5, 2023 updated by: AcusMu Medtech Co., Ltd.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Participants aged 18 to 99, irrespective of race or gender, and diagnosed with mild to moderate periorbital wrinkles by a dermatologist.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Placebo
FMD WK
Device: FMD WK
micro-needle patches containing active anti-wrinkle ingredients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessing the percentage change of the Wrinkle Severity Scale of periorbital wrinkles from baseline
Time Frame: Over the course of study completion, an average duration of 4 weeks was observed.
  1. Two weeks of treatment and 2 week follow-up post-treatment
  2. 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.)
Time Frame: Over the course of study completion, an average duration of 4 weeks was observed.
Evaluate through skin response sheets: erythema, pain, swelling, etc.
Over the course of study completion, an average duration of 4 weeks was observed.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AcusMu Medtech Co., Ltd.

Collaborators

Taipei Medical University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2023

Primary Completion (Estimated)

January 26, 2024

Study Completion (Estimated)

January 31, 2024

Study Registration Dates

First Submitted

November 28, 2023

First Submitted That Met QC Criteria

November 28, 2023

First Posted (Actual)

December 6, 2023

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 5, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 112S0069

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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