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

Wrinkle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06158867
• Other study ID #: 112S0069
• Status: Recruiting
• Start date: November 24, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: December 2023
• Source: AcusMu Medtech Co., Ltd.
• Contact: Leon Tsung-Ju Lee, MD
• Phone: 886-2-26548910
• Email: TJ.LEE.SKIN[@]GMAIL.COM
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: January 31, 2024
• Est. primary completion date: January 26, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Wrinkle

Intervention

Device:
• FMD WK
micro-needle patches containing active anti-wrinkle ingredients

Locations

Country	Name	City	State
Taiwan	Taipei Medical University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
AcusMu Medtech Co., Ltd.	Taipei Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.