跳至主要内容
临床试验/NCT06158867
NCT06158867已完成不适用

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

AcusMu Medtech Co., Ltd.1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2023年11月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
12
试验地点
1
主要终点
Proportion of Participants With Improvement in Periorbital Wrinkles From Baseline

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants aged 18 to 99 (regardless of race or gender).
  • Diagnosed with mild or moderate periorbital wrinkles by a dermatologist.

排除标准

  • 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.

结局指标

主要结局

Proportion of Participants With Improvement in Periorbital Wrinkles From Baseline

时间窗: Over the course of study completion, an average duration of 4 weeks was observed.

1. This is a half-face trial involving two weeks of treatment followed by a two-week post-treatment follow-up. 2. Improvements in periorbital wrinkles will be assessed using the Wrinkle Severity Rating Scale (WSRS), which ranges from 0 (no wrinkles) to 5 (severe wrinkles). A lower score indicates an improvement in wrinkle severity. 3. Each participant's treated half-face serves as the unit of measure. Any decrease in the WSRS score from baseline is counted as an improvement.

Number of Participants With Adverse Reactions

时间窗: Over the course of study completion, an average duration of 4 weeks was observed.

Evaluate through skin response sheets: erythema, pain, swelling, etc.

次要结局

未报告次要终点

研究者

发起方
AcusMu Medtech Co., Ltd.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验