Clinical trial NCT06158867: Confirmatory Study: Assessing the Efficacy and Safety of the AcusMu Microneedle Patch in Treating Periorbital Wrinkles
Official title: Assessing the Efficacy and Safety of the AcusMu Microneedle Patch in Treating Periorbital Wrinkles and Skin Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wrinkle
Keywords: Microneedle patch
Anti-wrinkle
Lead sponsor: AcusMu Medtech Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Taipei Medical University Hospital
First posted: 2023-12-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief 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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of Participants With Improvement in Periorbital Wrinkles From Baseline
timeFrame: Over the course of study completion, an average duration of 4 weeks was observed.
measure: Number of Participants With Adverse Reactions
timeFrame: Over the course of study completion, an average duration of 4 weeks was observed.
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
Study officials:
References: