WrinkleNCT06158867
Confirmatory Study: Assessing the Efficacy and Safety of the AcusMu Microneedle Patch in Treating Periorbital Wrinkles
An observational study of Wrinkle, run by AcusMu Medtech Co., Ltd. at 1 site in Taiwan.
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 Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrinkle
- What is being tested?
- FMD WK
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Nov 2023to 31 Jan 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants aged 18 to 99, irrespective of race or gender, and diagnosed with mild to moderate periorbital wrinkles by a dermatologist.
Who may be able to join
- Participants aged 18 to 99 (regardless of race or gender).
- Diagnosed with mild or moderate periorbital wrinkles by a dermatologist.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Wrinkle
- Being tested
- FMD WK
- Keywords
- Microneedle patch, Anti-wrinkle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMD WKDevice
micro-needle patches containing active anti-wrinkle ingredients
| Study group | Role | What they receive |
|---|---|---|
| FMD WK | Not described Receives: Device: FMD WK | |
| Placebo | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With Improvement in Periorbital Wrinkles From Baseline
- This is a half-face trial involving two weeks of treatment followed by a two-week post-treatment follow-up.
- 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.
- 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.
Measured: Over the course of study completion, an average duration of 4 weeks was observed.
Number of Participants With Adverse Reactions
Evaluate through skin response sheets: erythema, pain, swelling, etc.
Measured: Over the course of study completion, an average duration of 4 weeks was observed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start24 Nov 2023
- Primary completion26 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for WrinkleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- AcusMu Medtech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Taipei Medical University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06158867
- Sponsor's protocol ID
- 112S0069
- Status last verified
- Nov 2024
- First submitted
- 28 Nov 2023
- Last updated
- 4 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy and Safety of the AcusMu Microneedle Patch in Treating Periorbital Wrinkles and Skin Diseases
- ClinicalTrials.gov ID
- NCT06158867
- Acronym / sponsor ID
- 112S0069
- Conditions
- Wrinkle
- Keywords
- Microneedle patch, Anti-wrinkle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- AcusMu Medtech Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Taipei Medical University Hospital
- Study start
- 24 Nov 2023 (actual)
- Primary completion
- 26 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 6 Dec 2023 (actual)
- Results
- Posted 4 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FMD WK | – | Device: FMD WK |
| Placebo | – | – |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants aged 18 to 99, irrespective of race or gender, and diagnosed with mild to moderate periorbital wrinkles by a dermatologist.
Key inclusion criteria (2 listed)
- Participants aged 18 to 99 (regardless of race or gender).
- Diagnosed with mild or moderate periorbital wrinkles by a dermatologist.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FMD WKmicro-needle patches containing active anti-wrinkle ingredients | Device | FMD WK |
Primary outcome
Proportion of Participants With Improvement in Periorbital Wrinkles From Baseline
Time frame: 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
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wrinkle, run by AcusMu Medtech Co., Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With Improvement in Periorbital Wrinkles From Baseline (time frame: Over the course of study completion, an average duration of 4 weeks was observed.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.