Trial Outcomes & Findings for Confirmatory Study: Assessing the Efficacy and Safety of the AcusMu Microneedle Patch in Treating Periorbital Wrinkles (NCT NCT06158867)
NCT ID: NCT06158867
Last Updated: 2024-12-04
Results Overview
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.
COMPLETED
12 participants
Over the course of study completion, an average duration of 4 weeks was observed.
2024-12-04
Participant Flow
A total of 12 subjects provided informed consent to participate in this study. Participants were assigned two different types of patches to be applied under the eyes (a split-face study), with one type on each arm: one randomly allocated active anti-wrinkle ingredient patch and one placebo patch. The 12 subjects underwent non-invasive skin testing equipment to record periorbital wrinkle conditions and completed self-assessment questionnaires during their study visit.
Unit of analysis: Half-face
Participant milestones
| Measure |
FMD WK
Participants received the microneedle patch beneath their eyes (randomly assigned to one side of the face). Upon application, the microneedles penetrate the upper layers of the skin and dissolve in the interstitial fluid, releasing the active anti-wrinkle ingredients. Microneedle patches are painless and can be administered without training, requiring only video or image instructions.
Micro-needle patches containing active anti-wrinkle ingredients: Each microneedle (MN) patch consists of an array of solid, water-soluble, micron-scale needles that encapsulate the active anti-wrinkle ingredients. These patches can be directly applied to the skin.
|
Placebo
Participants received the patch beneath their eyes (randomly assigned to one side of the face). Upon application to the skin, the microneedles penetrate into the skin's upper layers and dissolve in the interstitial fluid, releasing the placebo. Microneedle patches are painless and can be administered without training, requiring only video or image instructions.
Micro-needle patches containing placebo: Each microneedle (MN) patch consists of an array of solid, water-soluble, micron-scale needles that encapsulate the placebo. These patches can be directly applied to the skin.
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|---|---|---|
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Overall Study
STARTED
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12 12
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12 12
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Overall Study
COMPLETED
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12 12
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12 12
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Overall Study
NOT COMPLETED
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0 0
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0 0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Confirmatory Study: Assessing the Efficacy and Safety of the AcusMu Microneedle Patch in Treating Periorbital Wrinkles
Baseline characteristics by cohort
| Measure |
FMD WK/Placebo (A Split-Face Study)
n=12 Participants
We recruited 12 participants, each receiving a microneedle patch beneath one eye, randomly assigned to one side of the face. Each participant received both types of patches: one containing active anti-wrinkle ingredients and the other a placebo.
Microneedle patches are painless, require no training for application, and can be used with only video or image instructions. Each patch contains an array of solid, water-soluble, micron-scale needles that penetrate the skin's upper layers, dissolve in interstitial fluid, and release either the active anti-wrinkle ingredients or placebo.
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|---|---|
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Age, Continuous
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47.75 years
STANDARD_DEVIATION 9.54 • n=5 Participants
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Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
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Region of Enrollment
Taiwan
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12 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
FMD WK
n=12 Participants
Participants received the microneedle patch beneath their eyes (randomly assigned to one side of the face). Upon application, the microneedles penetrate the upper layers of the skin and dissolve in the interstitial fluid, releasing the active anti-wrinkle ingredients. Microneedle patches are painless and can be administered without training, requiring only video or image instructions.
Micro-needle patches containing active anti-wrinkle ingredients: Each microneedle (MN) patch consists of an array of solid, water-soluble, micron-scale needles that encapsulate the active anti-wrinkle ingredients. These patches can be directly applied to the skin.
|
Placebo
n=12 Participants
Participants received the patch beneath their eyes (randomly assigned to one side of the face). Upon application to the skin, the microneedles penetrate into the skin's upper layers and dissolve in the interstitial fluid, releasing the placebo. Microneedle patches are painless and can be administered without training, requiring only video or image instructions.
Micro-needle patches containing placebo: Each microneedle (MN) patch consists of an array of solid, water-soluble, micron-scale needles that encapsulate the placebo. These patches can be directly applied to the skin.
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|---|---|---|
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Proportion of Participants With Improvement in Periorbital Wrinkles From Baseline
Week 2
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10 Participants
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2 Participants
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Proportion of Participants With Improvement in Periorbital Wrinkles From Baseline
Week 4
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8 Participants
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2 Participants
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PRIMARY outcome
Timeframe: Over the course of study completion, an average duration of 4 weeks was observed.Evaluate through skin response sheets: erythema, pain, swelling, etc.
Outcome measures
| Measure |
FMD WK
n=12 Participants
Participants received the microneedle patch beneath their eyes (randomly assigned to one side of the face). Upon application, the microneedles penetrate the upper layers of the skin and dissolve in the interstitial fluid, releasing the active anti-wrinkle ingredients. Microneedle patches are painless and can be administered without training, requiring only video or image instructions.
Micro-needle patches containing active anti-wrinkle ingredients: Each microneedle (MN) patch consists of an array of solid, water-soluble, micron-scale needles that encapsulate the active anti-wrinkle ingredients. These patches can be directly applied to the skin.
|
Placebo
n=12 Participants
Participants received the patch beneath their eyes (randomly assigned to one side of the face). Upon application to the skin, the microneedles penetrate into the skin's upper layers and dissolve in the interstitial fluid, releasing the placebo. Microneedle patches are painless and can be administered without training, requiring only video or image instructions.
Micro-needle patches containing placebo: Each microneedle (MN) patch consists of an array of solid, water-soluble, micron-scale needles that encapsulate the placebo. These patches can be directly applied to the skin.
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|---|---|---|
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Number of Participants With Adverse Reactions
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0 Participants
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0 Participants
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Adverse Events
FMD WK
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Leon Tsung-Ju Lee
Taipei Medical University Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place