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| Name | Class |
|---|---|
| Taipei Medical University Hospital | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FMD WK |
| ||
| Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FMD WK | Device | micro-needle patches containing active anti-wrinkle ingredients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Improvement in Periorbital Wrinkles From Baseline |
| 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. | Over the course of study completion, an average duration of 4 weeks was observed. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants aged 18 to 99, irrespective of race or gender, and diagnosed with mild to moderate periorbital wrinkles by a dermatologist.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Medical University Hospital | Taipei | Taiwan |
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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.
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FMD WK/Placebo (A Split-Face Study) | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Participants With Improvement in Periorbital Wrinkles From Baseline |
| Posted | Count of Participants | Participants | Over the course of study completion, an average duration of 4 weeks was observed. |
|
28 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Leon Tsung-Ju Lee | Taipei Medical University Hospital | +886-2-27372181 | 8281 | TJ.LEE.SKIN@GMAIL.COM |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2024 | Aug 2, 2024 | Prot_SAP_000.pdf |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 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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| Primary | Number of Participants With Adverse Reactions | Evaluate through skin response sheets: erythema, pain, swelling, etc. | Posted | Count of Participants | Participants | Over the course of study completion, an average duration of 4 weeks was observed. |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | 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. | 0 | 12 | 0 | 12 | 0 | 12 |
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