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| Name | Class |
|---|---|
| Asan Medical Center | OTHER |
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Prospective, single center, single arm, open label study to evaluate the efficacy and safety of treatment with LinearFirm(ULTRAcel Q+) in temporary eyebrow lifting
The goal of this open label study is to evaluate the efficacy and safety of treatment with HIFU system (LinearFirm(ULTRAcel Q+)) in temporary eyebrow lifting.
The target number of subjects for this clinical trial is set to 30 in a single group, without considering the statistical significance of hypothesis testing and dropout rate. Considering a dropout rate of 20%, the plan is to recruit a total of 38 subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm is composed of determined to need a forehead lift due to drooping upper eyelids | Experimental | The participant will visit the clinical trial institution at 4, 8, 12, and 16 weeks after the application visit (Visit 2, Baseline) of the medical device for clinical trials. They will participate in the efficacy evaluation of the clinical trial medical device for a total of 16 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LinearZ | Device | High Intensity Focues Ultrasound |
|
| Measure | Description | Time Frame |
|---|---|---|
| The avegrage change in AEH (Average Eyebrow Height) and MEH(Maximum Eyebrow Height) compared to the Baseline | - Evaluation of the efficacy : Average change in AEH (Average Eyebrow Height) and MEH (Maximum Eyebrow Height) from the baseline, after the application of a medical device for clinical trials, as evaluated by an independent evaluator's eyebrow lifting photo evaluation at 4 weeks, 8 weeks, 12 weeks, and 16 weeks. This result will be displayed as a percentage. | Base line and 4, 8, 12, 16weeks |
| The evaluation of the GLS (Glabellar Line Scale) compared to the Baseline | - Evaluation of the Exploratory
| Base line and 4, 8, 12, 16weeks |
| The evaluation of the TEAE (Treatment Emergent Adverse Event) and serious AE/ADE |
| after 16weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hye Jin Sun | Jeisys Medical Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | 05505 | South Korea |
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