High Intensity Focused Ultrasound
Conditions
Keywords
High Intensity Focused Ultrasound, Lifting
Brief summary
Prospective, single center, single arm, open label study to evaluate the efficacy and safety of treatment with LinearFirm(ULTRAcel Q+) in temporary eyebrow lifting
Detailed description
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. 1. Evaluation of the effacacy is includes: Evaluation of eyebrow lifting photos by an independent evaluator, Patient Satisfaction (PS) 2. Evaluation of the safety is includes: Adverse events, vital signs, physical examination, and Visual Analogue Scale (VAS) after the application of medical devices for clinical trials
Interventions
DEVICELinearZ
High Intensity Focues Ultrasound
Sponsors
Asan Medical Center
Jeisys Medical Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 19 years old or older * Voluntarily agreed to the clinical trial * Who is need to eyebrow lifing
Exclusion criteria
* A history of cosmetic treatment (laser, light therapy, surgery, etc..) within the last 6 months * A history of filler treatment (Collagen, AMA, etc...) within the last 6 months * A history of Botulinum toxin injection within the last 6 months * A history of treatment such as radiation therapy or chemotherapy, or history of malignat tumor * A history of infections dermatitis, rash and shingles casued by thermal energy stimulation * A history of treament with isotretinoin, retinoid preparations, or steroid preparations within the last 4 weeks * Pregnancy * Thos who participated in other clinical trials that affect the efficacy and safety evaluation of this clinical trial within 30 days of the screening date
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The avegrage change in AEH (Average Eyebrow Height) and MEH(Maximum Eyebrow Height) compared to the Baseline | Base line and 4, 8, 12, 16weeks | \- 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. |
| The evaluation of the GLS (Glabellar Line Scale) compared to the Baseline | Base line and 4, 8, 12, 16weeks | \- Evaluation of the Exploratory 1. The proportion of participants who showed an improvement of 2 points or more in the Glabellar Line Scale (GLS) evaluation of the most frowning state at 4 weeks, 8 weeks, 12 weeks, and 16 weeks after the application of a medical device for clinical trials, compared to the baseline. 2. The proportion of participants who showed an improvement of 1 points or more in the Glabellar Line Scale (GLS) evaluation of the most frowning state at 4 weeks, 8 weeks, 12 weeks, and 16 weeks after the application of a medical device for clinical trials, compared to the baseline. |
| The evaluation of the TEAE (Treatment Emergent Adverse Event) and serious AE/ADE | after 16weeks | 1. The frequency and percentage of Treatment-Emergent Adverse Events (TEAE), Adverse Device Effects (ADE), and Serious Adverse Events/Adverse Device Effects (Serious AE/ADE) that occurred after the application of the medical device for clinical trials are presented. 2. The frequency and percentage (%) of Treatment-Emergent Adverse Events (TEAE), Adverse Device Effects (ADE), and Serious Adverse Events/Adverse Device Effects (Serious AE/ADE) that occurred after the application of the medical device for clinical trials are presented. |
Countries
South Korea
Outcome results
None listed