Evaluating the Efficacy and Safety of Treatment With LinearFirm(ULTRAcel Q+) in Temporary Eyebrow Lifting

Prospective, Single Center, Single Arm, Open Label Study to Evaluate the Efficacy and Safety of Treatment With LinearFirm(ULTRAcel Q+) in Temporary Eyebrow Lifting

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.

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

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