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

NCT ID: NCT06457607

Last Updated: 2024-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-24
• Study Completion Date: 2023-09-27

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

Conditions

High Intensity Focused Ultrasound

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Arm is composed of determined to need a forehead lift due to drooping upper eyelids

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.

Group Type: EXPERIMENTAL

LinearZ

Intervention Type: DEVICE

High Intensity Focues Ultrasound

Interventions

LinearZ

High Intensity Focues Ultrasound

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Asan Medical Center

OTHER

Sponsor Role: collaborator

Jeisys Medical Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hye Jin Sun

Role: STUDY_DIRECTOR

Jeisys Medical Inc

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

JE_ULTRA_P01

Identifier Type: -

Identifier Source: org_study_id