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

NCT06457607 | Completed

• 1 other identifier: JE_ULTRA_P01
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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

Conditions

High Intensity Focused Ultrasound

Keywords

High Intensity Focused Ultrasound; Lifting

Outcome Measures

Primary Outcomes (3)

• 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 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.

  Base line and 4, 8, 12, 16weeks

• The evaluation of the TEAE (Treatment Emergent Adverse Event) and serious AE/ADE

  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.

  after 16weeks

Study Arms (1)

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.

Device: LinearZ

Interventions

LinearZ DEVICE

High Intensity Focues Ultrasound

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or older
• Voluntarily agreed to the clinical trial
• Who is need to eyebrow lifing

You may not qualify if:

• 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

Sponsors & Collaborators

• Jeisys Medical Inc: lead
• Asan Medical Center: collaborator

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

Study Officials

• Hye Jin Sun

  Jeisys Medical Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2024
• First Posted: June 13, 2024
• Study Start: February 24, 2023
• Primary Completion: September 27, 2023
• Study Completion: September 27, 2023
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)