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Completed

NCT Number: NCT06457607

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

Completed

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Key information

Conditions

High Intensity Focused Ultrasound

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asan Medical Center

Seoul, 05505, South Korea

About this study

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.

  • Evaluation of the effacacy is includes: Evaluation of eyebrow lifting photos by an independent evaluator, Patient Satisfaction (PS)
  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LinearZ

Device

High Intensity Focues Ultrasound

Primary outcomes

  1. The avegrage change in AEH (Average Eyebrow Height) and MEH(Maximum Eyebrow Height) compared to the Baseline

    Time frame: 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.

  2. The evaluation of the GLS (Glabellar Line Scale) compared to the Baseline

    Time frame: Base line and 4, 8, 12, 16weeks

    • Evaluation of the Exploratory
    • 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.
    • 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.

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

    Time frame: after 16weeks

    • 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.
    • 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.

Sponsors and collaborators

Lead sponsor

Jeisys Medical Inc

Industry

Collaborators

  • Asan Medical Center

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 13, 2024
Registry last updated
Jun 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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