High Intensity Focused UltrasoundNCT06457607
Evaluating the Efficacy and Safety of Treatment With LinearFirm(ULTRAcel Q+) in Temporary Eyebrow Lifting
A study testing LinearZ in people with High Intensity Focused Ultrasound, run by Jeisys Medical Inc at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- High Intensity Focused Ultrasound
- What is being tested?
- LinearZ
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Feb 2023to 27 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 19 years old or older
- Voluntarily agreed to the clinical trial
- Who is need to eyebrow lifing
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
Prospective, single center, single arm, open label study to evaluate the efficacy and safety of treatment with LinearFirm(ULTRAcel Q+) in temporary eyebrow lifting
Read the 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.
- 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
- Conditions
- High Intensity Focused Ultrasound
- Being tested
- LinearZ
- Keywords
- High Intensity Focused Ultrasound, Lifting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LinearZDevice
High Intensity Focues Ultrasound
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: LinearZ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Base line and 4, 8, 12, 16weeks
The evaluation of the GLS (Glabellar Line Scale) compared to the Baseline
- 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.
Measured: Base line and 4, 8, 12, 16weeks
The evaluation of the TEAE (Treatment Emergent Adverse Event) and serious AE/ADE
- 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.
Measured: after 16weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start24 Feb 2023
- Primary completion27 Sep 2023
- Study completion27 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Intensity Focused UltrasoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeisys Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Asan Medical Center
- Responsible party
- Sponsor
- Investigators
- Hye Jin Sun, Study director, Jeisys Medical Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06457607
- Sponsor's protocol ID
- JE_ULTRA_P01
- Status last verified
- Jun 2024
- First submitted
- 2 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06457607
- Acronym / sponsor ID
- JE_ULTRA_P01
- Conditions
- High Intensity Focused Ultrasound
- Keywords
- High Intensity Focused Ultrasound, Lifting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Jeisys Medical IncIndustry (pharma, biotech, devices)
- Collaborators
- Asan Medical Center
- Study start
- 24 Feb 2023 (actual)
- Primary completion
- 27 Sep 2023 (actual)
- Study completion
- 27 Sep 2023 (actual)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm is composed of determined to need a forehead lift due to drooping upper eyelids | Experimental | Device: LinearZThe 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 19 years old or older
- Voluntarily agreed to the clinical trial
- Who is need to eyebrow lifing
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LinearZHigh Intensity Focues Ultrasound | Device | Arm is composed of determined to need a forehead lift due to drooping upper eyelids |
Primary outcome
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.
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 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hye Jin Sun study director
Jeisys Medical Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LinearZ in people with High Intensity Focused Ultrasound, run by Jeisys Medical Inc at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.