CompletedNot Applicable

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

South Korea38 participantsStarted 2023-02-24

Plain-language 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

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Base line and 4, 8, 12, 16weeks

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

Timeframe: Base line and 4, 8, 12, 16weeks

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

Timeframe: after 16weeks

Trial details

NCT IDNCT06457607

SponsorJeisys Medical Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-09-27

View on ClinicalTrials.gov More High Intensity Focused Ultrasound trials

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Base line and 4, 8, 12, 16weeks

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

Timeframe: Base line and 4, 8, 12, 16weeks

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

Timeframe: after 16weeks