Safety and Efficacy Evaluation of High Intensity Focused Ultrasound Device in Eyebrow Lifting (NCT06724510) | Clinical Trial Compass
CompletedNot Applicable
Safety and Efficacy Evaluation of High Intensity Focused Ultrasound Device in Eyebrow Lifting
China180 participantsStarted 2024-11-18
Plain-language summary
The goal of this clinical trial is to assess the safety and efficacy of the high-intensity focused ultrasound (HIFU) device, ULTRAFORMER MPT (UF4-M400), developed by CLASSYS Inc., for eyebrow lifting. This study is a prospective, multicenter, evaluator-blinded, randomized, non-treatment-controlled, superiority clinical trial.
The main questions the study seeks to answer are:
Does the ULTRAFORMER MPT device effectively lift eyebrows? Is the safety profile of the ULTRAFORMER MPT device acceptable? Researchers will compare the investigational device to a non-treatment control group to determine whether the HIFU device demonstrates superiority in eyebrow lifting outcomes.
Participant Details:
Participants will receive a single treatment session using the investigational device or be assigned to the non-treatment control group.
Follow-up will occur over 3 months to evaluate the effectiveness and safety of the treatment.
Outcomes:
Primary Outcome: Eyebrow lifting improvement, assessed through standardized photographic evaluation and other aesthetic measurement tools.
Secondary Outcomes: Participant satisfaction using the Global Aesthetic Improvement Scale (GAIS) and pain assessment using a Visual Analog Scale (VAS).
Safety Measures: Monitoring for adverse events (AEs) and serious adverse events (SAEs) throughout the study period.
This trial aims to provide robust evidence supporting the use of the ULTRAFORMER MPT for non-invasive eyebrow lifting.
Who can participate
Age range
20 Years – 65 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
. Age: 20 to 65 years old at the time of consent.
. Condition: Forehead skin laxity with Forehead Lines Grading Scale score of 1-3.
. Consent: Ability to understand trial details, voluntarily participate, and comply with treatment and follow-up.
Exclusion criteria
. Skin Conditions: Hyperpigmentation, tattoos, scars, active skin diseases, or other conditions (e.g., eczema, psoriasis, vitiligo) in the treatment area that may affect efficacy or increase risk.
. Medical Devices or Implants: Presence of metal implants or embedded electronic devices in the treatment area.
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.
. Health Conditions: Severe dysfunction of vital organs (e.g., heart, liver, kidneys), autoimmune diseases, or uncontrolled diabetes.
. Medications: Recent use of anti-thrombotic agents, NSAIDs, or other drugs affecting coagulation within one week before screening.
. Prior Treatments: Use of fillers (e.g., hyaluronic acid, collagen) or cosmetic procedures (e.g., laser therapy, botulinum toxin) in the treatment area within the specified timeframes.
. Pregnancy: Women who are pregnant, nursing, or not using birth control during the trial.