Evaluating a device for eyebrow lifting using focused ultrasound
Safety and Efficacy Evaluation of High Intensity Focused Ultrasound Device in Eyebrow Lifting, a Prospective, Multi-center, Evaluator Blinded, Randomized, Non-treatment Controlled, and Superiority Clinical Trial
This study is testing a new ultrasound device to see if it can safely lift eyebrows for people aged 20 to 65 with loose skin on their foreheads.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 20 Years to 65 Years |
| Sex | All |
| Sponsor | CLASSYS Inc. Industry-sponsored |
| Locations | 3 sites (Beijing and 2 other locations) |
| Trial ID | NCT06724510 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety and efficacy of the ULTRAFORMER MPT device, which utilizes high-intensity focused ultrasound (HIFU) technology for eyebrow lifting. It is a prospective, multicenter, evaluator-blinded, randomized, non-treatment-controlled trial designed to compare the investigational device's effectiveness against a non-treatment control group. Participants aged 20 to 65 with forehead skin laxity will receive a single treatment session, followed by a 3-month follow-up to evaluate outcomes. The primary focus is on improvements in eyebrow lifting and the safety profile of the device.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 to 65 with mild to moderate forehead skin laxity.
Not a fit: Patients with significant skin conditions, metal implants, or severe health issues may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could provide a non-invasive option for patients seeking to improve eyebrow appearance and reduce skin laxity.
How similar studies have performed: While the use of HIFU for cosmetic procedures is gaining traction, this specific application for eyebrow lifting is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age: 20 to 65 years old at the time of consent. 2. Condition: Forehead skin laxity with Forehead Lines Grading Scale score of 1-3. 3. Consent: Ability to understand trial details, voluntarily participate, and comply with treatment and follow-up. Exclusion Criteria: 1. 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. 2. Medical Devices or Implants: Presence of metal implants or embedded electronic devices in the treatment area. 3. Health Conditions: Severe dysfunction of vital organs (e.g., heart, liver, kidneys), autoimmune diseases, or uncontrolled diabetes. 4. Medications: Recent use of anti-thrombotic agents, NSAIDs, or other drugs affecting coagulation within one week before screening. 5. 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. 6. Pregnancy: Women who are pregnant, nursing, or not using birth control during the trial.
Where this trial is running
Beijing and 2 other locations
- Beijing Anzhen Hospital of Capital Medical University — Beijing, China (Recruiting)
- TheThird Hospital of Hebei Medical University — Shijiazhuang, China (Recruiting)
- The Second Affiliated Hospital of Xian Jiaotong University — Xi'an, China (Recruiting)
Study contacts
- Study coordinator: Moonhee Lee
- Email: mhlee@classys.com
- Phone: +82 02-6313-2177
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.