Facial Wrinkles and Rhytides Reduction, Skin Laxity, Wrinkles
Conditions
Keywords
High Intensity Focused Ultrasound, HIFU, ULTRAFORMER MPT, ULTRAFORMER, MPT, Eyebrow, Eyebrow Lifting
Brief 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.
Interventions
DEVICEHIFU treatment with ULTRAFOMER MPT
The high-intensity focused ultrasound (HIFU) treatment, which is the primary intervention being evaluated for efficacy and safety in eyebrow lifting.
Sponsors
CLASSYS Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global Aestetic Improvement Scale(GAIS) | 3 months after treatment/randomization | Improvement was defined as GAIS score≤3 Min 1 Max 5 1. Very much improved 2. Much improved 3. Improved 4. No Change 5. Worse |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global Aestetic Improvement Scale(GAIS) | 1, 3, 6 months after treatment/randomization | by Blinded Evaluators, Investigators, and Participant Subects |
Countries
China
Outcome results
None listed