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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- CLASSYS Inc.
- Enrollment
- 180
- Locations
- 5
- Primary Endpoint
- Global Aestetic Improvement Scale(GAIS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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-
- •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.
- •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.
Arms & Interventions
ULTRAFOMER MPT
This arm receives the high-intensity focused ultrasound (HIFU) treatment, which is the primary intervention being evaluated for efficacy and safety in eyebrow lifting.
Intervention: HIFU treatment with ULTRAFOMER MPT (Device)
No Treatment
This arm does not receive any treatment, serving as a comparison group to evaluate the efficacy of the investigational device.
Outcomes
Primary Outcomes
Global Aestetic Improvement Scale(GAIS)
Time Frame: 3 months after treatment
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 Outcomes
No secondary outcomes reported