Safety and Efficacy Evaluation of High Intensity Focused Ultrasound Device in Eyebrow Lifting
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
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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Beijing, China
- Emergency General Hospital
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Beijing, China
- Beijing Anzhen Hospital of Capital Medical University
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Shijiazhuang, China
- TheThird Hospital of Hebei Medical University
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Xi'an, China
- The Second Affiliated Hospital of Xian Jiaotong University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 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.
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The high-intensity focused ultrasound (HIFU) treatment, which is the primary intervention being evaluated for efficacy and safety in eyebrow lifting.
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No Intervention: No Treatment
This arm does not receive any treatment, serving as a comparison group to evaluate the efficacy of the investigational device.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Global Aestetic Improvement Scale(GAIS)
Time Frame: 3 months after treatment/randomization
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Improvement was defined as GAIS score≤3 Min 1 Max 5
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3 months after treatment/randomization
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Global Aestetic Improvement Scale(GAIS)
Time Frame: 1, 3, 6 months after treatment/randomization
|
by Blinded Evaluators, Investigators, and Participant Subects
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1, 3, 6 months after treatment/randomization
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Wenzhi Li, Beijing Anzhen Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLSGQDWJJCHS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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