Actively Recruiting
Safety and Efficacy Evaluation of High Intensity Focused Ultrasound Device in Eyebrow Lifting
Led by CLASSYS Inc. · Updated on 2025-04-25
180
Participants Needed
3
Research Sites
49 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy Evaluation of High Intensity Focused Ultrasound Device in Eyebrow Lifting
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 20 and 65 years old at consent
- Forehead skin laxity with Forehead Lines Grading Scale score of 1-3
- Ability to understand study details and comply with treatment and follow-up
You will not qualify if you...
- Hyperpigmentation, tattoos, scars, active skin diseases (eczema, psoriasis, vitiligo) in treatment area
- Presence of metal implants or electronic devices in treatment area
- Severe dysfunction of vital organs, autoimmune diseases, or uncontrolled diabetes
- Recent use of anti-thrombotic agents, NSAIDs, or drugs affecting coagulation within one week before screening
- Use of fillers or cosmetic procedures in treatment area within specified timeframes
- Women who are pregnant, nursing, or not using birth control during the trial
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Beijing Anzhen Hospital of Capital Medical University
Beijing, China
Actively Recruiting
2
TheThird Hospital of Hebei Medical University
Shijiazhuang, China
Actively Recruiting
3
The Second Affiliated Hospital of Xian Jiaotong University
Xi'an, China
Actively Recruiting
Research Team
M
MOONHEE LEE
CONTACT
H
HongGI Ham
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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