Safety and Efficacy Evaluation of High Intensity Focused Ultrasound Device in Eyebrow Lifting

Not Applicable

Recruiting

• Conditions: Skin Laxity; Wrinkles; Facial Wrinkles and Rhytides Reduction

• Registration Number: NCT06724510
• Lead Sponsor: CLASSYS Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-18
• Study First Submitted: 2024-12-01
• Study First Submitted QC: 2024-12-05
• Study First Posted: 2024-12-09
• Status Verified: 2025-03
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-25
• Primary Completion: 2025-04-30
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Global Aestetic Improvement Scale(GAIS)	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

Trial Locations

Locations (3)

Beijing Anzhen Hospital of Capital Medical University; 🇨🇳 Beijing, China

TheThird Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, China

The Second Affiliated Hospital of Xian Jiaotong University; 🇨🇳 Xian, China