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

NCT06724510 | Recruiting

• 1 other identifier: CLSGQDWJJCHS
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 3

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.

Conditions

Skin Laxity; Wrinkles; Facial Wrinkles and Rhytides Reduction

Keywords

High Intensity Focused Ultrasound; HIFU; ULTRAFORMER MPT; ULTRAFORMER; MPT; Eyebrow; Eyebrow Lifting

Outcome Measures

Primary Outcomes (1)

• Global Aestetic Improvement Scale(GAIS)

  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

  3 months after treatment

Study Arms (2)

ULTRAFOMER MPT

EXPERIMENTAL

This arm receives the high-intensity focused ultrasound (HIFU) treatment, which is the primary intervention being evaluated for efficacy and safety in eyebrow lifting.

Device: HIFU treatment with ULTRAFOMER MPT

No Treatment

NO INTERVENTION

This arm does not receive any treatment, serving as a comparison group to evaluate the efficacy of the investigational device.

Interventions

HIFU treatment with ULTRAFOMER MPT DEVICE

The high-intensity focused ultrasound (HIFU) treatment, which is the primary intervention being evaluated for efficacy and safety in eyebrow lifting.

ULTRAFOMER MPT

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CLASSYS Inc.: lead

Study Sites (3)

Beijing Anzhen Hospital of Capital Medical University

Beijing, China

RECRUITING

TheThird Hospital of Hebei Medical University

Shijiazhuang, China

RECRUITING

The Second Affiliated Hospital of Xian Jiaotong University

Xi'an, China

RECRUITING

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Wenzhi Li

  Beijing Anzhen Hospital

  STUDY CHAIR

Central Study Contacts

MOONHEE LEE

CONTACT

+82 02-6313-2177; mhlee@classys.com

HongGI Ham

CONTACT

+82-02-6204-2163; hgham520@classys.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: December 9, 2024
• Study Start: November 18, 2024
• Primary Completion: April 30, 2025
• Study Completion: October 31, 2025
• Last Updated: April 25, 2025

Record last verified: 2025-03

Locations

CN (3)