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

NCT06724510 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-05-15

No results posted yet for this study

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

Interventions

DEVICE

HIFU treatment with ULTRAFOMER MPT

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

Sponsors & Collaborators

  • CLASSYS Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-18
Primary Completion
2025-09-16
Completion
2025-12-18

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06724510 on ClinicalTrials.gov