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

Last updated: March 7, 2025
Sponsor: CLASSYS Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Skin Aging

Treatment

HIFU treatment with ULTRAFOMER MPT

Clinical Study ID

NCT06724510
CLSGQDWJJCHS
  • Ages 20-65
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

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 complywith treatment and follow-up.

Exclusion

Exclusion Criteria:

  1. Skin Conditions: Hyperpigmentation, tattoos, scars, active skin diseases, or otherconditions (e.g., eczema, psoriasis, vitiligo) in the treatment area that may affectefficacy or increase risk.

  2. Medical Devices or Implants: Presence of metal implants or embedded electronicdevices 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 affectingcoagulation within one week before screening.

  5. Prior Treatments: Use of fillers (e.g., hyaluronic acid, collagen) or cosmeticprocedures (e.g., laser therapy, botulinum toxin) in the treatment area within thespecified timeframes.

  6. Pregnancy: Women who are pregnant, nursing, or not using birth control during thetrial.

Study Design

Total Participants: 180
Treatment Group(s): 1
Primary Treatment: HIFU treatment with ULTRAFOMER MPT
Phase:
Study Start date:
November 18, 2024
Estimated Completion Date:
October 31, 2025

Connect with a study center

  • Beijing Anzhen Hospital of Capital Medical University

    Beijing,
    China

    Active - Recruiting

  • TheThird Hospital of Hebei Medical University

    Shijiazhuang,
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Xian Jiaotong University

    Xian,
    China

    Active - Recruiting

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