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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-18

Study Completion Date

2025-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Skin Laxity Wrinkles Facial Wrinkles and Rhytides Reduction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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ULTRAFOMER MPT

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

Group Type EXPERIMENTAL

HIFU treatment with ULTRAFOMER MPT

Intervention Type DEVICE

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

No Treatment

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes