Safety and Efficacy Evaluation of High Intensity Focused Ultrasound Device in Eyebrow Lifting (NCT06724510) | Clinical Trial Compass
RecruitingNot Applicable
Safety and Efficacy Evaluation of High Intensity Focused Ultrasound Device in Eyebrow Lifting
China180 participantsStarted 2024-11-18
Plain-language 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.
Who can participate
Age range20 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.