NCT06724510

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

Safety and Efficacy Evaluation of High Intensity Focused Ultrasound Device in Eyebrow Lifting, a Prospective, Multi-center, Evaluator Blinded, Randomized, Non-treatment Controlled, and Superiority Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: CLASSYS Inc. · Industry
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-11-18
• Primary completion: 2025-04-30
• Completion: 2025-10-31
• First posted: 2024-12-09
• Last updated: 2025-04-25

Locations

3 sites across 1 country: China