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

Launched by CLASSYS INC. · Dec 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a device called the ULTRAFORMER MPT, which uses high-intensity focused ultrasound (HIFU) to lift eyebrows and improve skin tightness. The main goal is to see if this device is safe and effective for eyebrow lifting compared to a group that will not receive any treatment. Participants will have one treatment session and will be monitored for three months to evaluate how well the treatment works and if there are any side effects.

To join the study, participants need to be between 20 and 65 years old and have some skin laxity in their forehead. They should not have any significant skin conditions, metal implants, or severe health issues that could interfere with the treatment. During the trial, participants will take photos and provide feedback on their satisfaction with the results, as well as report any pain they may experience. This study aims to gather strong evidence on the ULTRAFORMER MPT's ability to lift eyebrows without surgery, making it an important option for those seeking non-invasive cosmetic treatments.

Gender

ALL

Eligibility criteria

• 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.