Safety and Efficacy Evaluation of the Mosaic Ultra Device

Launched by LUTRONIC CORPORATION · Nov 1, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a new treatment called the Mosaic Ultra Device. It is designed to help with various skin issues, such as uneven skin texture, wrinkles, scars, and even hair loss. The goal is to see how well this device works for improving skin appearance and rejuvenation.

To participate, you need to be a healthy adult between 18 and 60 years old and agree not to have any other treatments in the areas being studied during the trial. You'll also need to be able to come back for follow-up visits. However, there are some things that would prevent you from joining, like recent surgeries in the area being treated, certain medical conditions, or if you are pregnant. If you choose to take part, you will receive the treatment and will have follow-up visits to monitor your progress. This trial is currently looking for volunteers of all genders to help us learn more about this innovative treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Non-smoking, Male or Female
• • Age 18 - 60 years old
• • Understands and accepts the obligation not to undergo any other procedures in the areas to be treated.
• • Participants who are willing and able to comply with all study participation requirements including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
• • OPTIONAL - Participants who are willing to undergo biopsies.
• Exclusion Criteria:
• • Previous surgical or cosmetic procedure to the target area in the last 6 to 12 months that could interfere with the treatment procedure
• • A study participant must not be pregnant or have been pregnant in the last 3 months
• • A recent history of smoking (6 months)
• • Presence of an active skin disease or condition that may affect wound healing (ie. diabetes myelitis; connective tissue disease; radiation therapy; or chemotherapy)
• • Seizure disorder caused by bright light
• • A history of thrombophlebitis
• • A history of acute infections
• • A history of heart failure
• • Cancer, malignant disease, skin pathology, condition, or allergic reactions that could interfere with evaluation or with the use of typical ancillary medical treatments or care used before, during, or after treatments
• • Received or is anticipated to receive antiplatelets, anticoagulants, thrombolytics, vitamin E, or anti-inflammatories within 2 weeks prior to treatment
• • Intolerance or allergy to medications that could be prescribed before or after the procedure (eg, antibiotics, anesthesia)
• • A history of keloids
• • A history or evidence of poor wound healing
• • A history of coagulative disorder or current use of anticoagulant drugs within 2 weeks of study participation
• • Use of steroids within 2 weeks of study treatments
• • Patients with implanted pacemaker or defibrillator, or metal pins, or prosthetic joints within 4 cm of treatment area
• • History of psychoneurosis and/or a history of alcohol or drug abuse