Safety and Efficacy Evaluation of the Mosaic Ultra Device

Status unconfirmed · Not applicable

Conditions studied: Skin Texture Disorder, Photoaging, Wrinkle, Scar, Stretch Mark, Acne Vulgaris, Hair Loss

In brief

Evaluate the Safety and Efficacy of the Mosaic Ultra 1550nm system for the treatment of skin tone and texture, facial rejuvenation, photoaging, wrinkles, scars, stretch marks, acne vulgaris and hair loss.

Key facts

Study ID

NCT06117293

Run by

CynosureLutronic

People needed

200

Starts

2023-02-21

Expected to finish

2025-09-01

Last updated by the study team

2023-11-07

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Advanced Dermatology — Lincolnshire, Illinois, United States (enrolling)
• Lutronic — Billerica, Massachusetts, United States (enrolling)
• Dermatology & Skin Health — Peabody, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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