Evaluation of the Mosaic Ultra Device for skin treatment
Safety and Efficacy Evaluation of the Mosaic Ultra Device
This study is testing a new skin treatment device to see if it can improve skin tone and texture for adults aged 18 to 60.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | LUTRONIC Corporation Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 3 sites (Lincolnshire, Illinois and 2 other locations) |
| Trial ID | NCT06117293 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of the Mosaic Ultra 1550nm system, which is designed to improve skin tone and texture, treat facial rejuvenation, photoaging, wrinkles, scars, stretch marks, acne vulgaris, and hair loss. Participants will be non-smoking adults aged 18 to 60 who agree to refrain from other procedures in the treatment areas during the study. The trial will involve follow-up visits to assess the outcomes of the treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are non-smoking adults aged 18 to 60 with skin texture disorders or signs of photoaging.
Not a fit: Patients with recent surgical or cosmetic procedures in the target area, active skin diseases, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve skin appearance and texture for patients suffering from various skin conditions.
How similar studies have performed: Other studies have shown promising results with similar laser treatments for skin rejuvenation, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lincolnshire, Illinois and 2 other locations
- Advanced Dermatology — Lincolnshire, Illinois, United States (Recruiting)
- Lutronic — Billerica, Massachusetts, United States (Recruiting)
- Dermatology & Skin Health — Peabody, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Omar Ibrahimi — Lutronic Medical Director
- Study coordinator: Alexander Denis
- Email: adenis@lutronic.com
- Phone: 9788959206
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.