Safety and Efficacy Evaluation of the Mosaic Ultra Device
NCT ID: NCT06117293
Last Updated: 2023-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2023-02-21
2025-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Arm
Subjects will be treated up to 5 times with a 30- and 90-day post final-treatment follow-up. Subjects may be asked to participate in an elective biopsy collected from normal skin simultaneously.
Mosaic
1550 Fractional Laser System
Interventions
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Mosaic
1550 Fractional Laser System
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
Yes
Sponsors
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LUTRONIC Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Omar Ibrahimi
Role: PRINCIPAL_INVESTIGATOR
Lutronic Medical Director
Locations
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Advanced Dermatology
Lincolnshire, Illinois, United States
Lutronic
Billerica, Massachusetts, United States
Dermatology & Skin Health
Peabody, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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LMI22001
Identifier Type: -
Identifier Source: org_study_id
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