Safety and Efficacy Evaluation of the Mosaic Ultra Device

Study Overview
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Brief Summary
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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.

Official Title
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Safety and Efficacy Evaluation of the Mosaic Ultra Device

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

Intervention / Treatment
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* Device: Mosaic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br>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. | Device: Mosaic<br>* 1550 Fractional Laser System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Photographic Assessment | Evaluation of Randomized Before Treatment and 3-Month Follow-Up Images by Blinded Evaluators | 90-day Follow-Up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Assessment | Evaluation of Adverse Events | up to 90 days post final treatment | 
| Subject Satisfaction | Scoring of Satisfaction from Extremely Satisfied to Extremely Dissatisfied | 30-day and 90-day Follow-Up | 
| Physician Satisfaction | Scoring of Satisfaction from Extremely Satisfied to Extremely Dissatisfied | 30-day and 90-day Follow-Up | 
| Subject Clinical Global Aesthetic Improvement Scale | Scoring on the Clinical Global Aesthetic Improvement Scale is completed by having the subject select one option from the scale corresponding to their perspective of the improvement seen in their treated conditions. Response options are 1 - Very Much Improved, 2 - Much Improved, 3 - Improved, 4 - No Change, and 5 - Worsened. A response of 1 - Very Much Improved is the best outcome while a score of 5 - Worsened is the worse outcome. | 30-day and 90-day Follow-Up | 
| Physician Clinical Global Aesthetic Improvement Scale | Scoring on the Clinical Global Aesthetic Improvement Scale is completed by having the physician select one option from the scale corresponding to their perspective of the improvement seen in their treated conditions of the subject. Response options are 1 - Very Much Improved, 2 - Much Improved, 3 - Improved, 4 - No Change, and 5 - Worsened. A response of 1 - Very Much Improved is the best outcome while a score of 5 - Worsened is the worse outcome. | 30-day and 90-day Follow-Up | 
| Coagulation Zone Measurements | Biopsies taken from healthy tissue prior to treatment up to 21 days post treatment to evaluate histological effect of the device. Tissue samples will be evaluated and the depth and width of the coagulation zones due to the laser (measures in micrometers) | Baseline, Immediate Post Treatment, 4 Days Post, 14 Days Post, 21 Days Post | 
| Epidermal Inflammatory Response | Biopsies taken from healthy tissue prior to treatment up to 21 days post treatment to evaluate histological effect of the device. Tissue samples will be reviewed for markers of inflammation and coagulation in the epidermis. General comments and observations of the tissue will be completed by a pathologist. | Baseline, Immediate Post Treatment, 4 Days Post, 14 Days Post, 21 Days Post | 
| Dermal Inflammatory Response | Biopsies taken from healthy tissue prior to treatment up to 21 days post treatment to evaluate histological effect of the device. Tissue samples will be reviewed for markers of inflammation and coagulation in the dermis. General comments and observations of the tissue will be completed by a pathologist. | Baseline, Immediate Post Treatment, 4 Days Post, 14 Days Post, 21 Days Post | 
| Tissue Reepithelization | Biopsies taken from healthy tissue prior to treatment up to 21 days post treatment to evaluate histological effect of the device. Tissue samples will be evaluated to determine the timepoint in which there is a reepithelization of the treated tissue. Timepoint of reepithelization will be determined by a pathologist reviewing the imaging. | Baseline, Immediate Post Treatment, 4 Days Post, 14 Days Post, 21 Days Post |