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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
1550 Fractional Laser System
Advanced Dermatology
Lincolnshire, Illinois, United States
RECRUITINGLutronic
Billerica, Massachusetts, United States
RECRUITINGDermatology & Skin Health
Peabody, Massachusetts, United States
RECRUITINGPhotographic Assessment
Evaluation of Randomized Before Treatment and 3-Month Follow-Up Images by Blinded Evaluators
Time frame: 90-day Follow-Up
Safety Assessment
Evaluation of Adverse Events
Time frame: up to 90 days post final treatment
Subject Satisfaction
Scoring of Satisfaction from Extremely Satisfied to Extremely Dissatisfied
Time frame: 30-day and 90-day Follow-Up
Physician Satisfaction
Scoring of Satisfaction from Extremely Satisfied to Extremely Dissatisfied
Time frame: 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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Immediate Post Treatment, 4 Days Post, 14 Days Post, 21 Days Post