An interventional study of Mosaic in Skin Texture Disorder, Photoaging and Wrinkle, sponsored by LUTRONIC Corporation. Recruiting at 3 sites in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-07.
Sponsored by LUTRONIC Corporation (part of Cynosure Lutronic, Inc.) · Not applicable, Interventional, and Treatment
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.
611 studies on the registry are indexed under Cicatrix; 114 are open to participants now.
This study's planned enrollment of 200 is above the median of 40 across 512 interventional studies indexed under Cicatrix.
Browse Cicatrix studies →LUTRONIC Corporation is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
First submitted before LUTRONIC Corporation became part of Cynosure Lutronic, Inc..
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
1550 Fractional Laser System
Photographic 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.
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
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Plan will not be shared
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