Safety and Efficacy Evaluation of the Mosaic Ultra Device

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 Overview

• Status: Recruiting
• Conditions: Acne Vulgaris; Scar; Wrinkle; Photoaging; Skin Texture Disorder; Hair Loss; Stretch Mark
• Intervention / Treatment: Device: Mosaic

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexander Denis; Phone Number: 9788959206; Email: adenis@lutronic.com
• Study Contact Backup: Name: Paul Cardiarelli; Phone Number: 8012440058; Email: pcardarelli@lutronic.com

Study Locations

• United States
  • Illinois
    • Lincolnshire, Illinois, United States, 60069
      • Recruiting
      • Advanced Dermatology
      • Contact: Amy F Taub, MD, FAAD; Phone Number: 847-459-4610; Email: drtaub@advdermatology.com
  • Massachusetts
    • Billerica, Massachusetts, United States, 01821
      • Recruiting
      • Lutronic
      • Contact: Omar A Ibrahimi, MD, PHD; Phone Number: 203-428-4440; Email: omar.ibrahimi@gmail.com
    • Peabody, Massachusetts, United States, 01960
      • Recruiting
      • Dermatology & Skin Health
      • Contact: Robert D Murgia III, D.O.; Phone Number: 978-525-0100; Email: drmurgia@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Mosaic; 1550 Fractional Laser System

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: LUTRONIC Corporation
• Investigators: Principal Investigator: Omar Ibrahimi, Lutronic Medical Director

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: November 1, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Striae Distensae
• Other Study ID Numbers: LMI22001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Plan will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No