Safety and Efficacy Evaluation of the Mosaic Ultra Device

November 1, 2023 updated by: LUTRONIC Corporation
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Lincolnshire, Illinois, United States, 60069
    • Massachusetts
      • Billerica, Massachusetts, United States, 01821
      • Peabody, Massachusetts, United States, 01960
        • Recruiting
        • Dermatology & Skin Health
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Photographic Assessment
Time Frame: 90-day Follow-Up
Evaluation of Randomized Before Treatment and 3-Month Follow-Up Images by Blinded Evaluators
90-day Follow-Up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety Assessment
Time Frame: up to 90 days post final treatment
Evaluation of Adverse Events
up to 90 days post final treatment
Subject Satisfaction
Time Frame: 30-day and 90-day Follow-Up
Scoring of Satisfaction from Extremely Satisfied to Extremely Dissatisfied
30-day and 90-day Follow-Up
Physician Satisfaction
Time Frame: 30-day and 90-day Follow-Up
Scoring of Satisfaction from Extremely Satisfied to Extremely Dissatisfied
30-day and 90-day Follow-Up
Subject Clinical Global Aesthetic Improvement Scale
Time Frame: 30-day and 90-day Follow-Up

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
Time Frame: 30-day and 90-day Follow-Up

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
Time Frame: Baseline, Immediate Post Treatment, 4 Days Post, 14 Days Post, 21 Days Post
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
Time Frame: Baseline, Immediate Post Treatment, 4 Days Post, 14 Days Post, 21 Days Post
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
Time Frame: Baseline, Immediate Post Treatment, 4 Days Post, 14 Days Post, 21 Days Post
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
Time Frame: Baseline, Immediate Post Treatment, 4 Days Post, 14 Days Post, 21 Days Post
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
LUTRONIC Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Omar Ibrahimi, Lutronic Medical Director

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 21, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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