Skin Texture DisorderNCT06117293
Safety and Efficacy Evaluation of the Mosaic Ultra Device
A study testing Mosaic in people with Skin Texture Disorder and Photoaging, run by CynosureLutronic at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Texture Disorder, Photoaging, Wrinkle
- What is being tested?
- Mosaic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Feb 2023to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Lutronic
Billerica, Massachusetts, 01821
Omar A Ibrahimi, MD, PHD, 203-428-4440, omar.ibrahimi@gmail.com
- Recruiting
Advanced Dermatology
Lincolnshire, Illinois, 60069
Amy F Taub, MD, FAAD, 847-459-4610, drtaub@advdermatology.com
- Recruiting
Dermatology & Skin Health
Peabody, Massachusetts, 01960
Robert D Murgia III, D.O., 978-525-0100, drmurgia@gmail.com
About this study
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.
- Conditions
- Skin Texture Disorder, Photoaging, Wrinkle, Scar, Stretch Mark, Acne Vulgaris
- Being tested
- Mosaic
- Medical subject headings
- Cicatrix, Striae Distensae, Acne Vulgaris, Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MosaicDevice
1550 Fractional Laser System
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | 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. Receives: Device: Mosaic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Photographic Assessment
Evaluation of Randomized Before Treatment and 3-Month Follow-Up Images by Blinded Evaluators
Measured: 90-day Follow-Up
Secondary outcomes (9)
Safety Assessment
Evaluation of Adverse Events
Measured: up to 90 days post final treatment
Subject Satisfaction
Scoring of Satisfaction from Extremely Satisfied to Extremely Dissatisfied
Measured: 30-day and 90-day Follow-Up
Physician Satisfaction
Scoring of Satisfaction from Extremely Satisfied to Extremely Dissatisfied
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Immediate Post Treatment, 4 Days Post, 14 Days Post, 21 Days Post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start21 Feb 2023
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Texture DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CynosureLutronic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Omar Ibrahimi, Principal investigator, Lutronic Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117293
- Sponsor's protocol ID
- LMI22001
- Status last verified
- Nov 2023
- First submitted
- 23 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Plan will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Evaluation of the Mosaic Ultra Device
- ClinicalTrials.gov ID
- NCT06117293
- Acronym / sponsor ID
- LMI22001
- Conditions
- Skin Texture Disorder, Photoaging, Wrinkle, Scar, Stretch Mark, Acne Vulgaris
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- CynosureLutronicIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: MosaicSubjects 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mosaic1550 Fractional Laser System | Device | Treatment Arm |
Primary outcome
Photographic Assessment
Time frame: 90-day Follow-Up
Evaluation of Randomized Before Treatment and 3-Month Follow-Up Images by Blinded Evaluators
9 secondary outcomes
Safety Assessment
Time frame: up to 90 days post final treatment
Subject Satisfaction
Time frame: 30-day and 90-day Follow-Up
Physician Satisfaction
Time frame: 30-day and 90-day Follow-Up
Subject Clinical Global Aesthetic Improvement Scale
Time frame: 30-day and 90-day Follow-Up
Physician Clinical Global Aesthetic Improvement Scale
Time frame: 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
Epidermal Inflammatory Response
Time frame: 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
Tissue Reepithelization
Time frame: Baseline, Immediate Post Treatment, 4 Days Post, 14 Days Post, 21 Days Post
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: No. Plan will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omar Ibrahimi principal investigator
Lutronic Medical Director
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mosaic in people with Skin Texture Disorder and Photoaging, run by CynosureLutronic at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander Denis (9788959206, adenis@lutronic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Photographic Assessment (time frame: 90-day Follow-Up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.