Safety and Efficacy Evaluation of the Mosaic Ultra Device

Acne Vulgaris Clinical Trial

Official title:

Safety and Efficacy Evaluation of the Mosaic Ultra Device

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06117293
• Other study ID #: LMI22001
• Status: Recruiting
• Phase: N/A
• Start date: February 21, 2023
• Est. completion date: September 1, 2025

Study information

• Verified date: November 2023
• Source: LUTRONIC Corporation
• Contact: Alexander Denis
• Phone: 9788959206
• Email: adenis[@]lutronic.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris
• Hair Loss
• Photoaging
• Scar
• Skin Texture Disorder
• Stretch Mark
• Striae Distensae
• Wrinkle

Intervention

Device:
• Mosaic
1550 Fractional Laser System

Locations

Country	Name	City	State
United States	Lutronic	Billerica	Massachusetts
United States	Advanced Dermatology	Lincolnshire	Illinois
United States	Dermatology & Skin Health	Peabody	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
LUTRONIC Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Photographic Assessment	Evaluation of Randomized Before Treatment and 3-Month Follow-Up Images by Blinded Evaluators	90-day Follow-Up
Secondary	Safety Assessment	Evaluation of Adverse Events	up to 90 days post final treatment
Secondary	Subject Satisfaction	Scoring of Satisfaction from Extremely Satisfied to Extremely Dissatisfied	30-day and 90-day Follow-Up
Secondary	Physician Satisfaction	Scoring of Satisfaction from Extremely Satisfied to Extremely Dissatisfied	30-day and 90-day Follow-Up
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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