RECRUITING

Safety and Efficacy Evaluation of the Mosaic Ultra Device

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Safety and Efficacy Evaluation of the Mosaic Ultra Device

Quick Facts

Study Start:2023-02-21

Study Completion:2025-09-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06117293

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.

Ages Eligible for Study:18 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Alexander Denis

CONTACT

9788959206

adenis@lutronic.com

Paul Cardiarelli

CONTACT

8012440058

pcardarelli@lutronic.com

Principal Investigator

Omar Ibrahimi

PRINCIPAL_INVESTIGATOR

Lutronic Medical Director

Study Locations (Sites)

Advanced Dermatology

Lincolnshire, Illinois, 60069

United States

Lutronic

Billerica, Massachusetts, 01821

United States

Dermatology & Skin Health

Peabody, Massachusetts, 01960

United States

Collaborators and Investigators

Sponsor: LUTRONIC Corporation

Omar Ibrahimi, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2023-02-21

Study Completion Date2025-09-01

Study Record Updates

Study Start Date2023-02-21

Study Completion Date2025-09-01

Terms related to this study

Additional Relevant MeSH Terms

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