Safety and Efficacy Evaluation of the Mosaic Ultra Device

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.

Conditions

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

Study Overview

Study Details

Study overview

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.

Safety and Efficacy Evaluation of the Mosaic Ultra Device

Safety and Efficacy Evaluation of the Mosaic Ultra Device

Condition
Skin Texture Disorder
Intervention / Treatment

-

Contacts and Locations

Lincolnshire

Advanced Dermatology, Lincolnshire, Illinois, United States, 60069

Billerica

Lutronic, Billerica, Massachusetts, United States, 01821

Peabody

Dermatology & Skin Health, Peabody, Massachusetts, United States, 01960

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to 60 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

LUTRONIC Corporation,

Omar Ibrahimi, PRINCIPAL_INVESTIGATOR, Lutronic Medical Director

Study Record Dates

2025-09-01