Safety and Efficacy Evaluation of the Mosaic Ultra Device

Last updated: November 1, 2023
Sponsor: LUTRONIC Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Acne

Scalp Disorders

Hair Loss

Treatment

Mosaic

Clinical Study ID

NCT06117293
LMI22001
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Non-smoking, Male or Female
  • Age 18 - 60 years old
  • Understands and accepts the obligation not to undergo any other procedures in theareas to be treated.
  • Participants who are willing and able to comply with all study participationrequirements including returning for follow-up visits and abstaining from exclusionaryprocedures for the duration of the study.
  • OPTIONAL - Participants who are willing to undergo biopsies.

Exclusion

Exclusion Criteria:

  • Previous surgical or cosmetic procedure to the target area in the last 6 to 12 monthsthat 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 couldinterfere with evaluation or with the use of typical ancillary medical treatments orcare 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 theprocedure (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 weeksof study participation
  • Use of steroids within 2 weeks of study treatments
  • Patients with implanted pacemaker or defibrillator, or metal pins, or prostheticjoints within 4 cm of treatment area
  • History of psychoneurosis and/or a history of alcohol or drug abuse

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Mosaic
Phase:
Study Start date:
February 21, 2023
Estimated Completion Date:
September 01, 2025

Connect with a study center

  • Advanced Dermatology

    Lincolnshire, Illinois 60069
    United States

    Active - Recruiting

  • Lutronic

    Billerica, Massachusetts 01821
    United States

    Active - Recruiting

  • Dermatology & Skin Health

    Peabody, Massachusetts 01960
    United States

    Active - Recruiting

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