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
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 StatesActive - Recruiting
Lutronic
Billerica, Massachusetts 01821
United StatesActive - Recruiting
Dermatology & Skin Health
Peabody, Massachusetts 01960
United StatesActive - Recruiting
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