NCT06117293
Recruiting
Not Applicable
Safety and Efficacy Evaluation of the Mosaic Ultra Device
LUTRONIC Corporation3 sites in 1 country200 target enrollmentStarted: February 21, 2023Last updated:
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- LUTRONIC Corporation
- Enrollment
- 200
- Locations
- 3
- Primary Endpoint
- Photographic Assessment
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Photographic Assessment
Time Frame: 90-day Follow-Up
Evaluation of Randomized Before Treatment and 3-Month Follow-Up Images by Blinded Evaluators
Secondary Outcomes
- Safety Assessment(up to 90 days post final treatment)
- Physician Satisfaction(30-day and 90-day Follow-Up)
- Physician Clinical Global Aesthetic Improvement Scale(30-day and 90-day Follow-Up)
- Coagulation Zone Measurements(Baseline, Immediate Post Treatment, 4 Days Post, 14 Days Post, 21 Days Post)
- Tissue Reepithelization(Baseline, Immediate Post Treatment, 4 Days Post, 14 Days Post, 21 Days Post)
- Subject Satisfaction(30-day and 90-day Follow-Up)
- Subject Clinical Global Aesthetic Improvement Scale(30-day and 90-day Follow-Up)
- Epidermal Inflammatory Response(Baseline, Immediate Post Treatment, 4 Days Post, 14 Days Post, 21 Days Post)
- Dermal Inflammatory Response(Baseline, Immediate Post Treatment, 4 Days Post, 14 Days Post, 21 Days Post)
Investigators
Study Sites (3)
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