Clinical trial NCT06117293: Safety and Efficacy Evaluation of the Mosaic Ultra Device
Official title: Safety and Efficacy Evaluation of the Mosaic Ultra Device
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Skin Texture Disorder
Photoaging
Wrinkle
Scar
Stretch Mark
Acne Vulgaris
Hair Loss
Lead sponsor: LUTRONIC Corporation
Sponsor class: INDUSTRY
First posted: 2023-11-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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
* 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

Primary outcomes:
measure: Photographic Assessment
timeFrame: 90-day Follow-Up
Secondary outcomes:
measure: Safety Assessment
timeFrame: up to 90 days post final treatment
measure: Subject Satisfaction
timeFrame: 30-day and 90-day Follow-Up
measure: Physician Satisfaction
timeFrame: 30-day and 90-day Follow-Up
measure: Subject Clinical Global Aesthetic Improvement Scale
timeFrame: 30-day and 90-day Follow-Up
measure: Physician Clinical Global Aesthetic Improvement Scale
timeFrame: 30-day and 90-day Follow-Up
measure: Coagulation Zone Measurements
timeFrame: Baseline, Immediate Post Treatment, 4 Days Post, 14 Days Post, 21 Days Post
measure: Epidermal Inflammatory Response
timeFrame: Baseline, Immediate Post Treatment, 4 Days Post, 14 Days Post, 21 Days Post
measure: Dermal Inflammatory Response
timeFrame: Baseline, Immediate Post Treatment, 4 Days Post, 14 Days Post, 21 Days Post
measure: Tissue Reepithelization
timeFrame: Baseline, Immediate Post Treatment, 4 Days Post, 14 Days Post, 21 Days Post
Other outcomes:
Locations:
city: Lincolnshire
country: United States
facility: Advanced Dermatology
state: Illinois
city: Billerica
country: United States
facility: Lutronic
state: Massachusetts
city: Peabody
country: United States
facility: Dermatology & Skin Health
state: Massachusetts
Study officials:
affiliation: Lutronic Medical Director
name: Omar Ibrahimi
role: PRINCIPAL_INVESTIGATOR
References: