At least thirty (30) subjects, Fitzpatrick-Goldman Skin Type I-IV will be enrolled in 2 clinical sites; each clinic will enroll at least 15 subjects. Subjects should present visible wrinkles and/or striae requiring treatment. Hypothesis: The M22 ResurFX 1565nm module will improve the appearance of the wrinkles by at least 2 grades on the Fitzpatrick-Goldman Wrinkle and Elastosis Score, and striae by at least 50% using VAS as compared to baseline, for at least 75% of the subjects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
The system delivers pulsed near Infra-Red (NIR) laser light with a nominal wavelength of 1565 nm and has a unique treatment handpiece with epidermal cooling. The clinician is able to control the settings of energy, µBeams density, scan size, and shape option from the user interface (LCD GUI) display on the main M22 console.
DCLA
San Diego, California, United States
New York Laser & Skin Care
New York, New York, United States
Improvement
Investigator subjective evaluation of the extent of wrinkles improvement at the 3 month follow-up visit as assessed by Fitzpatrick-Goldman Wrinkle Class / Elastosis Score classification, striae improvement will be assessed using VAS.
Time frame: 3 months following 3rd treatment
Improvement
Investigator subjective evaluation of the extent of wrinkles/striae improvement by the investigator at 1 and 6 month follow-up visits as assessed by Fitzpatrick-Goldman Wrinkle Class / Elastosis Score classification, striae improvement will be assessed using VAS.
Time frame: 1 and 6 months following 3rd treatment
Blinded improvement
Blinded evaluation of wrinkles/striae skin improvement at the 1, 3 and 6 months follow-up as compared to baseline using photographs may be performed at the end of the study.
Time frame: 1 year following study initiation
Skin response
Investigator subjective evaluation of skin response following each treatment defined as severity of response and the time it took for it subside
Time frame: Following treatment #1, 2 and 3
Downtime
Downtime defined as the period of time following the procedure during which the subject felt uncomfortable, unwilling or unable to go out in public due to edema and erythema
Time frame: Following treatment #1, 2 and 3
Improvement by subject
Subject subjective opinion of improvement and satisfaction with the treatment based on a 5 point scale
Time frame: 1, 3 and 6 months follow up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Comfort
Subject subjective assessment of pain and discomfort associated with treatments using a 10 point VAS scale
Time frame: Following treatment #1, 2 and 3
Biopsies
Histological analysis of tissue samples with different staining for analysis of changes following treatment
Time frame: 1, 3 and 6 months follow up
Adverse Events
Any adverse events associated with various setting used during the treatment and follow-up period.
Time frame: Following treatment #1, 2 and 3 and all follow up visits