Study evaluating the efficacy of a micro coring device for the treatment of moderate to severe check wrinkles
Up to 35 subjects who meet the inclusion/exclusion criteria will be treated. All subjects will be monitored for a period of 90 days post treatment. Study results will be assessed with the following: * Lemperle Scale * Investigator GAIS Scale * Subject Satisfaction Scale
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Micro coring skin removal with automated coring device
Laser and Skin Surgery Center of Northern California
Sacramento, California, United States
ACTIVE_NOT_RECRUITINGAboutSkin Research, LLC
Greenwood Village, Colorado, United States
NOT_YET_RECRUITINGMiami Dermatology & Laser Institute
Miami, Florida, United States
Assess level of wrinkle improvement using the Lemperle Wrinkle Severity Scale
A mean change of 1 point or greater reduction in cheek wrinkle severity at 90 days post treatment using the Lemperle Wrinkle Severity Scale, as assessed by (3) blinded Independent Reviewers Lemperle Scale: No wrinkles =0 Just perceptible wrinkles =1 Shallow wrinkles=2 Moderately deep wrinkles=3 Deep wrinkles, well-defined edges =4 Very deep wrinkles, redundant fold=5
Time frame: 90 day post treatment
Assess aesthetic improvement using Global Aesthetic Improvement Scale
Overall aesthetic improvement level per Principal Investigator at 90 days compared to baseline on the Global Aesthetic Improvement Scale. Very Much Improved (Optimal cosmetic result)=3 Much Improved (Marked improvement from the initial condition, but not completely optimal)=2 No Change (The appearance is essentially the same as baseline)=0 Worse (The appearance is worse than the original condition)= -1 Much Worse (Marked worsening in appearance from the initial condition)= - 2 Very Much Worse (Obvious worsening in appearance from the initial condition)=- 3
Time frame: 90 day post treatment
Assess aesthetic improvement using Subject Satisfaction Scale
Satisfaction with the aesthetic appearance of the treatment area per Subject Satisfaction Scale compared to baseline. Extremely dissatisfied=0 Somewhat dissatisfied=1 Slightly dissatisfied=2 Neither satisfied or dissatisfied=3 Slightly satisfied=4 Somewhat satisfied=5 Extremely satisfied=6
Time frame: 90 day post treatment
Assess aesthetic improvement in wrinkles using OCT images (optional)
Assessment of improvement using OCT images with Vista software to determine wrinkle depth reduction, comparing pre-treatment depth to post treatment depth.
Time frame: Baseline to Day 90 post treatment
Assess efficacy results using Canfield Software,, by comparing the changes in wrinkles at baseline and 90 days post treatment.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Laser and Skin Surgery of New York
New York, New York, United States
RECRUITINGThe Office of Brian Biesman, M.D.
Nashville, Tennessee, United States
ACTIVE_NOT_RECRUITINGDallas Plastic Surgery Institute
Dallas, Texas, United States
NOT_YET_RECRUITINGValidated Canfield software comparing baseline wrinkles to day 90 follow up wrinkles via automated photo analysis.
Time frame: Baseline to Day 90 post treatment
Assess safety profile by recording of adverse events
The incidence and severity of systemic and local adverse events will be recorded by the PI at all visits and a 14 day diary completed by each subject will also be collected.
Time frame: Adverse events will be recorded immediately treatment, Day 1, Day 7, Day 30, Day 60 and Day 90 post treatment. Ad hoc assessment can occur upon subject report of AE.
Assess safety profile by reviewing completed 14 day subject diary for potential side effects.
14 day diary completed by each subject will record potential side effects, level of severity (mild = 1; moderate = 2; severe = 3), and end date of the potential side effects.
Time frame: For 14 days post treatment