Study evaluating the efficacy of a micro coring device for the treatment of moderate to severe check wrinkles
Males and females 40-70 years of age
Fitzpatrick Skin Type I to IV as judged by the Investigator
Cheek areas are at least a score of 3 using the Lemperle Wrinkle Assessment Scale as judged by the Investigator
Able to provide written informed consent, understand and willing to comply with all study related procedures and follow-up visits.
Lesions suspicious for any malignancy or the presence of actinic keratosis, melasma, vitiligo, cutaneous papules/nodules or active inflammatory lesions in the areas to be treated
History of keloid formation or hypertrophic scarring
History of trauma or surgery to the treatment areas in the past 6 months
Scar present in the areas to be treated
Single group
MCD
DeviceMicro coring skin removal with automated coring device
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
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
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
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.
Assess efficacy results using Canfield Software,, by comparing the changes in wrinkles at baseline and 90 days post treatment.
Validated Canfield software comparing baseline wrinkles to day 90 follow up wrinkles via automated photo analysis.
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