Wrinkle
Conditions
Keywords
facial wrinkles, skin laxity, sagging skin
Brief summary
Study evaluating the efficacy of a micro coring device for the treatment of moderate to severe check wrinkles
Detailed description
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
Interventions
DEVICEMCD
Micro coring skin removal with automated coring device
Sponsors
Cytrellis Biosystems, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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 * Silicone injections in the areas to be treated * Injection of dermal fillers, fat or botulinum toxin, as well as any minimally invasive/invasive medical device for skin treatment, in the study treatment areas, within the past 6 months (i.e., dermabrasion, laser, RF devices) * Active smokers (0.5 pack/day) or having quit within 3 months prior to treatment * Active, chronic, or recurrent infection * History of compromised immune system or currently being treated with immunosuppressive agents * History of sensitivity to analgesic agents, Aquaphor®, topical or local anesthetics (e.g., lidocaine, benzocaine, procaine) or chlorhexidine, povidone-iodine or epinephrine * Excessive sun exposure and use of tanning beds or tanning creams within 30 days prior to treatment * Treatment with aspirin or other blood thinning agents within 14 days prior to treatment * History or presence of any clinically significant bleeding disorder * Any issue that, at the discretion of the Investigator, would interfere with assessment of safety or efficacy or compromise the subject's ability to participate in the study * Treatment with an investigational device or agent within 30 days before treatment or during the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess level of wrinkle improvement using the Lemperle Wrinkle Severity Scale | 90 day post treatment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess aesthetic improvement using Subject Satisfaction Scale | 90 day post treatment | 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) | Baseline to Day 90 post treatment | Assessment of improvement using OCT images with Vista software to determine wrinkle depth reduction, comparing pre-treatment depth to post treatment depth. |
| Assess aesthetic improvement using Global Aesthetic Improvement Scale | 90 day post treatment | 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 safety profile by recording of adverse events | 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. | 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. |
| Assess safety profile by reviewing completed 14 day subject diary for potential side effects. | For 14 days post treatment | 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. |
| Assess efficacy results using Canfield Software,, by comparing the changes in wrinkles at baseline and 90 days post treatment. | Baseline to Day 90 post treatment | Validated Canfield software comparing baseline wrinkles to day 90 follow up wrinkles via automated photo analysis. |
Countries
United States
Outcome results
None listed