Laxity; Skin
Conditions
Keywords
facial wrinkles, skin laxity, sagging skin
Brief summary
Study evaluating the safety and efficacy of a micro-coring device for the treatment of moderate to severe cheek wrinkles.
Detailed description
Up to 60 subjects who meet the Inclusion/Exclusion criteria will be treated. All subjects will be monitored for a period of 90 days after treatments. Evaluation results will be based in the following: * Wrinkle severity score assessed using the Lemperle Wrinkle Scale * Subject Satisfaction Scale * PI Global Aesthetic Improvement 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 * Female and pregnant or plan on becoming pregnant during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess level of wrinkle improvement using the Lemperle Wrinkle Severity Scale at 90 days post treatment | 90 day post treatment | Assess level of wrinkle improvement from the baseline to 90 day post treatment an Independent Reviewer(s) using the Lemperle Wrinkle Severity Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess safety profile by recording of adverse events | 90 days | Adverse events will be recorded throughout the study |
Countries
United States
Contacts
STUDY_DIRECTORPatricia Krantz
Cytrellis Biosystems, Inc.
Outcome results
None listed