Pivotal Study to Evaluate the Effectiveness of a Micro-coring Device Treating Moderate to Severe Facial Wrinkles

Study Overview
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Brief Summary
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Study evaluating the effectiveness of a micro-coring device for the treatment of moderate to severe cheek wrinkles.

Detailed Description
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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

Official Title
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A Prospective, Multi-center, Pivotal Study to Evaluate the Safety and Efficacy of a Micro-Coring Device for the Treatment of Moderate to Severe Facial Wrinkles

Conditions
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Laxity; Skin

Intervention / Treatment
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* Device: MCD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Micro-coring of facial/neck skin with MCD<br>Micro coring of facial and neck skin will be conducted in up to 2 treatments and followed 90 days post treatment with MCD | Device: MCD<br>* Micro-coring skin removal with automated coring device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess level of wrinkle improvement using the Lemperle Wrinkle Severity Scale at 90 days 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 | 90 day post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess safety profile by recording of adverse events | Adverse events will be recorded throughout the study | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sagging skin, facial wrinkles, skin laxity