Pivotal Study to Evaluate the Effectiveness of a Micro-coring Device Treating Moderate to Severe Facial Wrinkles
NCT ID: NCT03573271
Last Updated: 2018-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2018-03-22
2019-03-21
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Micro-coring of facial/neck skin with MCD
Micro coring of facial and neck skin will be conducted in up to 2 treatments and followed 90 days post treatment with MCD
MCD
Micro-coring skin removal with automated coring device
Interventions
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MCD
Micro-coring skin removal with automated coring device
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
70 Years
ALL
Yes
Sponsors
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Cytrellis Biosystems, Inc.
INDUSTRY
Responsible Party
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Locations
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Laser and Skin Surgery Center of Northern California
Sacramento, California, United States
Miami Dermatology and Laser Institute
Miami, Florida, United States
Laser and Skin Surgery Center of New York
New York, New York, United States
The Practice of Brian S. Biesman, M.D
Nashville, Tennessee, United States
Dr A Jay Burns Cosmetic Surgery
Dallas, Texas, United States
Countries
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Facility Contacts
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Nicole Rieth
Role: primary
Brittany Schmidt
Role: primary
Casey Martin
Role: primary
Other Identifiers
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AIS 700-00041
Identifier Type: -
Identifier Source: org_study_id