NCT03793348NARecruitingAccepts Healthy Volunteers
Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Moderate to Severe Facial Wrinkles
Cytrellis Biosystems, Inc.
Start Date
11/12/2018
Completion Date
8/21/2019
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
Eligibility Criteria
Age Range: 40 years to 70 years
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
Interventions
DEVICE
MCD
Conditions
Wrinkle
Locations
Laser and Skin Surgery Center of Northern California
Sacramento, California 95816
United States
AboutSkin Research, LLC
Greenwood Village, Colorado 80111
United States
Miami Dermatology & Laser Institute
Miami, Florida 33173
United States
Laser and Skin Surgery of New York
New York, New York 10016
United States
The Office of Brian Biesman, M.D.
Nashville, Tennessee 37203
United States
Dallas Plastic Surgery Institute
Dallas, Texas 75231
United States