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Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Moderate to Severe Facial Wrinkles

RecruitingNAAges 40 Years - 70 YearsAllCytrellis Biosystems, Inc.
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In plain words

What the trial is, and whether it could suit you

Study evaluating the efficacy of a micro coring device for the treatment of moderate to severe check wrinkles

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • MCD
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Where

6 sites
Laser and Skin Surgery Center of Northern California
Sacramento, United States
AboutSkin Research, LLC
Greenwood Village, United States
Miami Dermatology & Laser Institute
Miami, United States
Laser and Skin Surgery of New York
New York, United States
The Office of Brian Biesman, M.D.
Nashville, United States
Dallas Plastic Surgery Institute
Dallas, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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