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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
RecruitingHealthy volunteers welcome
A Prospective, Multi-center, Pivotal Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Moderate to Severe Facial Wrinkles
Who can join
Ages 40 to 70 · All sexes · Healthy volunteers welcome
Full eligibility criteria
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
About the study
Study evaluating the efficacy of a micro coring device for the treatment of moderate to severe check wrinkles
What is being tested
- MCD (device)
Sponsor: Cytrellis Biosystems, Inc. · Participants: 35 · Started: Nov 12, 2018
Contact the study team
Official record on ClinicalTrials.gov — NCT03793348
Locations in the U.S.
| Colorado | AboutSkin Research, LLC, Greenwood Village (Not yet recruiting) |
| New York | Laser and Skin Surgery of New York, New York |
| Texas | Dallas Plastic Surgery Institute, Dallas (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.