RecruitingNot ApplicableNCT03793348

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

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

Sponsor

Cytrellis Biosystems, Inc.

Enrollment

35 participants

Start Date

Nov 12, 2018

Study Type

INTERVENTIONAL

Conditions

Wrinkle

Summary

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

Eligibility

Min Age: 40 YearsMax Age: 70 Years

Inclusion Criteria4

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 Criteria15

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