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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

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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