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NCT03782038NARecruitingAccepts Healthy Volunteers

Study to Evaluate the Efficacy of a Micro Coring Device for the Treatment of Scars of the Cytrellis Micro-Coring Device for the Treatment of Scars

Cytrellis Biosystems, Inc.

Start Date

9/13/2018

Completion Date

11/21/2019

Summary

A study to evaluate the safety and effectiveness of a micro coring device for the treatment of scars.

Detailed Description

The study subject population will consist to up to 30 subjects who meet the inclusion/exclusion criteria. All subjects will be monitored for a period of 6 months post last treatment. An study results will be assessed on the following: * POSAS - Patient Observer Scar Assessment * ASAS - Acne Scar Severity Scale * Subject Satisfaction Scale

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 18 years of age or older * Fitzpatrick scale I-VI. * Any type of scar except for keloid scars * Able to provide written informed consent, understand and willing to comply with study related procedures and follow-ups. Exclusion Criteria: * Previous treatment of the scar tissue within last 6 months. * Silicone, fat, collagen or synthetic material in the treatment area. * History of keloid formation. * Active smokers (smoking more than ½ pack per day) or having quit smoking (½ pack per day) for less than 3 months. * Active, chronic, or recurrent infection. * Compromised immune system (e.g. diabetes). * Hypersensitivity to analgesic agents. * Co-morbid condition that could limit ability to participate in the study or to comply with follow-up requirements. * Pregnant or breastfeeding. * Any issue that, at the discretion of the investigator, would contra-indicate the subject's participation. * Any medication that may cause bleeding such as anticoagulants. * Allergy to lidocaine and/or epinephrine

Interventions

DEVICE

MCD

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Conditions

Scars

Locations

Miami Dermatology & Laser Institute

Miami, Florida 33173

United States