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
Conditions
Scars
Locations
Miami Dermatology & Laser Institute
Miami, Florida 33173
United States