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

Recruiting now · Not applicable

Conditions studied: Scars

In brief

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

Key facts

Study ID

NCT03782038

Run by

Cytrellis Biosystems, Inc.

People needed

30

Starts

2018-09-13

Expected to finish

2019-11-21

Last updated by the study team

2018-12-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Miami Dermatology & Laser Institute — Miami, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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