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



Status:Recruiting
Conditions:Cosmetic
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:12/23/2018
Start Date:September 13, 2018
End Date:November 21, 2019

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A Prospective, Multi-center, Pilot Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Scars

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

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

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
We found this trial at
1
site
Miami, Florida 33173
Phone: 305-279-6060
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mi
from
Miami, FL
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