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