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 |
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.
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/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
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