A Prospective, Multi-center, Pilot Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Scars
Cytrellis Biosystems, Inc.
Summary
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
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 i…
Interventions
- DeviceMCD
Micro coring skin removal with automated coring device
Location
- Miami Dermatology & Laser InstituteMiami, Florida