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
Purpose
A study to evaluate the safety and effectiveness of a micro coring device for the treatment of scars.
Condition
- Scars
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Micro-coring of scars with MCD |
Micro coring of acne scars and straie will be conducted in up to 3 treatments and followed 6 months post last treatment with MCD. |
|
Recruiting Locations
Miami Dermatology & Laser Institute
Miami, Florida 33173
Miami, Florida 33173
More Details
- Status
- Recruiting
- Sponsor
- Cytrellis Biosystems, Inc.
Study Contact
Detailed 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