Scars
Conditions
Keywords
Acne Scars, Stretchmarks, Surgical Scars
Brief summary
A study to evaluate the safety and effectiveness of a micro coring device for the treatment of scars.
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
Interventions
DEVICEMCD
Micro coring skin removal with automated coring device
Sponsors
Cytrellis Biosystems, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess level of aesthetic improvement using POSAS scale 6 months post last treatment | 6 months post last treatment | Assessing the improvement in the aesthetic appearance of the subject based on the POSAS scale comparing baseline to 6 months post last treatment. Parameters of vascularity, pigmentation, thickness, relief, and pliability, range from 1 to 10. normal skin =1; worst scar imaginable =10. |
| Assess level of aesthetic improvement using ASAS scale 6 months post last treatment | 6 months post last treatment | Assessing the improvement in the aesthetic appearance of the subject based on the Acne Scar scale comparing baseline to 6 months post last treatment. Grades range 0-4. Clear =0; Very Mild=1; Mild= 2; Moderate= 3; Severe= 4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess safety profile by recording all adverse events reported during study | 6 months post last treatment | Adverse events will be recorded throughout the study |
Countries
United States
Outcome results
None listed