A Prospective, Multi-center, Pilot Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Scars
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Scars
- Sponsor
- Cytrellis Biosystems, Inc.
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Assess level of aesthetic improvement using ASAS scale 6 months post last treatment
- Last Updated
- 7 years ago
Overview
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
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Assess level of aesthetic improvement using ASAS scale 6 months post last treatment
Time Frame: 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
Assess level of aesthetic improvement using POSAS scale 6 months post last treatment
Time Frame: 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.
Secondary Outcomes
- Assess safety profile by recording all adverse events reported during study(6 months post last treatment)