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

Study Overview
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Brief Summary
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A study to evaluate the safety and effectiveness of a micro coring device for the treatment of scars.

Detailed Description
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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

Official Title
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A Prospective, Multi-center, Pilot Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Scars

Conditions
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Scars

Intervention / Treatment
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* Device: MCD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Micro-coring of scars with MCD<br>Micro coring of acne scars and straie will be conducted in up to 3 treatments and followed 6 months post last treatment with MCD. | Device: MCD<br>* Micro coring skin removal with automated coring device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess level of aesthetic improvement using POSAS scale 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. | 6 months post last treatment | 
| Assess level of aesthetic improvement using ASAS scale 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 | 6 months post last treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess safety profile by recording all adverse events reported during study | Adverse events will be recorded throughout the study | 6 months post last treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acne Scars, Stretchmarks, Surgical Scars