About this trial
A study to evaluate the safety and effectiveness of a micro coring device for the treatment of scars.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
MCD
DeviceMicro coring skin removal with automated coring device
Treatment groups
Trial outcomes
Primary outcomes
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.
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
Secondary outcomes
Assess safety profile by recording all adverse events reported during study
Adverse events will be recorded throughout the study
Sponsors and contacts
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