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
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03782038|
Recruitment Status : Recruiting
First Posted : December 20, 2018
Last Update Posted : December 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Scars||Device: MCD||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Multi-center, Pilot Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Scars|
|Actual Study Start Date :||September 13, 2018|
|Estimated Primary Completion Date :||September 17, 2019|
|Estimated Study Completion Date :||November 21, 2019|
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.
Micro coring skin removal with automated coring device
- 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.
- 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 safety profile by recording all adverse events reported during study [ Time Frame: 6 months post last treatment ]Adverse events will be recorded throughout the study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03782038
|United States, Florida|
|Miami Dermatology & Laser Institute||Recruiting|
|Miami, Florida, United States, 33173|
|Contact: Nicole Rieth 305-279-6060 firstname.lastname@example.org|