Actively Recruiting
A Prospective, Multi-center, Pilot Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Scars
Led by Cytrellis Biosystems, Inc. · Updated on 2018-12-21
30
Participants Needed
1
Research Sites
9 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of a micro coring device for treating scars. The study will include up to 30 participants with various types of scars, excluding keloid scars, and will monitor results over a 6-month period after the last treatment. Researchers will use specific scar assessment scales and satisfaction measures to understand the treatment effects. Participants will undergo up to three treatments using the Cytrellis Micro-Coring Device (MCD), which removes skin by automated micro coring. The treatment targets acne scars and stretch marks (straie), and after the last treatment, participants will be followed and observed for six months to assess outcomes. During the study, participants will be evaluated using the Patient Observer Scar Assessment Scale (POSAS), Acne Scar Severity Scale (ASAS), and a Subject Satisfaction Scale. Safety will be closely monitored by recording any adverse events throughout the study period. Overall participation involves initial treatments followed by regular assessments over six months post-treatment to track scar improvement and safety.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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 d pack per day) or having quit smoking (d 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of up to 3 treatment sessions as scheduled by the study team
Participants undergo up to 3 micro-coring treatments of scars using the Micro Coring Device (MCD).
Up to 3 treatment visits (in-person)
Duration - 6 months post last treatment
Participants are monitored for safety and assessed for scar improvement for 6 months after the last treatment.
Multiple follow-up visits over 6 months (in-person)
Trial Site Locations
Total: 1 location
1
Miami Dermatology & Laser Institute
Miami, Florida, United States, 33173
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here