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Study of a Micro Coring Device for Scar Treatment

This study is testing a new device called MCD (Micro Coring Device) to see how well it improves scars. Researchers want to know if using this device can make scars look better. You might be able to join if you are 18 or older, have any type of scar (except keloid scars), and haven't had other scar treatments in the last six months. The study will measure success by how much scars improve aesthetically (how they look) using two scales, POSAS and ASAS, six months after the last treatment. Up to 30 people are planned to join this study, but its current status is unclear.

Study design
This is an interventional study planning to enroll up to 30 participants. It is not specified if it is randomized or blinded.
What's involved
All participants will be monitored for a period of 6 months after their last treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months after their last treatment.

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NCT03782038

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

Recruiting
NAAges 18+InterventionalTreatment
Cytrellis Biosystems, Inc.
~30 participants
Updated 2018-12-21 on ClinicalTrials.gov
What's tested:MCD

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assess level of aesthetic improvement using POSAS scale 6 months post last treatment
Measured over 6 months post last treatment
+1 more outcome measured

Conditions

Scars

Explore related trials

Acne scarScarStretchmarksSurgical Scars

Where it's being run

1 sites across 1 states
Florida1

Who to contact

Nicole Rieth
[email protected]
305-279-6060
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Assess level of aesthetic improvement using POSAS scale 6 months post last treatment6 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 treatment6 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