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
NCT ID: NCT03782038
Last Updated: 2018-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2018-09-13
2019-11-21
Brief Summary
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Detailed Description
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An study results will be assessed on the following:
* POSAS - Patient Observer Scar Assessment
* ASAS - Acne Scar Severity Scale
* Subject Satisfaction Scale
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
MCD
Micro coring skin removal with automated coring device
Interventions
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MCD
Micro coring skin removal with automated coring device
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Cytrellis Biosystems, Inc.
INDUSTRY
Responsible Party
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Locations
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Miami Dermatology & Laser Institute
Miami, Florida, United States
Countries
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Facility Contacts
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Nicole Rieth
Role: primary
Other Identifiers
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AIS 700-00053
Identifier Type: -
Identifier Source: org_study_id