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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

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ClinicalTrials.gov Identifier: NCT03782038
Recruitment Status : Recruiting
First Posted : December 20, 2018
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
Cytrellis Biosystems, Inc.

Brief Summary:
A study to evaluate the safety and effectiveness of a micro coring device for the treatment of scars.

Condition or disease Intervention/treatment Phase
Scars Device: MCD Not Applicable

Detailed Description:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arm Intervention/treatment
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.
Device: MCD
Micro coring skin removal with automated coring device




Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

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


Locations
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United States, Florida
Miami Dermatology & Laser Institute Recruiting
Miami, Florida, United States, 33173
Contact: Nicole Rieth    305-279-6060    nicoler@miamidermlaser.com   
Sponsors and Collaborators
Cytrellis Biosystems, Inc.

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Responsible Party: Cytrellis Biosystems, Inc.
ClinicalTrials.gov Identifier: NCT03782038     History of Changes
Other Study ID Numbers: AIS 700-00053
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Cytrellis Biosystems, Inc.:
Acne Scars
Stretchmarks
Surgical Scars
Additional relevant MeSH terms:
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Cicatrix
Fibrosis
Pathologic Processes