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

December 19, 2018 updated by: Cytrellis Biosystems, Inc.

A Prospective, Multi-center, Pilot Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Scars

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months post last treatment
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
6 months post last treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months post last treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cytrellis Biosystems, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2018

Primary Completion (Anticipated)

September 17, 2019

Study Completion (Anticipated)

November 21, 2019

Study Registration Dates

First Submitted

December 18, 2018

First Submitted That Met QC Criteria

December 18, 2018

First Posted (Actual)

December 20, 2018

Study Record Updates

Last Update Posted (Actual)

December 21, 2018

Last Update Submitted That Met QC Criteria

December 19, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIS 700-00053

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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