search
Back to results

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

Primary Purpose

Scars

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MCD
Sponsored by
Cytrellis Biosystems, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scars focused on measuring Acne Scars, Stretchmarks, Surgical Scars

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Miami Dermatology & Laser InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Micro-coring of scars with MCD

Arm Description

Micro coring of acne scars and straie will be conducted in up to 3 treatments and followed 6 months post last treatment with MCD.

Outcomes

Primary Outcome Measures

Assess level of aesthetic improvement using POSAS scale 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.
Assess level of aesthetic improvement using ASAS scale 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

Assess safety profile by recording all adverse events reported during study
Adverse events will be recorded throughout the study

Full Information

First Posted
December 18, 2018
Last Updated
December 19, 2018
Sponsor
Cytrellis Biosystems, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT03782038
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 13, 2018 (Actual)
Primary Completion Date
September 17, 2019 (Anticipated)
Study Completion Date
November 21, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cytrellis Biosystems, Inc.

4. Oversight

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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scars
Keywords
Acne Scars, Stretchmarks, Surgical Scars

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Micro-coring of scars with MCD
Arm Type
Experimental
Arm Description
Micro coring of acne scars and straie will be conducted in up to 3 treatments and followed 6 months post last treatment with MCD.
Intervention Type
Device
Intervention Name(s)
MCD
Intervention Description
Micro coring skin removal with automated coring device
Primary Outcome Measure Information:
Title
Assess level of aesthetic improvement using POSAS scale 6 months post last treatment
Description
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.
Time Frame
6 months post last treatment
Title
Assess level of aesthetic improvement using ASAS scale 6 months post last treatment
Description
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
Time Frame
6 months post last treatment
Secondary Outcome Measure Information:
Title
Assess safety profile by recording all adverse events reported during study
Description
Adverse events will be recorded throughout the study
Time Frame
6 months post last treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Miami Dermatology & Laser Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Rieth
Phone
305-279-6060
Email
nicoler@miamidermlaser.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs