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

Purpose

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

Condition

  • Scars

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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 Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Miami Dermatology & Laser Institute
Miami, Florida 33173
Contact:
Nicole Rieth
305-279-6060
nicoler@miamidermlaser.com

More Details

Status
Recruiting
Sponsor
Cytrellis Biosystems, Inc.

Study Contact

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