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NCT Number: NCT03782038

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Miami Dermatology & Laser Institute

Miami, Florida, 33173, United States

Location status: Recruiting

Location contact

Nicole Rieth

CONTACT

[email protected]

305-279-6060

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MCD

Device

Micro coring skin removal with automated coring device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Cytrellis Biosystems, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 20, 2018
Registry last updated
Dec 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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