Recruiting

Cytrellis Device

Sponsor:

Cytrellis Biosystems, Inc.

Code:

NCT03782038

Conditions

Scars

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

MCD

Study Details

Brief summary:

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

Conditions

Scars

Study ID

NCT03782038

Start date

Sep 13, 2018

Status verified date

Dec, 2018

Completion date

Nov 21, 2019

Anticipated

Primary completion date

Sep 17, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

MCD

Micro coring skin removal with automated coring device

Primary outcome measure

  • Assess level of aesthetic improvement using POSAS scale 6 months post last treatment [ Time Frame: 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 ]

Central Contacts and Locations

Locations

Miami Dermatology & Laser Institute

Recruiting

Miami, Florida, United States, 33173

Contacts

Nicole Rieth

305-279-6060nicoler@miamidermlaser.com

More Information

Sponsor

Cytrellis Biosystems, Inc.

Last update posted

Dec 21, 2018

Last verified

Dec, 2018

Keywords

  • Acne Scars
  • Stretchmarks
  • Surgical Scars

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cytrellis Biosystems, Inc. on 2018-12-21.