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

NCT03782038 | Unknown FDA Device

• 1 other identifier: AIS 700-00053
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Scars

Keywords

Acne Scars; Stretchmarks; Surgical Scars

Outcome Measures

Primary Outcomes (2)

• 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.

  6 months post last treatment

• 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

  6 months post last treatment

Secondary Outcomes (1)

• Assess safety profile by recording all adverse events reported during study

  6 months post last treatment

Study Arms (1)

Micro-coring of scars with MCD

EXPERIMENTAL

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

Interventions

MCD DEVICE

Micro coring skin removal with automated coring device

Micro-coring of scars with MCD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cytrellis Biosystems, Inc.: lead

Study Sites (1)

Miami Dermatology & Laser Institute

Miami, Florida, 33173, United States

RECRUITING

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: December 20, 2018
• Study Start: September 13, 2018
• Primary Completion: September 17, 2019
• Study Completion: November 21, 2019
• Last Updated: December 21, 2018

Record last verified: 2018-12

Locations

US (1)