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

Not Applicable

• Conditions: Scars
• Interventions: Device: MCD

• Registration Number: NCT03782038
• Lead Sponsor: Cytrellis Biosystems, Inc.

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

Study Timeline

• Study Start: 2018-09-13
• Status Verified: 2018-12
• Study First Submitted: 2018-12-18
• Study First Submitted QC: 2018-12-18
• Last Update Submitted: 2018-12-19
• Study First Posted: 2018-12-20
• Last Update Posted: 2018-12-21
• Primary Completion: 2019-09-17
• Study Completion: 2019-11-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Micro-coring of scars with MCD	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.

Primary Outcome Measures

Name	Time	Method
Assess level of aesthetic improvement using ASAS scale 6 months post last treatment	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
Assess level of aesthetic improvement using POSAS scale 6 months post last treatment	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.

Secondary Outcome Measures

Name	Time	Method
Assess safety profile by recording all adverse events reported during study	6 months post last treatment	Adverse events will be recorded throughout the study

Trial Locations

Locations (1)

Miami Dermatology & Laser Institute; 🇺🇸 Miami, Florida, United States