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

Scars Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03782038
• Other study ID #: AIS 700-00053
• Status: Recruiting
• Phase: N/A
• Start date: September 13, 2018
• Est. completion date: November 21, 2019

Study information

• Verified date: December 2018
• Source: Cytrellis Biosystems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 21, 2019
• Est. primary completion date: September 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Scars

Intervention

Device:
• MCD
Micro coring skin removal with automated coring device

Locations

Country	Name	City	State
United States	Miami Dermatology & Laser Institute	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Cytrellis Biosystems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Assess safety profile by recording all adverse events reported during study	Adverse events will be recorded throughout the study	6 months post last treatment