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

• Sponsor: Cytrellis Biosystems, Inc. (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT03782038
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 14.3
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Scars	Device: MCD	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Sep 13, 2018
• Anticipated Primary Completion Date: Sep 17, 2019
• Anticipated Study Completion Date: Nov 21, 2019

Arms and Interventions

Arm	Intervention/Treatment
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.	Device: MCD; Micro coring skin removal with automated coring device

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

Secondary Outcome Measures

1. Assess safety profile by recording all adverse events reported during study [6 months post last treatment]

   Adverse events will be recorded throughout the study

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Miami Dermatology & Laser Institute	Miami	Florida	United States	33173

Sponsors and Collaborators

• Cytrellis Biosystems, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cytrellis Biosystems, Inc.
• ClinicalTrials.gov Identifier: NCT03782038
• Other Study ID Numbers: AIS 700-00053
• First Posted: Dec 20, 2018
• Last Update Posted: Dec 21, 2018
• Last Verified: Dec 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Cytrellis Biosystems, Inc.: Acne Scars; Stretchmarks; Surgical Scars
• Additional relevant MeSH terms: Cicatrix

Study Results

No Results Posted as of Dec 21, 2018