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

Cytrellis

Status

Unknown

Conditions

Scars

Treatments

Device: MCD

Study type

Interventional

Funder types

Industry

Identifiers

NCT03782038

AIS 700-00053

Details and patient eligibility

About

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

Full 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

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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