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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MCD.
- Who it may be relevant to
- Registry conditions: Scars. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
Interventions
- Device MCD
Micro coring skin removal with automated coring device
Primary outcome measures
- Assess level of aesthetic improvement using POSAS scale 6 months post last treatment [Time frame: 6 months post last treatment]
- Assess level of aesthetic improvement using ASAS scale 6 months post last treatment [Time frame: 6 months post last treatment]
Secondary outcome measures (1)
- Assess safety profile by recording all adverse events reported during study [Time frame: 6 months post last treatment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Miami Dermatology & Laser Institute — Miami
Identifiers
NCT: NCT03782038 · AIS 700-00053