Micro-coring device treatment for acne, surgical, and stretch scars
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
Run by Cytrellis Biosystems, Inc. · NCT03782038 · Data updated 2026-11-12
Researchers will try a micro-coring device to improve the appearance of acne, surgical, and stretch scars in adults.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Cytrellis Biosystems, Inc. Industry-sponsored |
| Locations | 1 site (Miami, Florida) |
| Status | Recruiting |
| Started | September 13, 2018 |
| Main results expected | September 17, 2019 |
| Study ends | November 21, 2019 |
| Registry record updated | December 21, 2018 |
| Trial ID | NCT03782038 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with non-keloid scars (including acne, surgical, or stretch scars), Fitzpatrick skin types I–VI, who can give informed consent and have not had scar treatment in the past 6 months are ideal candidates.
✕Probably not a fit
Patients with a history of keloid formation, recent scar treatments, active infection, significant immune compromise, pregnancy or breastfeeding, active heavy smoking, or on anticoagulant medications are unlikely to be eligible or benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-arm interventional study using a micro-coring device (MCD) to treat various non-keloid scars in up to 30 adult participants at a single site. Participants will receive the device treatment and be followed for safety and effectiveness outcomes for 6 months after their last treatment. Outcomes include the Patient and Observer Scar Assessment Scale (POSAS), the Acne Scar Severity Scale (ASAS), and a Subject Satisfaction Scale. Key exclusions include keloid-prone patients, recent scar treatments, active infection, significant immune compromise, pregnancy, and use of anticoagulant medications.
Why it matters
Potential benefit: If successful, the device could meaningfully reduce scar appearance and increase patient satisfaction with a minimally invasive approach.
How similar studies have gone: Early and small clinical reports of micro-coring devices have shown promising results for scar appearance and skin tightening, but larger controlled trials are still limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Miami Dermatology & Laser Institute
Miami, Florida, United States Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.