Micro-coring device treatment for acne, surgical, and stretch scars
A Prospective, Multi-center, Pilot Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Scars
Researchers will try a micro-coring device to improve the appearance of acne, surgical, and stretch scars in adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cytrellis Biosystems, Inc. Industry-sponsored |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT03782038 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Miami, Florida
- Miami Dermatology & Laser Institute — Miami, Florida, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.