Micro-coring device treatment for moderate to severe cheek wrinkles
A Prospective, Multi-center, Pivotal Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Moderate to Severe Facial Wrinkles
This study will try a micro-coring device to reduce moderate to severe cheek wrinkles in adults ages 40 to 70.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 40 Years to 70 Years |
| Sex | All |
| Sponsor | Cytrellis Biosystems, Inc. Industry-sponsored |
| Locations | 6 sites (Sacramento, California and 5 other locations) |
| Trial ID | NCT03793348 on ClinicalTrials.gov |
What this trial studies
Up to 35 adults with moderate to severe cheek wrinkles will receive a single treatment with the Cytrellis micro-coring device and be followed for 90 days. Effectiveness will be measured by physician-rated Lemperle and GAIS scales and by a subject satisfaction survey. Key eligibility includes ages 40–70, Fitzpatrick skin types I–IV, and a Lemperle wrinkle score of at least 3 on the cheeks, while patients with recent injections, scars, keloid history, active inflammatory lesions, or suspicious skin lesions are excluded. The sponsor is Cytrellis Biosystems, and the study is being conducted at three U.S. dermatology centers.
Who should consider this trial
Good fit: Ideal candidates are adults 40–70 years old with moderate to severe cheek wrinkles (Lemperle score ≥3) and Fitzpatrick skin types I–IV who can attend baseline and 90-day follow-up visits.
Not a fit: Patients with active lesions or pigmentation disorders in the treatment area, a history of keloids or hypertrophic scarring, recent fillers or cosmetic procedures in the area, or scars/silicone in the treatment area are unlikely to be eligible or benefit.
Why it matters
Potential benefit: If successful, the device could reduce cheek wrinkles with a minimally invasive procedure that may improve appearance and patient satisfaction with a short follow-up period.
How similar studies have performed: Early company-sponsored and pilot studies of micro-coring have reported promising cosmetic improvements, but larger independent randomized data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Males and females 40-70 years of age * Fitzpatrick Skin Type I to IV as judged by the Investigator * Cheek areas are at least a score of 3 using the Lemperle Wrinkle Assessment Scale as judged by the Investigator * Able to provide written informed consent, understand and willing to comply with all study related procedures and follow-up visits. Exclusion Criteria: * Lesions suspicious for any malignancy or the presence of actinic keratosis, melasma, vitiligo, cutaneous papules/nodules or active inflammatory lesions in the areas to be treated * History of keloid formation or hypertrophic scarring * History of trauma or surgery to the treatment areas in the past 6 months * Scar present in the areas to be treated * Silicone injections in the areas to be treated * Injection of dermal fillers, fat or botulinum toxin, as well as any minimally invasive/invasive medical device for skin treatment, in the study treatment areas, within the past 6 months (i.e., dermabrasion, laser, RF devices) * Active smokers (0.5 pack/day) or having quit within 3 months prior to treatment * Active, chronic, or recurrent infection * History of compromised immune system or currently being treated with immunosuppressive agents * History of sensitivity to analgesic agents, Aquaphor®, topical or local anesthetics (e.g., lidocaine, benzocaine, procaine) or chlorhexidine, povidone-iodine or epinephrine * Excessive sun exposure and use of tanning beds or tanning creams within 30 days prior to treatment * Treatment with aspirin or other blood thinning agents within 14 days prior to treatment * History or presence of any clinically significant bleeding disorder * Any issue that, at the discretion of the Investigator, would interfere with assessment of safety or efficacy or compromise the subject's ability to participate in the study * Treatment with an investigational device or agent within 30 days before treatment or during the study period
Where this trial is running
Sacramento, California and 5 other locations
- Laser and Skin Surgery Center of Northern California — Sacramento, California, United States (Active_not_recruiting)
- AboutSkin Research, LLC — Greenwood Village, Colorado, United States (Not_yet_recruiting)
- Miami Dermatology & Laser Institute — Miami, Florida, United States (Active_not_recruiting)
- Laser and Skin Surgery of New York — New York, New York, United States (Recruiting)
- The Office of Brian Biesman, M.D. — Nashville, Tennessee, United States (Active_not_recruiting)
- Dallas Plastic Surgery Institute — Dallas, Texas, United States (Not_yet_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.