NCT03793348 Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Moderate to Severe Facial Wrinkles
| NCT ID | NCT03793348 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cytrellis Biosystems, Inc. |
| Condition | Wrinkle |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2018-11-12 |
| Primary Completion | 2019-06-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 35 participants in total. It began in 2018-11-12 with a primary completion date of 2019-06-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Study evaluating the efficacy of a micro coring device for the treatment of moderate to severe check wrinkles
Eligibility 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
Frequently Asked Questions
Who can join the NCT03793348 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 70 Years, studying Wrinkle. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03793348 currently recruiting?
Yes, NCT03793348 is actively recruiting participants. Visit ClinicalTrials.gov or contact Cytrellis Biosystems, Inc. to inquire about joining.
Where is the NCT03793348 trial being conducted?
This trial is being conducted at Sacramento, United States, Greenwood Village, United States, Miami, United States, New York, United States and 2 additional locations.
Who is sponsoring the NCT03793348 clinical trial?
NCT03793348 is sponsored by Cytrellis Biosystems, Inc.. The trial plans to enroll 35 participants.