Trials / Completed
CompletedNCT03573271
Pivotal Study to Evaluate the Safety and Efficacy of a Micro-coring Device Treating Moderate to Severe Facial Wrinkles
A Prospective, Multi-center, Pivotal Study to Evaluate the Safety and Efficacy of a Micro-Coring Device for the Treatment of Moderate to Severe Facial Wrinkles
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Cytrellis Biosystems, Inc. · Industry
- Sex
- All
- Age
- 40 Years – 70 Years
- Healthy volunteers
- Accepted
Summary
Study evaluating the safety and efficacy of a micro-coring device for the treatment of moderate to severe cheek wrinkles.
Detailed description
Up to 60 subjects who meet the Inclusion/Exclusion criteria will be treated. All subjects will be monitored for a period of 90 days after treatments. Evaluation results will be based in the following: * Wrinkle severity score assessed using the Lemperle Wrinkle Scale * Subject Satisfaction Scale * PI Global Aesthetic Improvement Scale
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MCD | Micro-coring skin removal with automated coring device |
Timeline
- Start date
- 2018-03-26
- Primary completion
- 2019-02-28
- Completion
- 2019-02-28
- First posted
- 2018-06-29
- Last updated
- 2026-04-09
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03573271. Inclusion in this directory is not an endorsement.