Trials / Completed
CompletedNCT03650387
Safety, Effectiveness and Participant Satisfaction Study of a Dermal Filler (of RADIESSE® (+) Lidocaine) in the Treatment of Ageing Signs in the Face
Open-label, Multicenter, Uncontrolled, Rater-blinded, Post-market Clinical Follow-up [PMCF] Study to Confirm Performance and Safety of RADIESSE® (+) Lidocaine in the Treatment of Nasolabial Folds, Marionette Lines, and/or Cheek Volume Loss
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 207 (actual)
- Sponsor
- Merz North America, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective is to collect clinical data to confirm performance and safety for RADIESSE® (+) Lidocaine, when used in accordance with its labelling in the treatment of nasolabial folds, marionette lines and/or upper cheek volume loss.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | RADIESSE® (+) Lidocaine | RADIESSE® (+) Lidocaine will be injected as per its current approved labelling and investigator's usual practice |
Timeline
- Start date
- 2018-09-17
- Primary completion
- 2020-05-26
- Completion
- 2020-05-26
- First posted
- 2018-08-28
- Last updated
- 2023-12-05
- Results posted
- 2021-06-18
Locations
7 sites across 1 country: Germany
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03650387. Inclusion in this directory is not an endorsement.