Trials / Completed
CompletedNCT04647721
Evaluation of the Effectiveness and Safety of Radiesse for the Correction of Moderate to Severe Nasolabial Folds
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 134 (actual)
- Sponsor
- Merz North America, Inc. · Industry
- Sex
- All
- Age
- 22 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
Effectiveness: The purpose of this study is to demonstrate the non-inferiority of Radiesse (CaHA) to Restylane (HA) following subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as NLFs. Safety: To evaluate the incidence and type of adverse events and serious adverse events.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Radiesse injectable implant (dermal filler) | Subdermal injection. |
| DEVICE | Restylane injectable implant (dermal filler) | Subdermal injection. |
Timeline
- Start date
- 2021-01-13
- Primary completion
- 2021-11-08
- Completion
- 2022-04-27
- First posted
- 2020-12-01
- Last updated
- 2023-01-23
- Results posted
- 2023-01-23
Locations
7 sites across 1 country: China
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04647721. Inclusion in this directory is not an endorsement.