Trials / Completed
CompletedNCT04177212
Investigation of the Effectiveness and Safety of MRZF111 in the Treatment of Décolleté Wrinkles
Prospective, Multicenter, Parallel-group, Evaluator-blind, Randomized Study to Investigate the Effectiveness and Safety of MRZF111 in the Treatment of décolleté Wrinkles
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 117 (actual)
- Sponsor
- Merz Aesthetics GmbH · Industry
- Sex
- Female
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the effectiveness and safety of MRZF111 treatment for improvement of décolleté wrinkles as assessed on the Merz Aesthetics Scales (MAS) Décolleté Wrinkles-At Rest.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MRZF111 | MRZF111 kit consisting of one syringe of RADIESSE® Volume injectable implant, injection needles and additional components. Physiological saline solution (0.9% NaCl) is used to dilute Radiesse Volume by 1:2. Radiesse consists of calcium hydroxylapatite particles suspended in an aqueous-based gel carrier. |
Timeline
- Start date
- 2019-12-04
- Primary completion
- 2020-11-17
- Completion
- 2021-02-23
- First posted
- 2019-11-26
- Last updated
- 2023-12-26
- Results posted
- 2023-12-26
Locations
9 sites across 1 country: Germany
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04177212. Inclusion in this directory is not an endorsement.