Trials / Completed
CompletedNCT03532126
A 52-week Clinical Investigation of Princess® VOLUME PLUS Lidocaine in Subjects With Midface Volume Deficit
A Prospective, Multi-center, Non-comparative, 52-week Follow-up, Post-market Clinical Investigation of Princess® VOLUME PLUS Lidocaine in Subjects With Midface Volume Deficit
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 91 (actual)
- Sponsor
- Croma-Pharma GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This investigation aims to confirm the safety and effectiveness of Princess VOLUME PLUS Lidocaine in midface volume deficit augmentation and includes a long term safety followup.
Detailed description
This non-interventional study will evaluate subjects treated with Princess VOLUME PLUS Lidocaine for midface volume deficit augmentation. A touch-up treatment will be allowed, on discretion of the treating investigator, if the initial treatment didn't provide optimal correction. The effectiveness parameters will be evaluated based on a validated scale for midface volume deficit scale and confirmed by use of patient reported outcome questionnaires as well as based on photographs to be evaluated by an independent evaluator.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Dermal filler for midface deficit | During this procedure the device (a dermal filler) will be deep intradermal, subcutaneous or supraperiosteal injected according to its CE mark. |
Timeline
- Start date
- 2018-03-28
- Primary completion
- 2019-07-24
- Completion
- 2020-06-30
- First posted
- 2018-05-22
- Last updated
- 2024-12-10
Locations
4 sites across 2 countries: Austria, Germany
Source: ClinicalTrials.gov record NCT03532126. Inclusion in this directory is not an endorsement.