At a glance
ClinicalIndex Comparison RecordN/ACompleted· 207 enrolled
Drug / intervention
RADIESSE® (+) Lidocainedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating RADIESSE® (+) Lidocaine for Signs of Facial Aging With Volume Loss in the Upper Cheeks, Nasolabial Folds and Marionette Lines. Completed, enrolled 207 participants across 7 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSigns of Facial Aging With Volume Loss in the Upper Cheeks, Nasolabial Folds and Marionette Lines
CountriesGermany
CollaboratorsMerz Pharmaceuticals GmbH
Timeline
N/ACompletedFinished
20192020202120222023202420252026
First PostedAug 2018
Enrollment StartSep 2018
Primary CompletionMay 2020
TodayJul 2026
First PostedAug 28, 2018
Enrollment StartSep 17, 2018
Primary CompletionMay 26, 2020
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 7.8 years ago
Interventions
RADIESSE® (+) Lidocainedevice
RADIESSE® (+) Lidocaine will be injected as per its current approved labelling and investigator's usual practice