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.
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.
Study Type
OBSERVATIONAL
Enrollment
91
During this procedure the device (a dermal filler) will be deep intradermal, subcutaneous or supraperiosteal injected according to its CE mark.
Medizinisch Ästhetisches Zentrum Wien
Vienna, Austria
Yuvell
Vienna, Austria
Rosenpark Research
Darmstadt, Hesse, Germany
RZANY & HUND, Privatpraxis
Berlin, Germany
Primary performance endpoint
Response rate at week 4 based on investigator's midface volume deficit severity scale (MVDSS) assessment, where response is defined as a MVDSS grade improvement by ≥1 grade compared to baseline.
Time frame: 4 weeks
Secondary performance endpoint 1
Response rate based on investigator's midface volume deficit severity scale (MVDSS) assessment.
Time frame: 12, 24, 36 and 52 weeks
Secondary performance endpoint 2
Global aesthetic improvement scale (GAIS) grade determined by the investigator.
Time frame: 4, 12, 24, 36 and 52 weeks
Secondary performance endpoint 3
Global aesthetic improvement scale (GAIS) grade determined by the subject.
Time frame: 4, 12, 24, 36 and 52 weeks
Secondary performance endpoint 4
Subject satisfaction.
Time frame: 4, 12, 24, 36 and 52 weeks
Secondary performance endpoint 5
Response rate, based on midface volume deficit severity scale (MVDSS) assessment by the independent photography reviewer.
Time frame: 4, 12, 24, 36 and 52 weeks
Secondary performance endpoint 6
Proportion of subjects with a midface volume deficit severity scale (MVDSS) grade improvement by ≥2 grades.
Time frame: 4, 12, 24, 36 and 52 weeks
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