Open-label, Multi-center, Randomized, Parallel-group, Post-Market Clinical Follow-Up Investigation to Evaluate the Clinical Performance and Safety of Belotero® Volume and Belotero® Volume Lidocaine for Chin Augmentatio
- Conditions
- Chin augmentation
- Registration Number
- DRKS00031802
- Lead Sponsor
- Merz Aesthetics GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 125
Willing to abstain from all procedures in the face during the study
- Subject with a G-Sn-Pg angle of 155° to 170° at Screening visit
- Severe microgenia
- Previous treatment with silicone, polymethyl methacrylate, fat injections, poly L lactic acid, chin-implants or other permanent dermal fillers below the nose
- Surgeries below the nose and facial surgeries in the last 2 years that could potentially affect the area of the chin
- Treatment with dermal therapies in the chin area within the past 3 months
- Actinic damaged skin and/or premature skin aging in the area to be treated
- Acute inflammatory process or infection at the injection site or history of chronic or recurrent infection or inflammation with potential to interfere with study results or increase risk of adverse events (AEs)
- Any medical condition with the potential to interfere with the study or increase risk of AEs
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method • Change from Baseline to Week 12 after last injection in chin volume. It is measured by a validated 3D facial imaging method for volume measurement.
- Secondary Outcome Measures
Name Time Method • Change from Baseline to Week 12 after last injection in the glabella-subnasal-pogonion (G-Sn-Pg) angle<br>• Proportion of responders on the Merz Aesthetic Scale for Chin Projection at Week 12 after last injection as assessed by the investigator. Response is defined as at least a 1-point improvement compared to Baseline .<br>• Investigator’s Global Aesthetic Improvement Scale (iGAIS) at Week 12 after last injection <br>• Subject’s Global Aesthetic Improvement Scale (sGAIS) at Week 12 after last injection <br>• Change from Baseline to Week 12 after last injection on Rasch-transformed FACE Q: Satisfaction with Chin<br>• Incidence of treatment-emergent adverse events (TEAEs) related to treatment