Randomized, rater-blinded, uncontrolled, multi-center post-market clinical follow-up (PMCF) investigation to confirm effectiveness and safety of Belotero® Intense and Belotero® Intense Lidocaine in the treatment of nasolabial folds, marionette lines, and lip volume enhancement
- Conditions
- Volume enhancement of nasolabial folds, marionette lines and upper and lower lips
- Registration Number
- DRKS00031800
- Lead Sponsor
- Merz Aesthetics GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 98
Subject seeks Hyaluronic acid (HA) dermal filler/volumizing treatment in the face to correct at least two of the following facial areas:
oNasolabial folds
oMarionette lines
oUpper and lower lip volume
- In case nasolabial folds will be treated: Nasolabial folds volume deficit of moderate to very severe intensity (grade 2 to 4) on the Merz Nasolabial Folds Scale (MNLFS) as determined independently by the treating investigator and the blinded rater.
- In case marionette lines will be treated: Marionette lines volume deficit of moderate to very severe intensity (grade 2 to 4) on the Merz Marionette Lines Scale (MMLS) as determined independently by the treating investigator and the blinded rater.
- In case upper and lower lips will be treated: Upper and lower lip volume deficit of very thin to moderately thick intensity (grade 0 to 2) on the Merz Lip Fullness Assessment Scale (MLFAS) as determined independently by the treating investigator and the blinded rater.
- Willing to abstain from all procedures in the face during study participation
- Any previous treatment with silicone, polymethyl methacrylate, fat injections, poly L lactic acid or permanent dermal fillers in the face
- Prior surgery, including facial plastic surgery, or has a permanent implant or graft, thread lift or any unknown treatments within the past 2 years in the lower third part of the face including the nose that could interfere with effectiveness assessments
- Prior treatment within the past 18 months with calcium hydroxylapatite in the areas to be treated
- Prior treatment within the past 12 months with HA filler in the areas to be treated
- Prior treatment within the past 3 months with dermal therapies in the areas to be treated
- Planned surgery or dermal therapies in the face during study participation
- Cosmetic treatment (e.g., facials) or home peeling in the past 4 weeks
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method • Proportion of responders on the Merz Nasolabial Folds Scale (MNLFS) at 12 weeks after last injection as assessed by blinded rater. Response is defined as at least 1 point improvement in both nasolabial folds as compared to Baseline.<br><br>• Proportion of responders on the Merz Marionette Lines Scale (MMLS) at 12 weeks after last injection as assessed by blinded rater. Response is defined as at least 1 point improvement in both marionette lines as compared to Baseline. <br><br>• Proportion of responders on the Merz Lip Fullness Assessment Scale (MLFAS) at 12 weeks after last injection as assessed by blinded rater. Response is defined as at least 1 point improvement in both the upper and lower lip volume as compared to Baseline.
- Secondary Outcome Measures
Name Time Method • Proportion of subjects with any improvement (Scores +1, +2, or +3) on the Investigator Global Aesthetic Improvement Scale (iGAIS) at 12 weeks after last injection, as assessed by the treating investigator.<br><br>• Proportion of subjects with any improvement (Scores +1, +2, or +3) on the Subject Global Aesthetic Improvement Scale (sGAIS) at 12 weeks after last injection, as self-assessed by the subject. <br><br>• Incidence of treatment-emergent adverse events (TEAEs) related to treatment.