Volume enhancement of nasolabial folds, marionette lines and upper and lower lips
Conditions
Interventions
Group 1: Subjects will be injected with Belotero® Intense in two or three facial areas (nasolabial folds, marionette lines, and upper/lower lips including lip border). An optional touch-up injection i
Sponsors
Merz Aesthetics GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Subject seeks Hyaluronic acid (HA) dermal filler/volumizing treatment in the face to correct at least two of the following facial areas: o Nasolabial folds o Marionette lines o Upper 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| • 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. • 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. • Incidence of treatment-emergent adverse events (TEAEs) related to treatment. | — |
Primary
| Measure | Time frame |
|---|---|
| • 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. • 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. • 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. | — |
Countries
Germany
Outcome results
None listed