L98.8
Conditions
Interventions
Group 1: Participants will receive BELOTERO Balance Lidocaine administered using a single-use pre-filled plastic syringe in at least one treatment area (either the lip(s) only or one, two, or three p
Sponsors
Merz Aesthetics GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Participants seeking Hyaluronic acid (HA) dermal filler treatment (a) for lip enhancement in at least one lip or (b) to correct any (up to three) of the following perioral areas: marionette lines, perioral lines, and/or oral commissures. • For lip enhancement: Very thin to moderately thick upper and/or lower lip fullness (Grade 0 to 2) on the MLFS at rest, as determined by the treating investigator and the independent rater. • For correction of marionette lines: Moderate to severe marionette lines (Grade 2 to 3) on the MMLS at rest, as determined by the treating investigator and the independent rater. • For correction of perioral lines: Moderate to severe perioral lines (Grade 2 to 3) on the MLWS at rest, as determined by the treating investigator and the independent rater. • For correction of oral commissures: Moderate to severe oral commissures (Grade 2 to 3) on the MOCS at rest, as determined by the treating investigator and the independent rater. • Willing to abstain from all procedures in the face during participation in the clinical investigation.
Exclusion criteria
Exclusion criteria: • Previous treatment with silicone, polymethyl methacrylate, fat injections, polylactic acid, or permanent dermal fillers in the face, regardless of when the procedure occurred. • Participants had prior surgery that could interfere with effectiveness assessments • Calcium-hydroxylapatite injection within the past 18 months in the treatment area(s). • HA-filler injection within the past 12 months in the treatment area(s). • Dermal therapies within the past three months in the treatment area(s). • Plan to receive surgery or dermal therapies in the face during participation in the clinical investigation. • Underwent cosmetic treatment (e.g., facials) or home peeling in the past four weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Achievement of = 1-point improvement on the Merz Lip Fullness Scale (MLFS) from baseline in at least one treated lip at 8 weeks post-last treatment, as assessed live by the independent rater. - Achievement of = 1-point improvement on the Merz Marionette Lines Scale (MMLS) from baseline in marionette lines at 8 weeks post-last treatment, as assessed live by the independent rater. - Achievement of = 1-point improvement on the Merz Lip Wrinkle Scale (MLWS) from baseline in perioral lines at 8 weeks post-last treatment, as assessed live by the independent rater. - Achievement of = 1-point improvement on the Merz Oral Commissures Scale (MOCS) from baseline in oral commissures at 8 weeks post-last treatment, as assessed live by the independent rater. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Achievement of scores +1, +2, +3 according to the treating investigator’s assessment on the investigator Global Aesthetic Improvement scale (iGAIS) at 8 weeks post-last treatment. - Achievement of scores +1, +2, +3 according to the participant’s assessment on the participant Global Aesthetic Improvement Scale (pGAIS) at 8 weeks post-last treatment. | — |
Countries
Germany
Outcome results
None listed