Open-label, multi-center, uncontrolled, post-market clinical follow-up (PMCF) investigation to confirm effectiveness and safety of Belotero® Balance Lidocaine in the treatment of horizontal forehead lines

Open-label, multi-center, uncontrolled, post-market clinical follow-up (PMCF) investigation to confirm effectiveness and safety of Belotero® Balance Lidocaine in the treatment of horizontal forehead lines - BeFore

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00031795

Enrollment

100

Registered

2023-05-30

Start date

2023-01-27

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Horizontal forehead lines (HFL)

Interventions

Group 1: Belotero Balance Lidocaine will be injected into the forehead (excluding glabellar area). An optional touch-up injection is proposed at Week 4.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Seeks hyaluronic acid (HA) dermal filler treatment for horizontal forehead lines - Horizontal forehead lines with a mild to severe grade on the validated MASFL - At Rest rating - Willing to abstain from all surgical and non-surgical aesthetic procedures in the forehead and adjacent regions during study participation

Exclusion criteria

Exclusion criteria: - Previous treatment with silicone, polymethyl methacrylate, fat injections, poly L lactic acid, or permanent dermal fillers in the forehead and adjacent regions (e.g., crow´s feet, temple, and glabella) - Actinic damaged skin and/or premature skin aging in the forehead - Acute inflammatory process or infection at the injection site or history of chronic or recurrent infection or inflammation that could interfere with the investigation results - Any medical condition that could interfere with the investigation or increase the risk of Adverse Events

Design outcomes

Primary

Measure	Time frame
* Proportion of responders on the Merz Aesthetics Scales Forehead Lines (MASFL) - At Rest at 12 weeks after the last treatment as assessed by the independent rater. Response is defined as improvement of at least 1 point on the MASFL - At Rest from Baseline to 12 weeks after last treatment.	—

Secondary

Measure	Time frame
* Proportion of subjects with any improvement (Scores +1, +2, or +3) according to the treating investigator's assessment on the Investigator Global Aesthetic Improvement Scale (iGAIS) at 12 weeks after last treatment. * Proportion of subjects with any improvement (Scores +1, +2, or +3) according to the subject's self-assessment on the Subject Global Aesthetic Improvement Scale (sGAIS) at 12 weeks after last treatment. * Incidence of Treatment-emergent Adverse Events (TEAEs) related to treatment	—

Measure

Time frame

* Proportion of subjects with any improvement (Scores +1, +2, or +3) according to the treating investigator's assessment on the Investigator Global Aesthetic Improvement Scale (iGAIS) at 12 weeks after last treatment. * Proportion of subjects with any improvement (Scores +1, +2, or +3) according to the subject's self-assessment on the Subject Global Aesthetic Improvement Scale (sGAIS) at 12 weeks after last treatment. * Incidence of Treatment-emergent Adverse Events (TEAEs) related to treatment

—

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026