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
- Conditions
- Horizontal forehead lines (HFL)
- Registration Number
- DRKS00031795
- Lead Sponsor
- Merz Aesthetics GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 106
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
- 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method * 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 Outcome Measures
Name Time Method * 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.<br><br>* 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.<br><br>* Incidence of Treatment-emergent Adverse Events (TEAEs) related to treatment