[Trial of device that is not approved or cleared by the U.S. FDA]
(BILUS Trial)
Trial Summary
What is the purpose of this trial?
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications.
What data supports the effectiveness of the drug Belotero Intense Lidocaine?
How does the drug Belotero Intense Lidocaine differ from other treatments?
Research Team
Merz Medical Expert
Principal Investigator
Merz North America, Inc.
Eligibility Criteria
Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive lip injections with either Restylane® Silk or Belotero® Intense Lidocaine
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for delayed-onset treatment emergent adverse events
Treatment Details
Interventions
- Belotero Intense Lidocaine
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merz North America, Inc.
Lead Sponsor
Leonard Paolillo
Merz North America, Inc.
Chief Executive Officer
Bachelor of Science in Business Administration from Manhattan College
Dr. McKinnon
Merz North America, Inc.
Chief Medical Officer since 2024
Ph.D. in Pharmacology and Toxicology from the University of Western Ontario