[Trial of device that is not approved or cleared by the U.S. FDA]

(BILUS Trial)

Recruiting at 13 trial locations
PD
Overseen ByPublic Disclosure Manager Merz Aesthetics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

Research shows that lidocaine, a component of Belotero Intense Lidocaine, is effective in reducing pain in various conditions, such as neuropathic pain and sunburn pain, and is well-tolerated with minimal side effects.12345

How does the drug Belotero Intense Lidocaine differ from other treatments?

Belotero Intense Lidocaine is unique because it combines a dermal filler with lidocaine, a local anesthetic, to reduce pain during cosmetic procedures. This combination allows for smoother injections and a more comfortable experience compared to fillers without lidocaine.46789

Research Team

MM

Merz Medical Expert

Principal Investigator

Merz North America, Inc.

Eligibility Criteria

Inclusion Criteria

I want lip augmentation to increase volume due to thin or medium lips.

Exclusion Criteria

I have had surgery or implants in the lower part of my face.
I have had fat injections or dermal fillers in my face.
I haven't had certain facial fillers in the last 1-2 years.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive lip injections with either Restylane® Silk or Belotero® Intense Lidocaine

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Long-term follow-up

Participants are monitored for delayed-onset treatment emergent adverse events

52 weeks

Treatment Details

Interventions

  • Belotero Intense Lidocaine
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Belotero® Intense LidocaineExperimental Treatment1 Intervention
Lips injected with BIL.
Group II: Restylane® SilkActive Control1 Intervention
Lips injected with RS.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merz North America, Inc.

Lead Sponsor

Trials
67
Recruited
10,000+

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

Findings from Research

In a study involving 16 healthy volunteers, the 5% lidocaine medicated plaster significantly reduced pain sensitivity in both capsaicin and sunburn pain models, with a 53% reduction in pinprick hyperalgesia for capsaicin and an impressive 84% reduction for sunburn.
The lidocaine plaster was effective in alleviating mechanical hyperalgesia and cold pain perception, but it did not affect spontaneous pain or other pain responses, indicating its targeted analgesic action.
Antihyperalgesic efficacy of 5% lidocaine medicated plaster in capsaicin and sunburn pain models--two randomized, double-blinded, placebo-controlled crossover trials in healthy volunteers.Gustorff, B., Hauer, D., Thaler, J., et al.[2013]

References

Antihyperalgesic efficacy of 5% lidocaine medicated plaster in capsaicin and sunburn pain models--two randomized, double-blinded, placebo-controlled crossover trials in healthy volunteers. [2013]
A double-blind, randomized clinical study to determine the efficacy of benzocaine 10% on histamine-induced pruritus and UVB-light induced slight sunburn pain. [2018]
Safety and tolerability of the lidocaine patch 5%, a targeted peripheral analgesic: a review of the literature. [2019]
Intravenous lidocaine for neuropathic pain: a retrospective analysis of tolerability and efficacy. [2015]
Site-directed topical lidocaine spray attenuates perioperative respiratory adverse events in children undergoing elective surgery. [2018]
Tumescent technique without epinephrine for endovenous laser therapy and serum lidocaine concentration. [2018]
[Pharmacokinetics of lidocaine after intramuscular injection in patients with acute myocardial infarction (author's transl)]. [2013]
Effectiveness of nitrous oxide and analgesic cream (lidocaine and prilocaine) for prevention of pain during intramuscular botulinum toxin injections in children. [2018]
Onset and duration of hypoalgesia of lidocaine spray applied to oral mucosa--a dose response study. [2019]