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

(BILUS Trial)

Recruiting at 13 trial locations

Overseen By Public Disclosure Manager Merz Aesthetics

Age: Any Age

Sex:

Trial Phase: Academic

Sponsor: Merz North America, Inc.

Must not be taking: Collagen fillers, Juvéderm, Restylane

Disqualifiers: Facial surgery, Dermal fillers, Allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

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. ^{1 2 3 4 5}

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. ^{4 6 7 8 9}

Research Team

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.

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

Group I: Belotero® Intense Lidocaine Experimental Treatment 1 Intervention

Lips injected with BIL.

Group II: Restylane® Silk Active Control 1 Intervention

Lips injected with RS.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

1. England pubmed.ncbi.nlm.nih.gov

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]

2. England pubmed.ncbi.nlm.nih.gov

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]

3. England pubmed.ncbi.nlm.nih.gov

Safety and tolerability of the lidocaine patch 5%, a targeted peripheral analgesic: a review of the literature. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Intravenous lidocaine for neuropathic pain: a retrospective analysis of tolerability and efficacy. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Site-directed topical lidocaine spray attenuates perioperative respiratory adverse events in children undergoing elective surgery. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Tumescent technique without epinephrine for endovenous laser therapy and serum lidocaine concentration. [2018]

7. Germany pubmed.ncbi.nlm.nih.gov

[Pharmacokinetics of lidocaine after intramuscular injection in patients with acute myocardial infarction (author's transl)]. [2013]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness of nitrous oxide and analgesic cream (lidocaine and prilocaine) for prevention of pain during intramuscular botulinum toxin injections in children. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Onset and duration of hypoalgesia of lidocaine spray applied to oral mucosa--a dose response study. [2019]