Belotero Intense Lidocaine + Restylane Silk for Cosmetic Enhancement

(BILUS Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new lip filler treatment called Belotero Intense Lidocaine. Researchers aim to compare its effectiveness to an existing product, Restylane Silk, for enhancing lip volume. Individuals with very thin to medium lip volume who have not recently undergone facial surgeries or filler treatments might be suitable candidates. The goal is to identify a safe and effective option for achieving fuller lips.

As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants, providing an opportunity to contribute to the development of new cosmetic solutions.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Belotero Intense Lidocaine is generally safe. Studies have examined its safety and effectiveness, particularly as a dermal filler. One study found it safe for people, with serious side effects being rare.

However, caution is necessary. Injecting it into certain areas, such as the forehead, might increase the risk of blood vessel issues if not done correctly. A trained professional should perform the procedure.

Overall, Belotero Intense Lidocaine is well-tolerated, but like any treatment, it carries risks. Discuss any concerns with the trial team or a healthcare provider. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Belotero Intense Lidocaine is unique because it offers a different approach to enhancing lips compared to standard fillers like Restylane Silk. What sets Belotero Intense Lidocaine apart is its formulation that includes lidocaine, which helps minimize discomfort during the procedure. Additionally, its unique cross-linked hyaluronic acid structure allows for a smoother, more natural integration into the skin, potentially offering longer-lasting and more consistent results. Researchers are excited about this treatment because it promises improved patient comfort and outcomes in lip augmentation.

What evidence suggests that this trial's treatments could be effective?

Research has shown that Belotero Intense Lidocaine, one of the treatments in this trial, can effectively enhance lip fullness. In one study, 74% of participants noticed at least one level of improvement in lip fullness after six months. Other studies have found that over 95% of patients achieved natural and even results. Belotero products are known for adding volume to enhance lips. The lidocaine in the treatment reduces pain, making the procedure more comfortable. Another treatment option in this trial is Restylane® Silk, which will be compared to Belotero Intense Lidocaine for its effectiveness in lip enhancement. ^{6 7 8 9 10}

Who Is on the Research Team?

Merz Medical Expert

Principal Investigator

Merz North America, Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Belotero Intense Lidocaine

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8377277/

Hyaluronic Acid Is an Effective Dermal Filler for Lip ... Overall, 74% (95% CI: 66–82%) of included participants had at least one grade improvement on a validated lip fullness scale after 6 months of ...

2. thieme-connect.com thieme-connect.com/products/ejournals/abstract/10.1055/s-0036-1583534

Hyaluron Filler Containing Lidocaine on a CPM Basis for Lip ... A total of 146 patients from 21 German centers participated. Physicians rated natural outcome and evenness as good or very good for more than 95% of patients.

3. researchgate.net researchgate.net/figure/Belotero-R-dermal-fillers-summary-of-clinical-findings_tbl3_307939571

Belotero ® dermal fillers: summary of clinical findings Treatment outcomes were assessed by the WSRS, and other scales, at multiple time points up to 18 months postinjection. The co-primary effectiveness outcomes ...

4. withpower.com withpower.com/trial/phase-lip-augmentation-2-2023-82a02

Trial of device that is not approved or cleared by the U.S. FDA Research shows that lidocaine, a component of Belotero Intense Lidocaine, is effective in reducing pain in various conditions, such as neuropathic pain and ...

5. healthline.com healthline.com/health/belotero

Belotero: Effectiveness, Before and After Photos, Side ... Some Belotero products have more volume, which makes them effective for enlarging your lips, cheeks, or chin.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5076541/

Safety and performance of cohesive polydensified matrix ... The aim of this study was to investigate the safety and performance of CPM ® fillers with lidocaine in the clinical setting.

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf9/P090016S050C.pdf

BELOTERO BALANCE® (+) Lidocaine DERMAL Filler A post-approval clinical study was conducted to provide additional safety data ... define the safety, effectiveness, and patient-reported outcomes of BELOTERO ...

8. belotero.com belotero.com/hcp/clinical-data-moa/

Clinical Data & MOA | Belotero Balance® (+) HCP Overall, Belotero Balance (+) was found to be the most cohesive among FDA-approved HA fillers evaluated with the Gavard-Sundaram Cohesivity scale · Dyed blue ...

9. ifu.merzaesthetics.com ifu.merzaesthetics.com/products/download/52799/Belotero%C2%AE-Intense%20Lidocaine-AU-V02-29-SEP-2023.pdf

Belotero®-Intense Lidocaine-AU-V02-29-SEP-2023 BELOTERO Intense Lidocaine injected in the forehead (excluding glabellar) area may be associated with an increased risk for intravascular ...

10. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf9/P090016b.pdf

Injectable Dermal Filler Device Trade Nam - accessdata.fda.gov The results of the submitted biocompatibility tests illustrate that Belotero Balance has an acceptable human safety profile. Comparison of ...