Dermal Filler

Belotero® Intense Lidocaine for Lip Filler

N/A
Waitlist Available
Research Sponsored by Merz North America, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has very thin to medium upper and/or lower lip deficit
Desires lip augmentation to correct volume
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upbaseline (day 1) and week 8 post last injection, up to 12 weeks (v3)
Awards & highlights
No Placebo-Only Group

Study Summary

This trial studied the safety and effectiveness of a lip filler, Belotero Intense Lidocaine (BIL), to plump up thin lips.

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
You possess a scanty to moderate deficiency in your upper and/or lower lip.
Select...
You seek lip augmentation to increase volume.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1) and week 8 post last injection, up to 12 weeks (v3)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1) and week 8 post last injection, up to 12 weeks (v3) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Change of Treated Lips From Baseline to Visit 3 (V3), According to the Merz Lip Fullness Assessment Scale (MLFAS)
Responder Rates at V3, According to the MLFAS
Secondary outcome measures
Change From Baseline in Rasch-transformed Score of the FACE-Q Satisfaction with Lips
Investigator's Global Aesthetic Improvement Scale (GAIS) Scores
Number of Subjects With Related Serious or Related Delayed-onset Treatment Emergent Adverse Events (TEAEs)
+1 more

Side effects data

From 2014 Phase 4 trial • 40 Patients • NCT01602692
40%
Nausea
10%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tumescent Solution With Dilute Epinephrine
Tumescent Solution With Dilute Lidocaine and Epinephrine

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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 site

Who is running the clinical trial?

Merz North America, Inc.Lead Sponsor
60 Previous Clinical Trials
8,476 Total Patients Enrolled
Merz Medical ExpertStudy Director
Merz North America, Inc.
35 Previous Clinical Trials
6,771 Total Patients Enrolled

Media Library

Belotero Intense Lidocaine (Dermal Filler) Clinical Trial Eligibility Overview. Trial Name: NCT05773066 — N/A
Lip Filler Research Study Groups: Restylane® Silk, Belotero® Intense Lidocaine
Lip Filler Clinical Trial 2023: Belotero Intense Lidocaine Highlights & Side Effects. Trial Name: NCT05773066 — N/A
Belotero Intense Lidocaine (Dermal Filler) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05773066 — N/A
Lip Filler Patient Testimony for trial: Trial Name: NCT05773066 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available in this medical study?

"According to clinicaltrials.gov, this trial is actively seeking participants at present. The original post was made on March 3rd 2023 and the listing has been updated most recently on June 3rd 2023."

Answered by AI

Is this study seeking elderly volunteers aged 75 and above?

"According to the stated criteria, individuals between 21 and 65 years of age are eligible for this particular clinical trial."

Answered by AI

What are the qualifying criteria for taking part in this clinical trial?

"This clinical trial is accepting patients from 21 to 65 years old with lip fillers. In total, 220 participants are required for the study."

Answered by AI

What is the highest reported figure of participants in this experiment?

"Confirmed. According to the details hosted on clinicaltrials.gov, this medical experiment is currently enrolling participants and was first posted on March 3rd 2023 with an updated being published on March 6th 2023. It requires 220 individuals from 1 centre of care for completion."

Answered by AI

What is the intended outcome of this medical experiment?

"This clinical trial's primary outcome is the Responder Rates at V3, as evaluated through the MLFAS. Secondary outcomes include subjects' GAIS Scores, changes from Baseline in Rasch-transformed Score of the FACE-Q Satisfaction with Lips and Number of Subjects With Related Serious or Related Delayed-onset Treatment Emergent Adverse Events (TEAEs). These assessments span a period starting on Day 1 to Week 8 post last injection, up to 12 Weeks (V3)."

Answered by AI

Who else is applying?

What site did they apply to?
Merz Investigation Site #0010170
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Jus curious how good I good look.
Patient

What questions have other patients asked about this trial?

How many sessions will this trial require?
Patient
Recent research and studies
clinicaltrials.govStudy
A Study of Belotero® Intense Lidocaine for Lip Augmentation
2023. "A Study of Belotero® Intense Lidocaine for Lip Augmentation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05773066.
~0 spots leftby Nov 2023
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