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Dermal Filler
Belotero® Intense Lidocaine for Condition (BILUS Trial)
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1) and week 8 post last injection, up to 12 weeks (v3)
Awards & highlights
Summary
This trial studied the safety and effectiveness of a lip filler, Belotero Intense Lidocaine (BIL), to plump up thin lips.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (day 1) and week 8 post last injection, up to 12 weeks (v3)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1) and week 8 post last injection, up to 12 weeks (v3)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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 moreSide effects data
From 2014 Phase 4 trial • 40 Patients • NCT0160269240%
Nausea
10%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tumescent Solution With Dilute Epinephrine
Tumescent Solution With Dilute Lidocaine and Epinephrine
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.
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Who is running the clinical trial?
Merz North America, Inc.Lead Sponsor
65 Previous Clinical Trials
9,533 Total Patients Enrolled
Merz Medical ExpertStudy DirectorMerz North America, Inc.
39 Previous Clinical Trials
6,470 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility 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.I haven't had skin treatments on the lower part of my face in the last 3 months.I have had oral surgery within the last month.I want lip augmentation to increase volume due to thin or medium lips.I have thin lips because of a health condition.I want to increase my lip size for more volume.You possess a scanty to moderate deficiency in your upper and/or lower lip.
Research Study Groups:
This trial has the following groups:- Group 1: Restylane® Silk
- Group 2: Belotero® Intense Lidocaine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Condition Patient Testimony for trial: Trial Name: NCT05773066 — N/A
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