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Belotero® Intense Lidocaine for Condition (BILUS Trial)
BILUS Trial Summary
This trial studied the safety and effectiveness of a lip filler, Belotero Intense Lidocaine (BIL), to plump up thin lips.
BILUS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2014 Phase 4 trial • 40 Patients • NCT01602692BILUS Trial Design
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- 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.
- Group 1: Restylane® Silk
- Group 2: Belotero® Intense Lidocaine
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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)."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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