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Completed

NCT Number: NCT05773066

A Study of Belotero® Intense Lidocaine for Lip Augmentation

The purpose of this study is to demonstrate the safety and effectiveness of Belotero Intense Lidocaine (BIL) for lip augmentation in subjects with upper and/or lower lip deficit.

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Key information

Conditions

Lip Augmentation

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Merz Investigation Site #0010436, San Juan, Puerto Rico

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About this study

For all subjects, standardized photographs of the lips will be taken at the screening visit (prior to treatment) and at multiple intervals throughout the study to be used for comparisons and study assessments.

Subjects will receive an injection of either BIL or Restylane Silk (RS) in the upper and/or lower lips. A touch-up injection will be given 4 weeks after the initial treatment if the subject fails to show improvement in 1 or both lips or if the subject does not achieve optimal aesthetic correction. Subjects treated with BIL have the option of a retreatment with BIL 48 weeks post last injection.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Desires lip augmentation to correct volume and has very thin to medium upper and/or lower lip deficit

Exclusion criteria

  • Any previous surgery, including plastic surgery or permanent implant or graft in the lower third part of the face
  • Any previous treatment with fat injections or permanent and/or semi-permanent dermal fillers in the face
  • Any treatment with porcine-based collagen fillers or with Juvéderm® Voluma XC, Restylane® Lyft Lidocaine, Calcium hydroxyapatite (CaHA) within the past 24 months and/or other dermal fillers within the past 12 months in the lips, in the lower third part of the face, and/or the nose
  • Any previous treatment with dermal therapies within the past 3 months in the lower third part of the face
  • Has undergone oral surgery in the past 30 days
  • Lip volume deficit due to medical conditions
  • Known history of allergic/anaphylactic reactions/hypersensitivity to lidocaine or any of the device components

Treatment and study plan

Belotero® Intense Lidocaine

Device

Dermal hyaluronic acid (HA) filler for lip augmentation.

Restylane® Silk

Device

HA gel for lip augmentation.

Primary outcomes

  1. Responder Rate at Week 8, According to the MLFAS

    Time frame: At Week 8

    Responder rate was defined as percentage of subjects with greater than or equal to (>=) 1-point improvement on subject's treated lips compared to baseline as assessed live by a blinded evaluator. MLFAS was a validated 5-grade scale used to assess the volume of the upper and lower lips, where Grade 0=very thin lips with minimal volume and Grade 4=very full lips with significant volume. A positive number change from baseline indicated improvement.

  2. Mean Change of Treated Lips From Baseline to Week 8, According to the Merz Lip Fullness Assessment Scale (MLFAS)

    Time frame: Baseline, Week 8

    MLFAS was a validated 5-grade scale used to assess the volume of the upper and lower lips, where Grade 0=very thin lips with minimal volume and Grade 4=very full lips with significant volume, as assessed live by a blinded evaluator. A positive number change from baseline indicated improvement.

Secondary outcomes

  1. Percentage of Subjects With Investigator's Global Aesthetic Improvement Scale (iGAIS) Scores

    Time frame: At Week 8

    The treating investigator assessed the subject's treated lips compared to pre-treatment photos using the 7-point GAIS ranging as +3 (very much improved); +2 (much improved); +1 (improved); 0 (no change); -1 (worse); -2 (much worse); -3 (very much worse), as assessed by the investigator, where the higher the iGAIS score, the greater the improvement.

  2. Percentage of Subjects With Subject's GAIS Scores (sGAIS)

    Time frame: At Week 8

    Subjects assessed their treated lips compared to pre-treatment photos using the 7-point GAIS ranging as +3 (very much improved); +2 (much improved); +1 (improved); 0 (no change); -1 (worse); -2 (much worse); -3 (very much worse), as assessed by the investigator, where the higher the iGAIS score, the greater the improvement.

  3. Change From Baseline in Rasch-transformed Score of the FACE-Q Satisfaction With Lips

    Time frame: Baseline, Week 8

    FACE-Q was a set of validated, standardized patient-reported outcome scales for subjects received facial cosmetic procedures. The subject rated the level of satisfaction with their lips by answering 7 questions of the FACE-Q satisfaction using a 4- point scale where 1=Very Dissatisfied and 4=Very Satisfied. The sum FACE-Q scores were Rasch-transformed and ranged from 0 to 100. Higher scores reflected a better outcome (greater satisfaction).

  4. Number of Subjects With Related Serious or Related Delayed-onset Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to 48 weeks

    TEAEs were defined as adverse events (AEs) with onset or worsening on or after date of first administration of BIL. A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Delayed-onset TEAEs were those with onset > 21 days after last treatment.

Sponsors and collaborators

Lead sponsor

Merz North America, Inc.

Industry

Registry information

Official study title

A Prospective, Multicenter, Randomized, Comparator-controlled, Evaluator-blinded Study to Evaluate the Safety and Effectiveness of Belotero® Intense Lidocaine for Lip Augmentation

Acronym: BILUS

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Mar 17, 2023
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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