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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
220
Dermal hyaluronic acid (HA) filler for lip augmentation.
HA gel for lip augmentation.
Merz Investigation Site #0010463
Redondo Beach, California, United States
Merz Investigation Site #0010299
Santa Monica, California, United States
Merz Investigation Site #0010358
Responder Rate at Week 8, According to the MLFAS
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.
Time frame: At Week 8
Mean Change of Treated Lips From Baseline to Week 8, According to the Merz Lip Fullness Assessment Scale (MLFAS)
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.
Time frame: Baseline, Week 8
Percentage of Subjects With Investigator's Global Aesthetic Improvement Scale (iGAIS) Scores
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.
Time frame: At Week 8
Percentage of Subjects With Subject's GAIS Scores (sGAIS)
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.
Time frame: At Week 8
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Vista, California, United States
Merz Investigation Site #0010170
Washington D.C., District of Columbia, United States
Merz Investigation Site #0010101
Coral Gables, Florida, United States
Merz Investigation Site #0010464
Alpharetta, Georgia, United States
Merz Investigation Site #0010446
Atlanta, Georgia, United States
Merz Investigation Site #0010466
Chicago, Illinois, United States
Merz Investigation Site #0010472
Purchase, New York, United States
Merz Investigation Site #0010468
Ardmore, Pennsylvania, United States
...and 4 more locations
Change From Baseline in Rasch-transformed Score of the FACE-Q Satisfaction With Lips
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).
Time frame: Baseline, Week 8
Number of Subjects With Related Serious or Related Delayed-onset Treatment Emergent Adverse Events (TEAEs)
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.
Time frame: Up to 48 weeks