Lip Augmentation
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEBelotero® Intense Lidocaine
Dermal hyaluronic acid (HA) filler for lip augmentation.
DEVICERestylane® Silk
HA gel for lip augmentation.
Sponsors
Merz North America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responder Rate at Week 8, According to the MLFAS | 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. |
| Mean Change of Treated Lips From Baseline to Week 8, According to the Merz Lip Fullness Assessment Scale (MLFAS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Related Serious or Related Delayed-onset Treatment Emergent Adverse Events (TEAEs) | 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. |
| Percentage of Subjects With Investigator's Global Aesthetic Improvement Scale (iGAIS) Scores | 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. |
| Percentage of Subjects With Subject's GAIS Scores (sGAIS) | 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. |
| Change From Baseline in Rasch-transformed Score of the FACE-Q Satisfaction With Lips | 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). |
Countries
Puerto Rico, United States
Contacts
STUDY_DIRECTORMerz Medical Expert
Merz North America, Inc.
Participant flow
Recruitment details
Subjects were recruited from 14 investigational sites in the United States.
Pre-assignment details
Of the 250 screened, 30 were exited as screen failures. 165 subjects were randomized to Belotero® Intense Lidocaine (BIL) group, and 55 subjects were randomized to Restylane® Silk (RS) group.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 46.5 years STANDARD_DEVIATION 12.26 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 203 Participants |
| Sex: Female, Male Female | 212 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 165 | 0 / 55 |
| other Total, other adverse events | 41 / 165 | 12 / 55 |
| serious Total, serious adverse events | 2 / 165 | 0 / 55 |
Outcome results
None listed