Subjects Desiring Lip Augmentation
Conditions
Brief summary
This is a multicenter, double-blind, randomized, controlled study of the safety and effectiveness of JUVÉDERM VOLBELLA® XC Injectable Gel versus Restylane-L® for lip and perioral enhancement.
Interventions
DEVICEJUVEDERM VOLBELLA® XC
Up to 1.5 mL per lip (upper and lower) at each treatment (initial, touch-up, and repeat treatment). Additional product may be injected into the perioral area, as long as the total injection volume does not exceed 6.0 mL. Up to 6.0 mL allowed for repeat treatment.
DEVICERestylane-L®
Up to 1.5 mL per lip (upper and lower) at each treatment (initial, touch-up, and repeat treatment). Additional product may be injected into the perioral area, as long as the total injection volume does not exceed 6.0 mL.. Up to 6.0 mL allowed for repeat treatment.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 22 years of age or older * Has a score of minimal, mild, or moderate on the LFS2, as agreed upon by the Treating and Evaluating Investigators, and desires at least 1 point of correction for one or both lips * For treatment of perioral lines, has a POLSS score of severe or moderate as agreed upon by the Treating and Evaluating Investigators (all subjects are eligible for treatment in the vermilion body, oral commissures, vermilion border, Cupid's bow, and philtral columns)
Exclusion criteria
* Has lip tattoos, piercings, facial hair, or scars that would interfere with visualization of the lips and perioral area for the effectiveness assessments * Has dentures or any device covering all or part of the upper palate, and/or severe malocclusion or dentofacial or maxillofacial deformities as judged by the Treating Investigator * Has undergone oral surgery (e.g., tooth extraction, orthodontia, or implantation) within 6 weeks before enrollment or is planning to undergo any of these procedures during the study * Has ever undergone facial plastic surgery or received permanent facial implants (e.g., polymethylmethacrylate, silicone, polytetrafluoroethylene) anywhere in the face or neck, or is planning to be implanted with any of these products during the study * Has undergone semipermanent dermal filler treatment (e.g., calcium hydroxylapatite, poly-L-lactic acid) in the lower face (below the orbital rim) within 24 months before enrollment or is planning to undergo such treatment during the study * Has undergone temporary dermal filler treatment (e.g., hyaluronic acid or collagen) in the lower face (below the orbital rim) within 12 months before enrollment or is planning to undergo such treatment during the study * Has undergone mesotherapy or cosmetic resurfacing (laser, photo-modulation, intense pulsed light, radiofrequency, dermabrasion, chemical peel, or other ablative or non-ablative procedures) anywhere in the face or neck, or Botulinum toxin injections in the lower face (below the orbital rim) within 6 months before enrollment or is planning to undergo any of these procedures during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Evaluating Investigator's Assessment of Lip Fullness on a 5-Point Scale | Baseline, Month 3 | Lip fullness is assessed by the Evaluating Investigator on the 5-point Lip Fullness Scale 2. Assessments range from 0=minimal flat or nearly flat contour, minimal red lip show (worse) to 4=very marked very significant red lip show, lower lip pout, and upper lip pout (best). A positive number change from baseline indicates improvement and a negative number change from baseline indicates a worsening. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects in the JUVEDERM VOLBELLA® XC Treatment Arm With at Least a 1 Point Improvement From Baseline on the Perioral Lines Severity Scale (POLSS) | Baseline, Month 3 | The Evaluating Investigator evaluated the perioral lines severity using the 4-point POLSS where None=No lines; Mild=Few, shallow lines; Moderate=Some, moderate lines; and Severe=Many, deep lines or crevices. The percentage of subjects with at least a 1-point improvement is reported. In accordance with the analysis plan, the analysis with responder rate and 95% Confidence Interval was performed for the JUVEDERM VOLBELLA® XC group only. |
| Change From Baseline in Subject Satisfaction With Lips on the Lip Module of the FACE-Q Questionnaire | Baseline, Month 3 | Subjects evaluated satisfaction using the 22 items on the Satisfaction with Lip module of the FACE-Q questionnaire. Scores for each item are combined to create a scale ranging from 0 (worse) to 100 (best). A positive number in change from baseline indicates an improvement, and a negative number in change from baseline indicates a worsening. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| JUVEDERM VOLBELLA® XC Lips injected with JUVEDERM VOLBELLA® XC | 168 |
| Restylane-L® Lips injected with Restylane-L® | 56 |
| Total | 224 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Lost to Follow-up | 12 | 4 |
| Overall Study | Other reasons | 3 | 2 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Randomized but withdrew before treatment | 1 | 0 |
| Overall Study | Refused repeat treatment | 20 | 4 |
| Overall Study | Withdrawal by Subject | 8 | 1 |
Baseline characteristics
| Characteristic | JUVEDERM VOLBELLA® XC | Restylane-L® | Total |
|---|---|---|---|
| Age, Customized 30 to 50 years | 57 Participants | 17 Participants | 74 Participants |
| Age, Customized <30 year | 7 Participants | 1 Participants | 8 Participants |
| Age, Customized 51 to 65 years | 88 Participants | 33 Participants | 121 Participants |
| Age, Customized >65 years | 16 Participants | 5 Participants | 21 Participants |
| Sex: Female, Male Female | 164 Participants | 53 Participants | 217 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 85 / 168 | 28 / 56 | 12 / 30 |
| serious Total, serious adverse events | 5 / 168 | 1 / 56 | 0 / 30 |
Outcome results
Primary
Change From Baseline in Evaluating Investigator's Assessment of Lip Fullness on a 5-Point Scale
Lip fullness is assessed by the Evaluating Investigator on the 5-point Lip Fullness Scale 2. Assessments range from 0=minimal flat or nearly flat contour, minimal red lip show (worse) to 4=very marked very significant red lip show, lower lip pout, and upper lip pout (best). A positive number change from baseline indicates improvement and a negative number change from baseline indicates a worsening.
Time frame: Baseline, Month 3
Population: Modified Intent-to-Treat: subjects who were randomized with a Lip Fullness Scale 2 baseline score of minimal, mild, or moderate and who received at least 1 treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JUVEDERM VOLBELLA® XC | Change From Baseline in Evaluating Investigator's Assessment of Lip Fullness on a 5-Point Scale | Baseline | 1.2 Scores on a Scale | Standard Deviation 0.73 |
| JUVEDERM VOLBELLA® XC | Change From Baseline in Evaluating Investigator's Assessment of Lip Fullness on a 5-Point Scale | Change from Baseline at Month 3 (N=152, 48) | 1.1 Scores on a Scale | Standard Deviation 0.75 |
| Restylane-L® | Change From Baseline in Evaluating Investigator's Assessment of Lip Fullness on a 5-Point Scale | Baseline | 1.1 Scores on a Scale | Standard Deviation 0.7 |
| Restylane-L® | Change From Baseline in Evaluating Investigator's Assessment of Lip Fullness on a 5-Point Scale | Change from Baseline at Month 3 (N=152, 48) | 1.0 Scores on a Scale | Standard Deviation 0.85 |
Secondary
Change From Baseline in Subject Satisfaction With Lips on the Lip Module of the FACE-Q Questionnaire
Subjects evaluated satisfaction using the 22 items on the Satisfaction with Lip module of the FACE-Q questionnaire. Scores for each item are combined to create a scale ranging from 0 (worse) to 100 (best). A positive number in change from baseline indicates an improvement, and a negative number in change from baseline indicates a worsening.
Time frame: Baseline, Month 3
Population: Modified Intent-to-Treat: subjects who were randomized with data at both time points and received at least 1 treatment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| JUVEDERM VOLBELLA® XC | Change From Baseline in Subject Satisfaction With Lips on the Lip Module of the FACE-Q Questionnaire | 37.6 Scores on a Scale |
| Restylane-L® | Change From Baseline in Subject Satisfaction With Lips on the Lip Module of the FACE-Q Questionnaire | 29.0 Scores on a Scale |
Secondary
Percentage of Subjects in the JUVEDERM VOLBELLA® XC Treatment Arm With at Least a 1 Point Improvement From Baseline on the Perioral Lines Severity Scale (POLSS)
The Evaluating Investigator evaluated the perioral lines severity using the 4-point POLSS where None=No lines; Mild=Few, shallow lines; Moderate=Some, moderate lines; and Severe=Many, deep lines or crevices. The percentage of subjects with at least a 1-point improvement is reported. In accordance with the analysis plan, the analysis with responder rate and 95% Confidence Interval was performed for the JUVEDERM VOLBELLA® XC group only.
Time frame: Baseline, Month 3
Population: Subjects in the JUVEDERM VOLBELLA® XC group who received treatment in perioral lines with a baseline POLSS score of moderate or severe
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JUVEDERM VOLBELLA® XC | Percentage of Subjects in the JUVEDERM VOLBELLA® XC Treatment Arm With at Least a 1 Point Improvement From Baseline on the Perioral Lines Severity Scale (POLSS) | 65.9 Percentage of Subjects |