Lip Volume Enhancement
Conditions
Brief summary
The purpose of this study is evaluate lip fullness 3 months following treatment with Juvéderm® Volbella with Lidocaine or Restylane-L®
Interventions
DEVICEJuvéderm® Volbella with Lidocaine
Up to 4.0 mL at the discretion of the Investigator to achieve optimal results
DEVICERestylane-L®
Up to 4.0 mL at the discretion of the Investigator to achieve optimal results
Sponsors
Allergan Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Desire enhancement of his/her vermilion borders and/or vermilion mucosa 2. Have a baseline score of Minimal or Mild, as assessed by the Investigator, according to the 5-point LFS (Minimal, Mild, Moderate, Marked, Very Marked) 3. Have established a realistic Lip Fullness treatment goal that the Investigator agrees is achievable
Exclusion criteria
1. Have undergone cosmetic facial, lip or perioral procedures \[e.g., face-lift, or other surgeries, which may alter the appearance of the lips or perioral area (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures), tissue augmentation with dermal fillers or fat injections, or mesotherapy\] anywhere in the face or neck, or Botox® Cosmetic injections in the lower face (below the orbital rim), within 6 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study. NOTE: Prior treatment with HA fillers and/or collagen is allowed, provided the treatment was administered more than 6 months prior to study entry 2. Have ever received semi-permanent fillers or permanent facial implants, e.g., calcium hydroxyapatite, L-polylactic acid, polymethylmethacrylate (PMMA), silicone, expanded polytetrafluoroethylene (ePTFE) anywhere in the lips, or be planning to be implanted with any of these products at any time during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Month 3 Overall Lip Fullness Scale Responder Rate Based on Independent Central Reviewer's Assessment | 3 months | The primary effectiveness variable is the responder rate (percentage of subjects who show ≥ 1-point improvement on the 5-point Lip Fullness Scale (Minimal, Mild, Moderate, Marked, Very Marked) compared to baseline assessment, as determined by Independent Central Reviewer evaluation of 3D photographic images). |
Countries
France, United Kingdom
Participant flow
Pre-assignment details
Enrollment was defined as having signed the IRB-approved Informed Consent Form. Prior to randomization, 4 subjects were excluded as screen fails, leaving an Intent-to-Treat population of 281 subjects.
Participants by arm
| Arm | Count |
|---|---|
| Subjects Randomized to Receive VOLBELLA® | 139 |
| Subjects Randomized to Receive Restylane-L® | 141 |
| Total | 280 |
Baseline characteristics
| Characteristic | Subjects Randomized to Receive Restylane-L® | Total | Subjects Randomized to Receive VOLBELLA® |
|---|---|---|---|
| Age, Continuous | 48.3 years STANDARD_DEVIATION 12.61 | 47.7 years STANDARD_DEVIATION 12.28 | 47.1 years STANDARD_DEVIATION 11.94 |
| Region of Enrollment France | 49 participants | 97 participants | 48 participants |
| Region of Enrollment United Kingdom | 92 participants | 183 participants | 91 participants |
| Sex: Female, Male Female | 139 Participants | 274 Participants | 135 Participants |
| Sex: Female, Male Male | 2 Participants | 6 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 27 / 139 | 26 / 141 |
| serious Total, serious adverse events | 1 / 139 | 1 / 141 |
Outcome results
Primary
Month 3 Overall Lip Fullness Scale Responder Rate Based on Independent Central Reviewer's Assessment
The primary effectiveness variable is the responder rate (percentage of subjects who show ≥ 1-point improvement on the 5-point Lip Fullness Scale (Minimal, Mild, Moderate, Marked, Very Marked) compared to baseline assessment, as determined by Independent Central Reviewer evaluation of 3D photographic images).
Time frame: 3 months
Population: Per-protocol population (all subjects who are randomized, received at least 1 study treatment, and have no protocol deviations that affect the primary effectiveness endpoint)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subjects Randomized to Receive VOLBELLA® and Treated | Month 3 Overall Lip Fullness Scale Responder Rate Based on Independent Central Reviewer's Assessment | 34.1 Percentage of subjects |
| Subjects Randomized to Receive Restylane-L® and Treated | Month 3 Overall Lip Fullness Scale Responder Rate Based on Independent Central Reviewer's Assessment | 29.3 Percentage of subjects |
Comparison: The null hypothesis is that VOLBELLA® is inferior to Restylane-L® in terms of responder rate at Month 3, and the alternative hypothesis is that VOLBELLA® is inferior to Restylane-L® in terms of responder rate at Month 3 with 15% pre-defined non-inferiority margin. To test the null hypothesis, a difference in responder rates of these products (VOLBELLA® - Restylane-L®) at Month 3 and a 1-sided 97.5% Wald confidence interval for the difference is calculated.