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The purpose of this study is evaluate lip fullness 3 months following treatment with Juvéderm® Volbella with Lidocaine or Restylane-L®
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Juvéderm® Volbella with Lidocaine | Experimental | Subjects injected with Juvéderm® Volbella with Lidocaine in their lips |
|
| Restylane-L® | Active Comparator | Subjects injected with Restylane-L® in their lips |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Juvéderm® Volbella with Lidocaine | Device | Up to 4.0 mL at the discretion of the Investigator to achieve optimal results |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cannes | France | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25878932 | Background | Raspaldo H, Chantrey J, Belhaouari L, Saleh R, Murphy DK. Juvederm volbella with lidocaine for lip and perioral enhancement: a prospective, randomized, controlled trial. Plast Reconstr Surg Glob Open. 2015 Apr 7;3(3):e321. doi: 10.1097/GOX.0000000000000266. eCollection 2015 Mar. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Subject Randomized to Receive VOLBELLA® | |
| FG001 | Subjects Randomized to Receive Restylane-L® |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Baseline characteristics are based on the "modified Intent-to-Treat" population: subjects randomized to receive treatment and treated.
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects Randomized to Receive VOLBELLA® | |
| BG001 | Subjects Randomized to Receive Restylane-L® | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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) | Posted | Number | 95% Confidence Interval | Percentage of subjects | 3 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subjects Treated With VOLBELLA® |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment | This event was classified as not related to the anesthesia, study device, or procedure, and resolved without sequelae after treatment with medication and a procedure. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site mass | General disorders | MedDRA 16.1 | Systematic Assessment | lumps/bumps |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Monitor | Allergan, Inc. | 805 961 5000 | devicetrials@allergan.com |
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| Restylane-L® | Device | Up to 4.0 mL at the discretion of the Investigator to achieve optimal results |
|
| Glasgow |
| United Kingdom |
Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| 1 |
| 139 |
| 27 |
| 139 |
| EG001 | Subjects Treated With Restylane-L® | 1 | 141 | 26 | 141 |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment | This event was classified as not related to the anesthesia, study device, or procedure, and resolved with sequelae after treatment with a procedure. |
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| Injection site pain | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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Allergan, as the Sponsor, has proprietary interest in this study. Authorship and manuscript composition will reflect joint cooperation between multiple Investigators and sites and Allergan personnel. Authorship will be established prior to the writing of the manuscript. As this study involves multiple centers, no individual publications will be allowed prior to completion of the final report of the multicenter study except as agreed with Allergan.