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A prospective, multicenter postmarket study of the use of JUVÉDERM VOLBELLA™ with Lidocaine in the lips.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Volbella | Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crosslinked hyaluronic acid gel | Device | All treatments are carried out according to the physician's experience and the Directions for Use |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subject Rating of the Natural Look and Feel of the Lips | Percentage of subjects rating the look and feel of their lips as being extremely natural, very natural, slightly natural, and not natural. | 4 weeks |
| Injector Rating of the Natural Look and Feel of the Lips | Percentage of injectors who rated the look and feel of subjects' lips as being extremely natural, very natural, slightly natural, and not natural. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Bruising of the Lips | Injector assessment of whether there was none, little, some, moderate, or considerable bruising in subjects' lips | 15 minutes after injection |
| Swelling of the Lips | Injector assessment of whether there was none, little, some, moderate, or considerable swelling in subjects' lips |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy volunteers desiring lip augmentation
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Allergan Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Düsseldorf | North Rhine-Westphalia | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24910276 | Result | Philipp-Dormston WG, Hilton S, Nathan M. A prospective, open-label, multicenter, observational, postmarket study of the use of a 15 mg/mL hyaluronic acid dermal filler in the lips. J Cosmet Dermatol. 2014 Jun;13(2):125-34. doi: 10.1111/jocd.12085. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Volbella | Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Volbella | Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Subject Rating of the Natural Look and Feel of the Lips | Percentage of subjects rating the look and feel of their lips as being extremely natural, very natural, slightly natural, and not natural. | All subjects who met the criteria and treatment was initiated | Number | Percentage of subjects | 4 weeks |
|
|
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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 | Volbella | Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Monitor | Allergan, Inc. | 714-246-4500 | clinicaltrials@allergan.com |
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| 15 minutes after injection |
| Ease of Injection | Injectors rated the ease of injection on a scale ranging from 0 (Very easy) to 10 (Extremely difficult) | 15 minutes after injection |
| Malleability of Product | Injectors rated the malleability on a scale ranging from 0 (Extremely malleable/Not hard to mold) to 10 (Not malleable/Hard to mold) | 15 minutes after injection |
| Need for Massage | Injectors rated whether none/minimal, a little, some, or a lot of massage was required to optimize placement of VOLBELLA | 15 minutes after injection |
| Return to Social Engagement | Time to return to normal daily activities | 4 weeks |
| Comparative Rating With Previous Treatment | Subject rating of lip improvement with VOLBELLA compared with previous lip enhancement treatments as significantly better, somewhat better, no difference, somewhat worse, or significantly worse | 15 minutes after injection |
| Rating of Injection Discomfort | The level of discomfort during treatment on a scale of 0 (no discomfort) to 10 (extreme discomfort). | 15 minutes after injection |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Primary | Injector Rating of the Natural Look and Feel of the Lips | Percentage of injectors who rated the look and feel of subjects' lips as being extremely natural, very natural, slightly natural, and not natural. | All subjects who met the criteria and treatment was initiated | Number | Percentage of subjects | 4 weeks |
|
|
|
| Secondary | Bruising of the Lips | Injector assessment of whether there was none, little, some, moderate, or considerable bruising in subjects' lips | All subjects who met the criteria and treatment was initiated | Number | Percentage of subjects | 15 minutes after injection |
|
|
|
| Secondary | Swelling of the Lips | Injector assessment of whether there was none, little, some, moderate, or considerable swelling in subjects' lips | All subjects who met the criteria and treatment was initiated | Number | Percentage of subjects | 15 minutes after injection |
|
|
|
| Secondary | Ease of Injection | Injectors rated the ease of injection on a scale ranging from 0 (Very easy) to 10 (Extremely difficult) | All subjects who met the criteria and treatment was initiated | Number | Percentage of subjects | 15 minutes after injection |
|
|
|
| Secondary | Malleability of Product | Injectors rated the malleability on a scale ranging from 0 (Extremely malleable/Not hard to mold) to 10 (Not malleable/Hard to mold) | All subjects who met the criteria and treatment was initiated | Number | Percentage of subjects | 15 minutes after injection |
|
|
|
| Secondary | Need for Massage | Injectors rated whether none/minimal, a little, some, or a lot of massage was required to optimize placement of VOLBELLA | All subjects who met the criteria and treatment was initiated | Number | Percentage of subjects | 15 minutes after injection |
|
|
|
| Secondary | Return to Social Engagement | Time to return to normal daily activities | All subjects who met the criteria and treatment was initiated | Number | Percentage of subjects | 4 weeks |
|
|
|
| Secondary | Comparative Rating With Previous Treatment | Subject rating of lip improvement with VOLBELLA compared with previous lip enhancement treatments as significantly better, somewhat better, no difference, somewhat worse, or significantly worse | All subjects who met the criteria and treatment was initiated | Number | Percentage of subjects | 15 minutes after injection |
|
|
|
| Secondary | Rating of Injection Discomfort | The level of discomfort during treatment on a scale of 0 (no discomfort) to 10 (extreme discomfort). | All subjects who met the criteria and treatment was initiated | Mean | Standard Deviation | scale score | 15 minutes after injection |
|
|
|
| 0 |
| 62 |
| 0 |
| 62 |
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| Title | Measurements |
|---|---|
|
| Not natural |
|
| Title | Measurements |
|---|
|
| Moderate |
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| Considerable |
|
| Title | Measurements |
|---|
|
| Moderate |
|
| Considerable |
|
| Title | Measurements |
|---|---|
|
| A lot |
|
| Measurements |
|---|
|
| 4-5 Days |
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| > 6 Days |
|
| Title | Measurements |
|---|---|
|
| Somewhat worse |
|
| Significantly worse |
|