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The purpose of this study is to demonstrate the safety and effectiveness of Juvéderm® Ultra Lip Injectable Gel for lip enhancement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Juvéderm® Ultra Lip Injectable Gel | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hyaluronic acid gel | Device | Dosage per Investigator's discretion to obtain lip treatment goal; 1 touch-up treatment is allowed 14 days after initial treatment. Maximum total volume per subject is 2.0 mL |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Assessment of the Subject's Overall Lip Fullness on the 4-point Lip Fullness Scale | The responder rate at 3 months, where a responder was defined as an improvement (increase) on the Lip Fullness Scale of ≥ 1 grade compared with the baseline assessment | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Assessment of Perioral Line Severity Using the Perioral Line Severity Scale | Score on 4-point Perioral Line Severity Scale, where 0 is none and 3 is severe. A decreased score indicates improvement. | 12 months |
| Investigator Assessment of Oral Commissures Using the Oral Commissures Severity Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Belfast | United Kingdom | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23152693 | Background | Eccleston D, Murphy DK. Juvederm((R)) Volbella in the perioral area: a 12-month prospective, multicenter, open-label study. Clin Cosmet Investig Dermatol. 2012;5:167-72. doi: 10.2147/CCID.S35800. Epub 2012 Oct 26. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Juvéderm® Ultra Lip Injectable Gel |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Juvéderm® Ultra Lip Injectable Gel |
| 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 | Investigator Assessment of the Subject's Overall Lip Fullness on the 4-point Lip Fullness Scale | The responder rate at 3 months, where a responder was defined as an improvement (increase) on the Lip Fullness Scale of ≥ 1 grade compared with the baseline assessment | Intent-to-treat | Number | 95% Confidence Interval | percentage of responders | 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 | Juvéderm® Ultra Lip Injectable Gel |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nerve compression (unrelated to device) | Nervous system disorders | MedDRA 4.5.2 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bruising | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Monitor | Allergan Medical | (805) 961-5000 | devicetrials@allergan.com |
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Score on 4-point Oral Commissures Severity Scale, where 0 is none and 3 is severe. A decreased score indicates improvement. |
| 12 months |
| Subject Assessment of Appearance and Feel of the Lips Using the Look and Feel Scale | The scale consists of subcategories pertaining to how the subjects perceived aspects of their lips (e.g., softness, smoothness, etc). The outcome measure is the percentage of subjects who scored 0-3 on an 11-point scale, where a lower score on the scale indicates a positive result. | 3 months |
| Number of Subjects Who Attain Their Lip Treatment Goal | Prior to treatment and in consultation with the Investigator, the subject establishes a realistic lip fullness treatment goal. At follow-up, attainment is assessed as yes or no. The outcome measure is the percentage of subjects responding "yes" as to whether their pre-established lip fullness treatment goal had been attained. | 1-12 months |
| Adverse Events | 12 months |
| Cheadle |
| United Kingdom |
| Halesowen | United Kingdom |
| Sutton Coldfield | United Kingdom |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
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| Secondary | Investigator Assessment of Perioral Line Severity Using the Perioral Line Severity Scale | Score on 4-point Perioral Line Severity Scale, where 0 is none and 3 is severe. A decreased score indicates improvement. | All subjects who were treated for perioral lines | Mean | Standard Deviation | units on a scale | 12 months |
|
|
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| Secondary | Investigator Assessment of Oral Commissures Using the Oral Commissures Severity Scale | Score on 4-point Oral Commissures Severity Scale, where 0 is none and 3 is severe. A decreased score indicates improvement. | All subjects who were treated in their oral commissures | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
| Secondary | Subject Assessment of Appearance and Feel of the Lips Using the Look and Feel Scale | The scale consists of subcategories pertaining to how the subjects perceived aspects of their lips (e.g., softness, smoothness, etc). The outcome measure is the percentage of subjects who scored 0-3 on an 11-point scale, where a lower score on the scale indicates a positive result. | All subjects with a Look and Feel assessment | Number | percentage of subjects | 3 months |
|
|
|
| Secondary | Number of Subjects Who Attain Their Lip Treatment Goal | Prior to treatment and in consultation with the Investigator, the subject establishes a realistic lip fullness treatment goal. At follow-up, attainment is assessed as yes or no. The outcome measure is the percentage of subjects responding "yes" as to whether their pre-established lip fullness treatment goal had been attained. | All subjects who provided a lip fullness goal achievement assessment | Number | percentage of subjects | 1-12 months |
|
|
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| Secondary | Adverse Events | Intent-to-treat | Number | percentage of subjects | 12 months |
|
|
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| 1 |
| 60 |
| 37 |
| 60 |
| Swelling | General disorders | Systematic Assessment |
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| Lumps/bumps | General disorders | Systematic Assessment |
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The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 120 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title |
|---|
| Measurements |
|---|
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| Lips Look Even |
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| Lips Look Natural |
|
| Title | Measurements |
|---|
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| Month 9 (n = 59) |
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| Month 12 (n = 58) |
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