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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JUVEDERM VOLBELLA® XC | Experimental | Lips injected with JUVEDERM VOLBELLA® XC |
|
| Restylane-L® | Active Comparator | Lips injected with Restylane-L® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JUVEDERM VOLBELLA® XC | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Orleans | Louisiana | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28157728 | Background | Geronemus RG, Bank DE, Hardas B, Shamban A, Weichman BM, Murphy DK. Safety and Effectiveness of VYC-15L, a Hyaluronic Acid Filler for Lip and Perioral Enhancement: One-Year Results From a Randomized, Controlled Study. Dermatol Surg. 2017 Mar;43(3):396-404. doi: 10.1097/DSS.0000000000001035. |
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| ID | Title | Description |
|---|---|---|
| FG000 | JUVEDERM VOLBELLA® XC | Lips injected with JUVEDERM VOLBELLA® XC |
| FG001 | Restylane-L® | Lips injected with Restylane-L® |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Population: Subject who received at least 1 treatment
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| ID | Title | Description |
|---|---|---|
| BG000 | JUVEDERM VOLBELLA® XC | Lips injected with JUVEDERM VOLBELLA® XC |
| BG001 | Restylane-L® | Lips injected with Restylane-L® |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | 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. | 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 | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Month 3 |
|
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The Safety Population included subject who received at least 1 treatment. The Safety Population was used to assess adverse events and serious adverse events. Out of the safety population, 30 subjects were included in the JUVEDERM VOLBELLA® Repeat Treatment Arm for AE reporting.
During the repeat treatment period, at the month 12 visit, JUVEDERM VOLBELLA® was administered regardless of the product used for initial treatment.
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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 | JUVEDERM VOLBELLA® XC Initial Treatment | Lips injected with JUVEDERM VOLBELLA® XC |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-Small Cell Lung Cancer Stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Mass | General disorders | MedDRA version 18.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Allergan Inc., | Allergan, Inc | clinicaltrials@allergan.com |
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|
| Restylane-L® | Device | 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. |
|
| Baseline, Month 3 |
| 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. | Baseline, Month 3 |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Adverse Event |
|
| Other reasons |
|
| Randomized but withdrew before treatment |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Restylane-L® |
Lips injected with Restylane-L® |
|
|
| 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. | Subjects in the JUVEDERM VOLBELLA® XC group who received treatment in perioral lines with a baseline POLSS score of moderate or severe | Posted | Number | 95% Confidence Interval | Percentage of Subjects | Baseline, Month 3 |
|
|
|
| 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. | Modified Intent-to-Treat: subjects who were randomized with data at both time points and received at least 1 treatment | Posted | Mean | 95% Confidence Interval | Scores on a Scale | Baseline, Month 3 |
|
|
|
| 5 |
| 168 |
| 85 |
| 168 |
| EG001 | Restylane-L® | Lips injected with Restylane-L® | 1 | 56 | 28 | 56 |
| EG002 | JUVEDERM VOLBELLA® Repeat Treatment | Lips re-injected with JUVEDERM VOLBELLA® XC | 0 | 30 | 12 | 30 |
|
| Colitis | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
|
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA version 18.0 | Non-systematic Assessment |
|
| Cervical Spinal Stenosis | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 | Systematic Assessment |
|
| Goitre | Endocrine disorders | MedDRA version 18.0 | Systematic Assessment |
|
| Malignant Sweat Gland Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 | Systematic Assessment |
|
| Staphylococcal Infection | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 | Systematic Assessment |
|
| Injection Site Bruising | General disorders | MedDRA version 18.0 | Non-systematic Assessment |
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| Injection Site Pain | General disorders | MedDRA version 18.0 | Non-systematic Assessment |
|
| Injection Site Induration | General disorders | MedDRA version 18.0 | Non-systematic Assessment |
|
| Injection Site Swelling | General disorders | MedDRA version 18.0 | Non-systematic Assessment |
|
A disclosure restriction on the PI is that 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 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.