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The purpose of this study is to determine whether VOLUMA with Lidocaine is safe and effective for the improvement of volume and aesthetic appearance of the nose in the Chinese population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JUVÉDERM® VOLUMA® with Lidocaine | Experimental | Participants were treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel during the 24-week Control Period. Participants were eligible for touch-up treatment 8 weeks after the initial treatment, if applicable. Follow-up continued in the 24-week Post-Control period. |
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| No-treatment Control | Experimental | Participants received no treatment during the 24-week Control Period. After 24 weeks, participants had the option of treatment with JUVÉDERM® VOLUMA® with Lidocaine Injectable Gel in the nose area during the 24-week Post-Control period and were eligible for touch-up treatment 8 weeks after the initial treatment, if applicable. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JUVÉDERM® VOLUMA® with Lidocaine | Device | Treatment with JUVÉDERM® VOLUMA® with Lidocaine injectable gel with optional treatment 8 weeks later. |
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| Measure | Description | Time Frame |
|---|---|---|
| Volume Change From Baseline in the Nose Area | Volume of the nose was calculated by digital analysis of each participant's 3-dimensional (3D) images. A mixed-effects model for repeated measures (MMRM) was used for analysis. A positive change from Baseline indicates improvement. An analysis model was created by Canfield Scientific, only volume changes are available. Actual Baseline values are not available. | Baseline (Last value prior to treatment for the treatment group and last value prior to randomization for control group) to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Where the Evaluating Investigator Noted "Improved" or "Much Improved Using the Global Aesthetic Improvement Scale (GAIS) | The Evaluating Investigator assessed the aesthetic improvement of the nose using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. The percentage of participants who the Evaluating Investigator assessed as 2=much improved or 1=improved is reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lijuan Zhang | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100032 | China | ||
| Peking University Third Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | No-treatment Control | Participants received no treatment during the 24-week Control Period. After 24 weeks, participants had the option of treatment with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in the nose area during the 24-week Post-Control Period and were eligible for touch-up treatment 8 weeks after the initial treatment, if applicable. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| 24-week Control Period |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 22, 2017 | Dec 4, 2020 |
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| No-treatment control | Other | No treatment during the control period. |
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| Week 24 |
| Percentage of Participants Who Noted "Improved" or "Much Improved" as Assessed by the Participant Using the GAIS in the Treatment Group | The participant assessed the aesthetic improvement of the nose using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. The percentage of participants who assess themselves as 2=much improved or 1=improved is reported. | Week 24 |
| Percentage of Participants Who Noted "Satisfied" or "Very Satisfied" With Treatment Outcome on the Nose Satisfaction Scale (NSS) in the Treatment Group | The participant used the 5-point NSS to assess the treatment outcome of the nose where: +2=very satisfied, +1=satisfied, 0=neutral (neither satisfied or dissatisfied), -1=dissatisfied and -2= very dissatisfied. The percentage of participants who assessed themselves as +2=Very Satisfied or +1=Satisfied is reported. | Week 24 |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Control Period | An AE is any untoward medical occurrence in a patient or a participant using an investigational drug, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. | 24 Weeks |
| Beijing |
| Beijing Municipality |
| 100191 |
| China |
| Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine | Beijing | Shanghai Municipality | 200011 | China |
| Shanghai Sixth People's Hospital | Shanghai | Shanghai Municipality | 200233 | China |
| Union Hospital Tongji Medical College, Huazhong University of Science and Technology | Beijing | Wuhan | 430002 | China |
| FG001 |
| JUVÉDERM® VOLUMA® With Lidocaine |
Participants were treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel during the 24-week Control Period. Participants were eligible for touch-up treatment 8 weeks after the initial treatment, if applicable. Follow-up continued in the 24-week Post-Control period. |
| Treated as Randomized |
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| COMPLETED |
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| NOT COMPLETED |
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| 24-week Post-Control Period |
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Modified Intent-to-treat (mITT) included all participants who were randomized to study treatment and received at least one study device treatment and completed at least 1 effectiveness assessment (treatment group) and participants who were randomized to no treatment and complete at least 1 effectiveness assessment (control group).
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| ID | Title | Description |
|---|---|---|
| BG000 | No-treatment Control | Participants received no treatment during the 24-week Control Period. After 24 weeks, participants had the option of treatment with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in the nose area during the 24-week Post-Control Period and were eligible for touch-up treatment 8 weeks after the initial treatment, if applicable. |
| BG001 | JUVÉDERM® VOLUMA® With Lidocaine | Participants were treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel during the 24-week Control Period. Participants were eligible for touch-up treatment 8 weeks after the initial treatment, if applicable. Follow-up continued in the 24-week Post-Control period. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 | Volume Change From Baseline in the Nose Area | Volume of the nose was calculated by digital analysis of each participant's 3-dimensional (3D) images. A mixed-effects model for repeated measures (MMRM) was used for analysis. A positive change from Baseline indicates improvement. An analysis model was created by Canfield Scientific, only volume changes are available. Actual Baseline values are not available. | mITT Population included all participants who are randomized to study treatment and received at least one study device treatment and completed at least 1 effectiveness assessment (treatment group) and participants who are randomized to no treatment and complete at least 1 effectiveness assessment (control group). | Posted | Least Squares Mean | Standard Error | cubic centimeters (cc) | Baseline (Last value prior to treatment for the treatment group and last value prior to randomization for control group) to Week 24 |
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| Secondary | Percentage of Participants Where the Evaluating Investigator Noted "Improved" or "Much Improved Using the Global Aesthetic Improvement Scale (GAIS) | The Evaluating Investigator assessed the aesthetic improvement of the nose using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. The percentage of participants who the Evaluating Investigator assessed as 2=much improved or 1=improved is reported. | mITT Population included all participants who are randomized to study treatment and received at least one study device treatment and completed at least 1 effectiveness assessment (treatment group) and participants who are randomized to no treatment and complete at least 1 effectiveness assessment (control group). Participants analyzed are the number of participants with available data at the given timepoint. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 24 |
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| Secondary | Percentage of Participants Who Noted "Improved" or "Much Improved" as Assessed by the Participant Using the GAIS in the Treatment Group | The participant assessed the aesthetic improvement of the nose using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. The percentage of participants who assess themselves as 2=much improved or 1=improved is reported. | mITT Population included all participants who are randomized to study treatment and received at least one study device treatment and completed at least 1 effectiveness assessment (treatment group). Participants analyzed is the number of participants with available data at the given timepoint. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 24 |
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| Secondary | Percentage of Participants Who Noted "Satisfied" or "Very Satisfied" With Treatment Outcome on the Nose Satisfaction Scale (NSS) in the Treatment Group | The participant used the 5-point NSS to assess the treatment outcome of the nose where: +2=very satisfied, +1=satisfied, 0=neutral (neither satisfied or dissatisfied), -1=dissatisfied and -2= very dissatisfied. The percentage of participants who assessed themselves as +2=Very Satisfied or +1=Satisfied is reported. | mITT Population included all participants who are randomized to study treatment and received at least one study device treatment and completed at least 1 effectiveness assessment (treatment group). Participants analyzed is the number of participants with available data at the given timepoint. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 24 |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Control Period | An AE is any untoward medical occurrence in a patient or a participant using an investigational drug, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. | Safety Population included all randomized participants who received VOLUMA treatment in the Control Period (CP) or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment. | Posted | Count of Participants | Participants | 24 Weeks |
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JUVÉDERM® VOLUMA® with Lidocaine Treatment group: 48 Weeks after last treatment (Up to 56 Weeks); No-treatment Control group: no treatment for 24 weeks then 24 weeks following last treatment (Up to 32 Weeks)
Number of participants for All-cause Mortality included all randomized participants. Number of participants for Serious Adverse Events and Adverse Events is based on the Safety Population that included all randomized participants who received VOLUMA treatment in the CP or who did not receive VOLUMA treatment in the CP and had at least 1 follow-up assessment or participants in the VOLUMA Optionally Treated arm who received 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) |
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| EG000 | No-treatment Control (Control Period) | Participants who received no treatment during the 24-week Control Period. | 0 | 42 | 1 | 37 | 12 | 37 |
| EG001 | JUVÉDERM® VOLUMA® With Lidocaine (Control Period) | Participants were treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel to the nose area during the 24-week Control Period. Participants were eligible for touch-up treatment 8 weeks after the initial treatment, if applicable. | 0 | 122 | 0 | 120 | 20 | 120 |
| EG002 | VOLUMA Initially Treated (Post-Control Period) | Participants in the 24-week Post-Control Period who were treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel during the 24-week Control Period. | 0 | 118 | 2 | 118 | 23 | 118 |
| EG003 | VOLUMA Optionally Treated (Post-Control Period) | Participants in the 24-week Post-Control Period who received no treatment in the 24-week Control Period then were treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel with an optional treatment 8 weeks later, if applicable | 0 | 31 | 1 | 31 | 10 | 31 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast fibroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
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| Ligament injury | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
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| Foot fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| Periodontitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 22.1 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area, Head | Allergan | 714-246-4500 | clinicaltrials@allergan.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 3, 2020 | Dec 4, 2020 | SAP_001.pdf |
| Male |
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