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The objectives of this study are to evaluate the safety and effectiveness of JUVÉDERM® VOLUMA® with Lidocaine injectable gel in adult Chinese population seeking correction of temple hollowing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JUVÉDERM® VOLUMA® with Lidocaine | Experimental | Participants will be treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in temple. Participants are eligible for touch up treatment |
|
| Control- No treatment | No Intervention | No treatment is administered. Optional treatment at month 6. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JUVÉDERM® VOLUMA® with Lidocaine | Device | JUVÉDERM® VOLUMA® with Lidocaine injectable gel |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug and no more than 30 days after the last dose of the study drug. | Up to 14 Months |
| Participants With at Least a 1-Point Improvement (Decrease) in Temple as Assessed by the Evaluating Investigator (EI) Using the Allergan Temple Hollowing Scale (ATHS) | The Evaluating Investigator will assess the participant's temple hollowing using the ATHS 5-point scale where: 0=convex, rounded temple to 4=severe, deeply recessed, sunken appearance. A 1-point decrease from Baseline indicates improvement. | Change from Baseline to Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline on Rasch Transformed Score of FACE-Q Satisfaction With Temples Questionnaire at Month 6 | Participant-assessed satisfaction using the 12-item FACE-Q Satisfaction with Temples Questionnaire was measured on a 4-point scale where 1=very dissatisfied, 2=somewhat dissatisfied, 3=somewhat satisfied, and 4=very satisfied. The responses to the items were converted to a 100-point Rasch transformed score ranging from 0 (worst) to 100 (best). Higher scores indicate higher satisfaction. A positive change from Baseline indicates improvement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ALLERGAN, INC. | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital /ID# 241680 | Beijing | Beijing Municipality | 100029 | China | ||
| Beijing Hospital /ID# 233582 |
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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The 168 participants were enrolled and randomized (2:1 ratio) to a 12-month treatment group or a 6-month no-treatment group. Participants who completed the no-treatment group had the option to move to a post-control 6-month treatment group. A total of 112 participants were randomized to the 12-month treatment (JUVÉDERM® VOLUMA® with Lidocaine) group and 56 participants were initially randomized to the no-treatment control group.
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| ID | Title | Description |
|---|---|---|
| FG000 | JUVÉDERM® VOLUMA® With Lidocaine (Treatment Months 1 - 12) | Participants will be treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in temple. Participants are eligible for touch-up treatment. |
| FG001 | Control No-Treatment (Months 1 to 6) to JUVÉDERM® VOLUMA® With Lidocaine Treatment (Months 7 to 12) | No treatment is administered during the Control No-Treatment period (Months 1 to 6). Only those participants that opt to go on to the Control Treatment period will be treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in temple. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Modified Intent-to-Treat (mITT) Population
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| ID | Title | Description |
|---|---|---|
| BG000 | Control No-Treatment (Months 1 to 6) to JUVÉDERM® VOLUMA® With Lidocaine Treatment (Months 7 to 12) | No treatment is administered during the Control No-Treatment period (Months 1 to 6). Only those participants that opt to go on to the Control Treatment period will be treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in temple. |
| 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 | Number of Participants With Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug and no more than 30 days after the last dose of the study drug. | Control Period - Safety Population | Posted | Count of Participants | Participants | Up to 14 Months |
|
All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 6.4, 12.8 and 6.9 months for No Treatment (Control Period), JUVÉDERM® VOLUMA® with Lidocaine (Treatment Period), and JUVÉDERM® VOLUMA® with Lidocaine (Post-Control Treatment Period), respectively.
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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 | Control - No Treatment (Months 1 - 6) | No treatment is administered. Optional treatment at Month 6. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ATRIAL SEPTAL DEFECT | Congenital, familial and genetic disorders | MedDRA 26.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| INJECTION SITE PAIN | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
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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 | Jan 18, 2022 | Nov 11, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 5, 2023 | Nov 11, 2024 | SAP_001.pdf |
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| Change from Baseline to Month 6 |
| Change From Baseline on Rasch Transformed Score of FACE-Q Satisfaction With Facial Appearance Questionnaire at Month 6 | Participant-assessed satisfaction using the 10-item FACE-Q Satisfaction with Facial Appearance Questionnaire was measured on a 4-point scale where 1=very dissatisfied, 2=somewhat dissatisfied, 3=somewhat satisfied, and 4=very satisfied. The responses to the items were converted to a 100-point Rasch transformed score ranging from 0 (worst) to 100 (best). Higher scores indicate higher satisfaction. A positive change from Baseline indicates improvement. | Change from baseline to Month 6 |
| Participants "Improved" or "Much Improved" as Self-assessed by Participant Using the Global Aesthetic Improvement Scale (GAIS) | Participant will assess temple area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and-2=much worse. | Month 6 |
| Participants "Improved" or "Much Improved" as Assessed by the Evaluating Investigator Using the Global Aesthetic Improvement Scale (GAIS) | The Evaluating Investigator will assess the participant's temple area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and-2=much worse. | Month 6 |
| Beijing |
| Beijing Municipality |
| 100730 |
| China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 233602 | Wuhan | Hubei | 430022 | China |
| Nanjing Drum Tower Hospital /ID# 233607 | Nanjing | Jiangsu | 210008 | China |
| Zhongda Hospital Southeast University /ID# 233604 | Nanjing | Jiangsu | 210009 | China |
| Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of Medicine /ID# 233571 | Shanghai | Shanghai Municipality | 200011 | China |
| Shanghai Sixth People's Hospital /ID# 233568 | Shanghai | Shanghai Municipality | 200233 | China |
| Peking University International Hospital /ID# 242166 | Beijing | 102206 | China |
| BG001 |
| JUVÉDERM® VOLUMA® With Lidocaine (Treatment Months 1 - 12) |
Participants will be treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in temple. Participants are eligible for touch-up treatment. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Allergan Temple Hollowing Scale | Temple with worse baseline score will be used to represent the participant. | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | Control No-Treatment (Months 1 to 6) to JUVÉDERM® VOLUMA® With Lidocaine Treatment (Months 7 to 12) | No treatment is administered during the Control No-Treatment period (Months 1 to 6). Only those participants that opt to go on to the Control Treatment period will be treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in temple. |
| OG001 | JUVÉDERM® VOLUMA® With Lidocaine (Treatment Months 1 - 12) | Participants will be treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in temple. Participants are eligible for touch-up treatment. |
|
|
| Primary | Participants With at Least a 1-Point Improvement (Decrease) in Temple as Assessed by the Evaluating Investigator (EI) Using the Allergan Temple Hollowing Scale (ATHS) | The Evaluating Investigator will assess the participant's temple hollowing using the ATHS 5-point scale where: 0=convex, rounded temple to 4=severe, deeply recessed, sunken appearance. A 1-point decrease from Baseline indicates improvement. | Control Period - Observed Primary Endpoint Population N = Participants with analysis values at both baseline and Month 6 Visit. | Posted | Number | participants | Change from Baseline to Month 6 |
|
|
|
|
| Secondary | Change From Baseline on Rasch Transformed Score of FACE-Q Satisfaction With Temples Questionnaire at Month 6 | Participant-assessed satisfaction using the 12-item FACE-Q Satisfaction with Temples Questionnaire was measured on a 4-point scale where 1=very dissatisfied, 2=somewhat dissatisfied, 3=somewhat satisfied, and 4=very satisfied. The responses to the items were converted to a 100-point Rasch transformed score ranging from 0 (worst) to 100 (best). Higher scores indicate higher satisfaction. A positive change from Baseline indicates improvement. | Control Period - Modified Intent-to-Treat Population N = Participants with analysis values at both baseline and the specified analysis visits. | Posted | Mean | Standard Deviation | units on a scale | Change from Baseline to Month 6 |
|
|
|
|
| Secondary | Change From Baseline on Rasch Transformed Score of FACE-Q Satisfaction With Facial Appearance Questionnaire at Month 6 | Participant-assessed satisfaction using the 10-item FACE-Q Satisfaction with Facial Appearance Questionnaire was measured on a 4-point scale where 1=very dissatisfied, 2=somewhat dissatisfied, 3=somewhat satisfied, and 4=very satisfied. The responses to the items were converted to a 100-point Rasch transformed score ranging from 0 (worst) to 100 (best). Higher scores indicate higher satisfaction. A positive change from Baseline indicates improvement. | Control Period - Modified Intent-to-Treat Population Participants with analysis values at both baseline and the specified analysis visits. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to Month 6 |
|
|
|
|
| Secondary | Participants "Improved" or "Much Improved" as Self-assessed by Participant Using the Global Aesthetic Improvement Scale (GAIS) | Participant will assess temple area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and-2=much worse. | Control Period - Modified Intent-to-Treat Population Participants with analysis values at both baseline and the specified visit. | Posted | Count of Participants | Participants | Month 6 |
|
|
|
|
| Secondary | Participants "Improved" or "Much Improved" as Assessed by the Evaluating Investigator Using the Global Aesthetic Improvement Scale (GAIS) | The Evaluating Investigator will assess the participant's temple area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and-2=much worse. | Control Period - Modified Intent-to-Treat Population Participants with analysis values at both baseline and the specified visit. | Posted | Count of Participants | Participants | Month 6 |
|
|
|
|
| 0 |
| 56 |
| 1 |
| 56 |
| 18 |
| 56 |
| EG001 | JUVÉDERM® VOLUMA® With Lidocaine (Months 1 - 12) | Participants will be treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in temple. Participants are eligible for touch-up treatment. | 0 | 112 | 3 | 112 | 62 | 112 |
| EG002 | JUVÉDERM® VOLUMA® With Lidocaine - Post Control (Months 7 - 12) | Participants will be treated with optional JUVÉDERM® VOLUMA® with Lidocaine injectable gel in temple through study exit date. | 0 | 53 | 2 | 53 | 19 | 53 |
| OVARIAN CYST RUPTURED | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
|
| ABORTION INDUCED | Surgical and medical procedures | MedDRA 26.1 | Systematic Assessment |
|
| INJECTION SITE SWELLING | General disorders | MedDRA 26.1 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| OSTEOPOROSIS | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| TRISMUS | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
|
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