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The objectives of this study are to evaluate the safety and effectiveness of Juvederm® Voluma® XC injectable gel in adult participants seeking correction of temple hollowing
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Treatment then JUVÉDERM® VOLUMA® XC | Other | Participants received no treatment for 3 months during the Control Period. They either exited the study at Month 3 or received an optional treatment with JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Post-Control Period and an optional touch-up treatment 30 days later. Participants did not receive any treatment during the Maintenance Treatment Period. |
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| JUVÉDERM® VOLUMA® XC | Experimental | Participants received JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Control Period followed by an optional touch-up treatment 30 days later. Participants exited the study at Month 13 or received an optional maintenance treatment and were followed for 6 months during the Maintenance Treatment Period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JUVÉDERM® VOLUMA® XC | Device | JUVÉDERM® VOLUMA® XC injectable gel |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With ≥ 1-grade Improvement From Baseline in the Validated Allergan Temple Hollowing Scale (ATHS) Based on Evaluating Investigator (EI) Assessment at Month 3 | The Evaluating Investigator assessed the participant's temple hollowing using the 5-point ATHS scale where 0=convex, rounded temple and 4=severe, deeply recessed, sunken appearance. A 1-point decrease from Baseline indicates improvement. | Baseline, Month 3 (Control Period) |
| Number of Participants With Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant whether or not it is related to the investigational product. The investigator assesses the relationship of each event to the use of the investigational product. 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 participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first use of the investigational product. | From the time of informed consent until the participant exited the study, up to 13 months after their initial/touch-up treatment, and up to 6 months after the maintenance treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Score of "Improved " or "Much Improved" on the Global Aesthetic Improvement Scale (GAIS) for the Temple Area as Assessed by the Evaluating Investigator (EI) at Month 3 | The Evaluating Investigator assessed the participant's temple area using the 5-point GAIS where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. | Month 3 (Control Period) |
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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 |
|---|---|---|---|---|---|---|
| Skin Care and Laser Physicians of Beverly Hills /ID# 232967 | Los Angeles | California | 90069 | United States | ||
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Of 205 participants screened, 171 were randomized, with 113 in the treatment group and 58 in the control group. One participant was randomized to the treatment group but not treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | No Treatment Then JUVÉDERM® VOLUMA® XC | Participants received no treatment for 3 months during the Control Period. They either exited the study at Month 3 or received an optional treatment with JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Post-Control Period and an optional touch-up treatment 30 days later. Participants did not receive any treatment during the Maintenance Treatment Period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| 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 | May 10, 2021 | Mar 29, 2024 |
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| No-treatment control | Other | Participants received no treatment for 3 months during the Control Period. |
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| Percentage of Participants With a Score of "Improved" or "Much Improved" on the Global Aesthetic Improvement Scale (GAIS) for the Temple Area as Assessed by the Participants at Month 3 | Participants assessed their temple area using the 5-point GAIS where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. | Month 3 (Control Period) |
| Change From Baseline on FACE-Q Satisfaction With Facial Appearance Questionnaire at Month 3 | The participants responded to each item on the FACE-Q Satisfaction with Facial Appearance questionnaire using a 4-point scale where: 1=Very Dissatisfied, 2=Somewhat Dissatisfied, 3=Somewhat Satisfied, and 4=Very Satisfied. The total score was transformed to a score of 0 (worst) to 100 (best) for comparison. A positive change from Baseline indicates improvement. | Baseline, Month 3 (Control Period) |
| Change From Baseline to Month 3 on Participants Responses on FACE-Q Satisfaction With Temples Questionnaire | The participants responded to each item on the FACE-Q Satisfaction with Temples questionnaire using a 4-point scale where: 1=Very Dissatisfied, 2=Somewhat Dissatisfied, 3=Somewhat Satisfied, 4=Very Satisfied. The total score was transformed to a score of 0 (worst) to 100 (best) for comparison. A positive change from Baseline indicates improvement. | Baseline, Month 3 (Control Period) |
| Steve Yoelin MD Medical Associate Inc /ID# 232956 |
| Newport Beach |
| California |
| 92663 |
| United States |
| Steven Fagien MD PA /ID# 232807 | Boca Raton | Florida | 33431 | United States |
| Bradenton Dermatologist /ID# 232822 | Bradenton | Florida | 34209 | United States |
| Hevia Cosmetic Dermatology /ID# 232824 | Coral Gables | Florida | 33134 | United States |
| Skin and Cancer Associates, LLP /ID# 232923 | Miami | Florida | 33137-3254 | United States |
| Research Institute of the Southeast, LLC /ID# 233144 | West Palm Beach | Florida | 33401-2712 | United States |
| Delricht Research /ID# 233142 | New Orleans | Louisiana | 70115 | United States |
| Callender Center for Clinical Research /ID# 233167 | Glenn Dale | Maryland | 20769-9182 | United States |
| Skincare Physicians /ID# 233054 | Chestnut Hill | Massachusetts | 02467 | United States |
| Williams Plastic Surgery Specialists /ID# 232789 | Latham | New York | 12110 | United States |
| Aesthetic Solutions /ID# 232953 | Chapel Hill | North Carolina | 27517-9901 | United States |
| The Practice of Brian S. Biesman MD PLLC /ID# 232662 | Nashville | Tennessee | 37203 | United States |
| Dallas Plastic Surgery Institute /ID# 232971 | Dallas | Texas | 75231 | United States |
| Jose Raul Montes Eyes & Facial Rejuvenation-Torre Medica Aux /ID# 232706 | San Juan | 00917 | Puerto Rico |
| FG001 | JUVÉDERM® VOLUMA® XC | Participants received JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Control Period followed by an optional touch-up treatment 30 days later. Participants exited the study at Month 13 or received an optional maintenance treatment and were followed for 6 months during the Maintenance Treatment Period. |
| COMPLETED |
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| NOT COMPLETED |
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| Post-Control Period |
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| Maintenance Treatment Period |
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Modified Intent to Treat Population(mITT): all participants who were randomized and had non-missing Baseline Allergan Temple Hollowing Scale (ATHS) scores. Participants were summarized according to the randomized study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | No Treatment Then JUVÉDERM® VOLUMA® XC | Participants received no treatment for 3 months during the Control Period. They either exited the study at Month 3 or received an optional treatment with JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Post-Control Period and an optional touch-up treatment 30 days later. Participants did not receive any treatment during the Maintenance Treatment Period. |
| BG001 | JUVÉDERM® VOLUMA® XC | Participants received JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Control Period followed by an optional touch-up treatment 30 days later. Participants exited the study at Month 13 or received an optional maintenance treatment and were followed for 6 months during the Maintenance Treatment Period. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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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 | Percentage of Participants With ≥ 1-grade Improvement From Baseline in the Validated Allergan Temple Hollowing Scale (ATHS) Based on Evaluating Investigator (EI) Assessment at Month 3 | The Evaluating Investigator assessed the participant's temple hollowing using the 5-point ATHS scale where 0=convex, rounded temple and 4=severe, deeply recessed, sunken appearance. A 1-point decrease from Baseline indicates improvement. | Modified Intent to Treat Population(mITT): all participants who were randomized and had non-missing Baseline Allergan Temple Hollowing Scale (ATHS) scores. Participants were summarized according to the randomized study intervention. Multiple imputation was used for missing data. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Month 3 (Control Period) |
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| Primary | Number of Participants With Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant whether or not it is related to the investigational product. The investigator assesses the relationship of each event to the use of the investigational product. 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 participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first use of the investigational product. | Safety population: all participants who were randomized and received study intervention (JUVÉDERM® VOLUMA® XC or no-treatment control), analyzed by treatment received | Posted | Count of Participants | Participants | No | From the time of informed consent until the participant exited the study, up to 13 months after their initial/touch-up treatment, and up to 6 months after the maintenance treatment |
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| Secondary | Percentage of Participants With a Score of "Improved " or "Much Improved" on the Global Aesthetic Improvement Scale (GAIS) for the Temple Area as Assessed by the Evaluating Investigator (EI) at Month 3 | The Evaluating Investigator assessed the participant's temple area using the 5-point GAIS where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. | Modified Intent to Treat Population(mITT): all participants who were randomized and had non-missing Baseline Allergan Temple Hollowing Scale (ATHS) scores. Participants were summarized according to the randomized study intervention. Participants with analysis values at Month 3 are presented. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 3 (Control Period) |
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| Secondary | Percentage of Participants With a Score of "Improved" or "Much Improved" on the Global Aesthetic Improvement Scale (GAIS) for the Temple Area as Assessed by the Participants at Month 3 | Participants assessed their temple area using the 5-point GAIS where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. | Modified Intent to Treat Population(mITT): all participants who were randomized and had non-missing Baseline Allergan Temple Hollowing Scale (ATHS) scores. Participants were summarized according to the randomized study intervention. Participants with analysis values at Month 3 are presented. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 3 (Control Period) |
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| Secondary | Change From Baseline on FACE-Q Satisfaction With Facial Appearance Questionnaire at Month 3 | The participants responded to each item on the FACE-Q Satisfaction with Facial Appearance questionnaire using a 4-point scale where: 1=Very Dissatisfied, 2=Somewhat Dissatisfied, 3=Somewhat Satisfied, and 4=Very Satisfied. The total score was transformed to a score of 0 (worst) to 100 (best) for comparison. A positive change from Baseline indicates improvement. | Modified Intent to Treat Population(mITT): all participants who were randomized and had non-missing Baseline Allergan Temple Hollowing Scale (ATHS) scores. Participants were summarized according to the randomized study intervention. Overall number of participants analyzed were the participants with analysis values at both Baseline and Month 3. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 3 (Control Period) |
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| Secondary | Change From Baseline to Month 3 on Participants Responses on FACE-Q Satisfaction With Temples Questionnaire | The participants responded to each item on the FACE-Q Satisfaction with Temples questionnaire using a 4-point scale where: 1=Very Dissatisfied, 2=Somewhat Dissatisfied, 3=Somewhat Satisfied, 4=Very Satisfied. The total score was transformed to a score of 0 (worst) to 100 (best) for comparison. A positive change from Baseline indicates improvement. | Modified Intent to Treat Population(mITT): all participants who were randomized and had non-missing Baseline Allergan Temple Hollowing Scale (ATHS) scores. Participants were summarized according to the randomized study intervention. Overall number of participants analyzed were the participants with analysis values at both Baseline and Month 3. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 3 (Control Period) |
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No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6
Safety population: all participants who were randomized and received study intervention, analyzed by treatment received
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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 | No Treatment (Control Period) | Participants who received no treatment during the first 3 months of the Control Period. | 0 | 59 | 2 | 59 | 0 | 59 |
| EG001 | JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period) | Participants received JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Control Period followed by an optional touch-up treatment 30 days later. They were followed up to Month 13. | 0 | 112 | 5 | 112 | 19 | 112 |
| EG002 | JUVÉDERM® VOLUMA® XC (Post-Control Period) | Participants randomized to no treatment during the first 3 months of the Control Period who then received an optional treatment with JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Post-Control Period and an optional touch-up treatment 30 days later. They were followed up to Month 13. | 0 | 53 | 2 | 53 | 16 | 53 |
| EG003 | JUVÉDERM® VOLUMA® XC (Maintenance Period) | Participants randomized to JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Control Period who then received an optional maintenance treatment and were followed for 6 months during the Maintenance Treatment Period. | 0 | 40 | 4 | 40 | 5 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LOCALISED INFECTION | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| LYME DISEASE | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| SINUSITIS | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| STAPHYLOCOCCAL SKIN INFECTION | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| TOOTH INFECTION | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| RADIUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
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| INTERVERTEBRAL DISC DEGENERATION | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| LUMBAR SPINAL STENOSIS | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| SYSTEMIC LUPUS ERYTHEMATOSUS | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| LUNG ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
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| ENDOMETRIAL HYPERPLASIA | Reproductive system and breast disorders | MedDRA 25.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| PAIN IN JAW | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| TRISMUS | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
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AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 22, 2021 | Mar 29, 2024 | SAP_001.pdf |
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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Participants received JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Control Period followed by an optional touch-up treatment 30 days later. They were followed up to Month 13. |
| OG002 | JUVÉDERM® VOLUMA® XC (Post-Control Period) | Participants received an optional treatment with JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Post-Control Period and an optional touch-up treatment 30 days later. They were followed up to Month 13. |
| OG003 | JUVÉDERM® VOLUMA® XC (Maintenance Period) | Participants received an optional maintenance treatment and were followed for 6 months during the Maintenance Treatment Period. |
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