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Business decision to stop the program.
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This study will evaluate the safety and effectiveness of JUVÉDERM VOLUMA XC injectable gel in adult participants seeking correction of temple hollowing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VOLUMA® XC Treatment | Experimental | Participants will be treated with JUVÉDERM® VOLUMA® XC injectable gel in both temples (area above the eye). Participants are eligible for touch-up treatment 30 days later. |
|
| Control_No Treatment | No Intervention | No treatment is administered. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Juvéderm® VOLUMA XC | Device | Juvéderm® VOLUMA XC hyaluronic acid injectable gel |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least a 1-Point Improvement (Decrease) in Both Temples as Assessed by the Evaluating Investigator 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 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of 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. The percentage of participants who the Evaluating Investigator assesses as 2=much improved or 1=improved will be reported. |
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Inclusion Criteria:
-Has temple hollowing and is seeking restoration in the temple area.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nikki Amaratunge | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skin Care and Laser Physicians of Beverly Hills | Los Angeles | California | 90069 | United States |
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| Label | URL |
|---|---|
| More Information | View source |
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Up to 189 subjects were planned; 1 subject was enrolled but did not receive treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | VOLUMA® XC Treatment | Participants will be treated with JUVÉDERM® VOLUMA® XC injectable gel in both temples (area above the eye). Participants are eligible for touch-up treatment 30 days later. |
| FG001 | Control_No Treatment | No treatment is administered. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Up to 189 subjects were planned; 1 subject was enrolled in the control_No Treatment arm. Due to confidentiality considerations, baseline data is not being provided to protect participant privacy.
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| ID | Title | Description |
|---|---|---|
| BG000 | VOLUMA® XC Treatment | Participants will be treated with JUVÉDERM® VOLUMA® XC injectable gel in both temples (area above the eye). Participants are eligible for touch-up treatment 30 days later. |
| BG001 | Control_No Treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| 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 at Least a 1-Point Improvement (Decrease) in Both Temples as Assessed by the Evaluating Investigator 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. | Up to 189 subjects were planned; 1 subject was enrolled in the control_No Treatment arm. Terminated study; no treatment was administered and no analyses were conducted. | Posted | Change from Baseline to Month 3 |
|
3 months
Up to 189 subjects were planned; 1 subject was enrolled in the control_No Treatment arm
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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 | VOLUMA® XC Treatment | Participants will be treated with JUVÉDERM® VOLUMA® XC injectable gel in both temples (area above the eye). Participants are eligible for touch-up treatment 30 days later. |
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Due to low patient enrollment, the target number of participants needed to achieve target power and statistically reliable results was not met.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Allergan Sales LLC | 877-277-8566 | IR-CTRegistration@allergan.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 24, 2017 | Jul 17, 2018 | Prot_SAP_000.pdf |
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| Month 3 |
| Percentage of Participants "Improved" or "Much Improved" as Assessed by the Participant Using the GAIS | The participant will assess their temple area 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 will be reported. | Month 3 |
No treatment is administered.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | participants |
|
| Ethnicity (NIH/OMB) | Participants |
|
| Race (NIH/OMB) | Participants |
|
| OG001 | Control_No Treatment | No treatment is administered. |
|
| Secondary | Percentage of 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. The percentage of participants who the Evaluating Investigator assesses as 2=much improved or 1=improved will be reported. | Up to 189 subjects were planned; 1 subject was enrolled in the control_No Treatment arm. Terminated study; no treatment was administered and no analyses were conducted. | Posted | Month 3 |
|
|
| Secondary | Percentage of Participants "Improved" or "Much Improved" as Assessed by the Participant Using the GAIS | The participant will assess their temple area 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 will be reported. | Up to 189 subjects were planned; 1 subject was enrolled in the control_No Treatment arm. Terminated study; no treatment was administered and no analyses were conducted. | Posted | Month 3 |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Control_No Treatment | No treatment is administered. | 0 | 1 | 0 | 1 | 0 | 1 |
The TI is responsible for compliance with the protocol at the investigational site. A representative of Allergan will make frequent contact with the TI and his/her research staff and will conduct regular monitoring visits at the site to review subject and device accountability records for compliance with the protocol