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The objective of this study is to evaluate the safety and effectiveness of JUVÉDERM® VOLBELLA™ XC in adult participants seeking correction of hollowing of the tear troughs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JUVÉDERM VOLBELLA® XC | Experimental | JUVÉDERM® VOLBELLA™ XC injectable gel was injected into the infraorbital and adjacent area at Randomization as determined by the investigator. Participants were eligible to receive an optional touch-up treatment 1 month later and an optional repeat treatment 12 months after last treatment, if applicable. A maximum of 2.2 milliliter (mL) per side was injected for initial and touch-up treatments combined. |
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| No-treatment Control | No Intervention | Participants randomized to the No-treatment Control group completed a 3-month No-treatment Period. Participants were then eligible to receive optional treatment with JUVÉDERM® VOLBELLA™ XC injectable gel injected into the infraorbital and adjacent area followed by an optional touch-up treatment 1 month later. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JUVÉDERM VOLBELLA® XC injectable gel | Device | JUVÉDERM® VOLBELLA™ XC dermal filler injected into the infraorbital and adjacent area. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least a 1-point Improvement Change From Baseline on the Allergan Infraorbital Hollows Scale (AIHS) Based on Evaluating Investigator's (EI) Assessment | The evaluating investigator assessed hollowing in both infraorbital areas using the 5-point photonumeric AIHS where: 0=none (no visible hollowing or volume loss medially or laterally), 1=minimal (presence of hollowing with some volume loss medial to the mid-pupillary line; smooth lateral lid-cheek transition), 2=moderate (defined hollowing extending laterally beyond the mid-pupillary line with moderate volume loss; smooth lateral lid-cheek transition with mild volume loss), 3=severe (defined hollowing extending laterally beyond the mid-pupillary line with moderate volume loss creating a defined groove along the lid-cheek junction), 4=extreme (defined hollowing extends from medial to lateral canthus; severe volume loss creates a marked step along the lid-cheek junction). The percentage of participants with at least a 1-point improvement change (decrease) in the AIHS is reported. | Baseline (Screening) to Month 3 post last treatment (JUVÉDERM® VOLBELLA™ XC arm) or Month 3 post randomization (No-treatment Control arm) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Improved or Much Improved in the Overall Aesthetic Assessment Based on EI's Assessment of the Global Aesthetic Improvement Scale (GAIS) at Month 3 After the Last Treatment | The evaluating investigator assessed a participant's global aesthetic improvement in the infraorbital area compared to Baseline using the 5-point GAIS where: 2=much improved (marked improvement in appearance), 1=improved (improvement in appearance, but a touch-up or retreatment is indicated), 0=no change (appearance is essentially the same as the original condition), -1=worse (appearance is worse than the original condition), -2=much worse (appearance is much worse than the original condition). The percentage of participants where the EI selected improved or much improved is reported. |
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INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Steve Abrams | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christopher I. Zoumalan MD Inc. | Beverly Hills | California | 90212 | United States | ||
| Steve Yoelin MD Medical Associate, Inc. |
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| Label | URL |
|---|---|
| Additional information on study locations near you may be found at AllerganClinicalTrials.com. | View source |
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A total of 163 participants were enrolled in the study (signed the informed consent) out of which 140 were randomized to receive JUVÉDERM® VOLBELLA™ XC (treatment group) or no treatment (control group) in 3:1 ratio.
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| ID | Title | Description |
|---|---|---|
| FG000 | No-treatment Control | Participants randomized to the No-treatment Control group completed a 3-month No-treatment Period (Control Period). Participants were then eligible to receive optional treatment with JUVÉDERM® VOLBELLA™ XC injectable gel injected into the infraorbital and adjacent area followed by an optional touch-up treatment 1 month later. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Oct 10, 2017 | Oct 15, 2021 |
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| Baseline (Randomization) to Month 3 post last treatment (JUVÉDERM® VOLBELLA™ XC) or Month 3 post randomization (No-treatment Control arm) |
| Percentage of Participants Improved or Much Improved in the Overall Aesthetic Assessment Based on Participant's Assessment of the GAIS at Month 3 After the Last Treatment | The participant assessed their global aesthetic improvement in the infraorbital area compared to Baseline using the 5-point GAIS where: 2=much improved (marked improvement in appearance), 1=improved (improvement in appearance, but a touch-up or retreatment is indicated), 0=no change (appearance is essentially the same as the original condition), -1=worse (appearance is worse than the original condition), -2=much worse (appearance is much worse than the original condition). The percentage of participants who selected improved or much improved is reported. | Baseline (Randomization) to Month 3 post last treatment |
| Mean Change From Baseline in Rasch-Transformed Score Based on Participant Responses on the FACE-Q™ Appraisal of Lower Eyelids Questionnaire to Month 3 After the Last Treatment | Participants assessed their overall satisfaction by using 7 questions on the validated Appraisal of Lower Eyelids module of the FACE-Q™ questionnaire. Each question was answered on a 4-point scale where: 1=not at all, 2=a little, 3=moderately, and 4=extremely bothered. The responses to the items were transformed to create a Rasch transformed score that ranges from 0=worst to 100=best. Higher scores indicate higher satisfaction. A positive change from Baseline indicates improvement. | Baseline (Randomization) to Month 3 post last treatment |
| Newport Beach |
| California |
| 92663 |
| United States |
| Cosmetic Laser Dermatology | San Diego | California | 92121 | United States |
| Facesplus, Inc. | San Diego | California | 92121 | United States |
| Art of Skin MD | Solana Beach | California | 92128 | United States |
| Steven Fagien M.D.F.A.C.S. | Boca Raton | Florida | 33431 | United States |
| Center For Sight | Sarasota | Florida | 34239 | United States |
| Lupo Center for Aesthetic and General Dermatology | New Orleans | Louisiana | 70124 | United States |
| Image Dermatology, P.C. | Montclair | New Jersey | 07042 | United States |
| Williams Plastic Surgery Specialists | Latham | New York | 12110 | United States |
| Aesthetic Solutions, PA. | Chapel Hill | North Carolina | 27517 | United States |
| Duke Aesthetic Center | Durham | North Carolina | 27708 | United States |
| Brian Biesman, MD | Nashville | Tennessee | 37203 | United States |
| Precision Dermatology | Bellaire | Texas | 77401 | United States |
| The Center for Skin Research | Houston | Texas | 77056 | United States |
| FG001 |
| JUVÉDERM® VOLBELLA™ XC |
JUVÉDERM® VOLBELLA™ XC injectable gel was injected into the infraorbital and adjacent area at Randomization as determined by the investigator. Participants were eligible to receive an optional touch-up treatment 1 month later and an optional repeat treatment 12 months after last treatment, if applicable. A maximum of 2.2 mL per side was injected for initial and touch-up treatments combined. |
| Safety Population | Safety Population included participants who were randomized to study treatment (JUVÉDERM® VOLBELLA™ XC treatment group) and received at least 1 study device treatment and participants who were randomized to the control group. |
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| Received Optional or Repeat Treatment | Participants randomized to the No-treatment Control group who received optional treatment with JUVÉDERM® VOLBELLA™ XC injectable gel after Month 3 and participants randomized to the JUVÉDERM® VOLBELLA™ XC arm who received repeat treatment with JUVÉDERM® VOLBELLA™ XC injectable gel 12 months after the initial treatment. |
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| COMPLETED |
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| NOT COMPLETED |
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Modified Intent-to-treat (mITT) Population included participants who were randomized to study treatment (JUVÉDERM® VOLBELLA™ XC treatment group), received at least 1 study device treatment and had a Baseline and at least 1 posttreatment assessment of the primary effectiveness variable and participants who were randomized to the control group and had a Baseline and at least 1 follow-up assessment of the primary effectiveness variable.
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| ID | Title | Description |
|---|---|---|
| BG000 | No-treatment Control | Participants randomized to the No-treatment Control group completed a 3-month No-treatment Period (Control Period). Participants were then eligible to receive optional treatment with JUVÉDERM® VOLBELLA™ XC injectable gel injected into the infraorbital and adjacent area followed by an optional touch-up treatment 1 month later. |
| BG001 | JUVÉDERM® VOLBELLA™ XC | JUVÉDERM® VOLBELLA™ XC injectable gel was injected into the infraorbital and adjacent area at Randomization as determined by the investigator. Participants were eligible to receive an optional touch-up treatment 1 month later and an optional repeat treatment 12 months after last treatment, if applicable. A maximum of 2.2 mL per side was injected for initial and touch-up treatments combined. |
| 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 |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants With at Least a 1-point Improvement Change From Baseline on the Allergan Infraorbital Hollows Scale (AIHS) Based on Evaluating Investigator's (EI) Assessment | The evaluating investigator assessed hollowing in both infraorbital areas using the 5-point photonumeric AIHS where: 0=none (no visible hollowing or volume loss medially or laterally), 1=minimal (presence of hollowing with some volume loss medial to the mid-pupillary line; smooth lateral lid-cheek transition), 2=moderate (defined hollowing extending laterally beyond the mid-pupillary line with moderate volume loss; smooth lateral lid-cheek transition with mild volume loss), 3=severe (defined hollowing extending laterally beyond the mid-pupillary line with moderate volume loss creating a defined groove along the lid-cheek junction), 4=extreme (defined hollowing extends from medial to lateral canthus; severe volume loss creates a marked step along the lid-cheek junction). The percentage of participants with at least a 1-point improvement change (decrease) in the AIHS is reported. | Modified Intent-to-treat (mITT) Population included participants who were randomized to study treatment (JUVÉDERM® VOLBELLA™ XC treatment group), received at least 1 study device treatment and had a Baseline and at least 1 posttreatment assessment of the primary effectiveness variable and participants who were randomized to the control group and had a Baseline and at least 1 follow-up assessment of the primary effectiveness variable. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline (Screening) to Month 3 post last treatment (JUVÉDERM® VOLBELLA™ XC arm) or Month 3 post randomization (No-treatment Control arm) |
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| Secondary | Percentage of Participants Improved or Much Improved in the Overall Aesthetic Assessment Based on EI's Assessment of the Global Aesthetic Improvement Scale (GAIS) at Month 3 After the Last Treatment | The evaluating investigator assessed a participant's global aesthetic improvement in the infraorbital area compared to Baseline using the 5-point GAIS where: 2=much improved (marked improvement in appearance), 1=improved (improvement in appearance, but a touch-up or retreatment is indicated), 0=no change (appearance is essentially the same as the original condition), -1=worse (appearance is worse than the original condition), -2=much worse (appearance is much worse than the original condition). The percentage of participants where the EI selected improved or much improved is reported. | mITT Population included participants who were randomized to study treatment (JUVÉDERM® VOLBELLA™ XC treatment group), received at least 1 study device treatment and had a Baseline and at least 1 posttreatment assessment of the primary effectiveness variable and participants who were randomized to the control group and had a Baseline and at least 1 follow-up assessment of the primary effectiveness variable. Overall number analyzed are the participants with data available for analyses. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline (Randomization) to Month 3 post last treatment (JUVÉDERM® VOLBELLA™ XC) or Month 3 post randomization (No-treatment Control arm) |
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| Secondary | Percentage of Participants Improved or Much Improved in the Overall Aesthetic Assessment Based on Participant's Assessment of the GAIS at Month 3 After the Last Treatment | The participant assessed their global aesthetic improvement in the infraorbital area compared to Baseline using the 5-point GAIS where: 2=much improved (marked improvement in appearance), 1=improved (improvement in appearance, but a touch-up or retreatment is indicated), 0=no change (appearance is essentially the same as the original condition), -1=worse (appearance is worse than the original condition), -2=much worse (appearance is much worse than the original condition). The percentage of participants who selected improved or much improved is reported. | VOLBELLA™ Initially Treated (VIT) Population included participants who were randomized and received VOLBELLA™ treatment at the beginning of the Control Period. Overall number analyzed are the participants with data available for analyses. The GAIS assessed by the participant was only completed by participants in the JUVÉDERM® VOLBELLA™ XC arm. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline (Randomization) to Month 3 post last treatment |
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| Secondary | Mean Change From Baseline in Rasch-Transformed Score Based on Participant Responses on the FACE-Q™ Appraisal of Lower Eyelids Questionnaire to Month 3 After the Last Treatment | Participants assessed their overall satisfaction by using 7 questions on the validated Appraisal of Lower Eyelids module of the FACE-Q™ questionnaire. Each question was answered on a 4-point scale where: 1=not at all, 2=a little, 3=moderately, and 4=extremely bothered. The responses to the items were transformed to create a Rasch transformed score that ranges from 0=worst to 100=best. Higher scores indicate higher satisfaction. A positive change from Baseline indicates improvement. | VIT Population included participants who were randomized and received VOLBELLA™ treatment at the beginning of the Control Period. Overall number analyzed are the participants with data available for analyses at Baseline. Number analyzed is the number of participants with data available for analyses at a given time point. The FACE-Q™ was only completed by participants in the JUVÉDERM® VOLBELLA™ XC arm. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Randomization) to Month 3 post last treatment |
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From Randomization to the end of the study (JUVÉDERM® VOLBELLA™ XC: Up to 14 months; No-treatment Control: Up to 13 months)
All-Cause Mortality: All randomized participants. Serious Adverse Events and Other Adverse Events: Safety Population included participants who were randomized to study treatment (JUVÉDERM® VOLBELLA™ XC treatment group) and received at least 1 study device treatment and participants who were randomized to the control group. The data for adverse events is added as per treatment received by the participants.
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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 | Participants randomized to the No-treatment Control group completed a 3-month No-treatment Period (Control Period). Participants were then eligible to receive optional treatment with JUVÉDERM® VOLBELLA™ XC injectable gel injected into the infraorbital and adjacent area followed by an optional touch-up treatment 1 month later. | 0 | 35 | 0 | 34 | 0 | 34 |
| EG001 | JUVÉDERM® VOLBELLA™ Initial Treatment | JUVÉDERM® VOLBELLA™ XC injectable gel was injected into the infraorbital and adjacent area at Randomization as determined by the investigator. | 0 | 105 | 1 | 105 | 0 | 105 |
| EG002 | JUVÉDERM® VOLBELLA™ Optional Treatment | Participants randomized to the No-treatment Control group received optional treatment with JUVÉDERM® VOLBELLA™ XC injectable gel, injected into the infraorbital and adjacent area Month 3 after Randomization as determined by the investigator. | 0 | 29 | 0 | 29 | 3 | 29 |
| EG003 | JUVÉDERM® VOLBELLA™ Repeat Treatment | Participants randomized to the JUVÉDERM® VOLBELLA™ XC arm received JUVÉDERM® VOLBELLA™ XC injectable gel injected into the infraorbital and adjacent area 12 months after the last treatment as determined by the investigator. | 0 | 37 | 1 | 37 | 0 | 37 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mastitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
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| Tooth Fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site bruising | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA 22.0 | 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 | Dec 16, 2019 | Oct 15, 2021 | 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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| OG001 | JUVÉDERM® VOLBELLA™ XC | JUVÉDERM® VOLBELLA™ XC injectable gel was injected into the infraorbital and adjacent area at Randomization as determined by the investigator. Participants were eligible to receive an optional touch-up treatment 1 month later and an optional repeat treatment 12 months after last treatment, if applicable. A maximum of 2.2 mL per side was injected for initial and touch-up treatments combined. |
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