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The purpose of this study is to evaluate the safety and effectiveness of JUVÉDERM products in adults seeking improvement in facial volume and/or skin quality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-Label JUVÉDERM | Experimental | Participants will receive at least 2 JUVÉDERM products for at least 3 indications (specific products and indications will be at the discretion of the investigator and per participant eligibility criteria) at Treatment Visit 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JUVÉDERM VOLUX XC | Device | Injections |
| |
| JUVÉDERM VOLUMA XC |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q™ Satisfaction with Facial Appearance Scale | The FACE-Q Satisfaction with Facial Appearance is a validated questionnaire that asks participants to report their level of satisfaction with the appearance of their face. | Month 3 |
| Number of Participants with Adverse Events (AEs) | An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. | Up to approximately Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving "Responder" Status of Global Aesthetic Improvement on Facial Appearance Based on the Principal Investigator's Assessment Using the Global Aesthetic Improvement Scale (GAIS) | The GAIS uses a 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. A responder is defined as "improved" or "much improved" in the overall aesthetics assessment in the periorbital area. |
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Inclusion Criteria:
Must meet at least 3 of the following criteria for treatment in the face with at least 2 JUVÉDERM products, per investigator's assessment:
Must be in good health as determined by subject's medical history, physical examination, and vital sign measurements.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kian Aesthetic Institute /ID# 277045 | Los Angeles | California | 90025 | United States | ||
| West Dermatology La Jolla /ID# 277034 |
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/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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| Device |
Injections |
|
| JUVÉDERM VOLBELLA XC | Device | Injections |
|
| JUVÉDERM VOLLURE XC | Device | Injections |
|
| SKINVIVE by JUVÉDERM | Device | Injections |
|
| JUVÉDERM ULTRA XC | Device | Injections |
|
| JUVÉDERM ULTRA PLUS XC | Device | Injections |
|
| Month 3 |
| Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q Psychological Function Scale | The FACE-Q Psychological Function is a validated questionnaire that asks participants to report their level of satisfaction with psychological function. | Month 3 |
| Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q Social Function Scale | The FACE-Q Social Function Scale is a validated questionnaire that asks participants to report their level of satisfaction with social function. | Month 3 |
| Change from Baseline in the Participant's Rasch-Transformed Score of the SKIN-Q Feels Scale | The SKIN-Q Scale is a validated questionnaire that asks participants to report their level of satisfaction with skin quality related to how the skin feels. | Month 3 |
| Change from Baseline in the Participant's Rasch-Transformed Score of the SKIN-Q Looks Scale | The SKIN-Q Scale is a validated questionnaire that asks participants to report their level of satisfaction with skin quality related to how the skin looks. | Month 3 |
| Percentage of Participants Achieving "Responder" Status Based on Participant Responses on the Natural Look Satisfaction Scale (NLSS) Assessment | The NLSS is an 8-item scale that measures satisfaction with various attributes that are associated with natural looking results following aesthetic treatment. | Month 3 |
| San Diego |
| California |
| 92121 |
| United States |
| Pacific Clinical Innovations /ID# 277026 | Vista | California | 92083 | United States |
| Skin Research Institute LLC /ID# 277038 | Coral Gables | Florida | 33146-1837 | United States |
| Monarch Plastic Surgery and Skin Renewal Center /ID# 278182 | Atlanta | Georgia | 30328 | United States |
| Advanced Dermatology - Lincolnshire /ID# 277036 | Lincolnshire | Illinois | 60069 | United States |
| H&H Research, LLC /ID# 277084 | Metairie | Louisiana | 70001 | United States |
| DelRicht Research - New Orleans 308 /ID# 277039 | New Orleans | Louisiana | 70115 | United States |
| Bellaire Dermatology Associates /ID# 278180 | Bellaire | Texas | 77401 | United States |
| SkinDC /ID# 277062 | Arlington | Virginia | 22209 | United States |