Mid Face Volume Deficit
Conditions
Keywords
Mid Face Volume Deficit, JUVÉDERM VOLUX XC, JUVÉDERM VOLUMA XC, JUVÉDERM VOLLURE XC, JUVÉDERM VOLBELLA XC, SKINVIVE by JUVÉDERM, JUVÉDERM ULTRA XC, JUVÉDERM ULTRA PLUS XC
Brief summary
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.
Interventions
DEVICEJUVÉDERM VOLUX XC
Injections
DEVICEJUVÉDERM VOLUMA XC
Injections
DEVICEJUVÉDERM VOLBELLA XC
Injections
DEVICEJUVÉDERM VOLLURE XC
Injections
DEVICESKINVIVE by JUVÉDERM
Injections
DEVICEJUVÉDERM ULTRA XC
Injections
DEVICEJUVÉDERM ULTRA PLUS XC
Injections
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 65 Years
Healthy volunteers
No
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: * Minimal, moderate, or severe on Allergan Temple Hollowing Scale (ATHS) * Moderate or severe for both eyes on Allergan Infraorbital Hollow Scale (AIHS) * Moderate or severe on Allergan Cheek Smoothness Scale (ACSS) * Moderate, significant, or severe on Mid-face Volume Deficit Scale (MFVDS) * Moderate or severe on Nasolabial Fold Severity Scale (NLFSS) * Minimal, mild, or moderate on Allergan Lip Fullness Scale 2 (ALFS2) * Moderate or severe on Allergan Chin Retrusion Scale (ACRS) * Moderate or severe on Allergan Loss of Jawline Definition Scale (ALJDS) * Must be in good health as determined by subject's medical history, physical examination, and vital sign measurements.
Exclusion criteria
* Prior treatment with non-permanent soft tissue fillers or fat-reducing injectables in the face or neck within 12 months prior to screening. * Excessively loose skin in the face and/or neck. * Tendency to develop hypertrophic scarring and/or keloid scarring.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q™ Satisfaction with Facial Appearance Scale | Month 3 | 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. |
| Number of Participants with Adverse Events (AEs) | Up to approximately Month 6 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Month 3 | 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. |
| Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q Psychological Function Scale | Month 3 | The FACE-Q Psychological Function is a validated questionnaire that asks participants to report their level of satisfaction with psychological function. |
| Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q Social Function Scale | Month 3 | The FACE-Q Social Function Scale is a validated questionnaire that asks participants to report their level of satisfaction with social function. |
| Change from Baseline in the Participant's Rasch-Transformed Score of the SKIN-Q Feels Scale | Month 3 | 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. |
| Change from Baseline in the Participant's Rasch-Transformed Score of the SKIN-Q Looks Scale | Month 3 | 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. |
| Percentage of Participants Achieving "Responder" Status Based on Participant Responses on the Natural Look Satisfaction Scale (NLSS) Assessment | Month 3 | The NLSS is an 8-item scale that measures satisfaction with various attributes that are associated with natural looking results following aesthetic treatment. |
Countries
United States
Contacts
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed