Aging
Conditions
Keywords
voluma temporal, facial, volume loss
Brief summary
This study is to determine the efficacy and safety of JUVÉDERM VOLUMA™ XC when used in the facial temporal regions based on the change in the score of the investigator's Temporal. This study will be an open label, single center study.
Detailed description
Volume deficit in the temporal area (the side of the forehead) of the face is a common sign of aging. JUVÉDERM VOLUMA™ XC is a dermal filler, which was FDA-approved in October 2013 for the improvement and correction of age-related volume deficit in the mid-face area. JUVÉDERM VOLUMA™ XC is a gel implant composed of 20 mg/mL hyaluronic acid (HA) formulation, produced by Streptococcus equi bacteria, and 0.3 w/w lidocaine. JUVÉDERM VOLUMA™ XC is a clear, sterile, and biodegradable gel indicated for subcutaneous and/or supraperiosteal injection. JUVÉDERM VOLUMA™ XCwill be injected in the temple area and subjects will be followed for 12 months.
Interventions
DEVICEJUVÉDERM VOLUMA™ XC
Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, month 6, month 9, and month 12.
Sponsors
Baumann Cosmetic and Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open Label
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Willing and able to read and sign the informed consent and other study documents. * Treating investigator's score of 3, 4, or 5 on the Temporal Fossa Rating Scale. * Written informed consent has been obtained prior to any study-related procedures. * Written Authorization for Use and Release of Health and Research Study Information has been signed. * Ability to follow study instructions and complete study assessment tools including the subject diary * Female patients of childbearing potential must have a negative urine pregnancy test result and not be lactating. * Likely to complete all required visits with no plans to move from Miami in the next 12 months * Agree to not undergo other treatments or cosmetic procedures in the treatment area during the study such as facial laser treatments, botulinum toxin, hyaluronic acid injections, subcutaneous fat injections, any other permanent or semi-permanent facial fillers.
Exclusion criteria
* Any uncontrolled systemic disease * History of any of the following conditions: vision loss not corrected by lenses or LASIX surgery; glaucoma, retinal detachment, macular degeneration, history of multiple sclerosis or optic neuritis, or any uncontrolled eye disease. * Have a history of severe allergic/anaphylactic reactions or multiple allergies. * Conditions within the treatment area including acne, scarring, acute lupus erythematosus, dermatitis, or melasma. * Females planning to become pregnant, are pregnant, or are breast-feeding. * History or current evidence of drug or alcohol abuse within 12 months prior to the screening visit * Have severe thin skin, in the treatment area as determined by the PI. * Have undergone temporary facial dermal filler injections with hyaluronic acid-based fillers within 12 months in the treatment area. Have had neuromodulator injections, mesotherapy, or resurfacing (laser or other ablative or non-ablative procedures) within 5 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study. * Have undergone facial plastic surgery (with the exception of rhinoplasty or a brow lift), tissue grafting, or tissue augmentation with silicone, fat, or other permanent or semi-permanent dermal fillers or be planning to undergo any of these procedures affecting the treatment area, at any time during the study. * Unwilling to undergo injections in the temple area. * Have a history of migraines or frequent headaches, as determined by the PI. * Have blindness or partial vision loss in either eye. * Have received any other therapy, which, in the opinion of the investigator, could interfere with safety or efficacy evaluations. * Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study. * Patient who has a condition or is in a situation that, in the investigator's opinion, may put the patient at significant risk, or may significantly interfere with the patient's participation in the study. * Have received anti-coagulation, anti-platelet, or thrombolytic medications (e.g.,warfarin), anti-inflammatory drugs (NSAIDs, e.g., aspirin, ibuprofen), or other substances known to increase coagulation time from 10 days pre- to 3 days post injection. A wash out period of 10 days is allowed. * Have undergone immunosuppressive therapy, chemotherapy, biologics or systemic corticosteroids within 3 months prior to each study visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frontal Temporal Fossa Rating Scale | Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12 | Graded severity of the temporal line of the frontal bone (TLFB) using the Frontal Temporal Fossa Rating Scale: (these will have a picture assigned to each score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator's Satisfaction With the Appearance of the Temporal Regions | Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12 | Graded level of satisfaction with the current appearance of the temporal region making certain that the investigator is looking at the patient's right side and not the investigator's right side. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Subject's Satisfaction With Temple Appearance | Baseline, month 1, month 3, month 6, month 9, and Month 12 | Subject's Satisfaction with Temple Appearance |
| Subject Self-Perception of Age | Baseline, month 1, month 3, month 6, month 9, and Month 12 | Subjects perception of age when the subject looks at his/her right and left temples |
| Number of Participants With Specific Site Treatment Responses | Day 14 | Site treatment response reported by subject on diary day 0-14 post initial injection and touch-up injections |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| JUVÉDERM VOLUMA™ XC Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit.
JUVÉDERM VOLUMA™ XC: Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, and month 6. | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | JUVÉDERM VOLUMA™ XC |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 30 Participants |
| Region of Enrollment United States | 30 Participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 1 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Frontal Temporal Fossa Rating Scale
Graded severity of the temporal line of the frontal bone (TLFB) using the Frontal Temporal Fossa Rating Scale: (these will have a picture assigned to each score.
Time frame: Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12
Population: All subjects with data for for this outcome measure
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| JUVÉDERM VOLUMA™ XC | Frontal Temporal Fossa Rating Scale | Temporal Fossa Rating Scale at Baseline | Severe Concavity | 10 Participants |
| JUVÉDERM VOLUMA™ XC | Frontal Temporal Fossa Rating Scale | Temporal Fossa Rating Scale at Baseline | Moderate Concavity | 13 Participants |
| JUVÉDERM VOLUMA™ XC | Frontal Temporal Fossa Rating Scale | Temporal Fossa Rating Scale at Baseline | Mild Concavity | 7 Participants |
| JUVÉDERM VOLUMA™ XC | Frontal Temporal Fossa Rating Scale | Temporal Fossa Rating Scale at Baseline | Flat | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Frontal Temporal Fossa Rating Scale | Temporal Fossa Rating Scale at Baseline | Convexity | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Frontal Temporal Fossa Rating Scale | Temporal Fossa Rating Scale at Month 1 | Severe Concavity | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Frontal Temporal Fossa Rating Scale | Temporal Fossa Rating Scale at Month 1 | Moderate Concavity | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Frontal Temporal Fossa Rating Scale | Temporal Fossa Rating Scale at Month 1 | Mild Concavity | 1 Participants |
| JUVÉDERM VOLUMA™ XC | Frontal Temporal Fossa Rating Scale | Temporal Fossa Rating Scale at Month 1 | Flat | 27 Participants |
| JUVÉDERM VOLUMA™ XC | Frontal Temporal Fossa Rating Scale | Temporal Fossa Rating Scale at Month 1 | Convexity | 1 Participants |
| JUVÉDERM VOLUMA™ XC | Frontal Temporal Fossa Rating Scale | Temporal Fossa Rating Scale at Month 3 | Severe Concavity | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Frontal Temporal Fossa Rating Scale | Temporal Fossa Rating Scale at Month 3 | Moderate Concavity | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Frontal Temporal Fossa Rating Scale | Temporal Fossa Rating Scale at Month 3 | Mild Concavity | 4 Participants |
| JUVÉDERM VOLUMA™ XC | Frontal Temporal Fossa Rating Scale | Temporal Fossa Rating Scale at Month 3 | Flat | 22 Participants |
| JUVÉDERM VOLUMA™ XC | Frontal Temporal Fossa Rating Scale | Temporal Fossa Rating Scale at Month 3 | Convexity | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Frontal Temporal Fossa Rating Scale | Temporal Fossa Rating Scale at Month 6 | Severe Concavity | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Frontal Temporal Fossa Rating Scale | Temporal Fossa Rating Scale at Month 6 | Moderate Concavity | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Frontal Temporal Fossa Rating Scale | Temporal Fossa Rating Scale at Month 6 | Mild Concavity | 8 Participants |
| JUVÉDERM VOLUMA™ XC | Frontal Temporal Fossa Rating Scale | Temporal Fossa Rating Scale at Month 6 | Flat | 18 Participants |
| JUVÉDERM VOLUMA™ XC | Frontal Temporal Fossa Rating Scale | Temporal Fossa Rating Scale at Month 6 | Convexity | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Frontal Temporal Fossa Rating Scale | Temporal Fossa Rating Scale at Month 9 | Severe Concavity | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Frontal Temporal Fossa Rating Scale | Temporal Fossa Rating Scale at Month 9 | Moderate Concavity | 2 Participants |
| JUVÉDERM VOLUMA™ XC | Frontal Temporal Fossa Rating Scale | Temporal Fossa Rating Scale at Month 9 | Mild Concavity | 2 Participants |
| JUVÉDERM VOLUMA™ XC | Frontal Temporal Fossa Rating Scale | Temporal Fossa Rating Scale at Month 9 | Flat | 21 Participants |
| JUVÉDERM VOLUMA™ XC | Frontal Temporal Fossa Rating Scale | Temporal Fossa Rating Scale at Month 9 | Convexity | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Frontal Temporal Fossa Rating Scale | Temporal Fossa Rating Scale at Month 12 | Severe Concavity | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Frontal Temporal Fossa Rating Scale | Temporal Fossa Rating Scale at Month 12 | Moderate Concavity | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Frontal Temporal Fossa Rating Scale | Temporal Fossa Rating Scale at Month 12 | Mild Concavity | 5 Participants |
| JUVÉDERM VOLUMA™ XC | Frontal Temporal Fossa Rating Scale | Temporal Fossa Rating Scale at Month 12 | Flat | 20 Participants |
| JUVÉDERM VOLUMA™ XC | Frontal Temporal Fossa Rating Scale | Temporal Fossa Rating Scale at Month 12 | Convexity | 0 Participants |
Secondary
Investigator's Satisfaction With the Appearance of the Temporal Regions
Graded level of satisfaction with the current appearance of the temporal region making certain that the investigator is looking at the patient's right side and not the investigator's right side.
Time frame: Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12
Population: All subjects with data for this outcome measure
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| JUVÉDERM VOLUMA™ XC | Investigator's Satisfaction With the Appearance of the Temporal Regions | Investigator's Satisfaction at Baseline | Very Satisfied | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Investigator's Satisfaction With the Appearance of the Temporal Regions | Investigator's Satisfaction at Baseline | Moderately Satisfied | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Investigator's Satisfaction With the Appearance of the Temporal Regions | Investigator's Satisfaction at Baseline | Somewhat Satisfied | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Investigator's Satisfaction With the Appearance of the Temporal Regions | Investigator's Satisfaction at Baseline | Neither | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Investigator's Satisfaction With the Appearance of the Temporal Regions | Investigator's Satisfaction at Baseline | Somewhat Dissatisfied | 6 Participants |
| JUVÉDERM VOLUMA™ XC | Investigator's Satisfaction With the Appearance of the Temporal Regions | Investigator's Satisfaction at Baseline | Moderately Dissatisfied | 12 Participants |
| JUVÉDERM VOLUMA™ XC | Investigator's Satisfaction With the Appearance of the Temporal Regions | Investigator's Satisfaction at Baseline | Very Dissatisfied | 12 Participants |
| JUVÉDERM VOLUMA™ XC | Investigator's Satisfaction With the Appearance of the Temporal Regions | Investigator's Satisfaction at Month 1 | Very Satisfied | 24 Participants |
| JUVÉDERM VOLUMA™ XC | Investigator's Satisfaction With the Appearance of the Temporal Regions | Investigator's Satisfaction at Month 1 | Moderately Satisfied | 4 Participants |
| JUVÉDERM VOLUMA™ XC | Investigator's Satisfaction With the Appearance of the Temporal Regions | Investigator's Satisfaction at Month 1 | Somewhat Satisfied | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Investigator's Satisfaction With the Appearance of the Temporal Regions | Investigator's Satisfaction at Month 1 | Neither | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Investigator's Satisfaction With the Appearance of the Temporal Regions | Investigator's Satisfaction at Month 1 | Somewhat Dissatisfied | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Investigator's Satisfaction With the Appearance of the Temporal Regions | Investigator's Satisfaction at Month 1 | Moderately Dissatisfied | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Investigator's Satisfaction With the Appearance of the Temporal Regions | Investigator's Satisfaction at Month 1 | Very Dissatisfied | 1 Participants |
| JUVÉDERM VOLUMA™ XC | Investigator's Satisfaction With the Appearance of the Temporal Regions | Investigator's Satisfaction at Month 3 | Very Satisfied | 23 Participants |
| JUVÉDERM VOLUMA™ XC | Investigator's Satisfaction With the Appearance of the Temporal Regions | Investigator's Satisfaction at Month 3 | Moderately Satisfied | 3 Participants |
| JUVÉDERM VOLUMA™ XC | Investigator's Satisfaction With the Appearance of the Temporal Regions | Investigator's Satisfaction at Month 3 | Somewhat Satisfied | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Investigator's Satisfaction With the Appearance of the Temporal Regions | Investigator's Satisfaction at Month 3 | Neither | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Investigator's Satisfaction With the Appearance of the Temporal Regions | Investigator's Satisfaction at Month 3 | Somewhat Dissatisfied | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Investigator's Satisfaction With the Appearance of the Temporal Regions | Investigator's Satisfaction at Month 3 | Moderately Dissatisfied | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Investigator's Satisfaction With the Appearance of the Temporal Regions | Investigator's Satisfaction at Month 3 | Very Dissatisfied | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Investigator's Satisfaction With the Appearance of the Temporal Regions | Investigator's Satisfaction at Month 6 | Very Satisfied | 18 Participants |
| JUVÉDERM VOLUMA™ XC | Investigator's Satisfaction With the Appearance of the Temporal Regions | Investigator's Satisfaction at Month 6 | Moderately Satisfied | 7 Participants |
| JUVÉDERM VOLUMA™ XC | Investigator's Satisfaction With the Appearance of the Temporal Regions | Investigator's Satisfaction at Month 6 | Somewhat Satisfied | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Investigator's Satisfaction With the Appearance of the Temporal Regions | Investigator's Satisfaction at Month 6 | Neither | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Investigator's Satisfaction With the Appearance of the Temporal Regions | Investigator's Satisfaction at Month 6 | Somewhat Dissatisfied | 1 Participants |
| JUVÉDERM VOLUMA™ XC | Investigator's Satisfaction With the Appearance of the Temporal Regions | Investigator's Satisfaction at Month 6 | Moderately Dissatisfied | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Investigator's Satisfaction With the Appearance of the Temporal Regions | Investigator's Satisfaction at Month 6 | Very Dissatisfied | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Investigator's Satisfaction With the Appearance of the Temporal Regions | Investigator's Satisfaction at Month 9 | Very Satisfied | 19 Participants |
| JUVÉDERM VOLUMA™ XC | Investigator's Satisfaction With the Appearance of the Temporal Regions | Investigator's Satisfaction at Month 9 | Moderately Satisfied | 3 Participants |
| JUVÉDERM VOLUMA™ XC | Investigator's Satisfaction With the Appearance of the Temporal Regions | Investigator's Satisfaction at Month 9 | Somewhat Satisfied | 1 Participants |
| JUVÉDERM VOLUMA™ XC | Investigator's Satisfaction With the Appearance of the Temporal Regions | Investigator's Satisfaction at Month 9 | Neither | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Investigator's Satisfaction With the Appearance of the Temporal Regions | Investigator's Satisfaction at Month 9 | Somewhat Dissatisfied | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Investigator's Satisfaction With the Appearance of the Temporal Regions | Investigator's Satisfaction at Month 9 | Moderately Dissatisfied | 2 Participants |
| JUVÉDERM VOLUMA™ XC | Investigator's Satisfaction With the Appearance of the Temporal Regions | Investigator's Satisfaction at Month 9 | Very Dissatisfied | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Investigator's Satisfaction With the Appearance of the Temporal Regions | Investigator's Satisfaction at Month 12 | Very Satisfied | 16 Participants |
| JUVÉDERM VOLUMA™ XC | Investigator's Satisfaction With the Appearance of the Temporal Regions | Investigator's Satisfaction at Month 12 | Moderately Satisfied | 5 Participants |
| JUVÉDERM VOLUMA™ XC | Investigator's Satisfaction With the Appearance of the Temporal Regions | Investigator's Satisfaction at Month 12 | Somewhat Satisfied | 3 Participants |
| JUVÉDERM VOLUMA™ XC | Investigator's Satisfaction With the Appearance of the Temporal Regions | Investigator's Satisfaction at Month 12 | Neither | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Investigator's Satisfaction With the Appearance of the Temporal Regions | Investigator's Satisfaction at Month 12 | Somewhat Dissatisfied | 1 Participants |
| JUVÉDERM VOLUMA™ XC | Investigator's Satisfaction With the Appearance of the Temporal Regions | Investigator's Satisfaction at Month 12 | Moderately Dissatisfied | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Investigator's Satisfaction With the Appearance of the Temporal Regions | Investigator's Satisfaction at Month 12 | Very Dissatisfied | 0 Participants |
Other Pre-specified
Number of Participants With Specific Site Treatment Responses
Site treatment response reported by subject on diary day 0-14 post initial injection and touch-up injections
Time frame: Day 14
Population: Total number of subjects that reported symptom
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| JUVÉDERM VOLUMA™ XC | Number of Participants With Specific Site Treatment Responses | Tenderness/Pain | Mild | 17 Participants |
| JUVÉDERM VOLUMA™ XC | Number of Participants With Specific Site Treatment Responses | Tenderness/Pain | Moderate | 3 Participants |
| JUVÉDERM VOLUMA™ XC | Number of Participants With Specific Site Treatment Responses | Tenderness/Pain | Severe | 1 Participants |
| JUVÉDERM VOLUMA™ XC | Number of Participants With Specific Site Treatment Responses | Swelling | Mild | 17 Participants |
| JUVÉDERM VOLUMA™ XC | Number of Participants With Specific Site Treatment Responses | Swelling | Moderate | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Number of Participants With Specific Site Treatment Responses | Swelling | Severe | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Number of Participants With Specific Site Treatment Responses | Lumps/Bumps | Mild | 7 Participants |
| JUVÉDERM VOLUMA™ XC | Number of Participants With Specific Site Treatment Responses | Lumps/Bumps | Moderate | 1 Participants |
| JUVÉDERM VOLUMA™ XC | Number of Participants With Specific Site Treatment Responses | Lumps/Bumps | Severe | 1 Participants |
| JUVÉDERM VOLUMA™ XC | Number of Participants With Specific Site Treatment Responses | Bruising | Mild | 8 Participants |
| JUVÉDERM VOLUMA™ XC | Number of Participants With Specific Site Treatment Responses | Bruising | Moderate | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Number of Participants With Specific Site Treatment Responses | Bruising | Severe | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Number of Participants With Specific Site Treatment Responses | Redness | Mild | 7 Participants |
| JUVÉDERM VOLUMA™ XC | Number of Participants With Specific Site Treatment Responses | Redness | Moderate | 1 Participants |
| JUVÉDERM VOLUMA™ XC | Number of Participants With Specific Site Treatment Responses | Redness | Severe | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Number of Participants With Specific Site Treatment Responses | Itching | Mild | 3 Participants |
| JUVÉDERM VOLUMA™ XC | Number of Participants With Specific Site Treatment Responses | Itching | Moderate | 1 Participants |
| JUVÉDERM VOLUMA™ XC | Number of Participants With Specific Site Treatment Responses | Itching | Severe | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Number of Participants With Specific Site Treatment Responses | Headache | Mild | 7 Participants |
| JUVÉDERM VOLUMA™ XC | Number of Participants With Specific Site Treatment Responses | Headache | Moderate | 3 Participants |
| JUVÉDERM VOLUMA™ XC | Number of Participants With Specific Site Treatment Responses | Headache | Severe | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Number of Participants With Specific Site Treatment Responses | Jaw Pain/Tension | Mild | 7 Participants |
| JUVÉDERM VOLUMA™ XC | Number of Participants With Specific Site Treatment Responses | Jaw Pain/Tension | Moderate | 4 Participants |
| JUVÉDERM VOLUMA™ XC | Number of Participants With Specific Site Treatment Responses | Jaw Pain/Tension | Severe | 0 Participants |
Other Pre-specified
Subject Self-Perception of Age
Subjects perception of age when the subject looks at his/her right and left temples
Time frame: Baseline, month 1, month 3, month 6, month 9, and Month 12
Population: All subjects with data for this outcome measure
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| JUVÉDERM VOLUMA™ XC | Subject Self-Perception of Age | Subjects perception of age at Baseline | Same or Older | 23 Participants |
| JUVÉDERM VOLUMA™ XC | Subject Self-Perception of Age | Subjects perception of age at Baseline | 1-5 Years Younger | 4 Participants |
| JUVÉDERM VOLUMA™ XC | Subject Self-Perception of Age | Subjects perception of age at Baseline | 6-10 Years Younger | 3 Participants |
| JUVÉDERM VOLUMA™ XC | Subject Self-Perception of Age | Subjects perception of age at Baseline | 11-15 Years Younger | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Subject Self-Perception of Age | Subjects perception of age at Baseline | 16+ Years Younger | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Subject Self-Perception of Age | Subjects perception of age at Baseline | Returned to Baseline | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Subject Self-Perception of Age | Subjects perception of age at Month 1 | Same or Older | 5 Participants |
| JUVÉDERM VOLUMA™ XC | Subject Self-Perception of Age | Subjects perception of age at Month 1 | 1-5 Years Younger | 14 Participants |
| JUVÉDERM VOLUMA™ XC | Subject Self-Perception of Age | Subjects perception of age at Month 1 | 6-10 Years Younger | 9 Participants |
| JUVÉDERM VOLUMA™ XC | Subject Self-Perception of Age | Subjects perception of age at Month 1 | 11-15 Years Younger | 1 Participants |
| JUVÉDERM VOLUMA™ XC | Subject Self-Perception of Age | Subjects perception of age at Month 1 | 16+ Years Younger | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Subject Self-Perception of Age | Subjects perception of age at Month 1 | Returned to Baseline | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Subject Self-Perception of Age | Subjects perception of age at Month 3 | Same or Older | 2 Participants |
| JUVÉDERM VOLUMA™ XC | Subject Self-Perception of Age | Subjects perception of age at Month 3 | 1-5 Years Younger | 12 Participants |
| JUVÉDERM VOLUMA™ XC | Subject Self-Perception of Age | Subjects perception of age at Month 3 | 6-10 Years Younger | 8 Participants |
| JUVÉDERM VOLUMA™ XC | Subject Self-Perception of Age | Subjects perception of age at Month 3 | 11-15 Years Younger | 3 Participants |
| JUVÉDERM VOLUMA™ XC | Subject Self-Perception of Age | Subjects perception of age at Month 3 | 16+ Years Younger | 1 Participants |
| JUVÉDERM VOLUMA™ XC | Subject Self-Perception of Age | Subjects perception of age at Month 3 | Returned to Baseline | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Subject Self-Perception of Age | Subjects perception of age at Month 6 | Same or Older | 2 Participants |
| JUVÉDERM VOLUMA™ XC | Subject Self-Perception of Age | Subjects perception of age at Month 6 | 1-5 Years Younger | 12 Participants |
| JUVÉDERM VOLUMA™ XC | Subject Self-Perception of Age | Subjects perception of age at Month 6 | 6-10 Years Younger | 10 Participants |
| JUVÉDERM VOLUMA™ XC | Subject Self-Perception of Age | Subjects perception of age at Month 6 | 11-15 Years Younger | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Subject Self-Perception of Age | Subjects perception of age at Month 6 | 16+ Years Younger | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Subject Self-Perception of Age | Subjects perception of age at Month 6 | Returned to Baseline | 2 Participants |
| JUVÉDERM VOLUMA™ XC | Subject Self-Perception of Age | Subjects perception of age at Month 9 | Same or Older | 2 Participants |
| JUVÉDERM VOLUMA™ XC | Subject Self-Perception of Age | Subjects perception of age at Month 9 | 1-5 Years Younger | 11 Participants |
| JUVÉDERM VOLUMA™ XC | Subject Self-Perception of Age | Subjects perception of age at Month 9 | 6-10 Years Younger | 7 Participants |
| JUVÉDERM VOLUMA™ XC | Subject Self-Perception of Age | Subjects perception of age at Month 9 | 11-15 Years Younger | 2 Participants |
| JUVÉDERM VOLUMA™ XC | Subject Self-Perception of Age | Subjects perception of age at Month 9 | 16+ Years Younger | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Subject Self-Perception of Age | Subjects perception of age at Month 9 | Returned to Baseline | 3 Participants |
| JUVÉDERM VOLUMA™ XC | Subject Self-Perception of Age | Subjects perception of age Month 12 | Same or Older | 2 Participants |
| JUVÉDERM VOLUMA™ XC | Subject Self-Perception of Age | Subjects perception of age Month 12 | 1-5 Years Younger | 12 Participants |
| JUVÉDERM VOLUMA™ XC | Subject Self-Perception of Age | Subjects perception of age Month 12 | 6-10 Years Younger | 8 Participants |
| JUVÉDERM VOLUMA™ XC | Subject Self-Perception of Age | Subjects perception of age Month 12 | 11-15 Years Younger | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Subject Self-Perception of Age | Subjects perception of age Month 12 | 16+ Years Younger | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Subject Self-Perception of Age | Subjects perception of age Month 12 | Returned to Baseline | 3 Participants |
Other Pre-specified
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction with Temple Appearance
Time frame: Baseline, month 1, month 3, month 6, month 9, and Month 12
Population: All subjects with data for this outcome measure
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| JUVÉDERM VOLUMA™ XC | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction at Month 9 | Very Satisfied | 13 Participants |
| JUVÉDERM VOLUMA™ XC | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction at Month 9 | Moderately Satisfied | 6 Participants |
| JUVÉDERM VOLUMA™ XC | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction at Month 9 | Somewhat Satisfied | 4 Participants |
| JUVÉDERM VOLUMA™ XC | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction at Month 9 | Neither | 1 Participants |
| JUVÉDERM VOLUMA™ XC | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction at Month 9 | Somewhat Dissatisfied | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction at Month 12 | Somewhat Satisfied | 3 Participants |
| JUVÉDERM VOLUMA™ XC | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction at Month 12 | Neither | 1 Participants |
| JUVÉDERM VOLUMA™ XC | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction at Month 12 | Somewhat Dissatisfied | 1 Participants |
| JUVÉDERM VOLUMA™ XC | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction at Month 12 | Moderately Dissatisfied | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction at Baseline | Very Satisfied | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction at Baseline | Moderately Satisfied | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction at Baseline | Somewhat Satisfied | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction at Baseline | Neither | 2 Participants |
| JUVÉDERM VOLUMA™ XC | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction at Baseline | Somewhat Dissatisfied | 10 Participants |
| JUVÉDERM VOLUMA™ XC | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction at Baseline | Moderately Dissatisfied | 9 Participants |
| JUVÉDERM VOLUMA™ XC | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction at Baseline | Very Dissatisfied | 9 Participants |
| JUVÉDERM VOLUMA™ XC | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction at Month 1 | Very Satisfied | 18 Participants |
| JUVÉDERM VOLUMA™ XC | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction at Month 1 | Moderately Satisfied | 9 Participants |
| JUVÉDERM VOLUMA™ XC | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction at Month 1 | Somewhat Satisfied | 1 Participants |
| JUVÉDERM VOLUMA™ XC | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction at Month 1 | Neither | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction at Month 1 | Somewhat Dissatisfied | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction at Month 1 | Moderately Dissatisfied | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction at Month 1 | Very Dissatisfied | 1 Participants |
| JUVÉDERM VOLUMA™ XC | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction at Month 3 | Very Satisfied | 21 Participants |
| JUVÉDERM VOLUMA™ XC | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction at Month 3 | Moderately Satisfied | 3 Participants |
| JUVÉDERM VOLUMA™ XC | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction at Month 3 | Somewhat Satisfied | 2 Participants |
| JUVÉDERM VOLUMA™ XC | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction at Month 3 | Neither | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction at Month 3 | Somewhat Dissatisfied | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction at Month 3 | Moderately Dissatisfied | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction at Month 3 | Very Dissatisfied | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction at Month 6 | Very Satisfied | 15 Participants |
| JUVÉDERM VOLUMA™ XC | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction at Month 6 | Moderately Satisfied | 7 Participants |
| JUVÉDERM VOLUMA™ XC | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction at Month 6 | Somewhat Satisfied | 3 Participants |
| JUVÉDERM VOLUMA™ XC | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction at Month 6 | Neither | 1 Participants |
| JUVÉDERM VOLUMA™ XC | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction at Month 6 | Somewhat Dissatisfied | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction at Month 6 | Moderately Dissatisfied | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction at Month 6 | Very Dissatisfied | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction at Month 9 | Moderately Dissatisfied | 0 Participants |
| JUVÉDERM VOLUMA™ XC | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction at Month 9 | Very Dissatisfied | 1 Participants |
| JUVÉDERM VOLUMA™ XC | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction at Month 12 | Very Satisfied | 14 Participants |
| JUVÉDERM VOLUMA™ XC | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction at Month 12 | Moderately Satisfied | 5 Participants |
| JUVÉDERM VOLUMA™ XC | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction at Month 12 | Very Dissatisfied | 1 Participants |