Trial Outcomes & Findings for Open Label Study Evaluating the Efficacy and Safety of JUVÉDERM VOLUMA™ XC for the Facial Temporal Regions (NCT NCT02437903)
NCT ID: NCT02437903
Last Updated: 2018-02-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12
Results posted on
2018-02-15
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
Baseline Characteristics
Open Label Study Evaluating the Efficacy and Safety of JUVÉDERM VOLUMA™ XC for the Facial Temporal Regions
Baseline characteristics by cohort
| Measure |
JUVÉDERM VOLUMA™ XC
n=30 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12Population: All subjects with data for for this outcome measure
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.
Outcome measures
| Measure |
JUVÉDERM VOLUMA™ XC
n=30 Participants
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, month 6, month 9, and month 12
|
|---|---|
|
Frontal Temporal Fossa Rating Scale
Temporal Fossa Rating Scale at Baseline · Severe Concavity
|
10 Participants
|
|
Frontal Temporal Fossa Rating Scale
Temporal Fossa Rating Scale at Baseline · Moderate Concavity
|
13 Participants
|
|
Frontal Temporal Fossa Rating Scale
Temporal Fossa Rating Scale at Baseline · Mild Concavity
|
7 Participants
|
|
Frontal Temporal Fossa Rating Scale
Temporal Fossa Rating Scale at Baseline · Flat
|
0 Participants
|
|
Frontal Temporal Fossa Rating Scale
Temporal Fossa Rating Scale at Baseline · Convexity
|
0 Participants
|
|
Frontal Temporal Fossa Rating Scale
Temporal Fossa Rating Scale at Month 1 · Severe Concavity
|
0 Participants
|
|
Frontal Temporal Fossa Rating Scale
Temporal Fossa Rating Scale at Month 1 · Moderate Concavity
|
0 Participants
|
|
Frontal Temporal Fossa Rating Scale
Temporal Fossa Rating Scale at Month 1 · Mild Concavity
|
1 Participants
|
|
Frontal Temporal Fossa Rating Scale
Temporal Fossa Rating Scale at Month 1 · Flat
|
27 Participants
|
|
Frontal Temporal Fossa Rating Scale
Temporal Fossa Rating Scale at Month 1 · Convexity
|
1 Participants
|
|
Frontal Temporal Fossa Rating Scale
Temporal Fossa Rating Scale at Month 3 · Severe Concavity
|
0 Participants
|
|
Frontal Temporal Fossa Rating Scale
Temporal Fossa Rating Scale at Month 3 · Moderate Concavity
|
0 Participants
|
|
Frontal Temporal Fossa Rating Scale
Temporal Fossa Rating Scale at Month 3 · Mild Concavity
|
4 Participants
|
|
Frontal Temporal Fossa Rating Scale
Temporal Fossa Rating Scale at Month 3 · Flat
|
22 Participants
|
|
Frontal Temporal Fossa Rating Scale
Temporal Fossa Rating Scale at Month 3 · Convexity
|
0 Participants
|
|
Frontal Temporal Fossa Rating Scale
Temporal Fossa Rating Scale at Month 6 · Severe Concavity
|
0 Participants
|
|
Frontal Temporal Fossa Rating Scale
Temporal Fossa Rating Scale at Month 6 · Moderate Concavity
|
0 Participants
|
|
Frontal Temporal Fossa Rating Scale
Temporal Fossa Rating Scale at Month 6 · Mild Concavity
|
8 Participants
|
|
Frontal Temporal Fossa Rating Scale
Temporal Fossa Rating Scale at Month 6 · Flat
|
18 Participants
|
|
Frontal Temporal Fossa Rating Scale
Temporal Fossa Rating Scale at Month 6 · Convexity
|
0 Participants
|
|
Frontal Temporal Fossa Rating Scale
Temporal Fossa Rating Scale at Month 9 · Severe Concavity
|
0 Participants
|
|
Frontal Temporal Fossa Rating Scale
Temporal Fossa Rating Scale at Month 9 · Moderate Concavity
|
2 Participants
|
|
Frontal Temporal Fossa Rating Scale
Temporal Fossa Rating Scale at Month 9 · Mild Concavity
|
2 Participants
|
|
Frontal Temporal Fossa Rating Scale
Temporal Fossa Rating Scale at Month 9 · Flat
|
21 Participants
|
|
Frontal Temporal Fossa Rating Scale
Temporal Fossa Rating Scale at Month 9 · Convexity
|
0 Participants
|
|
Frontal Temporal Fossa Rating Scale
Temporal Fossa Rating Scale at Month 12 · Severe Concavity
|
0 Participants
|
|
Frontal Temporal Fossa Rating Scale
Temporal Fossa Rating Scale at Month 12 · Moderate Concavity
|
0 Participants
|
|
Frontal Temporal Fossa Rating Scale
Temporal Fossa Rating Scale at Month 12 · Mild Concavity
|
5 Participants
|
|
Frontal Temporal Fossa Rating Scale
Temporal Fossa Rating Scale at Month 12 · Flat
|
20 Participants
|
|
Frontal Temporal Fossa Rating Scale
Temporal Fossa Rating Scale at Month 12 · Convexity
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12Population: All subjects with data for this outcome measure
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.
Outcome measures
| Measure |
JUVÉDERM VOLUMA™ XC
n=30 Participants
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, month 6, month 9, and month 12
|
|---|---|
|
Investigator's Satisfaction With the Appearance of the Temporal Regions
Investigator's Satisfaction at Month 6 · Moderately Dissatisfied
|
0 Participants
|
|
Investigator's Satisfaction With the Appearance of the Temporal Regions
Investigator's Satisfaction at Baseline · Very Satisfied
|
0 Participants
|
|
Investigator's Satisfaction With the Appearance of the Temporal Regions
Investigator's Satisfaction at Baseline · Moderately Satisfied
|
0 Participants
|
|
Investigator's Satisfaction With the Appearance of the Temporal Regions
Investigator's Satisfaction at Baseline · Somewhat Satisfied
|
0 Participants
|
|
Investigator's Satisfaction With the Appearance of the Temporal Regions
Investigator's Satisfaction at Baseline · Neither
|
0 Participants
|
|
Investigator's Satisfaction With the Appearance of the Temporal Regions
Investigator's Satisfaction at Baseline · Somewhat Dissatisfied
|
6 Participants
|
|
Investigator's Satisfaction With the Appearance of the Temporal Regions
Investigator's Satisfaction at Baseline · Moderately Dissatisfied
|
12 Participants
|
|
Investigator's Satisfaction With the Appearance of the Temporal Regions
Investigator's Satisfaction at Baseline · Very Dissatisfied
|
12 Participants
|
|
Investigator's Satisfaction With the Appearance of the Temporal Regions
Investigator's Satisfaction at Month 1 · Very Satisfied
|
24 Participants
|
|
Investigator's Satisfaction With the Appearance of the Temporal Regions
Investigator's Satisfaction at Month 1 · Moderately Satisfied
|
4 Participants
|
|
Investigator's Satisfaction With the Appearance of the Temporal Regions
Investigator's Satisfaction at Month 1 · Somewhat Satisfied
|
0 Participants
|
|
Investigator's Satisfaction With the Appearance of the Temporal Regions
Investigator's Satisfaction at Month 1 · Neither
|
0 Participants
|
|
Investigator's Satisfaction With the Appearance of the Temporal Regions
Investigator's Satisfaction at Month 1 · Somewhat Dissatisfied
|
0 Participants
|
|
Investigator's Satisfaction With the Appearance of the Temporal Regions
Investigator's Satisfaction at Month 1 · Moderately Dissatisfied
|
0 Participants
|
|
Investigator's Satisfaction With the Appearance of the Temporal Regions
Investigator's Satisfaction at Month 1 · Very Dissatisfied
|
1 Participants
|
|
Investigator's Satisfaction With the Appearance of the Temporal Regions
Investigator's Satisfaction at Month 3 · Very Satisfied
|
23 Participants
|
|
Investigator's Satisfaction With the Appearance of the Temporal Regions
Investigator's Satisfaction at Month 3 · Moderately Satisfied
|
3 Participants
|
|
Investigator's Satisfaction With the Appearance of the Temporal Regions
Investigator's Satisfaction at Month 3 · Somewhat Satisfied
|
0 Participants
|
|
Investigator's Satisfaction With the Appearance of the Temporal Regions
Investigator's Satisfaction at Month 3 · Neither
|
0 Participants
|
|
Investigator's Satisfaction With the Appearance of the Temporal Regions
Investigator's Satisfaction at Month 3 · Somewhat Dissatisfied
|
0 Participants
|
|
Investigator's Satisfaction With the Appearance of the Temporal Regions
Investigator's Satisfaction at Month 3 · Moderately Dissatisfied
|
0 Participants
|
|
Investigator's Satisfaction With the Appearance of the Temporal Regions
Investigator's Satisfaction at Month 3 · Very Dissatisfied
|
0 Participants
|
|
Investigator's Satisfaction With the Appearance of the Temporal Regions
Investigator's Satisfaction at Month 6 · Very Satisfied
|
18 Participants
|
|
Investigator's Satisfaction With the Appearance of the Temporal Regions
Investigator's Satisfaction at Month 6 · Moderately Satisfied
|
7 Participants
|
|
Investigator's Satisfaction With the Appearance of the Temporal Regions
Investigator's Satisfaction at Month 6 · Somewhat Satisfied
|
0 Participants
|
|
Investigator's Satisfaction With the Appearance of the Temporal Regions
Investigator's Satisfaction at Month 6 · Neither
|
0 Participants
|
|
Investigator's Satisfaction With the Appearance of the Temporal Regions
Investigator's Satisfaction at Month 6 · Somewhat Dissatisfied
|
1 Participants
|
|
Investigator's Satisfaction With the Appearance of the Temporal Regions
Investigator's Satisfaction at Month 6 · Very Dissatisfied
|
0 Participants
|
|
Investigator's Satisfaction With the Appearance of the Temporal Regions
Investigator's Satisfaction at Month 9 · Very Satisfied
|
19 Participants
|
|
Investigator's Satisfaction With the Appearance of the Temporal Regions
Investigator's Satisfaction at Month 9 · Moderately Satisfied
|
3 Participants
|
|
Investigator's Satisfaction With the Appearance of the Temporal Regions
Investigator's Satisfaction at Month 9 · Somewhat Satisfied
|
1 Participants
|
|
Investigator's Satisfaction With the Appearance of the Temporal Regions
Investigator's Satisfaction at Month 9 · Neither
|
0 Participants
|
|
Investigator's Satisfaction With the Appearance of the Temporal Regions
Investigator's Satisfaction at Month 9 · Somewhat Dissatisfied
|
0 Participants
|
|
Investigator's Satisfaction With the Appearance of the Temporal Regions
Investigator's Satisfaction at Month 9 · Moderately Dissatisfied
|
2 Participants
|
|
Investigator's Satisfaction With the Appearance of the Temporal Regions
Investigator's Satisfaction at Month 9 · Very Dissatisfied
|
0 Participants
|
|
Investigator's Satisfaction With the Appearance of the Temporal Regions
Investigator's Satisfaction at Month 12 · Very Satisfied
|
16 Participants
|
|
Investigator's Satisfaction With the Appearance of the Temporal Regions
Investigator's Satisfaction at Month 12 · Moderately Satisfied
|
5 Participants
|
|
Investigator's Satisfaction With the Appearance of the Temporal Regions
Investigator's Satisfaction at Month 12 · Somewhat Satisfied
|
3 Participants
|
|
Investigator's Satisfaction With the Appearance of the Temporal Regions
Investigator's Satisfaction at Month 12 · Neither
|
0 Participants
|
|
Investigator's Satisfaction With the Appearance of the Temporal Regions
Investigator's Satisfaction at Month 12 · Somewhat Dissatisfied
|
1 Participants
|
|
Investigator's Satisfaction With the Appearance of the Temporal Regions
Investigator's Satisfaction at Month 12 · Moderately Dissatisfied
|
0 Participants
|
|
Investigator's Satisfaction With the Appearance of the Temporal Regions
Investigator's Satisfaction at Month 12 · Very Dissatisfied
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, month 1, month 3, month 6, month 9, and Month 12Population: All subjects with data for this outcome measure
Subject's Satisfaction with Temple Appearance
Outcome measures
| Measure |
JUVÉDERM VOLUMA™ XC
n=30 Participants
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, month 6, month 9, and month 12
|
|---|---|
|
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction at Baseline · Very Satisfied
|
0 Participants
|
|
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction at Baseline · Moderately Satisfied
|
0 Participants
|
|
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction at Baseline · Somewhat Satisfied
|
0 Participants
|
|
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction at Baseline · Neither
|
2 Participants
|
|
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction at Baseline · Somewhat Dissatisfied
|
10 Participants
|
|
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction at Baseline · Moderately Dissatisfied
|
9 Participants
|
|
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction at Baseline · Very Dissatisfied
|
9 Participants
|
|
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction at Month 1 · Very Satisfied
|
18 Participants
|
|
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction at Month 1 · Moderately Satisfied
|
9 Participants
|
|
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction at Month 1 · Somewhat Satisfied
|
1 Participants
|
|
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction at Month 1 · Neither
|
0 Participants
|
|
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction at Month 1 · Somewhat Dissatisfied
|
0 Participants
|
|
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction at Month 1 · Moderately Dissatisfied
|
0 Participants
|
|
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction at Month 1 · Very Dissatisfied
|
1 Participants
|
|
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction at Month 3 · Very Satisfied
|
21 Participants
|
|
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction at Month 3 · Moderately Satisfied
|
3 Participants
|
|
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction at Month 3 · Somewhat Satisfied
|
2 Participants
|
|
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction at Month 3 · Neither
|
0 Participants
|
|
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction at Month 3 · Somewhat Dissatisfied
|
0 Participants
|
|
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction at Month 3 · Moderately Dissatisfied
|
0 Participants
|
|
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction at Month 3 · Very Dissatisfied
|
0 Participants
|
|
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction at Month 6 · Very Satisfied
|
15 Participants
|
|
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction at Month 6 · Moderately Satisfied
|
7 Participants
|
|
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction at Month 6 · Somewhat Satisfied
|
3 Participants
|
|
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction at Month 6 · Neither
|
1 Participants
|
|
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction at Month 6 · Somewhat Dissatisfied
|
0 Participants
|
|
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction at Month 6 · Moderately Dissatisfied
|
0 Participants
|
|
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction at Month 6 · Very Dissatisfied
|
0 Participants
|
|
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction at Month 9 · Very Satisfied
|
13 Participants
|
|
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction at Month 9 · Moderately Satisfied
|
6 Participants
|
|
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction at Month 9 · Somewhat Satisfied
|
4 Participants
|
|
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction at Month 9 · Neither
|
1 Participants
|
|
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction at Month 9 · Somewhat Dissatisfied
|
0 Participants
|
|
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction at Month 9 · Moderately Dissatisfied
|
0 Participants
|
|
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction at Month 9 · Very Dissatisfied
|
1 Participants
|
|
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction at Month 12 · Very Satisfied
|
14 Participants
|
|
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction at Month 12 · Moderately Satisfied
|
5 Participants
|
|
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction at Month 12 · Somewhat Satisfied
|
3 Participants
|
|
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction at Month 12 · Neither
|
1 Participants
|
|
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction at Month 12 · Somewhat Dissatisfied
|
1 Participants
|
|
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction at Month 12 · Moderately Dissatisfied
|
0 Participants
|
|
Subject's Satisfaction With Temple Appearance
Subject's Satisfaction at Month 12 · Very Dissatisfied
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, month 1, month 3, month 6, month 9, and Month 12Population: All subjects with data for this outcome measure
Subjects perception of age when the subject looks at his/her right and left temples
Outcome measures
| Measure |
JUVÉDERM VOLUMA™ XC
n=30 Participants
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, month 6, month 9, and month 12
|
|---|---|
|
Subject Self-Perception of Age
Subjects perception of age at Baseline · Same or Older
|
23 Participants
|
|
Subject Self-Perception of Age
Subjects perception of age at Baseline · 1-5 Years Younger
|
4 Participants
|
|
Subject Self-Perception of Age
Subjects perception of age at Baseline · 6-10 Years Younger
|
3 Participants
|
|
Subject Self-Perception of Age
Subjects perception of age at Baseline · 11-15 Years Younger
|
0 Participants
|
|
Subject Self-Perception of Age
Subjects perception of age at Baseline · 16+ Years Younger
|
0 Participants
|
|
Subject Self-Perception of Age
Subjects perception of age at Baseline · Returned to Baseline
|
0 Participants
|
|
Subject Self-Perception of Age
Subjects perception of age at Month 1 · Same or Older
|
5 Participants
|
|
Subject Self-Perception of Age
Subjects perception of age at Month 1 · 1-5 Years Younger
|
14 Participants
|
|
Subject Self-Perception of Age
Subjects perception of age at Month 1 · 6-10 Years Younger
|
9 Participants
|
|
Subject Self-Perception of Age
Subjects perception of age at Month 1 · 11-15 Years Younger
|
1 Participants
|
|
Subject Self-Perception of Age
Subjects perception of age at Month 1 · 16+ Years Younger
|
0 Participants
|
|
Subject Self-Perception of Age
Subjects perception of age at Month 1 · Returned to Baseline
|
0 Participants
|
|
Subject Self-Perception of Age
Subjects perception of age at Month 3 · Same or Older
|
2 Participants
|
|
Subject Self-Perception of Age
Subjects perception of age at Month 3 · 1-5 Years Younger
|
12 Participants
|
|
Subject Self-Perception of Age
Subjects perception of age at Month 3 · 6-10 Years Younger
|
8 Participants
|
|
Subject Self-Perception of Age
Subjects perception of age at Month 3 · 11-15 Years Younger
|
3 Participants
|
|
Subject Self-Perception of Age
Subjects perception of age at Month 3 · 16+ Years Younger
|
1 Participants
|
|
Subject Self-Perception of Age
Subjects perception of age at Month 3 · Returned to Baseline
|
0 Participants
|
|
Subject Self-Perception of Age
Subjects perception of age at Month 6 · Same or Older
|
2 Participants
|
|
Subject Self-Perception of Age
Subjects perception of age at Month 6 · 1-5 Years Younger
|
12 Participants
|
|
Subject Self-Perception of Age
Subjects perception of age at Month 6 · 6-10 Years Younger
|
10 Participants
|
|
Subject Self-Perception of Age
Subjects perception of age at Month 6 · 11-15 Years Younger
|
0 Participants
|
|
Subject Self-Perception of Age
Subjects perception of age at Month 6 · 16+ Years Younger
|
0 Participants
|
|
Subject Self-Perception of Age
Subjects perception of age at Month 6 · Returned to Baseline
|
2 Participants
|
|
Subject Self-Perception of Age
Subjects perception of age at Month 9 · Same or Older
|
2 Participants
|
|
Subject Self-Perception of Age
Subjects perception of age at Month 9 · 1-5 Years Younger
|
11 Participants
|
|
Subject Self-Perception of Age
Subjects perception of age at Month 9 · 6-10 Years Younger
|
7 Participants
|
|
Subject Self-Perception of Age
Subjects perception of age at Month 9 · 11-15 Years Younger
|
2 Participants
|
|
Subject Self-Perception of Age
Subjects perception of age at Month 9 · 16+ Years Younger
|
0 Participants
|
|
Subject Self-Perception of Age
Subjects perception of age at Month 9 · Returned to Baseline
|
3 Participants
|
|
Subject Self-Perception of Age
Subjects perception of age Month 12 · Same or Older
|
2 Participants
|
|
Subject Self-Perception of Age
Subjects perception of age Month 12 · 1-5 Years Younger
|
12 Participants
|
|
Subject Self-Perception of Age
Subjects perception of age Month 12 · 6-10 Years Younger
|
8 Participants
|
|
Subject Self-Perception of Age
Subjects perception of age Month 12 · 11-15 Years Younger
|
0 Participants
|
|
Subject Self-Perception of Age
Subjects perception of age Month 12 · 16+ Years Younger
|
0 Participants
|
|
Subject Self-Perception of Age
Subjects perception of age Month 12 · Returned to Baseline
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 14Population: Total number of subjects that reported symptom
Site treatment response reported by subject on diary day 0-14 post initial injection and touch-up injections
Outcome measures
| Measure |
JUVÉDERM VOLUMA™ XC
n=30 Participants
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, month 6, month 9, and month 12
|
|---|---|
|
Number of Participants With Specific Site Treatment Responses
Tenderness/Pain · Moderate
|
3 Participants
|
|
Number of Participants With Specific Site Treatment Responses
Tenderness/Pain · Severe
|
1 Participants
|
|
Number of Participants With Specific Site Treatment Responses
Swelling · Mild
|
17 Participants
|
|
Number of Participants With Specific Site Treatment Responses
Swelling · Moderate
|
0 Participants
|
|
Number of Participants With Specific Site Treatment Responses
Swelling · Severe
|
0 Participants
|
|
Number of Participants With Specific Site Treatment Responses
Lumps/Bumps · Mild
|
7 Participants
|
|
Number of Participants With Specific Site Treatment Responses
Lumps/Bumps · Moderate
|
1 Participants
|
|
Number of Participants With Specific Site Treatment Responses
Lumps/Bumps · Severe
|
1 Participants
|
|
Number of Participants With Specific Site Treatment Responses
Bruising · Mild
|
8 Participants
|
|
Number of Participants With Specific Site Treatment Responses
Bruising · Moderate
|
0 Participants
|
|
Number of Participants With Specific Site Treatment Responses
Bruising · Severe
|
0 Participants
|
|
Number of Participants With Specific Site Treatment Responses
Redness · Mild
|
7 Participants
|
|
Number of Participants With Specific Site Treatment Responses
Redness · Moderate
|
1 Participants
|
|
Number of Participants With Specific Site Treatment Responses
Redness · Severe
|
0 Participants
|
|
Number of Participants With Specific Site Treatment Responses
Itching · Mild
|
3 Participants
|
|
Number of Participants With Specific Site Treatment Responses
Itching · Moderate
|
1 Participants
|
|
Number of Participants With Specific Site Treatment Responses
Itching · Severe
|
0 Participants
|
|
Number of Participants With Specific Site Treatment Responses
Headache · Mild
|
7 Participants
|
|
Number of Participants With Specific Site Treatment Responses
Headache · Moderate
|
3 Participants
|
|
Number of Participants With Specific Site Treatment Responses
Headache · Severe
|
0 Participants
|
|
Number of Participants With Specific Site Treatment Responses
Jaw Pain/Tension · Mild
|
7 Participants
|
|
Number of Participants With Specific Site Treatment Responses
Jaw Pain/Tension · Moderate
|
4 Participants
|
|
Number of Participants With Specific Site Treatment Responses
Jaw Pain/Tension · Severe
|
0 Participants
|
|
Number of Participants With Specific Site Treatment Responses
Tenderness/Pain · Mild
|
17 Participants
|
Adverse Events
JUVÉDERM VOLUMA™ XC
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
JUVÉDERM VOLUMA™ XC
n=30 participants at risk
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.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Unexpected Swelling
|
3.3%
1/30 • Number of events 1 • Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12
|
Additional Information
Leslie Baumann, MD
Baumann Cosmetic and Research Institute
Phone: (305) 531-5788
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place