An interventional study of JUVÉDERM VOLUMA® XC injectable gel with cannula and JUVÉDERM VOLUMA® XC injectable gel with needle in Age-related Volume Deficit in the Mid-face, sponsored by Allergan. Completed at 7 sites in United States. Open to participants aged 35 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-08-05.
Sponsored by Allergan · Not applicable, Interventional, and Treatment
The objective of this study is to evaluate the safety and effectiveness of JUVÉDERM VOLUMA® XC injectable gel using cannula in participants seeking correction of age-related volume deficit in the mid-face.
Male or female aged 35 to 65 (inclusive) years of age with overall mid-face severity of Moderate, Significant, or Severe for both cheeks on the Mid-Face Volume Deficit Scale (MFVDS);
Exclusion criteria:
Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula.
Device: JUVÉDERM VOLUMA® XC injectable gel with cannula
Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle.
Device: JUVÉDERM VOLUMA® XC injectable gel with needle
Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula.
Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle.
Change From Baseline in Mid-Face Volume Deficit Scale (MFVDS) Score
The evaluating investigator (EI) assessed the participant's overall mid-face volume deficit for each cheek using a 6-point photonumeric scale, where: 0=None (moon face; fullness) \[best\] to 5=Severe (wasting) \[worst\]. A negative change from Baseline indicates improvement.
Time frame: Baseline (Screening) to Month 1
Percentage of Participants With at Least a 1-Point Improvement (Decrease From Baseline) in MFVDS Score
The EI assessed the participant's overall mid-face volume deficit for each cheek using a 6-point photonumeric scale, where: 0=None (moon face; fullness) \[best\] to 5=Severe (wasting) \[worst\]. The percentage of participants who showed ≥1-point improvement (decrease in severity) from Baseline is reported.
Time frame: Baseline (Screening) to Month 1
Change From Baseline in FACE-Q Satisfaction With Cheeks Questionnaire Score
The participant completed the 5-item Satisfaction with Cheeks module of the FACE-Q questionnaire that evaluated various aspects of the cheeks including symmetry, smoothness, attractiveness, contour, and fullness using a 4-point scale where: 1=very dissatisfied to 4=very satisfied. The total score was transformed to a 0 to 100 point scale, with higher scores indicating greater satisfaction. A positive change from Baseline indicates improvement. The FACE-Q Satisfaction with Cheeks outcome was assessed by the participant overall and not by each cheek.
Time frame: Baseline (Screening) to Month 1
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE that initially occurred or increased in severity on or after the treatment start date.
Time frame: Up to 3 months
A total of 66 participants were enrolled in the study and 6 were excluded as screen failures. Only 60 participants were randomized and received study treatment.
| Milestone | JUVÉDERM VOLUMA® XC (All Participants) |
|---|---|
| Started | 60 |
| Completed | 60 |
| Not completed | 0 |
The evaluating investigator (EI) assessed the participant's overall mid-face volume deficit for each cheek using a 6-point photonumeric scale, where: 0=None (moon face; fullness) \[best\] to 5=Severe (wasting) \[worst\]. A negative change from Baseline indicates improvement.
| score on a scale | JUVÉDERM VOLUMA® XC Injectable Gel With Cannula | JUVÉDERM VOLUMA® XC Injectable Gel With Needle |
|---|---|---|
| Baseline | 3.5 ± 0.62 | 3.5 ± 0.62 |
| Change from Baseline at Month 1 | -1.8 ± 1.03 | -1.9 ± 0.96 |
The EI assessed the participant's overall mid-face volume deficit for each cheek using a 6-point photonumeric scale, where: 0=None (moon face; fullness) \[best\] to 5=Severe (wasting) \[worst\]. The percentage of participants who showed ≥1-point improvement (decrease in severity) from Baseline is reported.
| percentage of participants | JUVÉDERM VOLUMA® XC Injectable Gel With Cannula | JUVÉDERM VOLUMA® XC Injectable Gel With Needle |
|---|---|---|
| Percentage of Participants With at Least a 1-Point Improvement (Decrease From Baseline) in MFVDS Score | 93.3 (83.80 to 98.15) | 95.0 (86.08 to 98.96) |
The participant completed the 5-item Satisfaction with Cheeks module of the FACE-Q questionnaire that evaluated various aspects of the cheeks including symmetry, smoothness, attractiveness, contour, and fullness using a 4-point scale where: 1=very dissatisfied to 4=very satisfied. The total score was transformed to a 0 to 100 point scale, with higher scores indicating greater satisfaction. A positive change from Baseline indicates improvement. The FACE-Q Satisfaction with Cheeks outcome was assessed by the participant overall and not by each cheek.
| score on a scale | JUVÉDERM VOLUMA® XC (All Participants) |
|---|---|
| Baseline | 32.1 ± 15.62 |
| Change from Baseline at Month 1 | 55.5 ± 25.06 |
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE that initially occurred or increased in severity on or after the treatment start date.
| Participants | JUVÉDERM VOLUMA® XC (All Participants) |
|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 7 |
Collected over Up to 3 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| JUVÉDERM VOLUMA® XC (All Participants) | 0/60 (0%) | 0/60 (0%) | 3/60 (5%) |
| Event | JUVÉDERM VOLUMA® XC (All Participants) |
|---|---|
| HeadacheNervous system disorders | 3/60 |
Modified Intent-to-Treat (mITT) population included all randomized participants who received treatment with cannula on 1 cheek and treatment with needle on the contralateral (other) cheek.
| Age, Continuous(years) | JUVÉDERM VOLUMA® XC (All Participants) |
|---|---|
| Mean | 54.9 ± 6.41 |
| Sex: Female, Male(Participants) | JUVÉDERM VOLUMA® XC (All Participants) |
|---|---|
| Female | 49 |
| Male | 11 |
| Race/Ethnicity, Customized(Participants) | JUVÉDERM VOLUMA® XC (All Participants) |
|---|---|
| White | 59 |
| Black or African American | 1 |
| Race/Ethnicity, Customized(Participants) | JUVÉDERM VOLUMA® XC (All Participants) |
|---|---|
| Hispanic or Latino | 7 |
| Not Hispanic or Latino | 53 |
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