Age-related Volume Deficit in the Mid-face
Conditions
Brief summary
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.
Interventions
DEVICEJUVÉDERM VOLUMA® XC injectable gel with cannula
Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula.
DEVICEJUVÉDERM VOLUMA® XC injectable gel with needle
Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
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
* Has any facial procedures or trauma that may interfere with the study procedures and results; * Has a history of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), hyaluronic acid (HA) products, or Streptococcal protein, or is planning to undergo allergen desensitization therapy during the term of the study; * Has active autoimmune disease; * Has current cutaneous or mucosal inflammatory or infectious processes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mid-Face Volume Deficit Scale (MFVDS) Score | Baseline (Screening) to Month 1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With at Least a 1-Point Improvement (Decrease From Baseline) in MFVDS Score | Baseline (Screening) to Month 1 | 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. |
| Change From Baseline in FACE-Q Satisfaction With Cheeks Questionnaire Score | Baseline (Screening) to Month 1 | 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. |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Up to 3 months | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| JUVÉDERM VOLUMA® XC (All Participants) Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula and 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle. | 60 |
| JUVÉDERM VOLUMA® XC (All Participants) Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula and 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle. | 120 |
| Total | 180 |
Baseline characteristics
| Characteristic | JUVÉDERM VOLUMA® XC (All Participants) |
|---|---|
| Age, Continuous | 54.9 years STANDARD_DEVIATION 6.41 |
| Race/Ethnicity, Customized Black or African American | 1 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 7 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 53 Participants |
| Race/Ethnicity, Customized White | 59 Participants |
| Sex: Female, Male Female | 49 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 60 |
| other Total, other adverse events | 3 / 60 |
| serious Total, serious adverse events | 0 / 60 |
Outcome results
Primary
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
Population: mITT population included all randomized participants who received treatment with cannula on 1 cheek and treatment with needle on the contralateral (other) cheek.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JUVÉDERM VOLUMA® XC Injectable Gel With Cannula | Change From Baseline in Mid-Face Volume Deficit Scale (MFVDS) Score | Change from Baseline at Month 1 | -1.8 score on a scale | Standard Deviation 1.03 |
| JUVÉDERM VOLUMA® XC Injectable Gel With Cannula | Change From Baseline in Mid-Face Volume Deficit Scale (MFVDS) Score | Baseline | 3.5 score on a scale | Standard Deviation 0.62 |
| JUVÉDERM VOLUMA® XC Injectable Gel With Needle | Change From Baseline in Mid-Face Volume Deficit Scale (MFVDS) Score | Baseline | 3.5 score on a scale | Standard Deviation 0.62 |
| JUVÉDERM VOLUMA® XC Injectable Gel With Needle | Change From Baseline in Mid-Face Volume Deficit Scale (MFVDS) Score | Change from Baseline at Month 1 | -1.9 score on a scale | Standard Deviation 0.96 |
Comparison: Change from Baseline at Month 195% CI: [-0.05, 0.25]
Secondary
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
Population: mITT population included all randomized participants who received treatment with cannula on 1 cheek and treatment with needle on the contralateral (other) cheek. FACE-Q is a global assessment and was administered per participant.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JUVÉDERM VOLUMA® XC Injectable Gel With Cannula | Change From Baseline in FACE-Q Satisfaction With Cheeks Questionnaire Score | Baseline | 32.1 score on a scale | Standard Deviation 15.62 |
| JUVÉDERM VOLUMA® XC Injectable Gel With Cannula | Change From Baseline in FACE-Q Satisfaction With Cheeks Questionnaire Score | Change from Baseline at Month 1 | 55.5 score on a scale | Standard Deviation 25.06 |
Secondary
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
Population: Safety population included all randomized participants who received at least 1 study treatment. The data for adverse events is reported by participant because both treatments were received at the same time and it included both treatment-related and non-treatment-related adverse events.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| JUVÉDERM VOLUMA® XC Injectable Gel With Cannula | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 7 Participants |
Secondary
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
Population: mITT population included all randomized participants who received treatment with cannula on 1 cheek and treatment with needle on the contralateral (other) cheek.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JUVÉDERM VOLUMA® XC Injectable Gel With Cannula | Percentage of Participants With at Least a 1-Point Improvement (Decrease From Baseline) in MFVDS Score | 93.3 percentage of participants |
| JUVÉDERM VOLUMA® XC Injectable Gel With Needle | Percentage of Participants With at Least a 1-Point Improvement (Decrease From Baseline) in MFVDS Score | 95.0 percentage of participants |
95% CI: [-7.31, 3.98]