A Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Cheek Augmentation Using Cannula
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: JUVÉDERM VOLUMA® XC Injectable Gel with Cannula 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 cannula.
|
| Other: JUVÉDERM VOLUMA® XC Injectable Gel with Needle 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 a needle.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Skin Care and Laser Physicians of Beverly Hills | Los Angeles | California | United States | 90069 |
| 2 | Art of Skin MD | Solana Beach | California | United States | 92075 |
| 3 | Baumann Cosmetic and Research Institute | Miami | Florida | United States | 33137 |
| 4 | Saint Louis University Dermatology | Saint Louis | Missouri | United States | 63122 |
| 5 | Skin Laser & Surgery Specialists of NY/NJ | Hackensack | New Jersey | United States | 07601 |
| 6 | Rhoda S. Narins, MD, PC | White Plains | New York | United States | 10604 |
| 7 | Aesthetic Solutions, PA | Chapel Hill | North Carolina | United States | 27517 |
Sponsors and Collaborators
- Allergan
Investigators
- Study Director: Steve Abrams, Allergan
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- 1650-801-008
Study Results
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. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | JUVÉDERM VOLUMA® XC (All Participants) |
|---|---|
| Arm/Group Description | 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. |
| Period Title: Overall Study | |
| STARTED | 60 |
| COMPLETED | 60 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | JUVÉDERM VOLUMA® XC (All Participants) |
|---|---|
| Arm/Group Description | 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. |
| Overall Participants | 60 |
| Overall Cheeks | 120 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
54.9
(6.41)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
49
81.7%
|
| Male |
11
18.3%
|
| Race/Ethnicity, Customized (Count of Participants) | |
| White |
59
98.3%
|
| Black or African American |
1
1.7%
|
| Race/Ethnicity, Customized (Count of Participants) | |
| Hispanic or Latino |
7
11.7%
|
| Not Hispanic or Latino |
53
88.3%
|
Outcome Measures
| Title | Change From Baseline in Mid-Face Volume Deficit Scale (MFVDS) Score |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT population included all randomized participants who received treatment with cannula on 1 cheek and treatment with needle on the contralateral (other) cheek. |
| Arm/Group Title | JUVÉDERM VOLUMA® XC Injectable Gel With Cannula | JUVÉDERM VOLUMA® XC Injectable Gel With Needle |
|---|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 60 | 60 |
| Baseline |
3.5
(0.62)
|
3.5
(0.62)
|
| Change from Baseline at Month 1 |
-1.8
(1.03)
|
-1.9
(0.96)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | JUVÉDERM VOLUMA® XC Injectable Gel With Cannula, JUVÉDERM VOLUMA® XC Injectable Gel With Needle |
|---|---|---|
| Comments | Change from Baseline at Month 1 | |
| Type of Statistical Test | Non-Inferiority | |
| Comments | If the upper limit of the confidence interval at Month 1 was less than 0.5, then treatment with cannula was considered non-inferior to treatment with needle. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.1 | |
| Confidence Interval |
(2-Sided) 95% -0.05 to 0.25 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The 95% CI is based on the paired t-test. | |
| Title | Percentage of Participants With at Least a 1-Point Improvement (Decrease From Baseline) in MFVDS Score |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT population included all randomized participants who received treatment with cannula on 1 cheek and treatment with needle on the contralateral (other) cheek. |
| Arm/Group Title | JUVÉDERM VOLUMA® XC Injectable Gel With Cannula | JUVÉDERM VOLUMA® XC Injectable Gel With Needle |
|---|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 60 | 60 |
| Number (95% Confidence Interval) [percentage of participants] |
93.3
155.5%
|
95.0
79.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | JUVÉDERM VOLUMA® XC Injectable Gel With Cannula, JUVÉDERM VOLUMA® XC Injectable Gel With Needle |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage Difference |
| Estimated Value | -1.7 | |
| Confidence Interval |
(2-Sided) 95% -7.31 to 3.98 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in FACE-Q Satisfaction With Cheeks Questionnaire Score |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | JUVÉDERM VOLUMA® XC (All Participants) |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 60 |
| Baseline |
32.1
(15.62)
|
| Change from Baseline at Month 1 |
55.5
(25.06)
|
| Title | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | JUVÉDERM VOLUMA® XC (All Participants) |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 60 |
| Count of Participants [Participants] |
7
11.7%
|
Adverse Events
| Time Frame | Up to 3 months | |
|---|---|---|
| Adverse Event Reporting Description | 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/Group Title | JUVÉDERM VOLUMA® XC (All Participants) | |
| Arm/Group Description | 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. | |
All Cause Mortality |
||
| JUVÉDERM VOLUMA® XC (All Participants) | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/60 (0%) | |
Serious Adverse Events |
||
| JUVÉDERM VOLUMA® XC (All Participants) | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/60 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| JUVÉDERM VOLUMA® XC (All Participants) | ||
| Affected / at Risk (%) | # Events | |
| Total | 3/60 (5%) | |
| Nervous system disorders | ||
| Headache | 3/60 (5%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Therapeutic Area, Head |
|---|---|
| Organization | Allergan |
| Phone | 714-246-4500 |
| clinicaltrials@allergan.com |
- 1650-801-008