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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JUVÉDERM VOLUMA® XC Injectable Gel with Cannula | Experimental | Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula. |
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| JUVÉDERM VOLUMA® XC Injectable Gel with Needle | Other | Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JUVÉDERM VOLUMA® XC injectable gel with cannula | Device | Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Screening) to Month 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Steve Abrams | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skin Care and Laser Physicians of Beverly Hills | Los Angeles | California | 90069 | United States | ||
| Art of Skin MD |
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| Label | URL |
|---|---|
| Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance. | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 19, 2017 | May 29, 2019 |
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| JUVÉDERM VOLUMA® XC injectable gel with needle | Device | Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle. |
|
| 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. | 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. | Up to 3 months |
| Solana Beach |
| California |
| 92075 |
| United States |
| Baumann Cosmetic and Research Institute | Miami | Florida | 33137 | United States |
| Saint Louis University Dermatology | St Louis | Missouri | 63122 | United States |
| Skin Laser & Surgery Specialists of NY/NJ | Hackensack | New Jersey | 07601 | United States |
| Rhoda S. Narins, MD, PC | White Plains | New York | 10604 | United States |
| Aesthetic Solutions, PA | Chapel Hill | North Carolina | 27517 | United States |
| COMPLETED |
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| NOT COMPLETED |
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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.
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Cheeks |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years | Participants |
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| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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. | mITT population included all randomized participants who received treatment with cannula on 1 cheek and treatment with needle on the contralateral (other) cheek. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Screening) to Month 1 |
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| 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. | mITT population included all randomized participants who received treatment with cannula on 1 cheek and treatment with needle on the contralateral (other) cheek. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline (Screening) to Month 1 |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Screening) to Month 1 |
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| 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. | 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. | Posted | Count of Participants | Participants | Up to 3 months |
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Up to 3 months
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 60 | 0 | 60 | 3 | 60 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area, Head | Allergan | 714-246-4500 | clinicaltrials@allergan.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 13, 2018 | May 29, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000072601 | Cannula |
| D009339 | Needles |
| ID | Term |
|---|---|
| D057785 | Catheters |
| D004864 | Equipment and Supplies |
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