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Multicenter, single-blind, randomized, "no-treatment" control study to demonstrate the safety and effectiveness of VOLUMA XC for deep injection for cheek augmentation to correct age-related volume deficit in the mid-face.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VOLUMA® XC Treatment Arm | Experimental | Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable. |
|
| Control Arm_No Treatment then VOLUMA® XC | Other | No treatment for 6 months, then participants were treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). Participants were eligible for re-treatment if applicable. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Juvéderm® VOLUMA XC | Device | Treating Investigator determines the appropriate volume of VOLUMA XC to be injected up to a maximum total of 12 mL for initial and touch-up treatment. One repeat treatment with up to 12 mL may be performed at the Subject's option after study completion. |
| Measure | Description | Time Frame |
|---|---|---|
| Responder Rate Based on Improvement in Score on Validated 6-point Mid-Face Volume Deficit Scale (MFVDS) | The primary effectiveness variable was responder rate for the treatment group. The investigator evaluated the volume deficit of the patient's face using the MFVDS 6-point scale where: 0=none (best) to 5=severe (worst). To be considered a "responder," the average of the blinded, independent Evaluating Investigators' assessments of the participant's overall score on MFVDS at 6 months had to be improved (reduced) by ≥ 1 grade compared with the average of the Evaluating Investigator pre-treatment assessments. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Treatment Effect | Duration of treatment effect was determined by Kaplan-Meier (KM) product limit estimate of the percentage of participants in the treatment group that maintained at least a 1-point improvement in the overall mid-face volume deficit score on the Mid-Face Volume Deficit Scale (MFVDS) based on the average of the 2 blinded Evaluating Investigators' assessments (with 95% Greenwood's Confidence Interval). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24093664 | Result | Jones D, Murphy DK. Volumizing hyaluronic acid filler for midface volume deficit: 2-year results from a pivotal single-blind randomized controlled study. Dermatol Surg. 2013 Nov;39(11):1602-12. doi: 10.1111/dsu.12343. Epub 2013 Oct 4. | |
| 25964628 | Derived | Few J, Cox SE, Paradkar-Mitragotri D, Murphy DK. A Multicenter, Single-Blind Randomized, Controlled Study of a Volumizing Hyaluronic Acid Filler for Midface Volume Deficit: Patient-Reported Outcomes at 2 Years. Aesthet Surg J. 2015 Jul;35(5):589-99. doi: 10.1093/asj/sjv050. Epub 2015 May 11. |
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Prior to randomization, 16 patients were excluded as screen failures and the first two participants per site (30 total) were treated as run-in participants. Of the 299 randomized participants, 17 were discontinued prior to treatment, leaving a "modified intent-to-treat" population of 282 participants (235 in Treatment Arm and 47 in Control Arm).
345 participants were originally recruited for treatment at 15 sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | VOLUMA® XC Treatment Arm | Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable. |
| FG001 | Control Arm_No Treatment Then VOLUMA® XC | No treatment for 6 months, then participants were treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). Participants were eligible for re-treatment if applicable. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Initial Treatment Period |
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| Received Repeat Treatment |
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| ID | Title | Description |
|---|---|---|
| BG000 | VOLUMA® XC Treatment Arm | Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable. |
| BG001 | Control Arm_No Treatment Then VOLUMA® XC |
| Units | Counts |
|---|---|
| Participants |
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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 |
| 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 | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Responder Rate Based on Improvement in Score on Validated 6-point Mid-Face Volume Deficit Scale (MFVDS) | The primary effectiveness variable was responder rate for the treatment group. The investigator evaluated the volume deficit of the patient's face using the MFVDS 6-point scale where: 0=none (best) to 5=severe (worst). To be considered a "responder," the average of the blinded, independent Evaluating Investigators' assessments of the participant's overall score on MFVDS at 6 months had to be improved (reduced) by ≥ 1 grade compared with the average of the Evaluating Investigator pre-treatment assessments. | Participants from the Modified-intent-to-treat (MITT) population, all participants randomized to treatment who received treatment and all participants randomized to "no treatment" control arm, with data available for analysis. | Posted | Number | 95% Confidence Interval | percentage of responders | 6 months |
|
30 days after repeat treatment (Up to 28 months)
Only device- or procedure-related Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at >5% frequency are reported. More than 1 event can occur in 1 participant.
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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 | All Treated Participants_ AEs Initial Treatment | All participants in the original VOLUMA® XC Treatment Arm and all participants in the No Treatment then VOLUMA® XC Arm (who received delayed treatment) treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). AEs reported are AEs with onset prior to retreatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inflammation | General disorders | MedDRA 15.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site mass | General disorders | MedDRA 15.0 | Systematic Assessment | Administration site condition |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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| 24 Months |
| Responder Rate Based on Improvement in Score on Global Aesthetic Improvement Scale (GAIS) | The investigator evaluated the patient's overall mid-face volume using the GAIS 5-point scale where: 2=much improved to -2=much worse. To be considered a "responder," the average of the blinded, independent Evaluating Investigators' assessments of the participant's overall score on GAIS at 6 months had to be improved (reduced) by ≥ 1 grade compared with the average of the Evaluating Investigator pre-treatment assessments. | 6 months |
| Responder Rate Based on Improvement in Score on MFVDS by Facial Region | The investigator evaluated the volume deficit of the patient's face using the MFVDS 6-point scale where: 0=none (best) to 5=severe (worst). To be considered a "responder," the average of the blinded, independent Evaluating Investigators' assessments of the participant's respective mid-facial area score on MFVDS at 6 months had to be improved (reduced) by ≥ 1 grade compared with the average of the Evaluating Investigator pre-treatment assessments. The percentage of responders is categorized by facial region. | 6 months |
| Vancouver |
| British Columbia |
| Canada |
| Lost to Follow-up |
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| Adverse Event |
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| Discontinuation by Investigator/Sponsor |
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| Consent withdrawn |
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| Other Miscellaneous Reasons |
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| NOT COMPLETED |
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No treatment for 6 months, then participants were treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). Participants were eligible for re-treatment if applicable. |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable. |
| OG001 | Control Arm_No Treatment Then VOLUMA® XC | No treatment for 6 months, then participants were treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). Participants were eligible for re-treatment if applicable. |
|
|
| Secondary | Duration of Treatment Effect | Duration of treatment effect was determined by Kaplan-Meier (KM) product limit estimate of the percentage of participants in the treatment group that maintained at least a 1-point improvement in the overall mid-face volume deficit score on the Mid-Face Volume Deficit Scale (MFVDS) based on the average of the 2 blinded Evaluating Investigators' assessments (with 95% Greenwood's Confidence Interval). | Participants from the Modified-intent-to-treat (MITT) population, all participants randomized to the treatment arm who received treatment and all participants randomized to "no treatment" control arm who received treatment, with data available for analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | 24 Months |
|
|
|
| Secondary | Responder Rate Based on Improvement in Score on Global Aesthetic Improvement Scale (GAIS) | The investigator evaluated the patient's overall mid-face volume using the GAIS 5-point scale where: 2=much improved to -2=much worse. To be considered a "responder," the average of the blinded, independent Evaluating Investigators' assessments of the participant's overall score on GAIS at 6 months had to be improved (reduced) by ≥ 1 grade compared with the average of the Evaluating Investigator pre-treatment assessments. | Only those participants from the Modified-intent-to-treat (MITT) population randomized to the Treatment Arm who received treatment with available data are included in the analysis. | Posted | Number | Percentage of responders | 6 months |
|
|
|
| Secondary | Responder Rate Based on Improvement in Score on MFVDS by Facial Region | The investigator evaluated the volume deficit of the patient's face using the MFVDS 6-point scale where: 0=none (best) to 5=severe (worst). To be considered a "responder," the average of the blinded, independent Evaluating Investigators' assessments of the participant's respective mid-facial area score on MFVDS at 6 months had to be improved (reduced) by ≥ 1 grade compared with the average of the Evaluating Investigator pre-treatment assessments. The percentage of responders is categorized by facial region. | Only those participants from the Modified-intent-to-treat (MITT) population randomized to the Treatment Arm who received treatment with available data are included in the analysis. | Posted | Number | percentage of responders | 6 months |
|
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| 11 |
| 270 |
| 98 |
| 270 |
| EG001 | All Treated Participants_ AEs After Repeat Treatment | All participants in the original VOLUMA® XC Treatment Arm and all participants in the No Treatment then VOLUMA® XC Arm (who received delayed treatment) treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) and who received re-treatment. AEs reported are AEs with onset after retreatment. | 2 | 167 | 15 | 167 |
| Injection site mass | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
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| Carcinoid tumour pulmonary | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
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| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
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| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
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| Optic ischaemic neuropathy | Eye disorders | MedDRA 15.1 | Systematic Assessment |
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| Optic neuropathy | Eye disorders | MedDRA 15.1 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Skin mass | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Hip fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
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| Injection site induration | General disorders | MedDRA 15.1 | Systematic Assessment | Administration site condition |
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| Injection site swelling | General disorders | MedDRA 15.1 | Systematic Assessment | Administration site condition |
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| Injection site pain | General disorders | MedDRA 15.1 | Systematic Assessment | Administration site condition |
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As this study involves multiple centers, no individual publications will be allowed prior to completion of the final report of the multicenter study except as agreed with Allergan.
| Title | Measurements |
|---|---|
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