T
he FDA approved Allergan Inc’s JUVÉDERM VOLUMA™ XC in October 2013 for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face in adults age 21 and older. The product is a smooth, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid (HA) produced by Streptococcus equi bacteria, formulated to a concentration of 20 mg/mL.1
HA is a naturally occurring sugar found in the human body. The role of HA in the skin is to deliver nutrients and to help the skin retain its natural moisture and softness, according to the product’s patient labeling. As individual’s age, the cheek area can lose some of its youthful shape, causing the cheeks to flatten out and the skin to droop and sag. JUVÉDERM VOLUMA™ XC is a non-surgical option for patients desiring volume in the cheek area to correct age-related volume loss. The gel is made with Allergan’s proprietary VYCROSS™ technology, a manufacturing process that results in a smooth gel that flows consistently. This formulation contributes to the lift capacity to correct volume loss in the cheek area and to the duration of the product. Furthermore, the product contains a small quantity of lidocaine to help numb the treatment area during the injection procedure, according to a company.
The FDA approved JUVÉDERM VOLUMA™ XC based on a pivotal clinical trial in the United States and Canada assessing the safety and effectiveness of the injectable gel. The trial demonstrated that it was an effective treatment compared to the control group, which did not receive treatment. Furthermore, clinical benefit was observed up to 2 years.1,2
The Dermatologist Product Spotlight provides a summary of the pivotal trial that evaluated the safety and efficacy of JUVÉDERM VOLUMA™ XC to temporarily correct age-related volume loss in the cheek area.
Pivotal Trial
JUVÉDERM VOLUMA™ XC [directions for use]. Irvine, CA: Allergan Inc.; 2013.1
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;39(11):1602-1612.2
Study Objective
To study the safety and effectiveness of the 20-mg/mL HA filler JUVÉDERM VOLUMA™ XC for cheek augmentation to correct age-related volume deficit in the mid-face.1,2
Method
The multicenter, single-blind, randomized, controlled, pivotal trial was conducted at 13 US sites and 2 Canadian sites, each of which had a treating investigator and 2 blinded evaluating investigators. The treating investigators discussed treatment goals with the patients, performed the treatments and monitored patient safety throughout the study, and blinded evaluating investigators performed all effectiveness measures. At the FDA’s request, 3 facial subregions for treatment were defined: the zygomaticomalar region, the anteromedial cheek and the submalar region.2
The patients were randomized to treatment or no-treatment control in a 5:3:1 ratio. The treatment group underwent treatment with JUVÉDERM VOLUMA™ XC at the outset of the study. Up to 2 treatments approximately 1-month apart (initial treatment and up to 1 touch-up treatment) were allowed. The treating investigator determined the appropriate volume of JUVÉDERM VOLUMA™ XC to be injected in the 3 subregions of the mid-face. The control group had treatment delayed for 6 months.1
The patients completed 30-day diaries after each treatment to record incidence, severity and duration of prespecified common treatment site responses and attended follow-up visits at months 1 and 3 and then quarterly for up to 24 months. Between 12 and 24 months, the patients could receive optimal repeat treatment if they had lost their correction in all regions; any patient who did not receive treatment by month 24 was eligible to receive it at that time regardless of the correction maintained at that visit.2
Population
A total of 345 patients were enrolled in the study: 16 were screen failures primarily due to ineligibility, 30 were run-in patients and 17 discontinued after randomization but before treatment, resulting in 282 patients. Of these patients, 235 were randomized to the treatment group and 47 to the control group.1,2 Inclusion criteria included patients age 35 to 65 who wanted cheek augmentation to correct moderate, significant or severe age-related mid-face volume deficit (MVD). Patients were ineligible if they had undergone cosmetic facial plastic surgery (with the exception of rhinoplasty more than 2 years before enrollment), tissue grafting or tissue augmentation with silicone, fat or permanent or semi-permanent dermal fillers. Mandatory facial treatment washout periods before study entry were 24 months for porcine-based collagen fillers, 12 months for HA fillers and 6 months for neuromodulator injections, mesotherapy or resurfacing. The study population was primarily female (80.1%) and of Caucasian descent, with a median age of 55 years.
Anesthesia was administered to 66.0% of patients in preparation for their initial treatment, with the most common being topical agents applied an average of 27 minutes before treatment and ice applied for an average of 23 minutes. More than 90% of patients received treatment in all 3 facial subregions. Multiple injection techniques were used with the most common being tunneling, fanning and serial puncture. The majority of patients received a touch-up treatment 30 days after initial treatment. The overall total injection volume used to achieve optimal correction for all 3 subregions ranged from 1.2 mL to 13.9 mL, with a median of 6.6 mL.1,2
Primary Endpoint
• Average of the 2 blinded independent evaluating investigators’ live assessment of the subject’s overall MVD on the validated 6-point photometric Mid-Face Volume Deficit Scale (MFVDS). A responder was defined as a patient with ≥1 grade improvement in the average MFVDS score since baseline.1,2
Secondary Endpoint
• MFVDS responder rate in each facial subregion and the responder rate on the 5-point Global Aesthetic Improvement Scale (GAIS), both based on the average of the evaluating investigators’ assessments at month 6.2
Results
The researchers concluded that is JUVÉDERM VOLUMA™ XC is an effective treatment for age-related MVD, with correction lasting up to 2 years. The primary endpoint was met, with 85.6% of the treatment group improving by ≥1 on the MFVDS at month 6, and there was a statistically significant difference (P<.001) between the treatment and no-treatment control group responder rates. Month 6 MFVDS responder rates were also high for the facial subregions: 75.5% for zygomaticomalar, 83.2% for anteromedial and 76.9% for submalar. Furthermore, duration of effectiveness calculated using Kaplan-Meier analysis based on evaluating investigators’ assessments of overall MFVDS showed that 73.9% of patients were still responders at 1 year and that 44.6% were responders at 2 years. On the GAIS, 82.2% of investigators and 92.8% of patients rated mid-face volume as improved or much improved at 6 months.2
Safety Notes
JUVÉDERM VOLUMA™ XC was well-tolerated, with no unanticipated adverse device effects. Treatment site responses most frequently reported in patient diaries following initial treatment were tenderness (92.1%), swelling (85.7%), firmness (82.3%) and lumps or bumps (81.1%). A majority of the patients (80.7%) had responses that were mild to moderate in severity and lasted 2 weeks or less. Treatment site responses reported in participant diaries that lasted longer than 30 days were considered adverse events (AEs). AEs were also reported by the treating investigator at all follow-up visits where applicable. Treatment-related AEs reported in >5% of patients were injection site mass (lumps or bumps, 18.9%), injection site induration (firmness, 14.1%), injection site swelling (7.0%) and injection site pain (5.9%). These were predominately mild to moderate in severity, and all but 1 resolved.2
Two patients experienced severe AEs requiring treatment. The first patient reported lumps 7 months after the last treatment. The second patient suffered a scratch from a tree branch under the left eye. The next day it was diagnosed as cellulitis, and as the event progressed, the patient reported nodularity in the right cheek area. Treatment of severe AEs included antibiotics, anti-inflammatories and hyaluronidase, and all the events resolved without sequelae.2
Additional Resource
Directions for use for JUVÉDERM VOLUMA™ XC: https://www.allergan.com/Assets/pdf/juvederm_voluma_xc_dfu.pdf.
T
he FDA approved Allergan Inc’s JUVÉDERM VOLUMA™ XC in October 2013 for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face in adults age 21 and older. The product is a smooth, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid (HA) produced by Streptococcus equi bacteria, formulated to a concentration of 20 mg/mL.1
HA is a naturally occurring sugar found in the human body. The role of HA in the skin is to deliver nutrients and to help the skin retain its natural moisture and softness, according to the product’s patient labeling. As individual’s age, the cheek area can lose some of its youthful shape, causing the cheeks to flatten out and the skin to droop and sag. JUVÉDERM VOLUMA™ XC is a non-surgical option for patients desiring volume in the cheek area to correct age-related volume loss. The gel is made with Allergan’s proprietary VYCROSS™ technology, a manufacturing process that results in a smooth gel that flows consistently. This formulation contributes to the lift capacity to correct volume loss in the cheek area and to the duration of the product. Furthermore, the product contains a small quantity of lidocaine to help numb the treatment area during the injection procedure, according to a company.
The FDA approved JUVÉDERM VOLUMA™ XC based on a pivotal clinical trial in the United States and Canada assessing the safety and effectiveness of the injectable gel. The trial demonstrated that it was an effective treatment compared to the control group, which did not receive treatment. Furthermore, clinical benefit was observed up to 2 years.1,2
The Dermatologist Product Spotlight provides a summary of the pivotal trial that evaluated the safety and efficacy of JUVÉDERM VOLUMA™ XC to temporarily correct age-related volume loss in the cheek area.
Pivotal Trial
JUVÉDERM VOLUMA™ XC [directions for use]. Irvine, CA: Allergan Inc.; 2013.1
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;39(11):1602-1612.2
Study Objective
To study the safety and effectiveness of the 20-mg/mL HA filler JUVÉDERM VOLUMA™ XC for cheek augmentation to correct age-related volume deficit in the mid-face.1,2
Method
The multicenter, single-blind, randomized, controlled, pivotal trial was conducted at 13 US sites and 2 Canadian sites, each of which had a treating investigator and 2 blinded evaluating investigators. The treating investigators discussed treatment goals with the patients, performed the treatments and monitored patient safety throughout the study, and blinded evaluating investigators performed all effectiveness measures. At the FDA’s request, 3 facial subregions for treatment were defined: the zygomaticomalar region, the anteromedial cheek and the submalar region.2
The patients were randomized to treatment or no-treatment control in a 5:3:1 ratio. The treatment group underwent treatment with JUVÉDERM VOLUMA™ XC at the outset of the study. Up to 2 treatments approximately 1-month apart (initial treatment and up to 1 touch-up treatment) were allowed. The treating investigator determined the appropriate volume of JUVÉDERM VOLUMA™ XC to be injected in the 3 subregions of the mid-face. The control group had treatment delayed for 6 months.1
The patients completed 30-day diaries after each treatment to record incidence, severity and duration of prespecified common treatment site responses and attended follow-up visits at months 1 and 3 and then quarterly for up to 24 months. Between 12 and 24 months, the patients could receive optimal repeat treatment if they had lost their correction in all regions; any patient who did not receive treatment by month 24 was eligible to receive it at that time regardless of the correction maintained at that visit.2
Population
A total of 345 patients were enrolled in the study: 16 were screen failures primarily due to ineligibility, 30 were run-in patients and 17 discontinued after randomization but before treatment, resulting in 282 patients. Of these patients, 235 were randomized to the treatment group and 47 to the control group.1,2 Inclusion criteria included patients age 35 to 65 who wanted cheek augmentation to correct moderate, significant or severe age-related mid-face volume deficit (MVD). Patients were ineligible if they had undergone cosmetic facial plastic surgery (with the exception of rhinoplasty more than 2 years before enrollment), tissue grafting or tissue augmentation with silicone, fat or permanent or semi-permanent dermal fillers. Mandatory facial treatment washout periods before study entry were 24 months for porcine-based collagen fillers, 12 months for HA fillers and 6 months for neuromodulator injections, mesotherapy or resurfacing. The study population was primarily female (80.1%) and of Caucasian descent, with a median age of 55 years.
Anesthesia was administered to 66.0% of patients in preparation for their initial treatment, with the most common being topical agents applied an average of 27 minutes before treatment and ice applied for an average of 23 minutes. More than 90% of patients received treatment in all 3 facial subregions. Multiple injection techniques were used with the most common being tunneling, fanning and serial puncture. The majority of patients received a touch-up treatment 30 days after initial treatment. The overall total injection volume used to achieve optimal correction for all 3 subregions ranged from 1.2 mL to 13.9 mL, with a median of 6.6 mL.1,2
Primary Endpoint
• Average of the 2 blinded independent evaluating investigators’ live assessment of the subject’s overall MVD on the validated 6-point photometric Mid-Face Volume Deficit Scale (MFVDS). A responder was defined as a patient with ≥1 grade improvement in the average MFVDS score since baseline.1,2
Secondary Endpoint
• MFVDS responder rate in each facial subregion and the responder rate on the 5-point Global Aesthetic Improvement Scale (GAIS), both based on the average of the evaluating investigators’ assessments at month 6.2
Results
The researchers concluded that is JUVÉDERM VOLUMA™ XC is an effective treatment for age-related MVD, with correction lasting up to 2 years. The primary endpoint was met, with 85.6% of the treatment group improving by ≥1 on the MFVDS at month 6, and there was a statistically significant difference (P<.001) between the treatment and no-treatment control group responder rates. Month 6 MFVDS responder rates were also high for the facial subregions: 75.5% for zygomaticomalar, 83.2% for anteromedial and 76.9% for submalar. Furthermore, duration of effectiveness calculated using Kaplan-Meier analysis based on evaluating investigators’ assessments of overall MFVDS showed that 73.9% of patients were still responders at 1 year and that 44.6% were responders at 2 years. On the GAIS, 82.2% of investigators and 92.8% of patients rated mid-face volume as improved or much improved at 6 months.2
Safety Notes
JUVÉDERM VOLUMA™ XC was well-tolerated, with no unanticipated adverse device effects. Treatment site responses most frequently reported in patient diaries following initial treatment were tenderness (92.1%), swelling (85.7%), firmness (82.3%) and lumps or bumps (81.1%). A majority of the patients (80.7%) had responses that were mild to moderate in severity and lasted 2 weeks or less. Treatment site responses reported in participant diaries that lasted longer than 30 days were considered adverse events (AEs). AEs were also reported by the treating investigator at all follow-up visits where applicable. Treatment-related AEs reported in >5% of patients were injection site mass (lumps or bumps, 18.9%), injection site induration (firmness, 14.1%), injection site swelling (7.0%) and injection site pain (5.9%). These were predominately mild to moderate in severity, and all but 1 resolved.2
Two patients experienced severe AEs requiring treatment. The first patient reported lumps 7 months after the last treatment. The second patient suffered a scratch from a tree branch under the left eye. The next day it was diagnosed as cellulitis, and as the event progressed, the patient reported nodularity in the right cheek area. Treatment of severe AEs included antibiotics, anti-inflammatories and hyaluronidase, and all the events resolved without sequelae.2
Additional Resource
Directions for use for JUVÉDERM VOLUMA™ XC: https://www.allergan.com/Assets/pdf/juvederm_voluma_xc_dfu.pdf.
The FDA approved Allergan Inc’s JUVÉDERM VOLUMA™ XC in October 2013 for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face in adults age 21 and older. The product is a smooth, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid (HA) produced by Streptococcus equi bacteria, formulated to a concentration of 20 mg/mL.1
HA is a naturally occurring sugar found in the human body. The role of HA in the skin is to deliver nutrients and to help the skin retain its natural moisture and softness, according to the product’s patient labeling. As individual’s age, the cheek area can lose some of its youthful shape, causing the cheeks to flatten out and the skin to droop and sag. JUVÉDERM VOLUMA™ XC is a non-surgical option for patients desiring volume in the cheek area to correct age-related volume loss. The gel is made with Allergan’s proprietary VYCROSS™ technology, a manufacturing process that results in a smooth gel that flows consistently. This formulation contributes to the lift capacity to correct volume loss in the cheek area and to the duration of the product. Furthermore, the product contains a small quantity of lidocaine to help numb the treatment area during the injection procedure, according to a company.
The FDA approved JUVÉDERM VOLUMA™ XC based on a pivotal clinical trial in the United States and Canada assessing the safety and effectiveness of the injectable gel. The trial demonstrated that it was an effective treatment compared to the control group, which did not receive treatment. Furthermore, clinical benefit was observed up to 2 years.1,2
The Dermatologist Product Spotlight provides a summary of the pivotal trial that evaluated the safety and efficacy of JUVÉDERM VOLUMA™ XC to temporarily correct age-related volume loss in the cheek area.
Pivotal Trial
JUVÉDERM VOLUMA™ XC [directions for use]. Irvine, CA: Allergan Inc.; 2013.1
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;39(11):1602-1612.2
Study Objective
To study the safety and effectiveness of the 20-mg/mL HA filler JUVÉDERM VOLUMA™ XC for cheek augmentation to correct age-related volume deficit in the mid-face.1,2
Method
The multicenter, single-blind, randomized, controlled, pivotal trial was conducted at 13 US sites and 2 Canadian sites, each of which had a treating investigator and 2 blinded evaluating investigators. The treating investigators discussed treatment goals with the patients, performed the treatments and monitored patient safety throughout the study, and blinded evaluating investigators performed all effectiveness measures. At the FDA’s request, 3 facial subregions for treatment were defined: the zygomaticomalar region, the anteromedial cheek and the submalar region.2
The patients were randomized to treatment or no-treatment control in a 5:3:1 ratio. The treatment group underwent treatment with JUVÉDERM VOLUMA™ XC at the outset of the study. Up to 2 treatments approximately 1-month apart (initial treatment and up to 1 touch-up treatment) were allowed. The treating investigator determined the appropriate volume of JUVÉDERM VOLUMA™ XC to be injected in the 3 subregions of the mid-face. The control group had treatment delayed for 6 months.1
The patients completed 30-day diaries after each treatment to record incidence, severity and duration of prespecified common treatment site responses and attended follow-up visits at months 1 and 3 and then quarterly for up to 24 months. Between 12 and 24 months, the patients could receive optimal repeat treatment if they had lost their correction in all regions; any patient who did not receive treatment by month 24 was eligible to receive it at that time regardless of the correction maintained at that visit.2
Population
A total of 345 patients were enrolled in the study: 16 were screen failures primarily due to ineligibility, 30 were run-in patients and 17 discontinued after randomization but before treatment, resulting in 282 patients. Of these patients, 235 were randomized to the treatment group and 47 to the control group.1,2 Inclusion criteria included patients age 35 to 65 who wanted cheek augmentation to correct moderate, significant or severe age-related mid-face volume deficit (MVD). Patients were ineligible if they had undergone cosmetic facial plastic surgery (with the exception of rhinoplasty more than 2 years before enrollment), tissue grafting or tissue augmentation with silicone, fat or permanent or semi-permanent dermal fillers. Mandatory facial treatment washout periods before study entry were 24 months for porcine-based collagen fillers, 12 months for HA fillers and 6 months for neuromodulator injections, mesotherapy or resurfacing. The study population was primarily female (80.1%) and of Caucasian descent, with a median age of 55 years.
Anesthesia was administered to 66.0% of patients in preparation for their initial treatment, with the most common being topical agents applied an average of 27 minutes before treatment and ice applied for an average of 23 minutes. More than 90% of patients received treatment in all 3 facial subregions. Multiple injection techniques were used with the most common being tunneling, fanning and serial puncture. The majority of patients received a touch-up treatment 30 days after initial treatment. The overall total injection volume used to achieve optimal correction for all 3 subregions ranged from 1.2 mL to 13.9 mL, with a median of 6.6 mL.1,2
Primary Endpoint
• Average of the 2 blinded independent evaluating investigators’ live assessment of the subject’s overall MVD on the validated 6-point photometric Mid-Face Volume Deficit Scale (MFVDS). A responder was defined as a patient with ≥1 grade improvement in the average MFVDS score since baseline.1,2
Secondary Endpoint
• MFVDS responder rate in each facial subregion and the responder rate on the 5-point Global Aesthetic Improvement Scale (GAIS), both based on the average of the evaluating investigators’ assessments at month 6.2
Results
The researchers concluded that is JUVÉDERM VOLUMA™ XC is an effective treatment for age-related MVD, with correction lasting up to 2 years. The primary endpoint was met, with 85.6% of the treatment group improving by ≥1 on the MFVDS at month 6, and there was a statistically significant difference (P<.001) between the treatment and no-treatment control group responder rates. Month 6 MFVDS responder rates were also high for the facial subregions: 75.5% for zygomaticomalar, 83.2% for anteromedial and 76.9% for submalar. Furthermore, duration of effectiveness calculated using Kaplan-Meier analysis based on evaluating investigators’ assessments of overall MFVDS showed that 73.9% of patients were still responders at 1 year and that 44.6% were responders at 2 years. On the GAIS, 82.2% of investigators and 92.8% of patients rated mid-face volume as improved or much improved at 6 months.2
Safety Notes
JUVÉDERM VOLUMA™ XC was well-tolerated, with no unanticipated adverse device effects. Treatment site responses most frequently reported in patient diaries following initial treatment were tenderness (92.1%), swelling (85.7%), firmness (82.3%) and lumps or bumps (81.1%). A majority of the patients (80.7%) had responses that were mild to moderate in severity and lasted 2 weeks or less. Treatment site responses reported in participant diaries that lasted longer than 30 days were considered adverse events (AEs). AEs were also reported by the treating investigator at all follow-up visits where applicable. Treatment-related AEs reported in >5% of patients were injection site mass (lumps or bumps, 18.9%), injection site induration (firmness, 14.1%), injection site swelling (7.0%) and injection site pain (5.9%). These were predominately mild to moderate in severity, and all but 1 resolved.2
Two patients experienced severe AEs requiring treatment. The first patient reported lumps 7 months after the last treatment. The second patient suffered a scratch from a tree branch under the left eye. The next day it was diagnosed as cellulitis, and as the event progressed, the patient reported nodularity in the right cheek area. Treatment of severe AEs included antibiotics, anti-inflammatories and hyaluronidase, and all the events resolved without sequelae.2
Additional Resource
Directions for use for JUVÉDERM VOLUMA™ XC: https://www.allergan.com/Assets/pdf/juvederm_voluma_xc_dfu.pdf.
