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Callan et al (Clin Cosmet Investig Dermatol. 2013;6:81-89) reported on the efficacy and safety profile of Juvéderm Voluma (Allergan, Inc) for midface volume deficiency in 103 participants over 24 months. Study participants received treatment with the hyaluronic acid filler to the malar area in 1 or 2 sessions over a 4-week period. An additional treatment was administered at week 78 of the study. At least a 1-point improvement on the midface volume deficit scale (MFVDS) and on the global aesthetic improvement scale (GAIS) was defined as clinically meaningful improvement. Of the 103 participants enrolled, 84% had moderate or significant volume deficiency at baseline. At week 8, 96% were reported to be responders on the MFVDS and 98% deemed themselves responders on the GAIS.
Seventy-two participants completed 24 months of treatment; 45 of these participants did not receive supplementary filler at week 78. Forty-three of the 45 (95.6%) participants were deemed responders on the MFVDS. At end of the study (n=72), 66 participants were either satisfied or very satisfied with the product, with 70 participants indicating that they would recommend the product to others. Adverse events included bruising, swelling, pain/tenderness, erythema, eyelid edema, and vasovagal syncope. Injection-site bruising and swelling were the most commonly reported adverse events. There was a single case of swelling in the left tear trough area, which occurred approximately 17 weeks after the week 4 treatment with the study product and 2 months after bilateral administration of Juvéderm Ultra (Allergan, Inc) to the tear troughs (done outside the study), which was speculated to have led to bilateral hardening of the Juvéderm Voluma implant. Oral prednisolone 5 mg daily was administered over 5 days and Hyalase (sanofi-aventis Australia)(100–150 U) was injected 3 times over a 3-week period. The swelling completely resolved approximately 1 month after the third Hyalase session.
What’s the issue?
Juvéderm Voluma currently is not available in the United States. It differs from other hyaluronic acid fillers in that it has a lower cohesivity but higher gel hardness that results in a more viscous solution. These properties are purported to be more suited for deeper injection in the skin at the deep dermal/subcutaneous level and submuscular/supraperiosteal level, which would allow for higher lift of tissue and volume restoration, while still being injected via a small-diameter needle. Although this filler has been used outside the United States, it will be interesting to see the adaptation and adoption in the US filler market. Is it the future of fillers or another one to add to the toolbox?
Callan et al (Clin Cosmet Investig Dermatol. 2013;6:81-89) reported on the efficacy and safety profile of Juvéderm Voluma (Allergan, Inc) for midface volume deficiency in 103 participants over 24 months. Study participants received treatment with the hyaluronic acid filler to the malar area in 1 or 2 sessions over a 4-week period. An additional treatment was administered at week 78 of the study. At least a 1-point improvement on the midface volume deficit scale (MFVDS) and on the global aesthetic improvement scale (GAIS) was defined as clinically meaningful improvement. Of the 103 participants enrolled, 84% had moderate or significant volume deficiency at baseline. At week 8, 96% were reported to be responders on the MFVDS and 98% deemed themselves responders on the GAIS.
Seventy-two participants completed 24 months of treatment; 45 of these participants did not receive supplementary filler at week 78. Forty-three of the 45 (95.6%) participants were deemed responders on the MFVDS. At end of the study (n=72), 66 participants were either satisfied or very satisfied with the product, with 70 participants indicating that they would recommend the product to others. Adverse events included bruising, swelling, pain/tenderness, erythema, eyelid edema, and vasovagal syncope. Injection-site bruising and swelling were the most commonly reported adverse events. There was a single case of swelling in the left tear trough area, which occurred approximately 17 weeks after the week 4 treatment with the study product and 2 months after bilateral administration of Juvéderm Ultra (Allergan, Inc) to the tear troughs (done outside the study), which was speculated to have led to bilateral hardening of the Juvéderm Voluma implant. Oral prednisolone 5 mg daily was administered over 5 days and Hyalase (sanofi-aventis Australia)(100–150 U) was injected 3 times over a 3-week period. The swelling completely resolved approximately 1 month after the third Hyalase session.
What’s the issue?
Juvéderm Voluma currently is not available in the United States. It differs from other hyaluronic acid fillers in that it has a lower cohesivity but higher gel hardness that results in a more viscous solution. These properties are purported to be more suited for deeper injection in the skin at the deep dermal/subcutaneous level and submuscular/supraperiosteal level, which would allow for higher lift of tissue and volume restoration, while still being injected via a small-diameter needle. Although this filler has been used outside the United States, it will be interesting to see the adaptation and adoption in the US filler market. Is it the future of fillers or another one to add to the toolbox?
Callan et al (Clin Cosmet Investig Dermatol. 2013;6:81-89) reported on the efficacy and safety profile of Juvéderm Voluma (Allergan, Inc) for midface volume deficiency in 103 participants over 24 months. Study participants received treatment with the hyaluronic acid filler to the malar area in 1 or 2 sessions over a 4-week period. An additional treatment was administered at week 78 of the study. At least a 1-point improvement on the midface volume deficit scale (MFVDS) and on the global aesthetic improvement scale (GAIS) was defined as clinically meaningful improvement. Of the 103 participants enrolled, 84% had moderate or significant volume deficiency at baseline. At week 8, 96% were reported to be responders on the MFVDS and 98% deemed themselves responders on the GAIS.
Seventy-two participants completed 24 months of treatment; 45 of these participants did not receive supplementary filler at week 78. Forty-three of the 45 (95.6%) participants were deemed responders on the MFVDS. At end of the study (n=72), 66 participants were either satisfied or very satisfied with the product, with 70 participants indicating that they would recommend the product to others. Adverse events included bruising, swelling, pain/tenderness, erythema, eyelid edema, and vasovagal syncope. Injection-site bruising and swelling were the most commonly reported adverse events. There was a single case of swelling in the left tear trough area, which occurred approximately 17 weeks after the week 4 treatment with the study product and 2 months after bilateral administration of Juvéderm Ultra (Allergan, Inc) to the tear troughs (done outside the study), which was speculated to have led to bilateral hardening of the Juvéderm Voluma implant. Oral prednisolone 5 mg daily was administered over 5 days and Hyalase (sanofi-aventis Australia)(100–150 U) was injected 3 times over a 3-week period. The swelling completely resolved approximately 1 month after the third Hyalase session.
What’s the issue?
Juvéderm Voluma currently is not available in the United States. It differs from other hyaluronic acid fillers in that it has a lower cohesivity but higher gel hardness that results in a more viscous solution. These properties are purported to be more suited for deeper injection in the skin at the deep dermal/subcutaneous level and submuscular/supraperiosteal level, which would allow for higher lift of tissue and volume restoration, while still being injected via a small-diameter needle. Although this filler has been used outside the United States, it will be interesting to see the adaptation and adoption in the US filler market. Is it the future of fillers or another one to add to the toolbox?
