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Most patients who responded to surveys reported being satisfied after off-label treatment with Juvéderm Voluma XC hyaluronic acid filler for infraorbital hollowing, a study finds.

Adverse effects were reported in 12% of patients.

The treatment’s “high patient satisfaction profile and a similar safety profile among other soft-tissue fillers make it an excellent adjunct in the plastic surgeon’s armamentarium,” reported Michael B. Hall, MD, and his associates at their private, ambulatory facial plastic and reconstructive surgery practice in Austin, Texas, in JAMA Facial Plastic Surgery.

According to the researchers, the Food and Drug Administration has not approved any soft-tissue fillers for the periorbital complex. At their practice, Dr. Hall and his associates treat infraorbital hollows with Juvéderm Voluma XC, which is approved by the FDA for certain types of cheek augmentation. Other studies have examined Belotero or Restylane as treatments for building volume in the periorbital area, the authors wrote, but research into cosmetic injections of Juvéderm Voluma XC is lacking.

For the new study, the researchers retrospectively analyzed the cases of 101 patients (aged 32-75 years, with average age of 54 years; 89% female; 54% Fitzpatrick skin type II; racial breakdown not reported) who were electively treated with the filler for infraorbital hollowing in 2016 and 2017. The patients received an average 1 mL of the treatment gel.

The patients were photographed and answered surveys, and they were evaluated using the Allergan Infraorbital Hollows Scale. Follow-up time averaged 12 months.

A total of 18 patients (18%) required touch-up within 3 months, and 2 required multiple touch-ups. A total of 12 subjects (12%) had adverse effects (including 3 who had more than one), which included bruising (10%), contour irregularities (2%), edema (3%) and Tyndall effect (1%). Hyaluronidase was required in 3 patients (3%), and 24 patients sought further treatment after 3 months.

 

 


The researchers sent two satisfaction surveys to the participants. A total of 41% responded to the FACE-Q Satisfaction With Eyes survey, and 42% responded to the FACE-Q Satisfaction With Decision survey.

Depending on the question, 70%-85% of the respondents to the Satisfaction With Eyes survey said they were “definitely” or “somewhat” satisfied with the treatment outcome.

The highest levels of dissatisfaction came in response to a questions about whether the subjects felt their eyes looked alert (not tired) or youthful. The highest levels of satisfaction were in response to questions about whether the subjects were happy with the shape, attractiveness, and openness of their eyes.

Depending on the question, 73%-85% of the subjects who took the Satisfaction With Decision survey reported that they “definitely” or “somewhat” agree with positive statements about the treatment. While differences were small, they agreed the most with a statement saying the procedure was “worth the time and effort.”

No external funding or remuneration was received. The study authors reported no relevant disclosures.
 

SOURCE: Hall MB et al. JAMA Facial Plast Surg. 2018 Apr 5. doi:10.1001/jamafacial.2018.0230.

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Most patients who responded to surveys reported being satisfied after off-label treatment with Juvéderm Voluma XC hyaluronic acid filler for infraorbital hollowing, a study finds.

Adverse effects were reported in 12% of patients.

The treatment’s “high patient satisfaction profile and a similar safety profile among other soft-tissue fillers make it an excellent adjunct in the plastic surgeon’s armamentarium,” reported Michael B. Hall, MD, and his associates at their private, ambulatory facial plastic and reconstructive surgery practice in Austin, Texas, in JAMA Facial Plastic Surgery.

According to the researchers, the Food and Drug Administration has not approved any soft-tissue fillers for the periorbital complex. At their practice, Dr. Hall and his associates treat infraorbital hollows with Juvéderm Voluma XC, which is approved by the FDA for certain types of cheek augmentation. Other studies have examined Belotero or Restylane as treatments for building volume in the periorbital area, the authors wrote, but research into cosmetic injections of Juvéderm Voluma XC is lacking.

For the new study, the researchers retrospectively analyzed the cases of 101 patients (aged 32-75 years, with average age of 54 years; 89% female; 54% Fitzpatrick skin type II; racial breakdown not reported) who were electively treated with the filler for infraorbital hollowing in 2016 and 2017. The patients received an average 1 mL of the treatment gel.

The patients were photographed and answered surveys, and they were evaluated using the Allergan Infraorbital Hollows Scale. Follow-up time averaged 12 months.

A total of 18 patients (18%) required touch-up within 3 months, and 2 required multiple touch-ups. A total of 12 subjects (12%) had adverse effects (including 3 who had more than one), which included bruising (10%), contour irregularities (2%), edema (3%) and Tyndall effect (1%). Hyaluronidase was required in 3 patients (3%), and 24 patients sought further treatment after 3 months.

 

 


The researchers sent two satisfaction surveys to the participants. A total of 41% responded to the FACE-Q Satisfaction With Eyes survey, and 42% responded to the FACE-Q Satisfaction With Decision survey.

Depending on the question, 70%-85% of the respondents to the Satisfaction With Eyes survey said they were “definitely” or “somewhat” satisfied with the treatment outcome.

The highest levels of dissatisfaction came in response to a questions about whether the subjects felt their eyes looked alert (not tired) or youthful. The highest levels of satisfaction were in response to questions about whether the subjects were happy with the shape, attractiveness, and openness of their eyes.

Depending on the question, 73%-85% of the subjects who took the Satisfaction With Decision survey reported that they “definitely” or “somewhat” agree with positive statements about the treatment. While differences were small, they agreed the most with a statement saying the procedure was “worth the time and effort.”

No external funding or remuneration was received. The study authors reported no relevant disclosures.
 

SOURCE: Hall MB et al. JAMA Facial Plast Surg. 2018 Apr 5. doi:10.1001/jamafacial.2018.0230.

 

Most patients who responded to surveys reported being satisfied after off-label treatment with Juvéderm Voluma XC hyaluronic acid filler for infraorbital hollowing, a study finds.

Adverse effects were reported in 12% of patients.

The treatment’s “high patient satisfaction profile and a similar safety profile among other soft-tissue fillers make it an excellent adjunct in the plastic surgeon’s armamentarium,” reported Michael B. Hall, MD, and his associates at their private, ambulatory facial plastic and reconstructive surgery practice in Austin, Texas, in JAMA Facial Plastic Surgery.

According to the researchers, the Food and Drug Administration has not approved any soft-tissue fillers for the periorbital complex. At their practice, Dr. Hall and his associates treat infraorbital hollows with Juvéderm Voluma XC, which is approved by the FDA for certain types of cheek augmentation. Other studies have examined Belotero or Restylane as treatments for building volume in the periorbital area, the authors wrote, but research into cosmetic injections of Juvéderm Voluma XC is lacking.

For the new study, the researchers retrospectively analyzed the cases of 101 patients (aged 32-75 years, with average age of 54 years; 89% female; 54% Fitzpatrick skin type II; racial breakdown not reported) who were electively treated with the filler for infraorbital hollowing in 2016 and 2017. The patients received an average 1 mL of the treatment gel.

The patients were photographed and answered surveys, and they were evaluated using the Allergan Infraorbital Hollows Scale. Follow-up time averaged 12 months.

A total of 18 patients (18%) required touch-up within 3 months, and 2 required multiple touch-ups. A total of 12 subjects (12%) had adverse effects (including 3 who had more than one), which included bruising (10%), contour irregularities (2%), edema (3%) and Tyndall effect (1%). Hyaluronidase was required in 3 patients (3%), and 24 patients sought further treatment after 3 months.

 

 


The researchers sent two satisfaction surveys to the participants. A total of 41% responded to the FACE-Q Satisfaction With Eyes survey, and 42% responded to the FACE-Q Satisfaction With Decision survey.

Depending on the question, 70%-85% of the respondents to the Satisfaction With Eyes survey said they were “definitely” or “somewhat” satisfied with the treatment outcome.

The highest levels of dissatisfaction came in response to a questions about whether the subjects felt their eyes looked alert (not tired) or youthful. The highest levels of satisfaction were in response to questions about whether the subjects were happy with the shape, attractiveness, and openness of their eyes.

Depending on the question, 73%-85% of the subjects who took the Satisfaction With Decision survey reported that they “definitely” or “somewhat” agree with positive statements about the treatment. While differences were small, they agreed the most with a statement saying the procedure was “worth the time and effort.”

No external funding or remuneration was received. The study authors reported no relevant disclosures.
 

SOURCE: Hall MB et al. JAMA Facial Plast Surg. 2018 Apr 5. doi:10.1001/jamafacial.2018.0230.

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Key clinical point: Few adverse effects are reported after off-label use of hyaluronic acid filler for infraorbital hollowing, and responding subjects report overall satisfaction.

Major finding: Adverse effects occurred at a rate of 12%, and most who responded to surveys reported satisfaction postprocedure (70%-85%).

Study details: A retrospective observational study of 101 patients.

Disclosures: No external funding or remuneration was received. The study authors reported no relevant disclosures.

Source: Hall MB et al. JAMA Facial Plast Surg. 2018 Apr 5. doi:10.1001/jamafacial.2018.0230.

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