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Volumizing effects of a smooth, highly cohesive, viscous 20-mg/mL hyaluronic acid volumizing filler: prospective European study.

Hoffmann K, Juvéderm Voluma Study Investigators Gro - BMC Dermatol. (2009)

Bottom Line: Facial volume loss contributes significantly to facial aging.Procedural details, aesthetic outcomes, safety, and physician and patient ratings of their experience were recorded.The 20-mg/mL smooth, highly cohesive, viscous, volumizing HA filler was effective, well tolerated, and easy to use in current clinical practice.

View Article: PubMed Central - HTML - PubMed

Affiliation: Ruhr-University Bochum, St, Josef Hospital, Bochum, Germany. K.Hoffmann@derma.de

ABSTRACT

Background: Facial volume loss contributes significantly to facial aging. The 20-mg/mL hyaluronic acid (HA) formulation used in this study is a smooth, highly cohesive, viscous, fully reversible, volumizing filler indicated to restore facial volume. This first prospective study evaluated use in current aesthetic clinical practice.

Methods: A pan-European evaluation conducted under guidelines of the World Association of Opinion and Marketing Research, the trial comprised a baseline visit (visit 1) and a follow-up (visit 2) at 14 +/- 7 days posttreatment. Physicians photographed patients at each visit. Each patient was treated with the 20-mg/mL HA volumizing filler as supplied in standard packaging. Procedural details, aesthetic outcomes, safety, and physician and patient ratings of their experience were recorded.

Results: Fifteen physicians and 70 patients (91% female; mean age: 50 years) participated. Mean volume loss at baseline was 3.7 (moderate) on the Facial Volume Loss Scale. Local anesthesia was used in 64.3% of cases. Most injections (85%) were administered with needles rather than cannulas. Of the 208 injections, 59% were in the malar region, primarily above the periosteum. Subcutaneous injections were most common for other sites. The mean total injection volume per patient was 4.6 mL. The mean volume loss score declined significantly (P < .001) to 2.1 at visit 2. On the Global Aesthetic Improvement Scale, 88% and 76% of the treatments were rated very much improved or much improved by physicians and patients, respectively. Of the physicians, 95.6% rated this HA filler as very or fairly easy to use. Similarly, 92% of patients were very likely or quite likely to return for treatment; nearly all (98%) would recommend this treatment to friends. Transient (mean duration: 5.5 days) injection-site adverse events (AEs) occurred in 24 patients. Bruising was the most common AE.

Conclusion: The 20-mg/mL smooth, highly cohesive, viscous, volumizing HA filler was effective, well tolerated, and easy to use in current clinical practice. Participants were very likely to recommend this product to colleagues and friends, and patients would be very or quite likely to request this product for future treatments.

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Related in: MedlinePlus

Study flow and treatment.
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Figure 1: Study flow and treatment.

Mentions: The study comprised 2 visits. Visit 1 was the injection day, which took place on day 1. Visit 2 was the follow-up, which took place at day 14 (± 7 days) (Figure 1). Case assessment forms were completed by each investigator at each visit and served as the basis for data collection. This included details on the clinical practice and physician specialty, patient age and sex, and all outcome variables. Pre- and posttreatment digital photography of frontal, lateral, and oblique views were taken at both visits. Patients completed a questionnaire at the second visit to rate their perceptions of their experience.


Volumizing effects of a smooth, highly cohesive, viscous 20-mg/mL hyaluronic acid volumizing filler: prospective European study.

Hoffmann K, Juvéderm Voluma Study Investigators Gro - BMC Dermatol. (2009)

Study flow and treatment.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2749012&req=5

Figure 1: Study flow and treatment.
Mentions: The study comprised 2 visits. Visit 1 was the injection day, which took place on day 1. Visit 2 was the follow-up, which took place at day 14 (± 7 days) (Figure 1). Case assessment forms were completed by each investigator at each visit and served as the basis for data collection. This included details on the clinical practice and physician specialty, patient age and sex, and all outcome variables. Pre- and posttreatment digital photography of frontal, lateral, and oblique views were taken at both visits. Patients completed a questionnaire at the second visit to rate their perceptions of their experience.

Bottom Line: Facial volume loss contributes significantly to facial aging.Procedural details, aesthetic outcomes, safety, and physician and patient ratings of their experience were recorded.The 20-mg/mL smooth, highly cohesive, viscous, volumizing HA filler was effective, well tolerated, and easy to use in current clinical practice.

View Article: PubMed Central - HTML - PubMed

Affiliation: Ruhr-University Bochum, St, Josef Hospital, Bochum, Germany. K.Hoffmann@derma.de

ABSTRACT

Background: Facial volume loss contributes significantly to facial aging. The 20-mg/mL hyaluronic acid (HA) formulation used in this study is a smooth, highly cohesive, viscous, fully reversible, volumizing filler indicated to restore facial volume. This first prospective study evaluated use in current aesthetic clinical practice.

Methods: A pan-European evaluation conducted under guidelines of the World Association of Opinion and Marketing Research, the trial comprised a baseline visit (visit 1) and a follow-up (visit 2) at 14 +/- 7 days posttreatment. Physicians photographed patients at each visit. Each patient was treated with the 20-mg/mL HA volumizing filler as supplied in standard packaging. Procedural details, aesthetic outcomes, safety, and physician and patient ratings of their experience were recorded.

Results: Fifteen physicians and 70 patients (91% female; mean age: 50 years) participated. Mean volume loss at baseline was 3.7 (moderate) on the Facial Volume Loss Scale. Local anesthesia was used in 64.3% of cases. Most injections (85%) were administered with needles rather than cannulas. Of the 208 injections, 59% were in the malar region, primarily above the periosteum. Subcutaneous injections were most common for other sites. The mean total injection volume per patient was 4.6 mL. The mean volume loss score declined significantly (P < .001) to 2.1 at visit 2. On the Global Aesthetic Improvement Scale, 88% and 76% of the treatments were rated very much improved or much improved by physicians and patients, respectively. Of the physicians, 95.6% rated this HA filler as very or fairly easy to use. Similarly, 92% of patients were very likely or quite likely to return for treatment; nearly all (98%) would recommend this treatment to friends. Transient (mean duration: 5.5 days) injection-site adverse events (AEs) occurred in 24 patients. Bruising was the most common AE.

Conclusion: The 20-mg/mL smooth, highly cohesive, viscous, volumizing HA filler was effective, well tolerated, and easy to use in current clinical practice. Participants were very likely to recommend this product to colleagues and friends, and patients would be very or quite likely to request this product for future treatments.

Show MeSH
Related in: MedlinePlus