PMID- 19712480
OWN - NLM
STAT- MEDLINE
DCOM- 20091022
LR  - 20220310
IS  - 1471-5945 (Electronic)
IS  - 1471-5945 (Linking)
VI  - 9
DP  - 2009 Aug 27
TI  - Volumizing effects of a smooth, highly cohesive, viscous 20-mg/mL hyaluronic acid 
      volumizing filler: prospective European study.
PG  - 9
LID - 10.1186/1471-5945-9-9 [doi]
AB  - 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.
FAU - Hoffmann, Klaus
AU  - Hoffmann K
AD  - Ruhr-University Bochum, St, Josef Hospital, Bochum, Germany. K.Hoffmann@derma.de
CN  - Juvederm Voluma Study Investigators Group
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20090827
PL  - England
TA  - BMC Dermatol
JT  - BMC dermatology
JID - 100968541
RN  - 0 (Adjuvants, Immunologic)
RN  - 9004-61-9 (Hyaluronic Acid)
SB  - IM
MH  - Adjuvants, Immunologic/*administration & dosage
MH  - *Cosmetic Techniques
MH  - Female
MH  - Humans
MH  - Hyaluronic Acid/*administration & dosage
MH  - Injections
MH  - Male
MH  - Middle Aged
MH  - Patient Satisfaction
MH  - Prospective Studies
MH  - Rejuvenation
MH  - *Skin Aging
PMC - PMC2749012
FIR - Andre, Pierre
IR  - Andre P
FIR - Ascher, Benjamin
IR  - Ascher B
FIR - Bayton, Matilde Sanchez
IR  - Bayton MS
FIR - Etxarri, Ma Teresa Balda
IR  - Etxarri MT
FIR - Gutop, Ekaterina Olegovna
IR  - Gutop EO
FIR - Litvin, Alexey
IR  - Litvin A
FIR - Marini, Leonardo
IR  - Marini L
FIR - Potdevin, Didier
IR  - Potdevin D
FIR - Richards, Adrian M
IR  - Richards AM
FIR - Rowland-Payne, Christopher
IR  - Rowland-Payne C
FIR - Schelke, Leonie W
IR  - Schelke LW
FIR - Sebban, Sandrine
IR  - Sebban S
FIR - Signorini, Massimo
IR  - Signorini M
EDAT- 2009/08/29 09:00
MHDA- 2009/10/23 06:00
PMCR- 2009/08/27
CRDT- 2009/08/29 09:00
PHST- 2008/12/11 00:00 [received]
PHST- 2009/08/27 00:00 [accepted]
PHST- 2009/08/29 09:00 [entrez]
PHST- 2009/08/29 09:00 [pubmed]
PHST- 2009/10/23 06:00 [medline]
PHST- 2009/08/27 00:00 [pmc-release]
AID - 1471-5945-9-9 [pii]
AID - 10.1186/1471-5945-9-9 [doi]
PST - epublish
SO  - BMC Dermatol. 2009 Aug 27;9:9. doi: 10.1186/1471-5945-9-9.