comparison of smooth-gel hyaluronic acid dermal fillers...

Comparison of Smooth-Gel Hyaluronic Acid Dermal Fillers withCross-linked Bovine Collagen: A Multicenter, Double-Masked,Randomized, Within-Subject Study

LESLIE S. BAUMANN, MD,� AVA T. SHAMBAN, MD,y MARY P. LUPO, MD,z GARY D. MONHEIT, MD,y

JANE A. THOMAS, AAS, CCRA,J DIANE K. MURPHY, MBA,J AND PATRICIA S. WALKER, MD, PHD,J

FOR THE JUVEDERM VS. ZYPLAST NASOLABIAL FOLD STUDY GROUP

BACKGROUND A new family of next-generation non-animal hyaluronic acid (HA) dermal fillers wasapproved by the FDA in June 2006. Compared with other HA fillers available in the United States at thetime of writing, these new fillers have a higher concentration of HA, higher concentration of cross-linkedHA, and a smooth consistencyFwhich should promote long-lasting corrections and a smooth, naturallook and feel postinjection.

OBJECTIVE The objective was to compare the effectiveness and safety of these smooth-gel HA dermalfillers with bovine collagen for nasolabial fold (NLF) correction.

METHODS AND MATERIALS A total of 439 subjects with moderate or severe NLFs received one of threetypes of smooth-gel HA dermal filler (in one NLF) and cross-linked bovine collagen (in the other NLF) andwere evaluated for r24 weeks.

RESULTS All three HA dermal fillers achieved considerably longer-lasting clinical correction than bo-vine collagen; 81% to 90% of HA dermal filler–treated NLFs maintained a clinically significant improve-ment from baseline for � 6 months. Up to 88% of subjects preferred the HA dermal fillers over bovinecollagen. All fillers were similarly well tolerated.

CONCLUSION The smooth-gel HA dermal fillers offer longer-lasting correction than bovine collagenFwhich may lessen the frequency that repeat treatments are needed. Also, they were preferred by the vastmajority of subjectsFwhich should promote patient satisfaction.

Dr Baumann is a paid investigator and advisory board member for Inamed and Allergan. Drs Shamban, Lupo,and Monheit were paid investigators and were provided the equipment and product used in the study. JaneThomas, Diane Murphy, and Patricia Walker are employees, and stock holders with stock options, of Allergan.

Hyaluronic acid (HA)-based gels are now the

gold standard in dermal fillers, with more

cosmetic procedures in the United States using these

fillers than all other fillers combined.1 The wide-

spread acceptance of HA fillers is testament to their

biocompatibility (unlike protein-based fillers, they

are composed of polysaccharides that exhibit no

species specificity), the stability of their cross-linked

HA in vivo (which promotes longevity of clinical

improvement2), and their good record of safety and

effectiveness in other countries where they have been

in use for many years.

A new family of dermal fillers (the Juvederm dermal

fillers, Allergan, Santa Barbara, CA) was approved

by the U.S. Food and Drug Administration (FDA) in

June 2006. They are manufactured differently from

other HA fillers previously approved by the FDA

and, as a result, have a different consistency. A pro-

prietary manufacturing process (known as Hylacross

technology) avoids the need to press the filler through

sieves to ‘‘size’’ the gel and produces a gel with a

smooth consistency. The difference between this and

the granular and uneven consistency of earlier HA

fillers can be seen visually under a microscope.3

& 2007 by the American Society for Dermatologic Surgery, Inc. � Published by Blackwell Publishing �ISSN: 1076-0512 � Dermatol Surg 2007;33:S128–S135 � DOI: 10.1111/j.1524-4725.2007.33352.x

S 1 2 8

�University of Miami Cosmetic Center, Miami, Florida; yLaser Institute for Derm and European Skin Care,Santa Monica, California; zTulane University, New Orleans, Louisiana; yTotal Skin and Beauty Dermatology Center,Birmingham, Alabama; JAllergan, Santa Barbara, California

Compared with other HA fillers available in the

United States at the time of writing, the new smooth-

gel HA dermal fillers also contain a higher total

concentration of HAF24 mg/mL compared with

20 mg/mL with Restylane (Medicis, Scottsdale, AZ)

and 5.5 mg/mL with Captique and Hylaform

(Allergan, formerly Inamed, Santa Barbara, CA).4–6

In addition, they contain a higher concentration of

cross-linked HA. As cross-linking the HA helps

protect it from degradation in the body, a higher

concentration of cross-linked HA allows for a

greater portion of the product to contribute to the

clinical improvement.

The smooth gel HA dermal fillers are derived from

Streptococci equi and have been used successfully in

Europe and Canada (marketed as Juvederm by the

Corneal Group and by Allergan, formerly Inamed,

and in some countries as Hydrafill by Allergan,

formerly Inamed). Within this family of dermal fillers

are three productsFJ30 (Juvederm 30), 24HV

(Juvederm Ultra), and 30HV (Juvederm Ultra Plus)F

which differ from each other in the proportion of

un–cross-linked HA (‘‘un–cross-linked HA’’ includes

lightly cross-linked chains and fragments in addition

to un–cross-linked HA) and the degree of cross-

linking of HA (data on file, Allergan, 2006). The

24HV dermal filler is for contouring and adding

volume to facial wrinkles and folds using a

30-gauge needle.7 The 30HV dermal filler is for

adding volume to, and correcting, deeper folds and

wrinkles using a 27-gauge needle.7 The J30 dermal

filler is for the correction of fine facial wrinkles

(although it is not currently marketed in the

United States). The 24HV and 30HV dermal fillers

contain a higher proportion of un–cross-linked

HA than the J30 dermal filler, and the 30HV dermal

filler is more highly cross-linked than the J30 and

24HV dermal fillers.

A multicenter, double-masked, randomized, within-

subject study has been performed to compare the

effectiveness and safety of these three HA dermal

fillers with those of a cross-linked bovine collagen

filler for nasolabial fold (NLF) correction.

Methods

Subjects

Subjects were eligible for enrollment into the study

if they were at least 30 years of age and had fully

visible bilateral NLFs that were approximately

symmetrical. The NLFs were required to be both

moderate or both severe (on a scale of none, mild,

moderate, severe, and extreme) as judged by two

investigators. The deepest part of the fold was used

for the assessment of severity.

Subjects were required to have had no hypersensi-

tivity responses after two injections of bovine colla-

gen within 12 months of study entry and to refrain

from undergoing other antiwrinkle treatment in the

nasolabial and perioral areas before and during the

study period. (Sunscreen was allowed, however.)

Females of childbearing potential were required to

have a negative urine pregnancy test and to use re-

liable contraception while participating in the study.

Exclusion criteria included a history of anaphylaxis,

atopy, allergy to meat or lidocaine, or multiple severe

allergies; hypersensitivity to bovine collagen or HA;

receipt of immune therapy or a history of autoim-

mune disease; a tendency to develop hypertrophic

scarring; pregnancy or breastfeeding; use in the

4 weeks before study randomization (or intent to use

during the study) of oral retinoids, over-the-counter or

prescription antiwrinkle treatments, microdermabra-

sion, or chemical peels in the NLF area; and any prior

cosmetic procedure or tissue augmentation at the NLF

injection site in the 6 months before study entry (or

intent to undergo such a procedure during the study).

The study was approved by the relevant institutional

review boards, all subjects signed informed consent,

and the study protocol conformed to the guidelines

of the 1975 Declaration of Helsinki.

Treatment

Each study site had a single treating investigator and

a single evaluating investigator, both of whom were

3 3 : S 2 : D E C E M B E R 2 0 0 7 S 1 2 9

B A U M A N N E T A L

physician specialists in cosmetic dermatology or

plastic surgery and had extensive experience in

the use of dermal fillers. The evaluating

investigator and the subjects were masked to

treatment groups but, because of visual differences

in the fillers, the treating investigator could not

be masked.

Subjects were randomly assigned to receive one

of three smooth-gel HA dermal fillersFJ30

(Juvederm 30), 24HV (Juvederm Ultra), or 30HV

(Juvederm Ultra Plus)Fintradermally to the NLF

on one side of the face. In all subjects, the NLF on

the other side of the face was treated with a

cross-linked bovine collagen filler (Zyplast,

Allergan, formerly Inamed).

Before treatment, the area to be treated was disin-

fected thoroughly, and equal amounts of 5% lido-

caine were applied topically to the right and left

NLFs for anesthesia. The treating investigators were

instructed to fill each NLF to full correction (100%

of the defect)Fbut not to overcorrectFand then to

massage the treated area to ensure that the filler was

uniformly distributed. The amount injected was de-

termined by the length and depth of the NLF. In-

jections were performed using 30-gauge�0.4-in.

intradermal injection needles (RJ MAXflo, RJ De-

velopment Corp., Peabody, MA) for the HA fillers

and the 30-gauge�0.5-in. needles included in the

U.S. commercial packaging for the bovine collagen

filler. The investigators were instructed to introduce

the needle at a 451 angle to the skin and to then

inject slowly into the middermis at multiple injection

points in the NLF area.

Up to three treatments were allowed over a 4-week

period (initial treatment plus up to two touch-ups

approximately 2 weeks apart) to achieve optimal

correction of the NLFs. The level of correction was

assessed by the evaluating investigator at Weeks 2

and 4 after the initial treatment and, if less than

optimal, the treating investigator was directed to

retreat the undercorrected NLF(s) with the same

filler(s) assigned previously.

Outcome Measures

The severity of each NLF was determined by

the evaluating investigator via a live assessment

using the 5-point Wrinkle Assessment Scale (WAS)

together with a validated photographic guide.8

The WAS scale is defined as 0 = none (no wrinkle),

1 = mild (shallow, just perceptible wrinkle),

2 = moderate (moderately deep wrinkle), 3 = severe

(deep wrinkle, well-defined edges but not overlap-

ping), and 4 = extreme (very deep wrinkle, redundant

fold, overlapping skin). The subjects made live self-

assessments of NLF severity using the same WAS

scale but without photographs. At the study exit, the

subjects were asked to guess which filler had been

injected in which NLF and to report which filler (if

any) they preferred in terms of overall effects of

treatment.

Subjects were provided with a diary in which they

were asked to report their observations of common

treatment site reactions on a daily basis from 30

minutes after the first treatment (Day 0) through

Day 13 after each treatment (including touch-ups, if

any). Any additional adverse events reported by the

subject or observed by the investigators were also

recorded. Subjects were followed up at office visits at

least every 4 weeks for up to 24 weeks after their last

treatment. Some subjects had additional follow-up if

they returned after the end of the studyFe.g., for the

complimentary repeat treatment that had been

offered to them on entering the study.

Statistical Analyses

Statistical analyses were performed on the intent-to-

treat population for effectiveness data and on the

‘‘as-treated’’ population for safety data. An a level

of .05 was used to determine statistical significance.

The improvements in NLF severity score were

compared to baseline using a signed rank test. The

proportion of NLFs with a clinically significant im-

provement (�1-point reduction in NLF severity

score relative to baseline) was compared to baseline

using a one sample binomial test (using the exact

method).

D E R M AT O L O G I C S U R G E RYS 1 3 0

S M O O T H - G E L H A D E R M A L F I L L E R S

Results

Subjects

A total of 439 subjects were randomized and treated

(the intent-to-treat population), of whom 423 (96%)

completed the 24-week follow-up period. No sub-

jects discontinued due to lack of effectiveness or

adverse events.

The mean age of the subjects was 49 years (range,

26–75 years) and the majority were female (92%).

Overall, 74% were Caucasian and 26% were non-

Caucasian (12% Hispanic, 11% African American,

2% Asian, and 1% other). The full range of Fitz-

patrick skin types was represented (4% I, 24% II,

35% III, 20% IV, 13% V, 3% VI). Demographic

details were comparable in all treatment groups, and

34% to 39% of subjects were known to have pre-

viously received treatment with botulinum toxin

type A in the upper face.

Effectiveness

All the HA dermal fillers resulted in a mean im-

provement (i.e., a reduction) from baseline in NLF

severity score that was clinically significant at every

time point (Figures 1 and 2). Furthermore, the HA

dermal fillers provided longer-lasting clinical cor-

rection than bovine collagenFthe mean level of

improvement in NLF severity score at 24 weeks after

last treatment was �1 point with the HA dermal

fillers (i.e., still a clinically significant improvement

from baseline) and no more than 0.5 point with

bovine collagen (Figures 1 and 2, Table 1). The

proportion of NLFs retaining this clinically signifi-

cant level of improvement at 24 weeks after last

treatment was 81% with J30 dermal filler, 88% with

24HV dermal filler, and 90% with 30HV dermal

filler compared with 45%, 36%, and 40% in the

corresponding bovine collagen–treated NLFs (Figure

3, Table 1). Photographic documentation shows that

clinically significant improvement was maintained

not only up to 24 weeks after last treatment but, in

subjects who returned after the end of the study, for

longer periods also (Figure 4). Sustained clinical

improvement for 11 and 17 months after last treat-

ment is shown in two subjects (Figure 4).

For all of the fillers, the majority of subjects had only

one treatment visit (i.e., no touch-ups) and the total

injection volume was lower with the HA dermal

fillers (median, 1.6 mL; range, 0.8–5.6 mL) than with

bovine collagen (median, 2.0 mL; range, 0.8–7.7 mL).

Safety

The frequency and severity of treatment site reac-

tions were similar for all the fillers (Table 2), and

there were no treatment-related adverse events other

than those localized to the area of injection. For all

treatment groups, the majority of treatment site

reactions were mild to moderate in severity, did not

Figure 1. Mean improvement (i.e., reduction) from baselinein nasolabial fold (NLF) severity score based on assess-ments by evaluating investigators. At baseline, the meanNLF severity score was 2.5 to 2.6 across all groups. �pr.001versus baseline.

Figure 2. Mean improvement (i.e., reduction) from baselinein nasolabial fold (NLF) severity score based on assess-ments by subjects. At baseline, the mean NLF severity scorewas 2.3 to 2.4 across all groups. �pr.001 versus baseline.

3 3 : S 2 : D E C E M B E R 2 0 0 7 S 1 3 1


require intervention, and lasted no more than 7 days.

The only significant treatment-related adverse event

reported was a sterile abscess at the injection site

4 months after treatment with bovine collagen.

The pattern and incidence of treatment site reactions

were generally similar between Caucasian and

non-Caucasian subjects.9

Subject Preferences

At study end, while still masked to treatment as-

signment, the vast majority of subjects preferred

their HA filler over bovine collagenF78% with J30,

88% with 24HV, and 84% with 30HV dermal filler

(Figure 5). Subjects’ guesses of which filler had been

used on which side of their face were incorrect more

frequently than they were correct.

Discussion

The results of this multicenter, double-masked, ran-

domized, within-subject study demonstrate two

clinically important findingsFthat the smooth-gel

HA dermal fillers offer longer-lasting correction of

NLFs than bovine collagen and that the vast major-

ity of subjects prefer these smooth-gel fillers to bo-

vine collagen.

TA

BLE

1.

Resu

lts

of

Eff

ecti

ven

ess

Assessm

en

ts

Ass

ess

men

tJ30

Bo

vin

e

coll

ag

en

24H

V

Bo

vin

e

coll

ag

en

30H

V

Bo

vin

e

coll

ag

en

Mean

imp

rovem

en

t(i

.e.,

red

uct

ion

)

fro

mb

ase

lin

ein

NLF

sco

re

24

weeks

aft

er

last

treatm

en

t

(evalu

ati

ng

invest

igato

rass

ess

men

t),

mean

(95%

CI)

1.2�

(1.0

–1.3

)0.5�

(0.3

–0.6

)1.3�

(1.2

–1.5

)0.3�

(0.2

–0.4

)1.4�

(1.3

–1.6

)0.4�

(0.3

–0.6

)

Mean

imp

rovem

en

t(i

.e.,

red

uct

ion

)

fro

mb

ase

lin

ein

NLF

sco

re

24

weeks

aft

er

last

treatm

en

t

(su

bje

ctass

ess

men

t),

mean

(95%

CI)

1.1�

(0.9

–1.3

)0.4�

(0.3

–0.6

)1.3�

(1.1

–1.5

)0.4�

(0.2

–0.5

)1.3�

(1.1

–1.4

)0.4�

(0.2

–0.5

)

Pro

po

rtio

no

fN

LFs

main

tain

ing

acl

inic

all

ysi

gn

ific

an

tim

pro

vem

en

t

(�1-p

oin

tre

du

ctio

n)

fro

mb

ase

lin

e

inse

veri

tysc

ore

24

weeks

aft

er

last

treatm

en

t,%

(n/N

)

81%�

(116/1

43)

45%

(65/1

43)

88%�

(121/1

38)

36%

(50/1

38)

90%�

(125/1

39)

40%

(55/1

39)

� pr

.001

vers

us

base

lin

e.

Figure 3. Proportion of nasolabial folds (NLFs) maintaininga clinically significant improvement in NLF severity score(i.e., � 1-point reduction from baseline) as assessed by theevaluating investigators. zpr.05, ypr.01, �pr.001 versusbaseline.



The longer-lasting correction is demonstrated by the

considerably greater proportion of HA dermal filler–

treated NLFs maintaining a clinically significant

improvement from baseline compared with bovine

collagen–treated NLFsF81% to 90% versus 36%

to 45% at 24 weeks after the last treatment. It ap-

pears that clinical correction is maintained in many

subjects beyond 24 weeks, and extended follow-up

will help evaluate the true longevity of the clinical

improvements. Photographic documentation

published here and elsewhere8–10 demonstrates ex-

cellent clinical correction and a smooth natural look

that is maintained up to and well beyond 24 weeks in

some subjectsFincluding through 17 months in one

subject (who returned approximately 11 months af-

ter exiting the study). This is consistent with the

Figure 4. Photographic documentation of the longer-lasting clinical improvement with the smooth-gel HA dermal fillersrelative to bovine collagen, the good local tolerability of these HA dermal fillers, and the smooth natural look attainable.

TABLE 2. Treatment Site Reactions Occurring with an Incidence of at Least 10%

Treatment site reaction

Subjects (%)

J30 24HV 30HV Bovine collagen

Injection site induration 91 88 88 85–89

Injection site erythema 90 93 90 89

Injection site edema 89 86 86 84–86

Injection site pain 87 90 90 85–88

Injection site nodule 83 79 83 78–84

Application site bruising 61 59 60 48–55

Injection site discoloration 31 33 34 29–34

Injection site pruritus 28 36 34 35–36

3 3 : S 2 : D E C E M B E R 2 0 0 7 S 1 3 3


longevity of 12 to 15 months that has previously

been reported with one of these fillers (Juvederm

30 dermal filler) in Europe.11 The overwhelming

preference of the subjects for the smooth-gel HA

dermal fillers is presumably at least partly attribut-

able to the long-lasting effects of the fillers as well as

their natural look and feel posttreatment.

The longer-lasting corrections attained with the new

fillers are likely attributable to the high concentra-

tion of HA and high concentration of cross-linked

HA in the gels. The proprietary manufacturing pro-

cess ensures that the gels are both smooth and mal-

leableFwhich helps to achieve a smooth and natural

look and feel postinjection. As new HA fillers have

become available in recent years, many clinicians

have come to consider that key criteria for an ‘‘ideal

filler’’ should include easy injectability, the ability to

achieve persistent clinical corrections, and the

avoidance of animal-derived ingredients (to promote

biocompatibility). All three of the smooth-gel HA

dermal fillers studied in this trial meet these criteria.

The subjects’ inability to correctly guess which filler

had been used on which side of their face confirmed

the successful masking of the formulations. (This is in

contrast to the FDA Advisory Panel’s conclusion of

incomplete masking12 reported for a similar trial

comparing an HA filler of granular consistency with

bovine collagen.) The effectiveness results from this

trial are consistent with those from other trials that

show that, compared with cross-linked bovine colla-

gen, HA fillers can result in longer-lasting clinical

improvement and require a lower injection volume

for optimal correction.2,13 In the study presented here,

the median injection volumes were 1.6 mL for each of

the J30, 24HV, and 30HV dermal fillers and 2.0 mL

for bovine collagen. The previously mentioned study2

had a considerably smaller proportion of subjects

with severe NLFs at baseline (34% had severe NLFs

compared with 457% in our trial) which, as would

be anticipated, resulted in lower mean injection vol-

umes (1.0 mL for the HA filler of granular consistency

and 1.6 mL for the bovine collagen filler). Addition-

ally, this earlier study limited the injection volume to

no more than 1.5 mL per treatment session,4 whereas

our study had no predetermined maximum treatment

volume and investigators were instructed to inject as

much filler as needed to obtain optimal correction of

each NLF. A report in the literature suggests that, in

clinical practice, the typical injection volume of the

HA filler with granular consistency used in the pre-

vious study is actually 1.5 mL for NLF correction (i.e.,

considerably higher than reported in the study by

Narins and coworkers2).14

Conclusions

The new smooth-gel HA dermal fillers (Juvederm 30,

Juvederm Ultra, and Juvederm Ultra Plus) were

highly effective in correcting NLFs for 6 months or

longer posttreatment and achieved considerably

longer-lasting improvements than bovine collagen.

As a result, it is expected that repeat treatments will

be required less frequently than with bovine colla-

gen. The persistent corrections attained with the

smooth-gel HA dermal fillers are likely at least partly

attributable to the high concentration of HA and

high concentration of cross-linked HA in these next

generation formulations.

The majority of subjects achieved optimal correction

with only a single injection of the HA dermal filler

(i.e., without any need for touch-ups) and all of the

fillers were similarly well tolerated. The over-

whelming majority of subjects expressed a prefer-

ence for the smooth-gel HA dermal fillers over

bovine collagenFsuggesting that patient satisfaction

is likely to be greater with these fillers.

Figure 5. Subject preferences in terms of overall effects oftreatment 24 weeks after the last treatment.



Acknowledgments We thank all investigators in

the JUVEDERM vs. ZYPLAST Nasolabial Fold

Study GroupFLeslie Baumann, MD, and Heather

Woolery-Lloyd, MD (Miami, FL); Ava Shamban,

MD, and Reza Nabavian, MD (Santa Monica, CA);

Mary Lupo, MD, and Richard Sherman, MD (New

Orleans, LA); Gary Monheit, MD, and Betty Ann

Davis, MD (Birmingham, AL); Stacy Smith, MD,

and Dan Piacquadio, MD (San Diego, CA); Andrew

Frankel, MD, and John Vartanian, MD (Beverly

Hills, CA); Michael Gold, MD, and Nicholas Sieve-

king, MD (Nashville, TN); Pearl Grimes, MD, and

Mavis Billips, MD (Los Angeles, CA); Mark Pinsky,

MD, and David Lickstein, MD (West Palm Beach,

FL); Jessica Wu, MD, and Kevin Kevorkian, MD

(Los Angeles, CA); and Derek Jones, MD, and

Shilesh Iyer, MD (Los Angeles, CA). We also thank

Allergan for their financial support; Maggi Beck-

strand, MPH, and Gerard Smits, PhD, for their bi-

ostatistical assistance; and Gill Shears, PhD, for her

assistance in the development of the manuscript.

Juvederm mark owned by Corneal Industrie SAS.

Zyplast and Captique are registered trademarks of

Allergan, Inc. Restylane is a registered trademark of

HA North American Sales AB. Hylacross mark

owned by Allergan, Inc. Hylaform is a registered

trademark of Genzyme Corp.

References

1. 2005 Cosmetic Surgery National Data Bank Statistics [mono-

graph on the Internet]. Los Alamitos (CA): American Society of

Aesthetic Plastic Surgery; 2006 [accessed 2006 Jun 7]. Available

from: http://www.surgery.org/download/2005stats.pdf

2. Narins RS, Brandt F, Leyden J, et al. A randomized, double-blind,

multicenter comparison of the efficacy and tolerability of Resty-

lane versus Zyplast for the correction of nasolabial folds.

Dermatol Surg 2003;29:588–95.

3. Tezel A, Walker PS. The influence of formulation on persistence

with hyaluronic acid dermal fillers. Poster No. 2906 presented at

the 65th Annual Meeting of the American Academy of Derma-

tology; 2007 Feb 2–6; Washington, DC.

4. Summary of safety and effectiveness data [monograph on the

Internet]. Rockville (MD): Food and Drug Administration; 2003

[accessed 2006 Aug 7]. Available from: http://www.fda.gov/cdrh/

pdf2/P020023b.pdf

5. Dermal filler product comparison [monograph on the Internet].

Aliso Viejo (CA): Medical Insight, Inc.; 2006 [accessed 2006

Nov 13]. Available from: http://www.miinews.com/pdf/Dermal_

Chart.pdf

6. HYLAFORM product information [monograph on the Internet].

Santa Barbara (CA): Allergan Inamed; 2006 [accessed 2006

Nov 13]. Available from: http://www.allerganandinamed.com/

products/facial/us/physician/hylaform/prodinfo.aspx

7. Summary of safety and effectiveness data [monograph on the

Internet]. Rockville (MD): Food and Drug Administration; 2006

[accessed 2006 Aug 23]. Available from: http://www.fda.gov/cdrh/

pdf5/p050047b.pdf

8. Monheit GD, Thomas JA, Murphy DK, et al. Photographic

documentation from a double-blind randomized multicenter study

comparing new hyaluronic acid-based fillers vs crosslinked bovine

collagen. Poster No. 202 presented at the Academy ‘06 meeting of

the American Academy of Dermatology; 2006 Jul 26–30; San

Diego, CA.

9. Grimes PE, Thomas JA, Murphy DK, et al. Efficacy and safety of

novel hyaluronic acid-based fillers and bovine collagen in Cau-

casians and persons of color. Poster No. 204 presented at the

Academy ‘06 meeting of the American Academy of Dermatology;

2006 Jul 26–30; San Diego, CA.

10. Smith SR, Jones DH, Thomas JA, et al. Efficacy and safety fol-

lowing repeat treatment for a new family of hyaluronic acid-based

fillers. Poster No. 205 presented at the Academy ‘06 meeting of

the American Academy of Dermatology; 2006 Jul 26–30; San

Diego, CA.

11. Bergeret-Galley C. Comparison of resorbable soft tissue fillers.

Aesthet Surg J 2004;23:33–46.

12. Transcript from the 21 November 2003 meeting of the General

and Plastic Surgery Devices Panel of the Medical Devices Advisory

Committee [monograph on the Internet]. Rockville (MD): Food

and Drug Administration; 2003 [accessed 2006 Nov 15]. Avail-

able from: http://www.fda.gov/ohrms/dockets/ac/03/transcripts/

4004T1.htm

13. Lindqvist C, Tveten S, Bondevik BE, Fagrell D. A randomized,

evaluator-blind, multicenter comparison of the efficacy and

tolerability of Perlane versus Zyplast in the correction of naso-

labial folds. Plast Reconstr Surg 2005;115:282–9.

14. Kanchwala SK, Holloway L, Bucky LP. Reliable soft tissue aug-

mentation: a clinical comparison of injectable soft-tissue fillers for

facial-volume augmentation. Ann Plast Surg 2005;55:30–5.

Address correspondence and reprint requests to: LeslieBaumann, MD, University of Miami Cosmetic Center,Nichol Building, 4701 N. Meridian Avenue, Suite 7450,Miami Beach, FL 33140, or e-mail: [email protected]

3 3 : S 2 : D E C E M B E R 2 0 0 7 S 1 3 5


comparison of smooth-gel hyaluronic acid dermal fillers...

Documents