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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
B A U M A N N E T A L
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.
D E R M AT O L O G I C S U R G E RYS 1 3 2
S M O O T H - G E L H A D E R M A L F I L L E R S
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
B A U M A N N E T A L
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.
D E R M AT O L O G I C S U R G E RYS 1 3 4
S M O O T H - G E L H A D E R M A L F I L L E R S
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.
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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: lsb@derm.net
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