.
`Journal of·
`DUP G cosmetic dermatology
`W1 JOS;~eral Collection
`.
`
`v.8, no. 3
`Sept. 2009
`
`PROPERTY Of THE
`NATIONAL
`LIBRARY Of
`MEDICINE
`
`...,__'
`:.:::::::5-
`~ ~-
`
`OF A
`OSMETIC
`DERMA
`
`Exhibit 1070
`Prollenium v. Allergan
`
`

`

`Journal of Cosmetic Dermatology
`
`Editor-in-Chief
`Zoe Diana Draelos, MD
`USA
`Associate Editors
`Marc R. Avram, MD
`USA
`Anthony Benedetto, DO
`USA
`Mitchel Goldman, MD
`USA
`Greg Goodman, MD
`Australia
`Christian Oresajo
`USA
`Gerald Pierard, MD, PhD
`Belgium
`Jaggi Rao, MD
`Canada
`Neil Sadick, MD
`USA
`Ren-Yeu Tsai, MD
`Taiwan
`Founding Editor
`Christopher Rowland Payne, MD
`
`Advisory Board
`Murad Alam, MD
`USA
`Pierre Andre, MD
`France
`Robert Baran, MD
`France
`Frederic Bonte, PhD
`France
`Don Bissett, PhD
`USA
`Alex Camps Fresneda, MD
`Spain
`Joel Cohen, MD
`USA
`Lisa Donofrio, MD
`USA
`Patty Farris, MD
`USA
`Richard Fitzpatrick, MD
`USA
`Alina Fratila, MD
`Germany
`Bryan Fuller, PhD
`USA
`Barbara Green
`USA
`Eckart Haneke, MD
`Norway
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`USA
`
`Jana Hercogova, MD
`Czech Repu/Jlic
`Philippe Humbert, MD
`France
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`USA
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`USA
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`USA
`Jurgen Lademann, MD
`Germany
`JanLephart
`USA
`Jean-Luc Levy, MD
`France
`Torello Lotti, MD
`Italy
`Ken Maren us, PhD
`USA
`Gopi Menon, PhD
`USA
`Larry Millikan, MD
`USA
`Rhoda Narins, MD
`USA
`Keyvan Nouri, MD
`USA
`Christian Oresajo
`USA
`Lawrence Parish, MD
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`Gerald Pierard, MD
`Beliawn
`Tom Polelka, PhD
`USA
`Andre Rougier, PhD
`France
`Jean-Hilaire Saurat, MD
`Switzerland
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`USA
`Tony Simion, PhD
`USA
`Kenneth Smiles, MD
`USA
`Shyam Verma, MBBS, DV&D
`India
`Daniel Wallach, MD
`France
`Teresa Weber, PhD
`USA
`Ronni Weinkauf
`USA
`Robert Weiss, MD
`USA
`Tina West, MD
`USA
`Uwe Wollina, MD
`Germany
`Wolf-lngo Worret, MD
`Germany
`Hana Zelenkova, MD
`Slovakia
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`ISSN 14 7 3-2130 (Print)
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`

`

`I Original Contribution
`
`A multi-center, double-blind, randomized controlled study
`of the safety and effectiveness of Juvederm® injectable gel
`with and without lidocaine
`
`Susan H Weinkle, MD,1 David E Bank, MD,2 Charles M Boyd, MD,3 Michael H Gold, MD,4
`Jane A Thomas, AAS, CCRA,5 & Diane K Murphy, MBA5
`1 Bradenton, Florida, USA
`2The Center for Dermatology, Cosmetic & laser Surgery, Mt. Kisco, New York, USA
`3The Boyd Gillard Institute of Aesthetic and Dermatologic Surgery, Ypsilanti, Michigan, USA
`4 Tennessee Clinical Research Center, Nashville, Tennessee, USA
`5Allergan, Santa Barbara, California, USA
`
`Summary
`
`Introduction Pain is a common patient complaint during dennal filler injections. The
`primary objective of this study was to compare a new formulation of Juvcderm®
`injectable gel with lidocaine (denoted as JUV + L) to commercially-available Juvcderm®
`injectable gel without lidocaine (denoted as JUV) with respect to procedural pain scores
`in subjects desiring nasolabial fold (NLF) correction.
`Methods Subjects received randomized treatment with the lidocaine llller in one NLF and
`the llller without lidocaine in the other NLF. Investigators determined the appropriate
`formulation (Ultra or Ultra Plus) and volume of material to inject but were blinded as to
`which syringe contained lidocainc. Subjects rated procedural pain (pain during injection)
`using an I I-point scale within 30 min after receiving treatment in both NLFs and com(cid:173)
`pared procedural pain between right and left NLFs using a 5-point scale. NLF severity was
`rated by both subjects and investigators before and 2 weeks after treatment.
`Results The mean dilTerence on the procedural pain scale was 3.4 (P < 0.0001), and
`93% of subjects found JUV + L to be less or slightly less painful than JUV. Improvement
`in NLP severity was comparable for both products. Common treatment site reactions
`(CTRs) of pain and tenderness were considerably less frequent for JUV + L than JUV
`while all other CTRs showed no statistically significant di!Terences.
`Concl11sio11 The dermal filler formulated with lidocaine is effective in reducing proce(cid:173)
`dural pain during correction of facial wrinkles and folds while maintaining a similar
`safety and elTectiveness prollle to the filler without lidocaine.
`
`Keywords: dermal filler, hyaluronic acid. patient satisfaction, wrinkles, randomized
`controlled trial
`
`Introduction
`
`Pain is a common patient complaint during dermal liller
`injections, and anesthetics are frequently used to make
`
`Correspondence: Diane Murphy, 71 South Los Cameras, Goleta, CA 93117.
`E-mail: rnurphy_diane@allergan.com
`
`Accepted for publication April 24, 2009
`
`the procedure more comfortable. However, administra(cid:173)
`tion of injectable anesthesia takes time and may distort
`the area to be treated, and the effects of topical
`anesthetic are limited and not immediate.
`included an
`Collagen-based fillers have
`typically
`anesthetic {lidocaine) in their formulations to reduce
`procedural pain such that injectable anesthesia may not
`be required. Hyaluronic acid (HA)-based dermal fillers
`
`© 2009 Wiley Periodicals, Inc. • Journal of Cosmetic Dermatology, 8, 205-210
`
`205
`
`

`

`Safety and cITccUveness of Juvederm® with lidocainc • SH Weinkle et al.
`
`have gained market leadership over collagen, but most
`HA-based fillers do not contain lidocaine. This study was
`conducted to evaluate the e!Tectiveness of a smooth gel
`HA filler formulated with 0.3% lidocaine in reducing
`procedural pain.
`
`Methods
`
`Study design
`
`Four centers participated in this double-blind compari(cid:173)
`son study. Subjects received randomized treatment with
`Juvcderm® injectable gel containing lidocaine (desig(cid:173)
`nated as JUV + L) in one nasolabial fold (NLF) and the
`control device, Juvcderm® without lidocaine (designated
`as JUV), in the opposite NLF. Right and left NLF product
`assignments, us well as which side was treated first, were
`balanced at each site and across the study.
`The investigator was blinded as to which syringe
`contained lidocaine and treated both NLFs equivalently
`in terms of topical anesthesia, injection volume, tech(cid:173)
`nique. and needle gauge and length. No injectable
`investigators were
`anesthesia was allowed. The
`instructed to wait 3 s after initial injection to allow the
`lidocaine to lake effect.
`Subjects rated procedural pain (pain during injection)
`within 30 min after receiving treatment on both NLFs
`using an 11-point scale (Table 1), ranging from O (no
`pain) to 10 (worst pain imaginable). Subjects also
`compared procedural pain between the right and left
`NLFs on a 5-point scale (Table 2). The investigator and
`subject rated the severity of the subject's NLFs using the
`5-point Wrinkle Assessment Scale (WAS) before and
`2 weeks after treatment (Table 3 ),
`Subjects attended a single treatment visit followed by
`an investigator cull or email at 2 days and an oflice visit
`2 weeks after treatment. Subjects
`tracked common
`treatment site reactions (CTlls) dully for 2 weeks using
`a validated Interactive voice response system diary.
`
`Subjects
`
`Male or female subjects were enrolled in the study If they
`were ~18 years and had approximately symmetrical
`moderate-to-severe NLFs according to the WAS. Both
`NLFs must have had the same pretreatment NLF severity
`score.
`
`Table 1 Procedural Pain Scale
`
`(No Pain) 0 1 2 3 4 5 6 7 8 9 1 O r,Norst Pain Imaginable)
`
`Table 2 Comparative Pain Scale
`
`Score
`
`-2
`-1
`0
`1
`2
`
`Description
`
`Right NLF more painful than left NLF
`Right NLF slightly more painful than left NLF
`No difference
`Left NLF slightly more painful than right NLF
`Left NLF more painful than right NLF
`
`NLP, nasolabial fold,
`
`Subjects were excluded from the study if they had
`begun use of any new anti-wrinkle products in the NLF
`area, had received any investigational product, or had
`undergone cosmetic facial procedures in the lower two(cid:173)
`thirds of the face within 1 month prior to study entry;
`had ever received semi-permanent or permanent facial
`implants: were allergic to lidocaine, HA products, or
`streptococcal protein.
`
`Treatment
`
`The investigator determined the appropriate formulation
`(Ultra or Ultra Plus) and volume to inject based on
`clinical experience and severity of the subject's NLFs.
`The maximum total volume allowed for an individual
`subject was four syringes (1.6 mL per NLF). Investiga(cid:173)
`tors were allowed to apply topical anesthesia (ice, EMLA
`cream. or both) to the injection area prior to treatment.
`
`Statistical analyses
`
`Statistical analyses were performed on the intent-lo-treat
`population, which included all randomized subjects.
`Data were pooled across the four invesligational sites,
`and computation for all results was performed using
`SAS® Version 9.1.
`For the primary endpoint established a priori. JUV + L
`was considered to be clinically effective if the mean score
`for procedural pain was at least 1.4 points less on the
`11-point scale than the mean score for JUV using a
`paired t-tesl with I' < 0,05. Descriptive statistics were
`
`Table 3 Wrinkle ,\sscssmcnt Scale
`
`Score
`
`Description
`
`0
`1
`2
`3
`
`4
`
`None (no wrinkle)
`Mild (shallow, just perceptible wrinkle)
`Moderate (moderately deep wrinkle)
`Severe (deep wrinkle, well-defined edges,
`but not overlapping)
`Extreme (very deep wrinkle, redundant fold,
`overlapping skin)
`
`206
`
`© 2009 Wiley Periodicals, Inc. • Journal of Cosmetic Dermatology, 8, 205-21 O
`
`

`

`Safely and elTeclivencss of Juvedcrm® with lidocaine • SH Wei11k/e ct al.
`
`employed for other parameters, with 9 5% conlidence
`intervals utilized for comparisons of safety measures.
`
`Results
`
`Subjects
`
`A total of 72 subjects enrolled and completed the study.
`The majority of subjects were Caucasian and female
`with a median age of 5 3 years. All Fitzpatrick skin types
`were represented, with 28% Types lV-VI (Table 4).
`
`Treatment
`
`topical anesthetic applied
`All 72 subjects received
`equally to both sides of the face prior to treatment: 34
`(4 7%) received EMLA only, 20 (28%) received ice only,
`and 18 (25%) received both. Retrograde and antegrude
`tunneling were the most common injection techniques,
`and all injections were followed by gentle to moderate
`massage. The mean total volume injected per NLF was
`0.8 mL (range, 0.3-1.6 mL) for the Ultra formulations
`and 1.0 mL (range, 0.4-1.6 mL) for the Ultra Plus
`formulations. All of the Ultra injections used a 30-gauge,
`0.5 in needle whereas for the Ultra Plus injections half
`used the 30-gauge needle and the other half used a
`27-gauge, ½ in needle.
`
`Table 4 Subject dcmogruphlc data
`
`Characteristic
`
`Gender(%)
`Female
`Male
`Age (years)
`Median
`Range
`Ethnicity (%)
`Caucasian
`African American
`Hispanic
`Asian
`Other
`Fitzpatrick
`skin type (%}
`I
`II
`Ill
`IV
`V
`VI
`
`Overall
`subjects
`(N = 72)
`
`Juvederm
`Ultra subjects
`(N 36)
`
`Juvederm Ultra
`Plus subjects
`(N = 36)
`
`96
`4
`
`94
`6
`
`53
`32-80
`
`52
`32-73
`
`97
`3
`
`55.5
`43-80
`
`78
`17
`1
`1
`3
`
`4
`43
`25
`13
`7
`8
`
`75
`19
`0
`3
`3
`
`6
`44
`14
`19
`8
`8
`
`81
`14
`3
`0
`3
`
`3
`42
`36
`6
`6
`8
`
`Effectiveness
`The mean procedural pain score for JUV + L was
`significantly less than the mean score for JUV (2.0 vs.
`5.4, mean difference 3.4, P < 0.001), which was more
`than double the predefined endpoint for clinical effec(cid:173)
`tiveness. Similar significant results were obtained when
`analyzed by product type (Ultrn and Ultra Plus: Fig. 1).
`Use of topical anesthetic did not alTect the differences
`observed between JUV + Land JUV, though the relative
`difference in pain scores was greater when only ice was
`used (Table 5). Using a larger 27-gauge needle resulted
`in somewhat higher pain scores for both JUV + L and
`JUV (3.1 and 6.4, respectively) compared with using a
`30-gauge needle (1.6 and 5.1. respectively), although
`the differences in pain scores for JUV + L vs. JUV were
`similar (3.3 with 27-gauge needle and 3.5 with 30-
`gauge needle).
`Comparatively, JUV + L was less painful or slightly
`less painful than JUV for 93(Yo of subjects (Fig. 2). Mean
`NLF severity scores for all formulations improved > 1
`point after treatment, which is considered a clinically
`significant improvement (Fig. 3). Subject photographs
`demonstrating the improvement in NLF severity follow(cid:173)
`ing treatment are provided in Figure 4.
`
`Safety
`Both JUV + L and JUV had similar safety profiles, with
`the notable exception of pain (47% for JUV + L vs. 64%
`for JUV) and tenderness (71 % for JUV + L vs. 83% for
`JUV) as the only statistically significant differences
`between the products. There were no severe pain scores
`
`10-------------------.
`ll JUV+L
`a JUV
`
`Ultra
`Overall
`o "' No palo and 10 = Worst Palo Imaginable
`•P<.001
`
`Figure 1 Subject assessment of procedurul pain score.
`
`© 2009 Wiley Periodicals, tnc. • Journal of Cosmetic Dermatology, 8, 205-21 O
`
`207
`
`

`

`Safety and eO'ecllveness of Juvederm® with lidocaine • SH We/11/<IC' ct al.
`
`Table 5 Subject assessments of procedural pain score by use of
`topical anesthetic
`
`less, and there were no adverse events other than CTHs
`related to treatment.
`
`EMLA and ice
`Ice-only
`EMLA-only
`subjects (N 34) subjects (N = 20) subjects (N
`18)
`
`Discussion
`
`2.4 (1.7, 3.1)
`
`JUV + L
`pain score
`JUV pain score 5.6 (4.9, 6.4)
`3.2 (2.2, 4.2)
`Difference
`in pain scores
`
`1.6 (1.0, 2.1)
`
`1.7 (1.0, 2.4)
`
`6.2 (5.2, 7.1)
`4.6 (3.6, 5.6)
`
`4.3 (3.2, 5.4)
`2.6 (1.5, 3.6)
`
`Values are mean (95% CI). JUV, Juvcdcrm; L, lidocainc.
`
`■ Overall
`■ Ultra
`ll UltraPlu!I
`
`75
`
`t VI 50
`
`25
`
`JlN+L is loss/slightly
`lesll painful than JI.N
`
`JlN+L is morev'sr,ghtly
`more painful than JlN
`
`Figure 2 Subject assessment of comparative procedural pain
`score.
`
`for JUV + L whereas there were 5 (7%) for JUV. The
`most common CTRs for both JUV + L and JUV were
`firmness, swelling, tenderness, redness, and bruising,
`CTRs were predominantly mild, lasting for J week or
`
`Pain management with injectable dermal fillers is not a
`novel concept. Physicians have often utilized lidocainc
`with fillers to ease subjects' discomfort during treatment.
`As lidocainc is metabolized and cleared from the body
`and its efTects arc completely reversed within a few
`hours, it would not be expected to have any cfTect on
`product durability iii vivo.
`As most lillcrs do not include lidocaine, many physi(cid:173)
`cians currently mix lidocaine into the finished product
`supplied by
`the manufacturer. Not only docs this
`practice prompt questions of sterility, consistency, and
`quality of the final mixture, 1 but it can also change the
`product's flow characteristics and efTectivencss by dilut(cid:173)
`ing the HA concentration with the lidocainc solution.2
`This problem is solved with JUV + L by adding lidocaine
`powder during the formulation process so that the
`volume of HA per mL is not affected and there is no
`change in product consistency or llow characteristics. In
`addition,
`the preservative-free powder reduces
`the
`potential for allergic reactions to lidocainc because most
`patients who experience sensitivity to lidocainc-contain(cid:173)
`ing products arc sensitive to the preservative rather than
`lidocaine itself.
`Past research has shown that a difference of 1.4 on nn
`I I-point numeric rating scale is clinically significant
`when measuring pain. 3 JUV + L produced a difTcrencc of
`3.4, indicating that this was a clinically significant
`reduction in pain. A similar study of the product
`(Juvcderm® Ultra 3; Allergan, Marlow, UK) in Europe
`
`4..-------------------------,
`
`3 +---------------,,..,,...-------::,.,,.-----1
`
`A ~ l '!!---1
`2 I n l
`I
`
`Severe
`
`Modero1o
`
`Mild
`
`0 .;__,:._l ~~ - - - ,_ ; - -~
`Nono
`JW+LU:tra
`J'JV Ultrn Plus
`JWUttra
`JW+L Ultra Plus
`
`[l Baser,rn, (mean}
`
`■ Final Visll (mean}
`
`Figure 3 Investigator assessment of nasolabinl fold (NLF) severity.
`
`208
`
`© 2009 Wiley Periodicals, Inc. • Journal of Cosmetic Dermatology, 8, 205-21 o
`
`

`

`Safety and cffcclivcncss of Juvederm® with lidocainc • S H Weiukle ct al.
`
`Ultra
`
`Ultra Plus
`
`Baseline
`
`2 Weeks Post-treatment
`
`Figure 4 Subject photographs ut baseline and 2 weeks after treatment.
`
`also found a clinically sign!licant difference in pain: 3.6
`vs. 5.8 on the 11-point scale (P < 0.001).4 The same
`three European sites (France, Belgium, Switzerland)
`evaluated the product against a particle-based HA
`without lidocaine (Pcrlanc®: Q-MED, Uppsala, Sweden).
`In the split-face study of 12 6 subjects, the mean pain
`scores were 2.8 and 4.9 on the 11-point scale, again
`showing a clinically significant reduction in pain for the
`Iidocaine liller. 5
`To examine real world experience with the lidocainc
`liller shortly after it received CE mark approval, 485
`injectors across 16 countries evaluated 3 566 patients
`immediately following
`treatment. All patients had
`received a resorbable dermal filler, predominantly Resty(cid:173)
`lane® (Q-MED), within 18 months before study entry.
`Pain levels were low for the lidocaine injections, whether
`or not EMLA cream was applied (2.6 for those with
`EMLA and 2.8 for those without), and pain was rated as
`better than the previous dermal filler for 87.3% of the
`respondents."
`Direct comparison to a currently marketed HA filler
`with lidocainc (Prcvellc® Silk; Mentor, Irving, TX, USA)
`is not possible as a different pain scale was used in that
`clinical study. However. the similarities arc noticeable.
`On a 100 mm Visual Analog Scale, the mean pain at
`injection was 27.74 for the lidocaine filler and 60.26 for
`
`the non-Iidocaine filler (Captique®: Genzyme, Cam(cid:173)
`bridge, MA, USA). 7
`
`Conclusions
`The smooth gel dermal filler formulated with lidocaine is
`effective in reducing procedural pain during correction
`of facial vvrinkles and folds while maintaining a similar
`safety and effectiveness prolile to the filler without
`lidocaine.
`
`Disclosures
`Drs. Weinkle, Bank. Boyd, and Gold received research
`support for conducting this study. Ms. Thomas and Ms.
`Murphy are employees and stockholders of Allergan.
`
`Acknowledgments
`The authors thank Decpali Paradkar, PhD, for biostatis(cid:173)
`tical assistance and Allergan for financial support.
`
`References
`1 Ilusso M, Voigts R. An investigation of changes in physical
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