`
`‘
`
`[LQURNAL OF THE AMERICAN ACADEMY OF
`ERMATOLOGY
`
`FEBRUARY 2008 ' VOLUME 58 ' NUMBER 2
`
`Poster Abstracts
`
`:?_El__._____
`
`American Academy of Dermatology
`66th Annual Meeting
`February 1-5, 2008
`San Antonio, Texas
`
`Supported by
`Abbott Immunology
`
`CFAD v. Anacor, |PR2015—O1776 ANACOR EX. 2106 - 1/6
`
`v
`h fl Mosby
`
`CFAD v. Anacor, IPR2015-01776 ANACOR EX. 2106 - 1/6
`
`
`
`for
`
`ns
`
`I
`
`SUPPLEMENT TO
`JOURNAL OF THE AMERICAN ACADEMY OF
`
`DERMATOLOGY
`
`FEBRUARY 2008
`
`VOLUME 58
`
`NUMBER 2
`
`Poster Exhibit Task Force
`Mission Statement: The Poster Exhibit Task Force enhances the educational
`value of the annual Academy meeting by organizing poster exhibits. These
`poster exhibits are solicited, reviewed, and approved by a peer review Task
`Force. The Task Force develops guidelines and monitors posters for quality
`educational content.
`
`Task Force Members:
`Theodore Rosen, MD, FAAD, Chair
`Khalid Mohd AI Aboud, MD
`Brian Berman, MD, PhD, F AAD
`Nicole V. Brey, MD
`Peter G. Ehrnstrom, MD, FAAD
`Carlos A. Garcia, MD
`Timothy F. Kelly, MD, F AAD
`Eve Judith Lowenstein, MD, PhD, FAAD
`Barbara M. Mathes, MD, FAAD
`William D. Posten, MD, F AAD
`Julie V. Schaffer, MD, FAAD
`Kenneth J. Tomecki, MD, F AAD
`You wen Zhou, MD, F AAD
`
`2009 Annual Meeting Program Submissions
`
`Visit http://www.aad.org for information regarding program participation for
`the 67th Annual Meeting, March 6-10, 2009 in San Francisco, California.
`
`CFAD v. Anacor, IPR2015-01776 ANACOR EX. 2106 - 2/6
`
`
`
`I
`
`SUPPLEMENT TO
`JOURNAL OF THE AMERICAN ACADEMY OF
`
`DERMATOLOGY
`
`FEBRUARY 2008
`
`VOLUME 58
`
`NUMBER2
`
`Poster Abstracts
`
`American Academy of Dermatology
`66th Annual Meeting
`February 1-5, 2008
`San Antonio, Texas
`
`Supported by
`Abbott Immunology
`
`CFAD v. Anacor, IPR2015-01776 ANACOR EX. 2106 - 3/6
`
`
`
`SUPPLEMENT TO
`JOURNAL OF THE AMERICAN ACADEMY Of
`
`DERMATOLOGY
`
`FEBRUARY 2008
`
`Editor
`.Jeffrey D. Bcrnha nl , MD
`Deputy Editor>
`<.. ;. Cn1 pk·y. i\ \\)
`T\Hlllt:! :-
`1'-: ti"L' Il \\ ' i..,:-. . .\ ]\)
`Edito rial Office
`l ' ni\·~..: r.., il \' or .\ l:l' ....... :ll...'hl! ..... '-. .'11 :-.
`~\ Jt.:<Jh.::ll ~(.' \ ltH l l
`.:;::, l.:li\1. . .'
`.\
`\'\..' llllL'
`\'n rt h \\ 'urco..·.-:tl·r. .\ \i\ 0 \ (1':;::,
`::,1 J.~ - s.:; (J- ~.:;s.-;
`J>m.til: nK·liss:l .Lh:rl 1y't])
`t l!l\:l ......... ll 1l'l l .t:tltl
`Associate Editors
`J>oJ Ki: tt ll) \ ) . C n 11 ... lr. \ 1!)
`1 )olios.
`'ll'.W I-'
`I( l hll I. I ) j( ~i O\ '; l!ll1 : 1 .
`. ~ II )
`·/ 'r(JI'i~/t•lld'. !~hudt' !sloutl
`
`l:llh.' ( ;r:tnt -1\. L·l:-- . J\1\)
`./-(!l 'lllill,l~((l/1, (,'r l/11/('( / h ' llf
`
`~: ttluni 1.: l.l v llit h.'k. \ 11)
`/ 'rut ·idl'lf(('. N/1utle 1.-:.huu/
`
`Ti!llPl ll \. :\ 1. .)nhn:-.on. :\11)
`.·\/IJ! .·\ i:/Jrl r. .\fh ·/J(l!,0/1
`
`.\ Ltr\:1 _1. 1\: tc r...,L·n. i\ \ \ )
`..,,.(!/! /.dl,'t ' (.'fly
`l '!u/J
`
`\)J,·id ~ . J{uhL·n -..tvi n. \ \\) Jlh\)
`(.h t!f lcl 1 Jill. ,\ 'ur//1 c'o ruliuo
`M~1 rtin :\ . \VL·in.-.-tud..:. \ \]) . Pill >
`l'ro!'itleu cc '. Nhudc ls!ttlfrl
`Statistical Consultant
`-..,ud dlu -..~ 1 tt ~ l :\dl:tryy:L JlllJ >
`./ 11'111'/d('// l't'. Nhudc lsft111d
`Assistant Editors
`l.c·.till\c'l.t !.:tri:IIL .\ Il l
`\\"ol't , .. ,·ft ·r .\htSSdt'l!/l.'t 'll.'
`
`'\ li ,·ll.l v l I c. 1 \i,~l l\'. \ II l
`1111.-;.( u/1 .. \/r!3."t flh ltSd l.'
`k :ln 1 .. Hn l\);:,tlli:l . \ \\)
`·.\eu · I /tlf 't'll . Ciiii iH'<' fi t' lll
`
`Lui -.. ,\ . I )i.ll. . ,\ II )
`L'hrtj ld !Iii!. ,\'ur(/! C( tru/i/10
`
`.\brk I.L·]n\oh l. \ ll >
`.\e ll · )w'/,• . .\'<'fl' ){ 1/'/,'
`
`I ) {) ll . lid .1. \ lic<..' h . . \ II >
`,\ftll":o:l?flc/d \I"!St/ J/1 :\ ill
`t ;in:ll \\ ' \ lirt )\\·...,J.: i. 1 ),\ \\ > . .\ 11)
`lurlirlltO/ JIIIf.,·. lndfrllf(t
`...,~,_.1 111 :\ . \,jn fl t )!'\. J\ 11 >
`l klh<'.'t/d . . \lruyloud
`
`E \i -..L' ( )] -..L'I1 . .\ II )
`l )lfrht llll . . \urlh Cflr()lillfl
`
`lc li'rL'\' { )rrill~t·r. .\ 11 )
`· .. I !tit .··\r/Ju l'. .\!it"/Ji,t:J 111
`
`Amy "i . jl:i\ h.'r. .\ 11>
`C'hico,t:u. 11/i ii(Jis
`Founding Editor
`_1 . Cr: d1:1111 ~ mit h. ,l r . .\ 1])
`. \luhilt'. : 1/oiH IIII tl
`Edito r Em e ritus
`Ri t h:1rd 1.. \)o \h\)!1 . .\ \\)
`Chorl!' . .,fu/1 . . ' .. :uulh (.(fnl/1/ f{l
`
`VOLUME 58
`
`NUMBEFU
`
`C:ujil"r(~ l>! © .3(!()8 Iii ' II><' / 11//<'l"icou .·IU {(/eun· u( /)('1"!1)1//ulug l'. lu c
`
`PO STER DI SC USS ION SESS IO NS
`
`Sujif!Orl et!IJI' Ali/!011 illlliiiiiiUIOgl'
`
`PDS 491- Acn e
`
`PDS 49 2- Psoriasis I
`
`PDS 49 3--Psoriasis II
`
`PDS 494-Pediatl"ic De rmatology
`
`PDS 49 5-Medical Dennatology
`
`PDS 496-Mycology
`
`Ac n e
`
`Aging!Gel"iatrics
`
`Bas ic Science
`
`Clinica l De rmato logy a nd Oth e t· Cutaneous Diseases
`
`Co nnective Tissue Disease
`
`De nnatitis, Ato pic
`
`De nnatitis, Contact and Alle t·gic Inita nt
`
`Dermato patho lO!,'Y
`
`ABl
`
`All3
`
`All5
`
`All7
`
`AB9
`
`ABI .l
`
`Alll3
`
`AlH 9
`
`AB 27
`
`AB32
`
`AB45
`
`AB48
`
`AB54
`
`All 58
`
`Cu lllilllled 011 JH!p,c /11,·1
`
`Th e opinion s or views expressed in this professional educational supplement are tho se of t he autho r(s)
`and not necessa rily those of t he Ed itor( s), publisher, sponsor, or Academy, and t he Ed itor( s) publisher,
`sponsor, and Academy disclaim any responsibility or liability for such material. Neit her t he Ed itor(s),
`publisher, nor the Academy guarantees, warrants, or endorses any prod uct or service advertised in th is
`publication, nor do t hey guara ntee any cla im made by t he manufacturer of such product or serv ice.
`Dosages, indicat ions, and methods of use fo r products that are referred to in t he supplement by th e
`authors may reflect th eir cli nical experience or may be derived from t he professional literature or other
`cli nical sources. Because of the differences between in vitro and in vivo systems and between
`laboratory ani mal models and clinica l data in humans, in vitro and anima l data may not necessa rily
`correlate w ith clinical resu lts.
`Future citation agreement/How to cite abstracts from thi s supplement: Author( s) agree( s) that
`citations to post er abst racts published in th e Journal of rh e American Academy of Dermorology w ill
`adhere to th e fo rmat of t he examples g iven below, w hich cl arly indicate that the cited item has been
`published in abstract form .
`Aut hors. Ti t le of abstract (abstract). J Am Acad Derrnato l 2008;58:AB pag e number. Abstra ct number.
`Munavalli G. Rapid acne reg ression using photopneumatic therapy (ab stract) . J Am Acad Dermatol
`2008;58:AB 1. Abstract P1 02.
`
`9A
`
`CFAD v. Anacor, IPR2015-01776 ANACOR EX. 2106 - 4/6
`
`
`
`Contents
`
`co ntinued
`
`Dermatophannacology/Cosmeceuticals
`
`Digital/ Elecu·onic Technology
`
`Education and Collllnunity Service
`
`Epidemiology and Health Services Administration
`
`Genodermatoses
`
`Hair and Nail Disorders
`
`lmmunodermatology and Blistering Disorders
`
`InJection (Bacterial)
`
`Infection (Ftmgal)
`
`Infection (Viral)
`
`Internal Medicine Dennatoloh'Y
`
`Lymphoma, Cutaneous/Mycosis Fungoides
`
`Melanoma and Pigmented Lesions
`
`Noruuelanon1.a Skin Cancer
`
`Pediatl"ic Dennatology
`
`Photobiology, Phototherapy, and Photosensitivity Diseases
`
`Pigmentaqr Disorders and Vitiligo
`
`Psol"iasis and Other Papulosquatnous Disorders
`
`Skin Anatomy, Embryology, and Physiology
`
`Surgery (Cosmetic)
`
`Surgeqr (Dermatologic)
`
`Surgery (Laser)
`
`Wound Healing and Ulcers
`
`Authot· Disclosures
`
`Authot· Index
`
`Subject Index
`
`AB62
`
`AB73
`
`AB73
`
`AB76
`
`AB79
`
`AB81
`
`AB84
`
`AB86
`
`AB90
`
`AB92
`
`AB96
`
`ABIOO
`
`AB102
`
`ABI04
`
`AB107
`
`ABllO
`
`AB115
`
`AB119
`
`AB135
`
`AB135
`
`AB138
`
`AB139
`
`AB142
`
`ABI46
`
`ABI66
`
`AB173
`
`lOA
`
`F 1111tl1A RY 2008
`
`) AM A CI\1) D FRM i\TOI
`
`CFAD v. Anacor, IPR2015-01776 ANACOR EX. 2106 - 5/6
`
`
`
`P1702
`Terbinafine HCl nail solution with and without nail penetration enhancer:
`Evaluation of minimum inhibitory concentration and minimum fungici-
`dal concentrations
`Mahmoud Ghannoum, MS, MBA, PhD, Case Western Reserve University/University
`Hospitals, Cleveland, OH, United States; Nancy Isham, Case Western Reserve
`University, Cleveland, OH, United States; William Pfister, PhD, NexMed, Inc., East
`Windsor, NJ, United States
`
`P1704
`Pramiconazole, a novel oral antifungal agent, effectively treats pityriasis
`versicolor: Results of a dose-finding clinical study
`Jan Faergemann, MD, PhD, Department of Dermatology, Go¨teborg, Sweden;
`Marcel Borgers, PhD, Department of Molecular Cell Biology, Maastricht,
`Netherlands; Charles Barranco, MMSc, Barrier Therapeutics, Inc., Princeton,
`NJ, United States; Mary Spellman, MD, Strategic Pharmaceutical Research &
`Development, San Francisco, CA, United States
`
`Objective: There is a need for efficacious topical agents to treat onychomycosis. In
`this study, antifungal susceptibility of dermatophytes (Trichophyton rubrum, T
`mentagrophytes, Epidermophyton floccosum, and Microsporum canis), non-
`dermatophyte moulds (Scytalidium spp., Scopulariopsis spp.), and Candida
`albicans (25 isolates each) against 1% terbinafine HCl nail solution, with and
`without nail penetration enhancer dodecyl-2-N,N-dimethylaminoisopropionate hy-
`drochloride (DDAIP HCl) was determined using the Clinical Laboratory Standards
`Institute (CLSI) minimum inhibitory concentration (MIC) methodology, and mini-
`mum fungicidal concentration (MFC) assay. Ciclopirox and miconazole were used as
`comparators.
`
`Methods: The MICs of dermatophytes and moulds were determined using CLSI M38-
`A2 method, while that of yeast were evaluated according to CLSI M27-A2 document.
`MFCs were determined by subculturing all wells of the MIC showing no visible
`growth.
`
`Results: Our data showed that addition of nail penetration enhancer to terbinafine
`lowered the MIC50 (minimum concentration inhibiting 50% of isolates) of dermat-
`ophytes by one dilution, but did not change the MIC range nor the MIC90 (minimum
`concentration inhibiting 90% of isolates). Terbinafine with/without nail penetration
`enhancer was fungicidal against dermatophytes (MFC range, 0.008-1.0 g/ml for
`both). The MIC50 and MIC90 of terbinafine with enhancer were one dilution lower
`than those of terbinafine alone against Scytalidium strains. Additionally, terbinafine
`had fungistatic anti-Candida activity (MIC range, 0.007-0.12 g/ml). Ciclopirox and
`miconazole were fungistatic against dermatophytes with MICs 2-4 folds lower than
`those for terbinafine.
`
`Conclusion: MICs and MFCs of terbinafine with and without nail penetration
`enhancer against all fungal
`isolates tested were in agreement,
`indicating that
`combining this antifungal with the enhancer did not affect the susceptibility of the
`organisms to terbinafine and was not antagonistic.
`
`NexMed gave a grant to cover our antifungal research.
`
`Pramiconazole is a novel, orally active, broad spectrum antifungal agent, which
`inhibits the biosynthesis of ergosterol in the fungal plasma membrane. Malassezia
`spp. are identified as the causative agents for pityriasis versicolor, a common,
`superficial cutaneous fungal infection characterized by dyspigmented, slightly scaly
`macules and patches on the upper trunk and arms. The effectiveness of
`pramiconazole oral solution was evaluated in a multi-center, randomized, double-
`blind, placebo-controlled, dose-finding study, which enrolled 147 adult patients
`with clinically-evident, KOH-positive, pityriasis versicolor. The study drug was
`administered for three consecutive days; pramiconazole doses of 100 mg once, 200
`mg once, 400 mg once, 200 mg daily for 2 days, or 200 mg daily for 3 days were
`compared to placebo. Postbaseline clinical assessments were performed at days 14
`and 28,
`including evaluations of the signs and symptoms of disease, global
`assessment of disease, and mycological exam (KOH). The primary efficacy evalu-
`ation of treatment effectiveness was the proportion of patients with negative KOH
`concurrent with complete resolution of erythema, desquamation, and pruritus, or
`minimal residual signs and symptoms if the baseline evaluations were moderate or
`severe. At day 28, the trend in the success rate was statistically significant (P #.001),
`indicating a linear dose response. A statistically significant (P # .003) response to
`treatment was observed for pramiconazole 200 mg once (n ¼ 13, 59%), 400 mg once
`(n ¼ 16, 70%), 200 mg daily for 2 days (n ¼ 21, 84%), and 200 mg daily for 3 days (n ¼
`22, 85%), when compared with placebo (n ¼ 4, 16%). The most commonly reported
`treatment-emergent adverse event was diarrhea, occurring in all groups with an
`overall frequency of nearly 24%; this was attributed to a component of the studied
`formulation. Two SAEs were reported during the study; one before study drug
`administration (myocardial infarction) and one postdose (malaria); neither was
`considered to be related to the study drug. Brief regimens of oral pramiconazole, at
`doses of 200 mg once, 400 mg once, 200 mg daily for 2 days, and 200 mg daily for 3
`days were well tolerated and effective in the treatment of patients with pityriasis
`versicolor. Further clinical study of pramiconazole for the treatment of cutaneous
`fungal infections is warranted. Acknowledgement: the Pramiconazole-study group.
`
`This poster is 100% sponsered by Barrier Therapeutics.
`
`P1703
`Ketoconazole 2% foam in the treatment of mild to severe seborrheic
`dermatitis
`Boni Elewski, MD, University of Alabama School of Medicine, Birmingham, AL,
`United States; William Abramovits, MD, Dermatology Treatment and Research
`Center, Dallas, TX, United States
`
`Objective: To evaluate the safety and efficacy of ketoconazole (2%) in a hydro-
`ethanolic formulation foam vehicle vs. vehicle foam alone in patients with mild to
`severe seborrheic dermatitis (SD).
`
`Methods: In a phase III, multicenter, double-blind trial, 847 subjects aged 12 years or
`older with mild to severe SD were randomized to receive ketoconazole 2% foam (n ¼
`427) or vehicle foam (n ¼ 420) twice daily on the head, face, or trunk for 4 weeks.
`The primary efficacy endpoint was the proportion of subjects who attained
`treatment success, defined as an Investigator’s Static Global Assessment (ISGA)
`score of 0 (clear) or 1 (average score of 1 for scaling, erythema, and induration) at
`week 4. A secondary endpoint was the proportion of subjects who had modified
`treatment success at week 4 (ISGA score of 0 or 1, an erythema score of 0 [normal]
`or 1 [faint] at the target area, and a scaling score of 0 [normal] or 1 [minimal] at the
`target area, with a minimum improvement of 2 grades for each parameter). Subject
`reports of adverse events (AEs) were recorded at each study visit. Subjects were
`evaluated at baseline (day 1), week 2, and week 4. All endpoints were analyzed using
`an intent-to-treat analysis.
`
`Results: Significantly more subjects achieved treatment success using ketoconazole
`foam versus vehicle foam (56% vs. 42%, respectively; P \ .0001). Treatment
`responses for the primary efficacy endpoint were similar across age, gender, race,
`and baseline disease severity. The proportion of subjects who attained modified
`treatment success was significantly higher for the ketoconazole foam group (50%)
`compared with the vehicle foam group (33%; P \.0001). Ketoconazole foam was
`safe and well tolerated. The most commonly reported AEs were mild, transient
`application site burning and mild application site reactions. There was no statisti-
`cally significant difference in the incidence of AEs between the 2 treatment groups
`(P ¼ .8075).
`Conclusions: Ketoconazole 2% foam, the first available antifungal foam formulation
`for the treatment of mild to severe SD, is effective, safe, and suitable for patients with
`SD on the head, face, or trunk, regardless of age, gender, race, and baseline disease
`severity.
`
`P1705
`New world leishmaniasis: A surge in incidence in the United States
`Robyn McCullem, MD, Mayo Clinic-Jacksonville, Jacksonville, FL, United States;
`Donald Lookingbill, MD, Mayo Clinic-Jacksonville, Jacksonville, FL, United States
`
`Leishmaniasis is caused by obligate, intracellular protozoa endemic in the tropics
`and subtropics. The majority of cases in the United States result from travelers who
`have acquired the disease elsewhere. US tourist travel to Central America has
`increased 47% over the last 6 years, with Costa Rica being the most popular country
`visited in that region. The number of culture-positive cases identified by the US
`Centers for Disease Control and Prevention has increased 68-fold between 1986 and
`2006, with the largest percentage (15%) coming from Costa Rica. Diagnosis of
`leishmaniasis requires a high level of clinical suspicion and can be difficult, because
`several biopsies are needed and a special culture medium must be used. Because of
`the increased incidence of leishmaniasis in the United States secondary to the travel
`of US citizens to endemic areas, dermatologists must be familiar with the diagnostic
`work up of leishmaniasis. We present the clinical features, diagnostic work up, and
`management of a patient with culture-positive Leishmaniasis panamensis after
`travel to Costa Rica.
`
`This clinical trial was sponsored by Stiefel Laboratories, Inc.
`
`Commercial support: None identified.
`
`AB12 J AM ACAD DERMATOL
`
`FEBRUARY 2008
`
`CFAD v. Anacor, IPR2015-01776 ANACOR EX. 2106 - 6/6