Doc Code: PA ..
`Document Description: Power of Attorney
`
`PTO/AIA/828 (07-13)
`Approved for use through 11130/2014. OMB 0651-0051
`U.S. Paten! and Trademark Office; U S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number
`
`(
`
`POWER OF ATTORNEY BY APPLICANT
`
`)
`
`I hereby revoke all previous powers of attorney given in the application identified in either the attached transmittal letter or
`the boxes below.
`
`I Application Numbe<
`
`I Filing DafB
`
`I
`(Note: The boxes above may be left blank if information is provided on form PTO/AIA/82A.)
`[l] I hereby appoint the Patent Practitioner(s) associated with the following Customer Number as my/our attomey(s) or agent(s), and
`to transact all business in the United States Patent and Trademark Office connected therewith for the application referenced in
`~:attached transmittal letter (form PTO/AIAI82A) or identified above: @~-~-~~---------··:·----------------------]
`
`D I hereby appoint Practitioner(s) named in the attached list (form PTO/AIA/82C) as my/our attomey(s) or agent(s), and to transact
`
`all business in the United States Patent and Trademark Office connected therewith for the patent application referenced in the
`attached transmittal letter (form PTO/AIA/82A) or identified above. (Note: Complete form PTO/AIAI82C.)
`
`Please recognize or change the correspondence address for the application identified in the attached transmittal
`letter or the boxes above to:
`[{] The address associated with the above-mentioned Customer Number
`------------------------]
`D : : address associated with Customer Number: [ ______________
`
`OR
`
`Firm or
`Individual Name
`
`Address
`City
`Country
`Telephone
`
`I State
`J Email
`I
`I am the Applicant (if the Applicant is a juristic entity, list the Applicant name in the box):
`
`I
`
`I Zip
`
`I
`
`I
`
`I
`
`D Inventor or Joint Inventor (title not required below)
`D Legal Representative of a Deceased or Legally Incapacitated Inventor (title not required below)
`[Z] Assignee or Person to Whom the Inventor is Under an Obligation to Assign (provide signer's title if applicant is a juristic entity)
`D Person Who Otherwise Shows Sufficient Proprietary Interest (e.g., a petition under 37 CFR 1.46(b)(2) was granted in the
`
`application or is concurrently_ being filed with this document) (provide signer's title if applicant is a juristic entity)
`SIGNATURE of Applicant for Patent
`The undersigned (whose title is supplied below) is authorized to act on behalf of the applicant (e.g., where the applicant is a juristic entity).
`I Date (Optional) I
`,
`'
`!
`Signature
`.:S':~·· / ••• ••••·
`-~·''!\.-·;-
`···),~~ .. ~~· •• ~··',:'.··f ~ .......
`,...:;.;:
`l ...
`. .(·~ ....... , .....
`"'
`Debra D. Condino
`Name
`Vice President, Allergan, Inc.
`Title
`NOTE: Signature - This form must be signed by the applicant in accordance with 37 CFR 1.33. See 37 CFR 1.4 for signature requirements
`and certifications. If more than one applicant, use multiple forms.
`
`0Totalof 1
`forms are submitted.
`Th1s collection of Information 1s reqwred by 37 CFR 1.131, 1.32, and 1.33. The mformation 1s requ1red to obta1n or retain a benefrt by the publ1c which IS to file (and by the
`USPTO to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.11 and 1.14. This collection is estimated to take 3 minutes to complete,
`induding gathering, preparing, and submitting the completed application form to the USPTO. Time will vary depending upon the indiVidual case. Any comments on the amount
`of time you require to complete this form and/or suggestions for reducing this burden, should be sent to the Chief Information Officer, U.S. Patent and Trademark Office, U.S.
`Department of Commerce, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS SEND TO: Commissioner
`for Patente, P.O. Box 1450, Alexandria, VA 22313-1450.
`If you need assistance in completing the form, call1-800-PT0-9199 and select option 2.
`
`1
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`AMN1017
`
`

`

`PTO!I'·JAiOi (06·12}
`AppW\N .. :::U {or US\.?. ~hrD:Jgh 0~.13~,:2014. QMB 065~"0032
`U.S. Pt=:t'3f1~ 3J1\..i T~'<Jemark O:iii'.::~). U.S. DeP.c>..Hrf\{~NT OF COMME~={CE_
`~3mi:..>r i.h~ Pi):)t.::n.v-orK Rsdu.;t1cn f..d of ·~ ~:~6. no pE:rscns- are req>J··:·~>=~ t-o r~:5spun~ t:) \.=t \..iDlk->:..~:(~;'1 oi :n~orm~~~k~~~ u:'lk'!Ss ;~ d:s~ls•nf n ve~iiG 01"./~~~ xn~r-:)~ :"!umt~r
`
`(
`
`DECLARATION (37 CFR 1.63) FOR UTILITY OR DESIGN APPLICATION USING AN
`APPLICATION DATA SHEET (37 CFR 1.76)
`
`Title of
`Invention
`
`TOPICAL DAPSONE AND DAPSONE/ADAPALENE COMPOSITIONS AND
`METHODS FOR USE THEREOF
`
`This declaration
`1 is directed to:
`
`D Uni!ed StBies application m PCT inlernatiooal <!pp!icatlon number ······--~'"·
`
`Tn'~ abc.,,N~--tdentified app!icatkm was made or authorized to be made by me.
`
`I tdimr~: th<;~ i <lm the originE<i irwentcr or Clrt or>gina! joint invsmtm .<af a chlimed inver:! ion in the applie<ltbn.
`
`I hereby acknowledge that any willful false statement made in this declaration is punishable under 18 U.S.C. 10{)1
`by fine or imprisonment of not more than five (5) years, or both.
`
`WARNING:
`Pelilioner/applican! is cautioned to avoid submiWng personal information in documents filed in a patant application that may
`contribule to identity theft Personal information such as social security numbers, bank account numbers, or credit card numbers
`{other than a check or credit card authorization form PT0-2038 submitted for payment purposes) is never required by the USPTO
`k> support a pel1tion or an application. If this type of personal information is included in documents submitted to the USPTO,
`petitioners/applie<lnts should consider redacting such personal information from the documents before submitting them to the
`USPTO. Petitioner/applicant is advised that the record of a patent application is available to the public after publication of the
`application (unless a non-pubiicat:on request in compliance with 37 CFR 1.213(a) is made in the appllcation) or Issuance of a
`patent. Furthermore, the record from an abandoned application may also be available to the public if the application is
`referenced in a published app:ication or an i:;sued patent (see 37 CFR 1.14). Checks and credit card authorization forms
`PT0-2038 submiH~d for p<lyment purposes are not retained in the application file and therefore are not pubiicly available.
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`LEGAL NA!\ .. ~E OF INVENTOR
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`Note: An application d<:ta sheet {PTO/SB/14 o(equivalent), including naming the entire inventiv<.' entit)' must accompany this form or must tKwe
`been previously flied. Use an additional PTO!A1Ai01 form for each additional inventor.
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`This coa~":z:~:on -::;~ 1nfcrm~t!on !& reqwrOO by 35 U.S .. C.: i5 ;.~n€1 3J GH~ 135:5. 1"h.s !:-:frnrrwtK::n ~; req;;lmd k~ v.bh~in r.;;r mk=::~; ~ h~=m~fi~ hy ~.h!!' pub:~c wh~ch tt:> lo m1Z (.v~ti
`by the USFrO ic P!•:<(::eS5) a:1 up~·i:('ai:on. Co?l~1Cens;ali~y :~ go·to&mad by 3:5 U.S. C. 122 em.: :37 CF~~ 1.:1 ~.:::n0 i. iJ!, ·r:-;.ls \;r;l!~<.:~i;,m i~ &$~!m:;;t(j~1 tt1 w.kt:-: ;-;:h~ut-t:? :r;
`compt.:::~:·. lndt:tiH1g g~tr.ttfl~g, pr~p3rlng. and ~uhm~!li:-:g ~~f; ctvr.p!ek~-; a;')p~r. •. nt;f)n ft·Hm ))')the USP'TO. T~m* t.vm vary ~..:~ndiNQ upon tht~ indiv~~·.h~RI '.<1$~ • .A.l)Y
`comma'lts en ;hf: am.:kmi cf ~!ma you require ~o mm~!~W ihis !orm ~£r.d!or s;;gges~h..-')ns for :-eduo~g ~}>~s ~.'I!Jn1?.n. 5!1:):.:!\.i tM: s~nt k'~ th~ Ch:...-?1 ~m'":JP:~~a!!t1:~ O~ik:~:-. ;; .$
`P3t-3...-11 ar!d 'lfade:m3rX Of:(a, U 3. 0!?~-a:i~~:o:fH ot Commw-::.a, P.O. 8·0:{ 1·1£i0, .-'\Jax-:s~dlia, VA 223"13--14~~0. DO NO"f SEND FEES 0~~ CDMPlET[O ;=ORM~; ":"0
`THI8 1~DDHoSS. SEND TO: Commlssis:mer for Pat~n~s, P.O. Bol( f450, .A!I1)(<1ndrhs, VA 223.1:3·1450.
`ll }'Otr tl•.;~:d ar;si::.:.wnc;,.~ m cr;mph;Nr.VJ ~h~ lcrq•. ca.~ 1'~:..-:::)'.p'fo .. ;;1$19 ~:n~J s;).~~· fiPJ!n;,,;.:
`
`2
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`

`

`PTO/.D·.IAi01 (06-12}
`l~pptTJ\Ied for U5f: th:·cmgh Cll/3':/2014. OMB 0651 ~003~
`U.S Pa\;or;\ and Tcadem;;.r·k Otlice; US. DEPARTMENT OF COMMERCE
`
`DECLARA T!ON {37 CFR 1 J33} FOR UTlUTY OR __ DESIGN APPLICATION -USlN-G ~N\
`j
`APPLICATION DATA SHEET (37 CFR 1.76)
`"
`/
`----··-·····-·· ·. .................
`TOPICAL DAPSONE AND OJ\PSONEii\DAPALENE COf\.•1POSITiONS Ai\10
`Titre of
`Invention METHODS FOR USE THEREOF
`
`i\s the below named inventm, I hereby declare !hat
`
`This declaration
`is directed to:
`
`H1e attached app.iicaiion, or
`[f United States application or PCT international application nurnber - - - - - - - - - - - - -
`
`filed on
`
`i The above-identified .appl:cst1on was rnade or authorized io be rnade by rrm.
`
`! believe that I arn the original inventor or an original joint inventor of a claimed invention in ihe application.
`
`I hereby acknowledge that any willful false st;:;ternent made :n this dedaralion is punisr1able under i 8 U S.C. "1001
`by fine or impnwnment of not rnore than fnm (5) years. m boUt
`
`WARNING:
`Petitionerlappllcant is cautioned lo avoid submitting persona! information in documents flied in a patent appilcat:on that may
`contribute to idei;tity theft. Persona! information such as social security numbers. bank iKCOlmt numbers, or cre(jit w:·d numbers
`(other than a check or credit card authorization form PT0-203t. submitted for payment purposes) is never required by the USPTO
`to support a petition or an appl:cation. !fthis type of personal information is included in docurnenls submitted to ti1EO USPTO,
`petit!oners/appl:cants shouid consider redacting such personal irrfonn:aUon from the docurnents before submitting then1 to the
`USfTH). Petiiionerfapplican! is advised that lhe record of a pa!enl application is available to H1e public after publication of the
`appi:.cat:on (unless a non~publicalion requesl i.n comp!iance with 37 CFR 1.213(a) is made in the application) or issuance of a
`palent Fur!herrnore, the record from an abandoned appi!cation may 8lso be available to the public if ihe application is
`~ referencetj in a published application or an issued patent (see 3? CF R i. ·14). Checks and credil c..ard authoriz.<;tior; forrns
`PT0-2038 submitted for payment purposes are not retained in the applicaiion ftle and therefore <lm not publicly available
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`LEGil..L N/!..[1/;E OF INVENTOF~
`
`Date (Option::d) :
`
`Note: An appiicatior: dnta sh~et (PTO/S.B/14 or equivalent), induding nan1ing the entire inventive ent:ty: frHJ5t accornpanythis fnrm or must have
`been pfeviot~sly f~lf:fl. Use an ;;)dc~~tior:a! PTO/A!.~.lOi forrn for each addiUona! ~nven~r.Jr.
`
`this t:oltec:t~or. cf ~nforrr~stJon lS r~qwred by 35 V.S.C. ·t·l 5 and j/ CFR 1.63. The ~nfon-nm:or: 1s requ:~ed to obtatn Vi reta:n;:, t;e~e"it:. Dy th-e pun:1s wh:c~1 iS lC fJ~e (ar.c
`by t~~fr USPTO to process) an ap.pJ;caticn_ Confidentiality !s gcvetned by 35 U S..C !22 .;"r'ci 37 CFR ~ .11 a,;r; I_ 14. This coH;actlon lr:.- es~~mBteiJ to -take: : minut•::- tt·
`com~-::·!ete, ~n·::.t:..1ding gathering, prep;;;ring, Bnd submitttng :.h€ con:ph:~~ed app!ica~ior: fom1 to tne USPTO. Time v.n!! vary depend;fig upor: 1he ;ndiv~cldai esse. J\ny
`comn:ents on t!lf! 2.n:eum of t!me you r~qu~rE t0 comp~st~ this fc.rrp and:'or sugg~st:or.s f·:J: feduci:~Q· this bu:·den~ sht,~!d be s::::-:t to the Chief !nf<Jrm3t:en o~"llce; ,. U.S.
`Patent. ~mfJ Tror;em8:·k Oftlce. U.S. Department of Ccmrr:erc~. P.O. B·::.x 1450, /~.:ex~n1ria, VA 223·!3-1450. DO NOT SEND FEES OR COMPLETED fOR~;1S TO
`TH:s 1\DDHE'SS SEND TO: Commissioner for Patents, P.O. Sox '1450, Alexandria, VA. 22313-1450.
`
`3
`
`

`

`PTO/AIN01 (06-12)
`Approved for use through 01/31/2014. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMS control number
`
`DECLARATION (37 CFR 1.63) FOR UTILITY OR DESIGN APPLICATION USING AN
`APPLICATION DATA SHEET (37 CFR 1.76)
`
`TOPICAL DAPSONE AND DAPSONE/ADAPALENE COMPOSITIONS AND
`Title of
`Invention METHODS FOR USE THEREOF
`
`As the below named inventor, I hereby declare that:
`
`This declaration
`is directed to:
`
`The attached application, or
`
`United States application or PCT international application numbe r - - - - - - - - - -
`
`filed on - - - - - - - - - - - - - - -
`
`The above-identified application was made or authorized to be made by me.
`
`I believe that I am the original inventor or an original joint inventor of a claimed invention in the application.
`
`I hereby acknowledge that any willful false statement made in this declaration is punishable under 18 U.S. C. 1001
`by fine or imprisonment of not more than five (5} years, or both.
`
`WARNING:
`Petitioner/applicant is cautioned to avoid submitting personal information in documents filed in a patent application that may
`contribute to identity theft. Personal information such as social security numbers, bank account numbers, or credit card numbers
`(other than a check or credit card authorization form PT0-2038 submitted for payment purposes) is never required by the USPTO
`to support a petition or an application. If this type of personal information is included in documents submitted to the USPTO,
`petitioners/applicants should consider redacting such personal information from the documents before submitting them to the
`USPTO. Petitioner/applicant is advised that the record of a patent application is available to the public after publication of the
`application (unless a non-publication request in compliance with 37 CFR 1.213(a} is made in the application) or issuance of a
`patent. Furthermore, the record from an abandoned application may also be available to the public if the application is
`referenced in a published application or an issued patent {see 37 CFR 1.14). Checks and credit card authorization forms
`PT0-2038 submitted for payment purposes are not retained in the application file and therefore are not publicly available.
`
`LEGAL NAME OF INVENTOR
`
`Inventor: Vijaya Swaminathan
`.· (~t~~c•'N;:v
`. '
`
`Signature:
`
`'
`
`Date (Optional) :._...:.1.:....i .;..l...:.l...:.t.~-i;j:.-;_3 ____ _
`
`Note: An application data sheet (PTO/SB/14 or equivalent), including naming the entire inventive entity, must accompany this form or must have
`been previously filed. Use an additional PTO/AIA/01 form for each additional inventor.
`
`Th1s collection of Information IS requ1red by 35 U.S.C. 115 and 37 CFR 1.63. The mformat1on IS requtred to obtam or retam a benefit by the public wh1ch IS to file (and
`by the USPTO to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.11 and 1.14. This collection is estimated to take 1 minute to
`complete, including gathering, preparing, and submitting the completed application form to the USPTO. Time will vary depending upon the individual case. Any
`comments on the amount of time you require to complete this form and/or suggestions for reducing this burden, should be sent to the Chief Information Officer, U.S.
`Patent and Trademark Office, U.S. Department of Commerce, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO
`THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`If you need assistance in completing the form, cafi1·800-PT0·9199 and select option 2.
`
`4
`
`

`

`PTO/AIA/01 (06-12)
`Approved fof US<3 lhrough 01131i20H. OMB CSSi-0032
`U.S. Patent a~rl Tmdemari< Office: U.S. nt:P."-I~TMENT OF COMMERCE
`U;o~>>r (he Par.-t~tw<>rk R,,duction Act of 1995. no persons~''' requrred to respond to a collection of lnforrnalion unless it o:s;:,lays a valili OM!J c;;ntrol number.
`
`DECLARATION (37 CFR 1.63) FOR UTILITY OR DESIGN APPLICATION USING AN
`APPLICATION DATA SHEET (37 CFR 1.76)
`
`l
`
`~
`
`TOPICAL DAPSONE AND DAPSONE/ADAPALENE COMPOSITIONS AND
`METHODS FOR USE THEREOF
`
`I Title of
`invention
`.
`j As ~he below· named trwentor. I hereby declare that:
`j This declaration
`1m
`! ls directed to:
`0
`
`The attached application, or
`
`United States application or PCT intema!forcal application number __ ~---~--··-~·-·---··
`
`I I !
`! i The ;,bovs-cidenlitied appitcation was made or aulhorlzed lo be made by me.
`l I l believe that I ;;Jm the orii}inal irwen!or or <m original joint inventor of a claimed imren!:on ir: the app!icalion.
`!
`I I hereby acknowledge that any willful false statement made In this declaration is puqlshable under 16 U.S.C 1001
`! l ! !
`t
`WARNmG:
`I Petitmner!apphcar:! is cautioned to avoid submitting persona! ~nformasion in doc<;menw flied ir: g patent app!icalkm th<lt may
`! contribute io identity ihdt Persor.al information such as m~cial secud!y numl:mrs, bank i3ccmmt numbers, or credit card nwnt•ers
`l (other than a check or cred!! card authorizattor. !'om·• PT0-2038 :suomitted for paj111ent p<.trposes} is never required by the USPTO
`lto :support a pelillon or an applk.atlort if this type of personal infomwlion is included in documents submitted ~o the USPTO,
`! pe!i!ioner:s!applicanl.s should consider redacting such pemonal information from the documents before submitting them to the
`
`fi!edon
`
`by fine or imprisonment of not more than five (5) years, or both.
`
`I USPTO. Pelitionerlappllcant m aalf:sed tnet !he record or a patent application ls available to the public after publication of the
`I patent fl.:rtllennwe, the recon:l from an abandoned applicalkm ma}i also be available tc the public lf the applicallon is
`
`;~ppiication {unless F.l non-pub!lcat~on reqm:sl ~n compHance wi1h 37 GFR 1 .213(a} is made ln !hs application} or issuance of a
`
`ref<:renced m a pub!1shed appilcation or an issued patent (see :·n CfR 1. '14). Checks and credit card authorization fom1s
`PT0··2038 submitted for payment purposes am rml m!ained lro ihe app!it:<ltion me <md !lle<ef(lre ar~: not publicly aYailable.
`l
`
`LEGAL NA!'.·lE OF IN\/ENTOR
`
`Inventor: Kevin S. Warner
`
`Signature:
`
`i ·· '----··-
`
`I
`
`<.:,.-
`
`I ( J ! 2
`' '
`Date (Optional) :
`--'---..,--.;...~,.,:;--2.!-..----
`(
`
`/'.wta: An applic<'lt:on d;>!<> sheet (PTO/SB/14 or equivalent). incluci:1g naming the entire invenl:ve entity, must accompany this form or must h'we
`! b;>en previously filed. Use an add;!!onal PTOIAIA!01 form for e;;;ch additkmal invenl,:r.
`"riHs c;oli~~:"iit~i"' of i?~fu:lflBtt)n i5 :--ecu;1.o:d Cv 35 U.S.C.. 1·~~l ;snd ~7 CFR- 1.6i The infom-:atHJn ~~ rsqu:md to ob~Si~ fir r$la:N ~ h~~~§t by ih~ p~jhf:C l¥hk1h is ti"';o ~~'J {ami
`t~y fh.s USPiO ~>J. proc:~ss} ~n spp:;c;Ji}cn '<:c~ilde'ltiP-l•ty t~ go>.;emeti by 35 U.S.C. ~22 ar:d 3'J CFR 1, ~ i and i. ~~~ Th~ c:.~H~t.Ucn i~ ~~trnr:tad ~o ~~k~ ~ rr1:~,~~E~ \O
`,::):-:-:p:~z~~. iNd;;ding g._~!h&~~g. p;-~pBnng .. ~nd $Uhmitt:ng ~f: t":fSm~~t~~d .a:;.~hcr.stiUn furm ~-:> rh* USPTG. T1m~ wi~: ..... a~~/ d~p~~~dlng :..:p!.lt: ti~G !tld:\'id:.;rJ! C:J$;~1. A~1y
`comm:snts on !h~ am~~u;'~~- 'iS:~ time yvu ffiquiro ft-: t-;Nl"::p:~~* thi~ fum~ ~ndfor ~ugg'Sshonf. icr rad::d!')~} H~l~ b~.mJ*n, shtJt!~d a"n":' SGl')t tD tt~~ Ch:ar ~nf~l"r"f:a~~!Jn Omtwr U ~i.
`?a,~n! anG Tro,~emark Offc:-;B. U ~; (l<lpa,tm»n< r.ri Cornm~""'· P.O. ilox 145G. Alexandria. \/A ;12313-1450 DO NOY SO'NO FEO'S OR COMPlETED FORMS TO
`·::·ii8 ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450, A!a.xam:irla, VA 223·l~>·1450,
`If you nG~d assistance i:: oom.n:'·"2Nng t~•a form, csi! t.,.s~-x:..PT0..91t;9 01ni ss.:oc~ :Jpt:::n 2
`
`5
`
`

`

`19107DIV(AP)
`
`TOPICAL DAPSONE AND DAPSONE/ADAPALENE COMPOSITIONS AND
`
`METHODS FOR USE THEREOF
`
`By
`
`Kevin S. Warner, Ajay P. Parashar, Vijaya Swaminathan, and Varsha Bhatt
`
`CROSS REFERENCE TO RELATED APPLICATIONS
`
`[001] This application is a divisional of copending U.S. Patent Application No.
`
`14/082,955, filed on November 18, 2013, which claims the benefit of U.S. Provisional
`
`Application Ser. No. 611728,403 filed on November 20, 2012 and U.S. Provisional
`
`Application Ser. No. 611770,768 filed on February 28, 2013, all of which are incorporated by
`
`reference herein in their entirety.
`
`FIELD
`
`[002] The present embodiments relate generally to compositions useful for treating a
`
`variety of dermatological conditions. In particular, some embodiments relate to dapsone and
`
`dapsone/adapalene compositions and methods for use thereof.
`
`BACKGROUND
`
`[003] Acne is a group of common skin conditions characterized by the so-called
`
`"acneiform" or acne-like skin eruptions, which can be contaminated with bacteria, such as
`
`Propionibacterium acnes, and can also be marked by inflammation. Acne tends to occur in
`
`the areas of skin where the sebaceous glands are most active, such as the face. Acne is
`
`associated with psychological trauma, and, if left untreated, can lead to scar formation and
`
`disfigurement.
`
`[004] Classification and the diagnosis of various acne conditions can be complex,
`
`and even contradictory. Given this complexity and unpredictability, medication and other
`
`therapies, are often developed on a trial-and-error basis in order to determine the most
`
`effective course of treatment for a particular patient. The outcome of any particular acne
`
`treatment regimen greatly varies from patient to patient, as well as throughout treatment of a
`
`particular patient. In addition to the complexity and variability of acne conditions, treatment
`
`efficacy can be greatly affected by a patient's compliance with the treatment regimen.
`
`Patient compliance during acne treatment may be influenced by side effects, which, for
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`topical medications, commonly include redness, itching, and skin peeling. The complexity of
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`the drug regimen can also negatively affect patient compliance, particularly where two or
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`more different topical medications are prescribed simultaneously. Another factor that
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`negatively affects patient compliance is the cost of a drug regiment, which is considerably
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`higher when multiple medications are prescribed. In some countries, acne is considered a
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`cosmetic problem, and acne treatments are not covered by insurance plans, thus further
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`increasing patient's treatment costs. Certain compositions for treatment of acne are available.
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`Many of the available compositions include one active agent known to have anti-acne
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`activity. Stability of compositions with multiple anti-acne agents can be problematic. Also,
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`these compositions can be difficult to manufacture.
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`[005] The problems described above are not confined to the treatment or acne, but
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`are also applicable to a variety of other skin conditions, including, but not limited, to
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`conditions or classes of conditions with complex or unknown etiology and that are difficult to
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`classify or diagnose, in which, nevertheless, topical application of agents are known to be
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`effective at least in some cases. Examples of such conditions or classes of conditions include
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`psoriasis, rosacea and ichthyosis.
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`[006] Accordingly, there is a continuing need for compositions and methods used in
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`a treatment of a variety of skin conditions, such as acne, in which topical application is
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`potentially effective. The compositions and methods provided herein address these and other
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`needs in the art.
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`SUMMARY
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`[007] Dapsone, (4,4'-diaminodiphenyl sulfone) is a medicament possessing several
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`beneficial medicinal activities. Dapsone is typically administered as one of the medicinal
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`agents used in the treatment of leprosy. Dapsone and its derivatives are also effective for
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`treatment of bacterial infections, protozoal infections such as malaria, pneumocystis carinii,
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`and plasmonic infections such as toxoplasmosis.
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`[008] Dapsone is also useful as an anti-inflammatory agent. It has been used to treat
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`skin diseases characterized by the abnormal infiltration of neutrophils, such as Dermatitis
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`herpetiformis, linear IgA dermatosis, pustular psoriasis, pyoderma gangrenosum, acne
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`vulgaris, and Sweet's Syndrome.
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`[009] Use of topical compositions of dapsone can be problematic. Topical
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`compositions may act as drying agents for the skin. They remove essential oils and natural
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`skin softeners from the skin thus causing it to be dry, itch and crack. Inclusion of exogeneous
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`skin emollients, oils and the like, however, causes phase separation and precipitation of
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`dapsone. Use of typical emulsifiers does not solve the dapsone precipitation owing to the
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`lowered dapsone solubility and conflicting physical characteristics of the phases of the
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`resulting composition. In particular, topical compositions including dapsone and methods are
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`needed that would, for example, exhibit improved effectiveness, reduced side effects, or both,
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`when used in a particular patient with a skin condition. Such improved topical compositions
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`including dapsone and methods of their uses are also needed to improve treatment of patients
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`with acne or suspected acne. The present dapsone and dapsone/adapalene compositions can
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`be useful for treating a variety of dermatological conditions. Some useful compositions
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`include dapsone and/or adapalene in a polymeric viscosity builder. Some compositions can
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`be adjusted to optimize the dermal delivery profile of dapsone to effectively treat
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`dermatological conditions and improve the efficiency of pharmaceutical products applied to
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`the skin. Diethylene glycol monoethyl ether is a solubilizer for dapsone, thereby allowing
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`compositions to be prepared with increased solubilized concentrations of dapsone. As a
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`result, the compositions described herein are effective in treating dermatological conditions in
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`a subject in need thereof.
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`[010] Moreover, it has been found that use of a polymeric viscosity builder
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`minimizes the intensity of yellowing of the composition caused by the increased solubility of
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`dapsone in diethylene glycol monoethyl ether. In addition, the polymeric viscosity builder
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`influences dapsone crystallization. This, in turn, results in compositions with improved
`
`aesthetics (i.e., reduction in particle size which minimizes "gritty" feeling upon application).
`
`[011]
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`In one embodiment, there are provided compositions including dapsone, a first
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`solubilizing agent which is diethylene glycol monoethyl ether, optionally at least one second
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`solubilizing agent, a polymeric viscosity builder, and water, wherein the dapsone is present at
`
`a concentration of about 5% w/w to about 10% w/w.
`
`[012]
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`In one embodiment, there are provided compositions including dapsone, a first
`
`solubilizing agent which is diethylene glycol monoethyl ether, optionally at least one second
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`solubilizing agent, a polymeric viscosity builder, and water, wherein the dapsone is present at
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`a concentration of about 3% w/w to 8% w/w.
`
`[013]
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`In another embodiment,
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`there are provided methods
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`for
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`treating a
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`dermatological condition. Such methods can be performed, for example, by administering to
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`a subject in need thereof a therapeutically effective amount of a pharmaceutical composition
`
`described herein.
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`BRIEF DESCRIPTION OF THE FIGURES
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`[014] Figure 1 presents the impact of an acrylamide/sodium acryloyldimethyltaurate
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`copolymer emulsion viscosity builder on color change.
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`[015] Figure 2 presents the impact of an acrylamide/sodium acryloyldimethyltaurate
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`copolymer emulsion viscosity builder on dapsone crystal growth.
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`[016] Figure 3 presents the impact of anti-oxidants and chelating agents on color
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`change.
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`DETAILED DESCRIPTION
`
`[017]
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`It is to be understood that both the foregoing general description and the
`
`following detailed description are exemplary and explanatory only and do not restrict the
`
`claims. As used herein, the use of the singular includes the plural unless specifically stated
`
`otherwise. As used herein, "or" means "and/or" unless stated otherwise. Furthermore, use of
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`the term "including" as well as other forms, such as "includes," and "included," is not
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`limiting. The section headings used herein are for organizational purposes only and are not to
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`be construed as limiting the subject matter described.
`
`[018] Some embodiments include compositions and products for treatment of skin
`
`conditions and methods of treating skin conditions. The term "skin condition" as used herein
`
`encompasses human and animal conditions, disorders, or diseases affecting skin. Such skin
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`conditions include, but are not limited to, conditions involving skin inflammation, conditions
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`involving sebaceous glands and hair follicles, conditions characterized by acneiform
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`symptoms, and conditions involving skin dryness, skin thickening, skin scaling or skin
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`flaking. Skin conditions that can be treated using some compositions, products and methods
`
`described herein include, but are not limited to, acne, rosacea, folliculitis, perioral dermatitis,
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`photodamage, skin aging, psoriasis, ichtiosis, atopic dermatitis, treatment of chronic wounds,
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`bed sores, keratosis piralis, scars, including surgical and acne scars, sebaceous cysts,
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`inflammatory dermatoses, post inflammatory hyperpigmentation, eczema, xerosis, pruritis,
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`lichen planus, nodular prurigo, eczema, and miliaria.
`
`[019] The term "acne," as used herein, encompasses skin conditions involving
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`acneiform or acne-like symptoms. For example, a skin condition characterized by follicular
`
`eruptions, such as papules and pustules resembling acne, can be categorized as acne. It is to
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`be understood that the term "acne" is not to be limited to diseases and conditions
`
`characterized by papules and pustules, but can be characterized by a variety of symptoms. It
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`is also to be understood that a particular patient having acne can be in remission, or the
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`patient's acne can be controlled by continuing treatments, and therefore the patient can
`
`exhibit reduced symptoms or be asymptomatic. Nevertheless, continuing treatment of acne
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`can be recommended in such a patient in order to reduce the probability of the return of the
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`acne symptoms.
`
`[020] Symptoms of acne or acne-like conditions include, but are not limited to, the
`
`appearance of various skin lesions. The term "lesion" is generally used to denote an infected
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`or diseased patch of skin. A lesion can involve an infected sebaceous gland. Some lesions
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`are more severe than others. Examples of skin lesions are comedones, macules, papules,
`
`pustules, nodules and cysts. The term "comedo" (plural "comedones") is used to describe a
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`sebaceous follicle plugged with dirt, other cells, tiny hairs, or bacteria. Comedones include
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`the so-called "blackheads," which can also refer to as "open comedones," which have a spot
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`or a surface that appears black. Comedones also include slightly inflamed, skin colored
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`bumps, as well as "whiteheads," which have a spot or a surface that appears white. The term
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`"macule" generally refers to a flat spot or area of the skin with a changed color, such as a red
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`spot. The term "pustule" is generally used to refer to an inflamed, pus-filled lesion, or a
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`small inflamed elevation of the skin that is filled with pus. The term "papule" is generally
`
`used to refer to a small, solid, usually inflammatory elevation of the skin that does not contain
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`pus. The term "nodule" is generally used to refer to an elevation of a skin that is similar to a
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`papule but is white and dome-shaped. Colloquially, a papule, a pustule or a nodule can be
`
`referred to as "a pimple" or "a zit." The term "cyst" generally refers to an abnormal
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`membranous sac containing a liquid or semi-liquid substance containing white blood cells,
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`dead cells, and bacteria. Cysts can be painful and extend to deeper layers of skin.
`
`[021]
`
`In dermatological science and dermatological and cosmetology practice, acne
`
`can be classified or categorized into one or more types or categories, according to one or
`
`more lines of categorization, such as a predominantly observed type of symptoms, severity of
`
`condition or predominant localization. It is to be understood that classification of acne into
`
`one of the subtypes does not mean that the characteristics of the classified condition are
`
`limited to the symptoms associated with the specific type.
`
`[022] Comedonal acne is characterized by the appearance of non-inflammatory
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`lesions, such as blackheads and whiteheads. Localized cystic acne is characterized by
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`appearance of a few cysts on face, chest and back. Diffuse cystic acne is characterized by
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`the appearance of cysts on wide areas of face, chest and back. Nodular acne is characterized
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`by the appearance of nodules. Nodulocystic acne is characterized by appearance of nodules
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`and cysts. Acne vulgaris is a common form of acne