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ARTICLES

1) Draelos ZDCarter EMaloney JM et al.  Two randomized studies demonstrate the

efficacy and safety of dapsone gel, 5 for the treatment of acne !ulgaris. J Am Acad 

 Dermatol 2007;56 (3) 439.e1- 439.e10

 Background 

A ne a!"eo"s #el $or%"lat&on o$ 'asone as *een 'e+eloe' tat allos ,l&n&,ally-e$$e,t&+e 'oses

o$ 'asone to *e a'%&n&stere' to&,ally &t %&n&%al syste%&, a*sort&on.

Objectives

e #oal o$ tese st"'&es as to e+al"ate te e$$&,a,y an' sa$ety o$ 'asone #el 5/ &n te treat%ent

o$ a,ne.

 Methods

at&ents 12 years o$ a#e an' ol'er &t a,ne +"l#ar&s ( 3010) art&,&ate' &n to &'ent&,ally-

'es&#ne' 12-ee ran'o%&e' 'o"*le-*l&n' st"'&es o$ t&,e-'a&ly %onoteray &t 'asone #el

5/ +ers"s a +e&,le #el.

 Results

Dasone #eltreate' at&ents a,&e+e' s"er&or res"lts &n ter%s o$ te &n+est&#ators #lo*al a,ne

assess%ent ( P   .001) an' te %ean er,enta#e re'",t&on &n &n$la%%atory non&n$la%%atory an'

total les&on ,o"nts (all P   .001) at ee 12. 8e'",t&ons &n &n$la%%atory les&on ,o"nts $a+or&n#

'asone #el o+er +e&,le ere aarent as early as 2 ees an' rea,e' stat&st&,al s&#n&$&,an,e *y 4

ees. o ,l&n&,ally s&#n&$&,ant ,an#es &n la*oratory ara%eters &n,l"'&n# e%o#lo*&n e+en

a%on# #l",ose-6-osate 'ey'ro#enase'e$&,&ent at&ents ere o*ser+e'. A'+erse e+ents ere

,o%ara*le *eteen te treat%ent #ro"s an' rarely le' to '&s,ont&n"at&on.

 Limitations

A'"n,t&+e to&,al treat%ents an' te&r &%a,t on a,ne ere not st"'&e' &n t&s tr&al.

Conclusions

Dasone #el 5/ aears to *e an e$$e,t&+e sa$e an' ell-tolerate' treat%ent $or a,ne +"l#ar&s

&t a ra&' onset o$ a,t&on.

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2):",y A Maloney JM 8o*erts J et al. "apsone gel 5 for the treatment of acne

!ulgaris# safety and efficacy of long$term %& year' treatment. J Dr"#s Der%atol. 2007;6 <9=1 

9=7.

Abstract

Dasone #el 5/ a to&,al $or%"lat&on o$ 'asone as son to 'el&+er ,l&n&,ally e$$e,t&+e 'oses o$ 'asone &t %&n&%al syste%&, a*sort&on &n 2 ran'o%&e' +e&,le-,ontrolle' 12-ee st"'&es o$  at&ents &t a,ne +"l#ar&s. A 12-%ont oen-la*el lon#-ter% sa$ety st"'y $"rter e+al"ate' tesa$ety an' e$$&,a,y o$ 'asone #el. at&ents at least 12 years o$ a#e &t a,ne +"l#ar&s ( 4=6)al&e' 'asone #el t&,e 'a&ly $or " to 12 %onts. Al&,at&on s&te rea,t&ons relate' to treat%entere reorte' &n =.2/ o$ te at&ents an' ere %ostly %&l' to %o'erate &n se+er&ty. Co%%onnonal&,at&on s&te a'+erse e+ents &n,l"'e' ea'a,e (20/) an' nasoaryn#&t&s (15/). os&#n&$&,ant ,an#es &n e%atolo#y or *loo' ,e%&stry ara%eters ere o*ser+e'. At one %ont%ean re'",t&on $ro% *asel&ne &n &n$la%%atory les&on ,o"nts as 30.6/. At 12 %onts %eanre'",t&on $ro% *asel&ne as 5=.2/ 19.5/ an' 49.0/ $or &n$la%%atory non&n$la%%atory an'total les&on ,o"nts rese,t&+ely (all .002 ,o%are' to *asel&ne). ese res"lts so tat 'asone#el 5/ &s sa$e an' e$$e,t&+e $or lon#-ter% treat%ent o$ a,ne +"l#ar&s an' as a ra&' onset o$ a,t&on.

3)an#ett& E >arer JC ?e$ele&n M@. The efficacy and tolera(ility of dapsone 5 gel in

female !s male patients with facial acne !ulgaris# gender as a clinically rele!ant outcome!aria(le)  J Dr"#s Der%atol. 2012;11 <14171421.

Abstract

BACKGROUND:

@en'er '&$$eren,es &n s&n an' a,ne a+e *een reorte'.

OBJECTIVE:

o e+al"ate te e$$e,t o$ #en'er on te e$$&,a,y an' tolera*&l&ty o$ 'asone 5/ #el.

METHODS:

&s as a oole' analys&s o$ 'ata $ro% 2 &'ent&,al ase 3 ran'o%&e' 'o"*le-*l&n' an' +e&,le-,ontrolle' tr&als (DA0203 an' DA0204) o$ 'asone 5/ #el ,on'",te' &n te n&te' Btates an'Cana'a *eteen o+e%*er 2002 an' Bete%*er 2003. A total o$ 2=9= at&ents &t a,ne +"l#ar&sere &n,l"'e' &n te oole' analys&s. ?$ tese 1453 at&ents (753 $e%ale 700 %ale) re,e&+e''asone 5/ #el t&,e 'a&ly an' 1445 at&ents (767 $e%ale 67= %ale) re,e&+e' +e&,le t&,e 'a&ly.En' o&nts &n,l"'e' te %ean er,enta#e re'",t&on $ro% *asel&ne &n a,ne les&on ,o"nts an' te

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 roort&on o$ at&ents a,&e+&n# ,l&n&,al s",,ess (@lo*al A,ne Assess%ent B,ale s,ore o$ 0 ,lear s&n or 1 al%ost ,lear s&n). Assess%ents ere er$or%e' at *asel&ne an' at ees 2 4 6 = an'12.

RESULTS:

e %ean er,enta#e re'",t&on &n a,ne les&on ,o"nts at 12 ees as s&#n&$&,antly #reater &n$e%ales tan %ales &n *ot treat%ent #ro"s. e %ean re'",t&on &n total les&on ,o"nts &n 'asone-treate' $e%ales an' %ales as rese,t&+ely 46.6/ +s 35.=/ (.0001). 8e'",t&ons &n a"lo"st"lar an' ,o%e'onal les&on ,o"nts ere l&e&se s&#n&$&,antly &#er &n $e%ale tan %ale at&ents (ea, .0001). B&#n&$&,antly %ore 'asone-treate' $e%ales tan %ales a,&e+e' ,l&n&,als",,ess (4=.6/ +s 34.4/; .0003).

CONCLUSION:

e resonse to 'asone 5/ #el aears to *e &n$l"en,e' *y #en'er &t $e%ale at&entseer&en,&n# a s&#n&$&,antly #reater re'",t&on &n a,ne les&on ,o"nts an' a s&#n&$&,antly &#er ,l&n&,al s",,ess rate $ollo&n# 12 ees o$ treat%ent. ese 'ata s"##est tat #en'er &s a no+el re'&,tor o$ o"t,o%e tat so"l' *e ,ons&'ere' &n a,ne ,l&n&,al tr&al 'es&#n an' analys&s

4) The efcacy o 5% dapsone gel plus oral isotretinoin versus oral isotretinoin

alone in acne vulgaris: A randomized double-blind study

@&ta a#&& Mer'a' 8asano"r  aare A*ta&-ae&n& an' Moa%%a' Al&

 &l$oro"sa'e1

INTRODUCTION

A,ne +"l#ar&s &s a ,o%%on 'er%atolo#&, '&sease tat &s "s"ally %ana#e' *y al&,at&on o$ to&,al

 rearat&ons syste%&, %e'&,at&ons or a ,o%*&nat&on o$ te to.F12G A,ne &s r&%ar&ly an

&n$la%%atory '&sease ,allen#&n# te ,"rrent no%en,lat"re o$ non-&n$la%%atory +ers"s

&n$la%%atory a,ne les&ons s"##est&n# tat te no%en,lat"re &s o"t'ate' an' &n,orre,t.F3G e

e+&'en,e &n s"ort o$ a,ne as an &n$la%%atory '&sease also as ,l&n&,al &%l&,at&ons &n tat ant&-&n$la%%atory 'r"#s "se' to treat te '&sease ,an *e ee,te' to eert e$$e,ts a#a&nst all les&on

sta#es al*e&t +&a '&st&n,t %e,an&s%s o$ ant&-&n$la%%at&on.F3G o'ay '&$$erent to&,al tera&es are

a+a&la*le $or at&ents &t a,ne +"l#ar&s &n,l"'&n# ,o%e'olyt&, a#ents ant&-&n$la%%atory

%e'&,at&ons ant&*&ot&,s syste%&, ret&no&' an' e+en er*al rearat&ons. Ant&*&ot&,s lay a &+otal

role &n treat%ent.F4G Dasone (4 4H-'&a%&no'&enyls"l$one) &s a 'r"# o$ te s"l$one ,lass an' as

'&s,o+ere' &n 190=.F5G ?ral 'asone as 'e%onstrate' e$$&,a,y &n a,ne *"t as asso,&ate' &t

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se+ere s&'e-e$$e,ts s", as ane%&a &, as art&,"larly ser&o"s &n at&ents &t #l",ose-6-

 osate 'ey'ro#enase (@6D) 'e$&,&en,y. o&,al 'asone as 'e+eloe' to o+er,o%e t&s

l&%&tat&on.F6G A "n&!"e roerty o$ 'asone &s tat &t as '"al terae"t&, a,t&+&ty an' 'e%onstrates

ant&%&,ro*&al an' ant&-&n$la%%atory roert&es.F7G Dasone 5/ #el (A,one) as 'e+eloe' to treat

a,ne +"l#ar&s an' to'ay as oo' an' Dr"# A'%&n&strat&on (DA) aro+al.F=G ere are a +ery

l&%&te' n"%*er o$ st"'&es on te to&,al "se o$ ant&-&n$la%%atory a#ent &n ,o%*&nat&on &t oter syste%&, %e'&,at&ons s", as &sotret&no&n &n a,ne +"l#ar&s. D"e to a 'elay &n start&n# o$ &sotret&no&n

resonse &t &ll *e el$"l to a'' a to&,al ant&-&n$la%%atory a#ent to treat%ent re#&%e to $asten te

onset o$ ,l&n&,al resonse an' ,ontrol &n&t&al ea,er*at&on o$ sy%to%s. o te *est o$ o"r 

nole'#e t&s &s te $&rst t&%e to ,o%*&ne to&,al 'asone #el as an ant&-&n$la%%atory a#ent &t

oral &sotret&no&n &n treat%ent o$ %o'erate to se+ere a,ne &n or'er to enan,e te e$$&,a,y. >en,e t&s

st"'y a&%e' to e+al"ate te e$$&,a,y o$ 5/ 'asone #el &t syste%&, &sotret&no&n &n $a,&al a,ne

+"l#ar&s &n Iran&an at&ents.

MATERIALS AND METHODS

&s 'o"*le-*l&n' la,e*o-,ontrolle' ,l&n&,al tr&al as ,on'",te' at Al-Zara @eneral >os&tal a

re$erral ,l&n&, o$ 'er%atolo#y &n Is$aan Iran. 5= yo"n# a'"lts (a#e ran#e< 1=-25 years) &t

%o'erate to se+ere $a,&al a,ne +"l#ar&s a,,or'&n# to te @lo*al A,ne Assess%ent B,ore (@AAB)

ere re,r"&te' $ro% Bete%*er 2012 tro"# J"ly 2013. 8easons $or e,l"s&on ere< A,ne *e&n#

se,on'ary to oter ro*le%s; re#nan,y or &ntent&on o$ re#nan,y; *reast$ee'&n#; oter 

'er%atolo#&,al '&seases o$ te $a,e; @6D 'e$&,&en,y; ta&n# any oter a,ne treat%ent; &story o$ 

a+&n# taen any %e'&,at&on tat ,o"l' &ntera,t &t 'asone (e.#. r&%etor&%-s"l$a%etoaol) or 

&sotret&no&n (e.#. tetra,y,l&nes %etotreate an' +&ta%&n A s"le%ents) &t&n te re+&o"s 3

%onts; an' non yersens&t&+&ty to te st"'y %e'&,at&on. e at&ents ere '&+&'e' &nto #ro"sran'o%ly< (#ro" A< 5/ 'asone #el an' #ro" +e&,le ne"tral #el). e st"'y roto,ol as

aro+e' *y te Et&,s Co%%&ttee o$ Is$aan n&+ers&ty o$ Me'&,al B,&en,es Is$aan Iran (?<

392090). All at&ents ro+&'e' r&tten &n$or%e' ,onsent *e$ore art&,&at&on.

All at&ents ere a'%&n&stere' oral &sotret&no&n (8oa,,"tane . >o$$%ann-:a 8o,e :t'.) 20 %#

on,e a 'ay $or = ees. e 5/ 'asone #el as reare' &n Is$aan n&+ers&tys Deart%ent o$ 

ar%a,y. Dasone #el as reare' $ro% &ts o'er sol+e' &n a l&ttle etanol an' %&e' &t

l"*r&,ant non-,o%e'o#en&, #el " to 5/ ,on,entrat&on. e 'asone #el an' +e&,le non-

,o%e'o#en&, ne"tral #el ere $&lle' &n s&%&lar t"*es tat ere %are' KAL or KL &n'&,at&n# te s&'e

on &, tey so"l' *e al&e'. o&,al 5/ 'asone #el an' non-,o%e'o#en&, +e&,le #el as

al&e' on te $a,e t&,e 'a&ly $or = ees &n o"r at&ents (#ro" A< 5/ 'asone #el an' #ro"

+e&,le #el). D"r&n# te st"'y er&o' only a ,are#&+er o as not &n+ol+e' &n te eer&%ent as

aare o$ te ,ontents o$ te t"*es; te at&ents an' te ea%&ner ere *l&n' to te to&,al

,o%o"n's. e at&ents ,a%e $or $ollo-" ea%&nat&ons on 'ay 2 an' ees 4 = an' 12.

oto#ra&, &%a#&n# as er$or%e' "s&n# a ,a%era (Canon oer sot @12 Cannon ,o%onents

In,. Jaan) &n te sa%e ys&,al ,on'&t&on *y one erson at *ase l&ne an' on ea, $ollo-" +&s&t.

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e n"%*ers o$ a,ne les&ons ere ,o"nte' %an"ally *y te &n+est&#ator $or *ot te treat%ent s&te

an' ,ontrol s&te at *asel&ne an' on ea, $ollo-" +&s&t. e ,o"nt&n# as assesse' *y %ar&n# ea,

,o"nte' les&on &t a en to ens"re tat ea, les&on as only re#&stere' on,e. e #lo*al se+er&ty o$ 

a,ne as assesse' *y te &n+est&#ator "s&n# te 5-o&nt s,ale at *ase l&ne an' te en' o$ te st"'yF 9G

Fa*le 1G. All at&ents ,o%lete' te st"'y er&o'. resen,e o$ any oss&*le ,o%l&,at&onss&'e

e$$e,ts as assesse' an' 'o,"%ente' on ea, +&s&t *y a s&lle' 'er%atolo#&st. C?B?8 $lo ,arto$ te st"'y as soe' &n one '&a#ra% F&#"re 1G.

 Table

!lobal acne assessment scale

"igure

#$&$'T (o chart o the study

Btat&st&,al e+al"at&on as 'one "s&n# BBB $or &n'os +ers&on 1=.0 (BBB In,. II BA). Data

ere son as $re!"en,y (er,enta#e) or %ean N stan'ar' 'e+&at&on. e reeate'-%eas"res

analys&s (A?OA) an' te C&-s!"are test ere "se' as te aror&ate %eas"res.  P  P 0.001 as

,ons&'ere' to *e stat&st&,ally s&#n&$&,ant.

RESULTS

&$ty e&#t at&ents 25 %ales (43.1/) an' 33 $e%ales (56.9/) ran#e< 1=-25 years ere enrolle' &n

t&s st"'y. e %ean '"rat&on o$ a,ne &n te st"'y o"lat&on as 3.19 N 1.= years (ran#e< 2-5

years). e at&ents ere '&+&'e' &nto #ro"s ran'o%ly< (#ro" A< 5/ 'asone #el an' #ro"

+e&,le ne"tral #el); tere ere no s&#n&$&,ant '&$$eren,es *eteen te to #ro"s ( P  Q 0.001).

De%o#ra&, 'ata an' n"%*er o$ &n$la%%atory non-&n$la%%atory $a,&al les&ons an' @AAB are

s"%%ar&e' &n a*le 2 an' ,o%are' *eteen te to #ro"s at *asel&ne Fa*le 2G. All at&ents a'

nor%al o$ @6D le+el. &nally te to #ro"s ere ,o%are' &t re#ar' to *asel&ne ,o"nts.

De,rease &n te %ean &n$la%%atory an' non-&n$la%%atory les&on ,o"nts as s&#n&$&,antly %ore &n

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#ro" A ,o%are' to #ro" on all $ollo-" +&s&ts ( P   0.001) F&#"res 2G Alto"# re'",t&on &n

@AAB as not s&#n&$&,ant on all $ollo-" +&s&ts ( P   0.264) Fa*le 3G. ?"r res"lt soe' tat

,l&n&,al e$$&,a,y (&.e. n"%*er o$ les&on) &n to&,al 'asone l"s oral &sotret&no&n #ro" &n $e%ale

 at&ents are s&#n&$&,antly s"er&or to te %ale ones a$ter treat%ent at te en' o$ te st"'y ( P  

0.001). e s&'e-e$$e,ts on te 'asone-treate' #ro" ere a %&l' *"rn&n# sensat&on &n 7 at&ents

(24.13/) %&l' eryte%a o$ te s&n an' %&l' 'ryness &n 4 (13.79/) an' 3 (10.34/) ,asesrese,t&+ely ( P   0.001. e s&'e-e$$e,ts are s"%%ar&e' an' ,o%are' &n te to #ro"s on

'&$$erent o,,as&ons are son &n a*le 4. ?ne at&ent 'e+eloe' ,onta,t ,on"n,t&+&t&s '"e to

al&,at&on o$ 'asone too ,lose to te eye. >oe+er none o$ tese s&'e-e$$e,ts le' to

'&s,ont&n"at&on o$ treat%ent an' all te art&,&ants ,o%lete' te st"'y. o ,l&n&,ally s&#n&$&,ant

,an#es ere %a'e &n la*oratory ara%eters &n,l"'&n# e%o#lo*&n ( P   0.345).

 Table *

+aseline demographics and disease characteristics

"igure *

 The number o in(ammatory and non-in(ammatory lesions reduced signi,cantly ater ee.s o treatment ith topical dapson gel plus isotretinoin as shon in these

pictures

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 Table /

0ean !AA&: 1ee.s 42 and *

 Table 4

A3s occurring during the course o treatment

DISCUSSION

In te resent st"'y 5/ 'asone #el as an e$$e,t&+e an' sa$e to&,al %e'&,at&on $or at&ents tat

re,e&+e' &sotret&no&n $or a,ne +"l#ar&s treat%ent &t a s&#n&$&,ant re'",t&on &n te n"%*er o$ les&ons

 *"t t&s ,o%*&nat&on al&e' to teray '&' not alter te $&nal o"t,o%e an' e @AAB. ere areonly a l&%&te' n"%*er o$ st"'&es tat a+e s&%&larly ea%&ne' te e$$e,t o$ te ,o%*&nat&on o$ 

&sotret&no&n an' to&,al al&,at&on on a,ne +"l#ar&s an' te res"lts are &n,on#r"o"s. D&r et al .

$o"n' no s&#n&$&,ant *ene$&t &n te ,o%*&nat&on o$ to&,al ant&-a,ne an' &sotret&no&n o+er &sotret&no&n

alone &n &%ro+&n# no'"lo,yst&, a,ne +"l#ar&s.F4G >oe+er &n o"r st"'y te s&#n&$&,ant e$$&,a,y

o*ser+e' &n te "se o$ to&,al 5/ 'asone &n a s&%&lar sett&n# &n re'",&n# te ,o"nt o$ les&ons &n

ees 4 = an' 12 &s ro*a*ly '"e to te a''&t&onal ant&-&n$la%%atory e$$e,t o$ 'asone. In a st"'y

 *y an#ett& et al . ,o%are' te e$$&,a,y an' tolera*&l&ty o$ 'asone 5/ #el &n $e%ale +ers"s %ale

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 at&ents &t $a,&al a,ne +"l#ar&s an' reorte' tat te resonse to 'asone 5/ #el aears to *e

&n$l"en,e' *y #en'er &t $e%ale at&ents eer&en,&n# a s&#n&$&,antly #reater re'",t&on &n a,ne

les&on ,o"nts an' a s&#n&$&,antly &#er ,l&n&,al s",,ess rate $ollo&n# 12 ees o$ treat%ent.F10G

?"r $&n'&n#s are &n ,on,or'an,e &t te res"lts o$ an#ett&s st"'y. e &# e$$&,a,y o$ 5/

'asone #el &n $e%ale at&ents s"##ests tat #en'er &s an &%ortant re'&,tor o$ te terae"t&,

o"t,o%e &n a,ne treat%ent an' so"l' *e ,ons&'ere' &n a,ne ,l&n&,al tr&al 'es&#n an' analys&s. ?"r $&n'&n#s so s&#n&$&,ant re'",t&on &n *ot R&n$la%%atoryS an' Rnon-&n$la%%atoryS (,o%e'onal)

les&ons &n all ees. Draelos et al . 'o,"%ente' e$$&,a,y o$ to&,al 5/ 'asone #el $or te re'",t&on

o$ *ot &n$la%%atory an' non-&n$la%%atory a,ne les&ons so te ant&-&n$la%%atory 'asone &s

e$$e,t&+e &n treat%ent o$ *ot R&n$la%%atoryS an' Rnon-&n$la%%atoryS les&ons.F101112G

Me,an&s%s oter tan *a,ter&,&'al a,t&on %ay "n'erl&e te terae"t&, e$$e,t o$ 'asone s", as

ant&-&n$la%%atory an' ant&-&nterle"&n = a,t&ons as ell as te &n&*&t&on o$ ne"tro&l a'eren,e.

Dasone as %"lt&le ant&-&n$la%%atory roert&es.F1314G Alto"# a to&,al $or%"lat&on o$ 

'asone (A,one Aller#an In,. Ir+&ne CA BA) as *een aro+e' *y te DA $or te treat%ent

o$ a,ne +"l#ar&s *"t te r&ss o$ ser&o"s s&'e e$$e,ts a+e %a'e &t an "n'es&ra*le 'r"# $or "se &n te

relat&+ely ealty a,ne o"lat&on.F=G In o"r st"'y tere &s no s&#n&$&,ant '&$$eren,e *eteen *e$ore

an' a$ter e%o#lo*&n le+el. Draelos et al . soe' no ,l&n&,ally s&#n&$&,ant ,an#es &n la*oratory

 ara%eters &n,l"'&n# e%o#lo*&n e+en a%on# @6D-'e$&,&ent at&ents as as te ,ase &n o"r 

st"'y. ?ter a'+erse e+ents ere ,o%ara*le *eteen te treat%ent #ro"s an' rarely le' to

'&s,ont&n"at&on o$ te to&,al 'r"#.F11G

CONCLUSION

e res"lts s"##est tat ant&-&n$la%%atory a#ents s", as 'asone ,an e$$e,t&+ely re'",e te ,o"nt

o$ les&ons *"t 'o not alter te $&nal o"t,o%e an' e @AAB treat en "se' &n ,o%*&nat&on &tsyste%&, &sotret&no&n. e l&%&tat&ons o$ o"r st"'y ere sort '"rat&on o$ treat%ent an' la, o$ %ore

o*e,t&+e %eto's $or res"lt assess%ent.

5) #ohort study on the treatment ith dapsone 5% gel  o mild to moderatein(ammatory acne o the ace in omen

:yn'e C An'r&essen A.

A(stract

o&,al 'asone 5/ #el $or te treat%ent o$ %&l' to %o'erate a,ne as *een son to *e e$$e,t&+e &nran'o%&e' ,ontrolle' st"'&es. A total o$ 101 a'"lt o%en &t %&l' to %o'erate $a,&al&n$la%%atory a,ne art&,&ate' &n a 12-ee ,oort st"'y to e+al"ate te e$$&,a,y tolera*&l&ty an'sa$ety o$ 'asone #el 5/ &n t&s se,&$&, #ro" o o$ten ,o%la&n o$ sens&t&+e s&n. e o%enere &nstr",te' to aly 'asone 5/ #el t&,e 'a&ly a$ter as&n# te&r $a,e &t a stan'ar'non,o%e'o#en&, soa-$ree ,leanser. reat%ent o"t,o%e as e+al"ate' "s&n# ys&,&an-s,ore'@lo*al A,ne Assess%ent B,ale (@AAB) an' at&ent-reorte' $a,&al s&n ,on'&t&on. &nety-tree

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o%en ,o%lete' te st"'y (6 ere lost to $ollo-" an' 2 a' %&l' s&n &rr&tat&on). At 12 eess&#n&$&,ant ys&,&an @AAB s,ores (t55 =.=5 .001) an' at&ent-reorte' les&on re'",t&onsere son. reat%ent s",,ess (@AAB 0 or 1) at 12 ees as a,&e+e' &n 69.4/ (n 75) o$ o%en (t94 4.17 .001) &%ro+&n# at&ent-reorte' !"al&ty-o$-l&$e ase,ts. o&,al 'asone#el 5/ as son to *e sa$e %&n&%ally &rr&tat&n# an' e$$e,t&+e &n te treat%ent o$ %&l' to %o'erate&n$la%%atory $a,&al a,ne &n a'"lt o%en &t sens&t&+e s&n.

) apsone 5% gel : a revie o its efcacy and saety in the treatment o acnevulgaris

Btotlan' M1  Bal&ta A8 T&ssl&n# 8.

Abstract

Dasone a syntet&, s"l$one tat as *een a+a&la*le $or o+er 60 years as *een "se' to treat a%yr&a' o$ ,"taneo"s '&sor'ers. r&or to te #eneral a,,etan,e o$ &sotret&no&n oral 'asone a' *eenreorte' to *e e$$e,t&+e &n te treat%ent o$ no'"lo,yst&, a,ne. >oe+er te otent&al $or syste%&,to&,&ty re+ente' &ts &'esrea' a'ot&on &n te treat%ent o$ a,ne. or %any years s,&ent&stselore' te oss&*&l&ty o$ 'e+elo&n# a to&,al $or%"lat&on o$ 'asone $or te treat%ent o$ a,ne &nte oe o$ %&n&%&&n# te a'+erse e%atolo#&, e$$e,ts o$ oral 'asone. B", a $or%"lat&on a' *een "na+a&la*le "nt&l re,ently. Dasone 5/ #el (A,one) as re,ently 'e+eloe' to treat a,ne+"l#ar&s. &s to&,al $or%"lat&on as aro+e' &n te B *ase' on to ran'o%&e' +e&,le-,ontrolle' st"'&es. A 12-%ont oen-la*el st"'y as also ,on'",te' to assess te sa$ety an'e$$&,a,y o$ to&,al 'asone o+er te lon# ter%. &nally to oen-la*el ase I ar%a,o&net&,

st"'&es ere ,on'",te' to e+al"ate te syste%&, a*sort&on o$ to&,al 'asone ,o%are' &t oral'asone. &s art&,le reorts te res"lts o$ tese st"'&es &, so a re'",t&on &n a,ne les&on ,o"nt,o%ara*le to tose o*ser+e' &n ,l&n&,al tr&als o$ oter aro+e' to&,al a,ne tera&es. &t re#ar'to sa$ety te st"'&es 'e%onstrate' tat te ,on,entrat&ons o$ 'asone an' -a,etyl 'asone re%a&nlo an' 'o not a,,"%"late o+er t&%e on,e stea'y state &s rea,e'. ?$ te total o$ 50 at&ents &t#l",ose-6-osate 'ey'ro#enase (@6D) 'e$&,&en,y &n all te st"'&es only to eer&en,e' a'ro &n e%o#lo*&n le+els an' tose s&$ts &n +al"es ere ,ons&stent &t $l",t"at&ons o*ser+e' $or oter st"'y art&,&ants. A re,ent st"'y e+al"at&n# te r&s o$ e%olys&s &n at&ents &t @6D'e$&,&en,y $o"n' to&,al 'asone 5/ #el to *e sa$e to "se &n t&s at&ent o"lat&on. ase' on teo*ser+at&ons note' &n te a*o+e-%ent&one' st"'&es e ,on,l"'e tat to&,al 'asone 5/ #el &s sa$ean' e$$e,t&+e &n te treat%ent o$ a,ne +"l#ar&s.

*) 3fcacy and saety o dapsone gel  5% or the treatment o acne vulgaris inadolescents

8a&%er B1  Maloney JM o"r,&er M &lson D a T B&e#$r&e' E @arrett B; n&te'

BtatesCana'a Dasone @el Bt"'y @ro".

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Abstract

o 12-ee ran'o%&e' +e&,le-,ontrolle'. 'o"*le-*l&n'e' &+otal st"'&es an' a 12-%ont. lon#-ter% oen-la*el non,o%arat&+e sa$ety st"'y ere ,on'",te' to e+al"ate te e$$&,a,y an' sa$ety o$ 'asone #el 5/ &n at&ents &t a,ne +"l#ar&s. ?$ 3516 art&,&ants enrolle' &n te 3 tr&als 1306 art&,&ants (37/) ere a'oles,ents a#e' 12 to 15 years an' ,o%r&se' te s"*#ro" reorte' ere.

art&,&ants ran'o%ly ere ass&#ne' to t&,e-'a&ly treat%ent &t 'asone #el (n57=) or +e&,le#el (n547) &n te &+otal st"'&es an' re,e&+e' oen-la*el treat%ent &t 'asone #el &n te lon#-ter% sa$ety st"'y (n1=1). In te &+otal st"'&es s",,ess *ase' on a,&e+&n# a @lo*al A,neAssess%ent B,ore (@AAB) o$ 0 (none) or 1 (%&n&%al) at ee 12 as s&#n&$&,antly #reater $or te'asone #el-treate' a'oles,ent art&,&ants (40.1/; 23257=) ,o%are' &t te +e&,le #el-treate'a'oles,ent art&,&ants (2=.2/; 154547) (.001). reat%ent &t 'asone #el &n a'oles,ents alsores"lte' &n ,l&n&,ally %ean&n#$"l &%ro+e%ents &n a,ne les&on ,o"nts *y ee 12 &n te &+otalst"'&es an' $or " to 12 %onts &n te lon#-ter% sa$ety st"'y. e &n,&'en,e o$ a'+erse e+ents&n,l"'&n# al&,at&on-s&te e+ents as lo an' s&%&lar *eteen treat%ent #ro"s &n te &+otalst"'&es an' as s&%&larly lo &n te lon#-ter% sa$ety st"'y. 8es"lts $ro% te lar#e n"%*er o$ a'oles,ent art&,&ants &n tese 3 st"'&es so tat 'asone #el &s an e$$e,t&+e an' sa$e to&,al

teray $or te treat%ent o$ a,ne +"l#ar&s &n a'oles,ents a#e' 12 to 15 years $or " to 12 %onts.

/) #linical evidence or the role o a topical anti-in(ammatory agent in

comedonal  acne : ,ndings rom a randomized study o dapsone gel  5% incombination ith tazarotene cream 6% in patients ith acne vulgaris

an#ett& E1  Daan B @reen :  :&n# M  Don&e J @er%a&n MA Tasteler JB T&r,& : ?e$ele&n

M@ Draelos Z .

A(stract

 BACKGROUND

A,ne ato#enes&s &s %"lt&$a,tor&al an' &n,l"'es &n$la%%at&on. Co%*&n&n# 'r"#s tar#et&n# %"lt&le,o%onents o$ a,ne ato#enes&s &s stan'ar' ra,t&,e.

OB!"C#$%"

o assess te sa$ety an' e$$&,a,y o$ 'asone #el 5/ an ant&-&n$la%%atory a#ent &n ,o%*&nat&on&t taarotene ,rea% 0.1/ $or treat%ent o$ a,ne +"l#ar&s.

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 M"#&OD'

at&ents ere ran'o%&e' to re,e&+e ,o%*&nat&on teray ('asone #el 5/ t&,e-'a&ly l"staarotene ,rea% 0.1/ 'a&ly) or %onoteray (taarotene ,rea% 0.1/ 'a&ly). E$$&,a,y an' sa$ety'ata ere ,olle,te' a$ter 1 2 4 = an' 12 ees o$ treat%ent.

 R"'UL#'

at&ents &n *ot ar%s (n=6 'asone U taarotene; n=5 taarotene) soe' s&#n&$&,ant re'",t&ons$ro% *asel&ne &n &n$la%%atory non&n$la%%atory an' total les&on ,o"nts ( &s less tan .001 $or all).At 12 ees at&ents treate' &t 'asone l"s taarotene soe' a #reater re'",t&on $ro% *asel&ne&n non&n$la%%atory (,o%e'onal) an' total les&on ,o"nts tan taarotene-treate' at&ents(non&n$la%%atory 59.7 er,ent +s. 46.5 er,ent .01; total 63.3/ +s. 53.6/ .02). e er,enta#e o$ at&ents a,&e+&n# treat%ent s",,ess (an &n+est&#ator s"*e,t&+e s,ore o$ 0 FnoneG or 1F%&n&%alG) as #reater &n 'asone l"s taaroteneVtreate' at&ents (42.2/) tan &n taarotene-treate' at&ents (21.=/;.01). ot treat%ents ere ell tolerate'.

CONCLU'$ON

Co%*&nat&on teray &t 'asone #el 5/ l"s taarotene ,rea% 0.1/ as %ore e$$e,t&+e tantaarotene %onoteray $or treat%ent o$ ,o%e'onal a,ne. e res"lts s"##est tat ant&-&n$la%%atorya#ents s", as 'asone ,an e$$e,t&+ely treat early sta#es o$ a,ne (*ot ,o%e'onal an'non,o%e'onal) en "se' &n ,o%*&nat&on &t a ret&no&'

4) apsone gel 5% in combination ith adapalene gel 6%2 benzoyl pero7idegel 4% or moisturizer or the treatment o acne vulgaris: a *-ee.2randomized2 double-blind study

le&s,er A Jr1  Bal&ta A E&,en$&el' : A*ra%o+&ts :",y A  @arrett B; Dasone @el &n

Co%*&nat&on reat%ent Bt"'y @ro".

Abstract

 (UR(O'"

o e+al"ate te sa$ety an' e$$&,a,y o$ 'asone #el 5/ &n te treat%ent o$ a,ne en "se' &n,o%*&nat&on &t a'aalene #el 0.1/ *enoyl ero&'e #el 4/ or %o&st"r&er.

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 M"#&OD'

&s as a tel+e-ee ran'o%&e' 'o"*le-*l&n' st"'y. at&ents a#e' 12 years an' ol'er (n301)al&e' 'asone #el t&,e 'a&ly an' ere ran'o%ly ass&#ne' (1<1<1) to one o$ tree a''&t&onaltreat%ents al&e' on,e 'a&ly.

 R"'UL#'

y ee 12 'asone #el ,o%*&ne' &t any o$ te tree a''&t&onal treat%ents re'",e' te %eann"%*er o$ &n$la%%atory les&ons. >oe+er te a"tors '&' not 'ete,t a s&#n&$&,ant '&$$eren,e &n tere'",t&on o$ &n$la%%atory les&ons en 'asone as "se' &n ,o%*&nat&on &t a'aalene #el or &t *enoyl ero&'e #el ,o%are' to te 'asone l"s %o&st"r&er ,o%*&nat&on #ro" (0.052$or *ot +ers"s %o&st"r&er ,o%*&nat&on). at&ents treate' &t 'asone #el ,o%*&ne' &ta'aalene soe' a s&#n&$&,antly *etter resonse &n re'",t&on &n non-&n$la%%atory an' total a,neles&on ,o"nt tan tose o re,e&+e' te %o&st"r&er ,o%*&nat&on. :o,al a'+erse rea,t&ons &n alltree treat%ent #ro"s ere %&n&%al an' #enerally %&l' &n se+er&ty.

CONCLU'$ON

Dasone #el &n ,o%*&nat&on &t a'aalene #el or *enoyl ero&'e #el &s sa$e an' ell tolerate' $or te treat%ent o$ a,ne +"l#ar&s.

17) Comparati!e efficacy and tolera(ility of dapsone 5 gel in adult !ersus adolescent females

with acne !ulgaris .Del 8osso JW T&r,& : @alla#er CJ

A,ne +"l#ar&s (AO) &n a'"lt o%en as *een re,e&+&n# &n,rease' attent&on *ot &n te n&te' Btatesan' #lo*ally as te $re!"en,y o$ o$$&,e +&s&ts $or AO a$$e,t&n# ost-a'oles,ent o%en aears to *e

&n,reas&n#.1A s"r+ey o$ 1013 reson'ents &n te n&te' Btates soe' tat 51 35 an' 26 er,ent

o$ o%en reort a+&n# AO &n te&r 20s 30s an' 40s rese,t&+ely.2 A''&t&onally AO &s ,o%%on &n

a'"lt o%en o$ all etn&,&t&es s&n tyes (o&ly 'ry ,o%*&nat&on sens&t&+e) an' s&n ,olors

(&tatr&, s&n tye I-OI); *ot +&s&*ly non&n$la%%atory les&ons (&.e. ,o%e'ones) an' +&s&*ly

&n$la%%atory les&ons (&.e. a"les "st"les) are $o"n' &n *ot a'oles,ent $e%ales an' a'"lt o%en

&t AO; an' te anato%&, '&str&*"t&on o$ AO &s s&%&lar o+erall &n *ot s"*o"lat&ons.3-7 A+a&la*le

'ata an' ,l&n&,al o*ser+at&on a+e son tat te relat&+e !"ant&t&es o$ $a,&al AO les&on tyes (&.e.

,o%e'ones a"les) o+erla a%on# at&ents &n *ot a#e-relate' s"*sets.3-7 Alto"# a -sae' attern o$ re'o%&nantly &n$la%%atory a"les &n+ol+&n# te loer ,ees al&ne an' anter&or 

an' lateral ne, as *een note' &n so%e a'"lt o%en &t AO an' &t as *een state' tat AO &n a'"lt

o%en resents re'o%&nantly as &n$la%%atory les&ons &t as *een reorte' tat aro&%ately

tree-$o"rts o$ a'"lt o%en &t AO resent &t a %&e' attern o$ ,o%e'onal an' &n$la%%atory

$a,&al a,ne les&ons tat are o$ten $o"n' %ore '&$$"sely on te $a,e an' not "st &n te -sae'

re#&on.14-=

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It &s &%ortant $or te ,l&n&,&an to ,ons&'er te oss&*&l&ty o$ "n'erly&n# '&sor'ers tat ,a"se

an'ro#en e,ess &n a'"lt o%en resent&n# &t AO; oe+er te %aor&ty e&*&t nor%al +al"es

en la*oratory test&n# &s er$or%e'.156910 Most o$ te '&s,"ss&ons a*o"t treat%ent o$ AO &n

a'"lt o%en $o,"s on te "se o$ syste%&, tera&es s", as oral ,ontra,et&+es an' s&ronola,tone

&t l&ttle e%as&s on to&,al tera&es.569-11 ?+erall ,ontrolle' tr&als e+al"at&n# te e$$&,a,y

an' sa$ety o$ to&,al a#ents se,&$&,ally &n a'"lt o%en &t AO are la,&n# &t s"*#ro" analyses,o%lete' &t only a $e terae"t&, a#ents an' $or%"lat&ons.6=

Dasone &s a s"l$one 'er&+at&+e tat as *een reorte' to 'e%onstrate a +ar&ety o$ ant&-&n$la%%atory

 roert&es.1213 en al&e' to&,ally to te $a,e t&,e 'a&ly 'asone 5/ #el as $o"n' &n

,l&n&,al st"'&es to *e e$$e,t&+e $or AO $or at least 12 %onts. 1415 In to lar#e ase 3 'o"*le-

 *l&n' ran'o%&e' +e&,le-,ontrolle' 12-ee tr&als &n s"*e,ts X12 years o$ a#e &t $a,&al AO

'asone 5/ #el al&e' t&,e 'a&ly ro+e' to *e s"er&or to +e&,le #el &n re'",&n# &n$la%%atory

non&n$la%%atory an' total les&ons $ro% *asel&ne.14 o '&$$eren,es &n a'+erse e+ents (AEs) ere

o*ser+e' *eteen te 'asone-treate' an' +e&,le-treate' st"'y #ro"s. e o"t,o%es o$ tese

ase 3 st"'&es le' to te aro+al o$ 'asone 5/ #el t&,e 'a&ly $or AO *y te n&te' Btates oo'

an' Dr"# A'%&n&strat&on (DA) &n 2005.

A s"*#ro" analys&s o$ o"t,o%es &n %en ,o%are' &t o%en $ro% te to ase 3 tr&als

'e%onstrate' tat e$$&,a,y an' tolera*&l&ty ere $a+ora*le &n *ot sees. 14 >oe+er a s"*#ro"

analys&s soe' s&#n&$&,antly #reater re'",t&ons &n &n$la%%atory les&ons ( p0.0001)

non&n$la%%atory les&ons ( p0.0001) an' total AO les&ons ( p0.0001) &n *ot te a,t&+ely treate'

an' +e&,le-treate' st"'y ar%s &n $e%ales (n1520) ,o%are' &t %ales (n137=).16 e

 er,enta#e o$ s"*e,ts a,&e+&n# en'o&nt s",,ess (,lear or al%ost ,lear) *ase' on #lo*al a,ne

assess%ent s,ore (@AAB) as stat&st&,ally s&#n&$&,antly s"er&or &n $e%ales ,o%are' &t %ales &n *ot te 'asone-treate' st"'y ar% ( p0.0003) an' te +e&,le-treate' st"'y ar% ( p0.0013).16

In t&s %an"s,r&t te a"tors reort te o"t,o%e o$ a s"*#ro" analys&s $ro% te to ase 3

 &+otal tr&als &n $e%ale s"*e,ts &t $a,&al AO treate' &t 'asone 5/ #el or +e&,le &n to a#e-

 *ase' s"*#ro"s a'oles,ent (12-17 years o$ a#e) an' a'"lt (ost-a'oles,ent; X1= years o$ a#e)

$e%ales. e a"tors yotes&e' *e$ore ,o%let&on o$ t&s s"*#ro" analys&s tat te resonse to

'asone 5/ #el o"l' *e s&%&lar &n e$$&,a,y an' sa$ety &n *ot te a'oles,ent an' a'"lt $e%ale

 o"lat&ons $or $a,&al AO.

MATERIALS AND METHODS

Study design and participants) &s s"*#ro" analys&s as *ase' on 'ata $ro% to &'ent&,ally

'es&#ne' 12-ee %"lt&,enter ran'o%&e' 'o"*le-*l&n' ase 3 st"'&es o$ 'asone 5/ #el t&,e

'a&ly +ers"s +e&,le #el (n3010) as 'es,r&*e' re+&o"sly.14 B"*e,ts (X12 years o$ a#e) ere

ran'o%ly ass&#ne' to e&ter treat%ent an' &nstr",te' to aly te test %ater&al t&,e 'a&ly to te $a,e

a$ter as&n# &t a stan'ar'&e' soa-$ree ,leanser. B"*e,ts &n,l"'e' &n te tr&als a' ,l&n&,ally

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'&a#nose' AO &t 20 to 50 &n$la%%atory les&ons an' 20 to 100 non&n$la%%atory les&ons lo,ate' on

te $a,e a*o+e te %an'&*"lar l&ne at *asel&ne. B"*e,ts ere e,l"'e' &$ se+ere ,yst&, a,ne or 

,on#lo*ate a,ne as resent or &$ any e%er#&n# no'"lar les&ons a*o+e te %an'&*le ere note'.

B"*e,ts ere also e,l"'e' &$ tey "se' oter treat%ents (&.e. to&,al syste%&, 'e+&,es) tat ,o"l'

a$$e,t AO &n,l"'&n# te "se &t&n $o"r ees o$ *asel&ne o$ any syste%&, or &%%"nos"ress&+e

a#ents or oter tera&es non to a$$e,t AO or &n$la%%atory resonses an'or te "se o$ oral&sotret&no&n &t&n tree %onts o$ *asel&ne. o%en o$ ,&l'*ear&n# otent&al ,o"l' not *e re#nant

or n"rs&n# an' a' to *e "s&n# an e$$e,t&+e $or% o$ ,ontra,et&on as 'eter%&ne' *y te &n+est&#ator.

o%en ta&n# oral ,ontra,et&+es ere re!"&re' to a+e *een "s&n# te% $or at least tree %onts

 r&or to st"'y entry. o *e &n,l"'e' &n t&s s"*#ro" analys&s $e%ale s"*e,ts treate' &t 'asone

5/ #el t&,e 'a&ly an' +e&,le #el ere strat&$&e' *y a#e< X1= years (a'"lt or ost-a'oles,ent) an'

12 to 17 years (a'oles,ent).

Study !isits and assessments) Enrolle' s"*e,ts ere e+al"ate' at *asel&ne an' at ees 2 4 6 =

an' 12. At ea, +&s&t all s"*e,ts "n'erent &n+est&#ator #lo*al assess%ent "s&n# @AAB an'

,o"nt&n# o$ &n$la%%atory an' non&n$la%%atory AO les&ons alon# &t te total AO les&on

,o"nt.14 e @AAB as s,ore' on a 5-o&nt s,ale (0none l%&n&%al 2%&l' 3%o'erate an'

4se+ere).

Efficacy assessments) E$$&,a,y at te 12-ee t&%e o&nt (st"'y en'o&nt) as assesse' *y

,o%ar&n# te %ean @AAB s,ore at *asel&ne an' at st"'y en'o&nt as ell as ,an#e $ro% *asel&ne.

In a''&t&on e$$&,a,y as e+al"ate' *ase' on te roort&on o$ s"*e,ts a,&e+&n# s",,ess on @AAB

'e$&ne' as a,&e+&n# a rat&n# o$ none (0) or %&n&%al.1 E$$&,a,y as also 'eter%&ne' +&a a,ne les&on

,o"nts. En'o&nt s",,ess $or AO les&ons as 'e$&ne' as a s&#n&$&,antly #reater %ean er,enta#e

re'",t&on $ro% *asel&ne &n at least to o$ te tree tyes o$ AO les&ons (&n$la%%atorynon&n$la%%atory total) at ee 12.

Tolera(ility and safety monitoring) AEs &n,l"'&n# an' s&#ns an' sy%to%s o$ al&,at&on s&te

rea,t&ons (lo,al s&n tolera*&l&ty) ere %on&tore' an' ,at"re' tro"#o"t te st"'y at ea, st"'y

+&s&t or &$ reorte' oter&se *y te st"'y s"*e,t.

STATISTICAL METHODS

&t&n-#ro" ,an#e $ro% *asel&ne as analye' an' ,o%ar&sons ere er$or%e' "s&n# te

&l,oon s&#ne'-ran test. 8ane' analys&s o$ ,o+ar&an,e as "se' to analye te er,enta#e o$ 

re'",t&on &n a,ne les&on ,o"nts.

RESULTS

Su(*ect disposition and characteristics) A%on# te 2507 e+al"a*le s"*e,ts o ,o%lete' te

to ase 3 &+otal tr&als 7=1 $e%ale s"*e,ts &n te 'asone 5/ #el #ro" (n347 a'oles,ent #&rls

1217 years o$ a#e; n434 a'"lt o%en X1= years o$ a#e) ere el&#&*le $or t&s analys&s (a*le 1).

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e %ean a#e o$ te a'oles,ent s"*#ro" as 14 years an' te %ean a#e o$ te a'"lt s"*#ro" as

27 years. Most s"*e,ts ere &te &t ra,eetn&,&ty 'e$&n&t&ons an' te&r '&sos&t&ons o"tl&ne'

&n a*le 1. At *asel&ne no '&$$eren,e as note' *eteen #ro"s &n @AAB s,ores. Mean n"%*ers o$ 

AO les&ons ere &#er at *asel&ne &n te a'oles,ent s"*#ro" *y 1.5 &n$la%%atory les&ons 7.=

non&n$la%%atory les&ons an' 9.2 total les&ons; oe+er te stan'ar' 'e+&at&on ran#es &n'&,ate tat

tere as ,ons&'era*le o+erla &n les&on tyes an' !"ant&t&es *eteen *ot a#e-relate' $e%ales"*#ro"s.

 TA+83

emographics and clinical characteristics at baseline

Efficacy) At ee 12 'asone 5/ #el &%ro+e' AO &n *ot te a'oles,ent an' a'"lt $e%ale

s"*#ro"s as 'e%onstrate' *y s&#n&$&,antly re'",e' %ean @AAB &n *ot s"*sets ( p0.001) (&#"re

1A). >oe+er te roort&on o$ s"*e,ts &t ,l&n&,al s",,ess (@AAB s,ore 0 or 1) at ee 12 as

#reater &n a'"lt o%en (53.5/) +ers"s a'oles,ents (45.3/ p0.022; &#"re 1). Dasone 5/ #el

s&#n&$&,antly re'",e' %ean @AAB $ro% *asel&ne ( p0.001) &n *ot #ro"s &t no '&$$eren,es &n

%ean ,an#e $ro% *asel&ne to ee 12 &n @AAB *eteen 'asone-treate' a'oles,ent #&rls an' a'"lt

o%en (&#"re 1C). ot #ro"s soe' s&#n&$&,antly #reater %ean ,an#es $ro% *asel&ne &n

@AAB tan te&r +e&,le-treate' ,o"nterarts< $or a'oles,ents 'asone 5/< -0.=5; +e&,le< -0.67

( p0.01=7); $or a'"lts 'asone 5/< -0.94; +e&,le< -0.=0 ( p0.0426).

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"igure

3fcacy o dapsone 5% gel in adolescent and adult emales ith acne vulgaris 9A)

!AA& rating at baseline and 1ee. * 9+) ercentage o dapsone 5% gel-treated

sub;ects achieving !A&& success 9score 6 or ) at 1ee. * 9#) 0ean change rom

baseline in ...

reat%ent &t 'asone 5/ #el res"lte' &n stat&st&,ally s&#n&$&,ant re'",t&ons &n &n$la%%atory non-

&n$la%%atory an' total les&on ,o"nts eresse' as er,enta#e ,an#e $ro% *asel&ne &n *ot

a'oles,ent $e%ales an' a'"lt o%en (a*le 2). e er,enta#e ,an#es $ro% *asel&ne &n all les&onen'o&nts ere n"%er&,ally #reater $or ea, tye o$ les&on &n a'"lt o%en ,o%are' &t

a'oles,ent $e%ales. In te 'asone 5/ #el st"'y ar% stat&st&,ally s&#n&$&,ant les&on re'",t&ons ere

o*ser+e' &n te a'"lt-#ro" ,o%are' &t te a'oles,ent-#ro" $or *ot non&n$la%%atory

( p0.0001) an' total les&on ,o"nts ( p0.000=).

 TA+83 *

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ercentage 9%) change rom baseline in acne lesion counts 91ee. *)

Tolera(ility and safety) a,&al al&,at&on o$ 'asone 5/ #el $or 12 ees re'",e' (&%ro+e') te

 er,enta#e o$ s"*e,ts reort&n# eryte%a 'ryness o&l&ness an' eel&n# ,o%are' &t *asel&ne &n

 *ot a'oles,ent an' a'"lt $e%ales (&#"re 2). ese res"lts '&' not re+eal any '&$$eren,es $ro%

$&n'&n#s o*ser+e' &n te $"ll o"lat&on o$ s"*e,ts &n te to &+otal ase 3 tr&als. 14 &s ,"rrentanalys&s o$ AE 'ata $ro% *ot $e%ale s"*#ro"s soe' no %aor sa$ety &ss"es an' no re+&o"sly

"nre,o#n&e' sa$ety s&#nals ere o*ser+e'.

"igure *

apsone 5% gel e<ect on tolerability in adolescent and adult emales ith acnevulgaris= +8>baseline

DISCUSSION

Dasone 5/ #el al&e' t&,e 'a&ly $or $a,&al AO as 'e%onstrate' e$$&,a,y an' sa$ety &n *ot %ale

an' $e%ale s"*e,ts *ase' on o"t,o%es reorte' $ro% to 'o"*le-*l&n' ran'o%&e' +e&,le-

,ontrolle' 12-ee tr&als an' as also *een son to e&*&t a #reater ,l&n&,al s",,ess rate &n

$e%ales ,o%are' &t %ales.1416e s"*#ro" analys&s reorte' ere as 'es&#ne' to ,o%are

te e$$&,a,y o$ 'asone 5/ #el al&e' t&,e 'a&ly &n to s"*#ro"s o$ $e%ale at&ents *ase' on

a#e< a'oles,ents (12-17 years o$ a#e) an' a'"lts (X1= years o$ a#e). e res"lts o$ t&s s"*-analys&s

'e%onstrate' tat 'asone 5/ #el as e$$e,t&+e &n *ot a'oles,ent an' a'"lt $e%ales &n re'",&n#

$a,&al AO. A ,o%ara*le re'",t&on as o*ser+e' &n &n$la%%atory AO les&ons &n *ot a'"lt an'

a'oles,ent $e%ales ereas re'",t&ons &n non&n$la%%atory an' total AO les&ons ere #reater &n

a'"lt o%en ,o%are' &t a'oles,ents. ese 'ata s"##est tat te e$$&,a,y o$ 'asone 5/ #el

al&e' t&,e 'a&ly $or $a,&al AO alto"# son to *e e$$e,t&+e &n $e%ales a#e' X12 years %ay

e&*&t #reater e$$&,a,y o+erall &n a'"lt o%en (X1= years o$ a#e) ,o%are' &t a'oles,ent $e%ales

(12-17 years o$ a#e). olera*&l&ty an' sa$ety ere &#ly $a+ora*le &n *ot s"*#ro"s.

@AAB reson'er rates &n *ot a'oles,ent (45.3/) an' a'"lt $e%ales (53.5/) ere #reater tan teo+erall reson'er rate (40.5/) reorte' $ro% te ,o%*&ne' %ale an' $e%ale o"lat&on &n te

 &+otal ase 3 st"'&es $"rter s"ort&n# tat 'asone 5/ #el as %ore e$$e,t&+e &n $e%ales

o+erall.1416 Dasone 5/ #el as e!"ally e$$e,t&+e &n *ot a#e #ro"s &n re'",&n# te er,enta#e

,an#e $ro% *asel&ne &n &n$la%%atory les&ons. Interest&n#ly alto"# a'oles,ent $e%ales a'

s&#n&$&,antly #reater n"%*ers o$ *ot &n$la%%atory an' non&n$la%%atory AO les&ons at *asel&ne

tan '&' a'"lt o%en enrolle' &n te st"'y 'asone 5/ #el as %ore e$$e,t&+e &n re'",&n#

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non&n$la%%atory les&ons &n a'"lt o%en ,o%are' &t re'",t&ons note' &n te a'oles,ent $e%ale

#ro".

?ne l&%&tat&on o$ t&s analys&s &s s&%&lar to l&%&tat&ons o$ oter a#e-*ase' s"*#ro" analyses

,o%lete' &t to&,al a#ents "se' to treat AO6-= e a#e ran#es tat 'e$&ne te '&+&'&n# l&ne to

searate te AO s"*#ro"s &n $e%ales a+e *een ar*&trar&ly sele,te' &n *ot re+&o"s l&terat"re an' &ns"*#ro" analyses o$ 'ata $ro% &+otal st"'&es. ey a+e not *een 'er&+e' $ro% any esta*l&se'

s,&ent&$&, *as&s to '&$$erent&ate a#e-*ase' s"*#ro"s. e+erteless a '&+&'&n# l&ne nee's to *e

sele,te' to ,reate a reasona*le $ra%e o$ re$eren,e $or analys&s an' '&s,"ss&on. In t&s s"*analys&s te

a#e o$ 1= years as "se' as te l&ne '&+&'&n# a'oles,ent an' a'"lt $e%ales &nto to s"*#ro"s &t

te re,o#n&t&on tat t&s ara%eter as *een "se' re+&o"sly to '&+&'e tese sa%e s"*#ro"s.7

A se,on' l&%&tat&on o$ t&s s"*#ro" analys&s &s tat te ,o%ar&son o$ e$$&,a,y o"t,o%es *eteen

te a#e-*ase' s"*#ro"s as $o,"se' on 'ata o*ta&ne' only $ro% $e%ales a,t&+ely treate' &t

'asone 5/ #el. e r&%ary 'es&#n o$ te s"*#ro" analys&s as not $o,"se' on o"t,o%es &n

a'oles,ent an' a'"lt $e%ales treate' &t +e&,le #el; oe+er res"lts o*ser+e' &n +e&,le-treate'

a'"lt o%en an' a'oles,ents ere also 'o,"%ente' an' reorte'. Dasone 5/ #el as *een

'e%onstrate' to *e %ore e$$e,t&+e tan +e&,le #el &n &%ro+&n# AO &n te o+erall o"lat&on o$ 

enrolle' s"*e,ts &, &n,l"'e' $e%ales an' %ales X12 years o$ a#e.14 ?"t,o%es note' &n te

+e&,le-treate' $e%ale s"*e,ts $or *ot a#e-*ase' s"*#ro"s (a'oles,ents an' a'"lts) are 'e&,te'

&n &#"re 1C an' a*le 2.

A,ross all etn&, #ro"s AO &s te %ost ,o%%on '&a#nos&s seen &n 'er%atolo#y a%*"latory ra,t&,e

&n te n&te' Btates &t aro&%ately to-t&r's o$ +&s&ts $or AO %a'e *y $e%ales an' one-t&r'

o$ +&s&ts $or AO %a'e *y o%en Q25 years o$ a#e.171= Alto"# teena#ers are te %ost ,o%%on#ro" a$$e,te' o+erall %ore tan 50 er,ent o$ $e%ales &t AO are o+er te a#e o$ 20 years.2419

Aro&%ately tree-$o"rts o$ a'"lt o%en &t AO a+e a' te '&sor'er as an a'oles,ent

alto"# te se+er&ty as an a'"lt %ay *e %ore se+ere te sa%e or less se+ere tan &n te ast.14-

6 e re%a&n&n# one-$o"rt o$ a'"lt o%en &t AO eer&en,e' onset o$ te '&sor'er a$ter 

a'oles,en,e. I$ an "n'erly&n# ,a"se o$ an'ro#en e,ess &s &'ent&$&e' teray nee's to *e '&re,te' at

treat&n# tat '&sor'er. >oe+er %ost a'"lt o%en &t AO 'o not a+e an &'ent&$&a*le "n'erly&n#

'&sor'er an' are treate' &t a +ar&ety o$ ,on+ent&onal tera&es $or AO o$ten &t oral

,ontra,et&+es an'or oral s&ronola,tone.1569-1120n$ort"nately to&,al teray &n a'"lt

o%en &t AO as not re,e&+e' %", '&re,t resear, to 'eter%&ne eter se,&$&, a#ents an'or 

+e&,le $or%"lat&ons are #enerally re$erre' '"e to %ore $a+ora*le e$$&,a,y an'or tolera*&l&ty.

&t re#ar' to to&,al teray s&n ,olor o$ten reorte' as te &tatr&, s&n ototye &s

$re!"ently a''resse' as an &%ortant ,l&n&,al ,ons&'erat&on *e,a"se o$ ,on,ern re#ar'&n# ers&stent

res&'"al yer&#%entat&on tat %ay *e ,a"se' *y resol+e' &n$la%%atory AO les&ons an'or s&n

&rr&tat&on $ro% to&,ally "se' ro'",ts.2122 In a''&t&on so%e a'"lt o%en &t AO resent &t

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&n$la%%atory AO les&ons lo,ate' *elo te al&ne &n+ol+&n# te s"*%an'&*"lar an' lateral ne, 

re#&ons &, are s&tes %ore rone to &rr&tat&on $ro% to&,al %e'&,at&ons "se' to treat

AO.156910 Certa&n a,t&+e &n#re'&ents "se' &n to&,al a,ne %e'&,at&ons (&.e. *enoyl ero&'e

ret&no&'s sal&,yl&, a,&') or +e&,les tat a+e a roens&ty to &n'",e ,"taneo"s &rr&tat&on re!"&re

%ore ,a"t&o"s "se en al&e' on te ne, an'or to te loer $a,e ese,&ally te er&oral

re#&on.11

Alto"# AO &n a'"lt o%en %ay *e resons&+e o+erall to %any o$ te ,on+ent&onal tera&es "se'

to treat at&ents o$ e&ter #en'er so%e '&$$erent&at&n# ,ons&'erat&ons nee' to *e taen &nto a,,o"nt

en treat&n# a'"lt o%en &t AO &, are &%ortant to a''ress &n o tey %ay or %ay not

aly to ea, a$$e,te' o%an.13-51023 Bo%e o$ te %aor $a,tors tat are &%ortant to ,ons&'er 

an' atte%t to '&$$erent&ate en %ana#&n# AO &n a'"lt o%en are o"tl&ne' &n a*le 3.

 TA+83 /

Acne vulgaris 9A?) in adult omen: i<erentiating actors that can impact

management o individual casesa

It &s &%ortant to tae &nto a,,o"nt &t ea, at&ent er a#e an' ase &n l&$e. o%en o are &n

te&r 20s 30s an' *eyon' are o$ten $r"strate' an' e%*arrasse' *y a+&n# AO a $a,&al s&n ,on'&t&on

tat tey to"#t o"l' ne+er ers&st a$ter te teena#e years or e+en *e#&n later &n l&$e.23 Many

a+e te stress o$ *alan,&n# t&%e-,ons"%&n# resons&*&l&t&es s", as $a%&ly ,&l'ren an'or $"ll-

t&%e e%loy%ent. As AO %ost o$ten &n+ol+es te $a,e &t &s not "n,o%%on $or a'"lt o%en &t AO

to $eel sel$-,ons,&o"s less attra,t&+e an' less &ll&n# to &ntera,t so,&ally or ro$ess&onally as te

 resen,e o$ AO les&ons a'+ersely a$$e,ts te&r sel$-&%a#e an' sel$-estee%.523

A s"r+ey o$ a'"lt o%en &t AO (409) &n'&,ate' 54 er,ent "se' X3 treat%ents $or AO o+er te

 ast year &t 74 er,ent &n'&,at&n# tat tey ant treat%ent $or te&r AO tat as *een son to *ee$$e,t&+e $or a'"lt $e%ales; %any also reort tat &t &s &%ortant $or te ,l&n&,&an to ela&n te&r 

ot&ons $or treat%ent an' &n+ol+e te% &n te 'e,&s&on.623 De'&,at&n# t&%e to o*ta&n a 'eta&le'

&story an' to ,are$"lly e+al"ate te s&n o$ te at&ent &s &%ortant to a'"lt o%en o are see&n#

treat%ent $or AO. ro% a ,l&n&,al erse,t&+e a ra,t&,al R,e,l&stS o$ &%ortant ,ara,ter&st&,s tat

%ay *e el$"l '"r&n# e+al"at&on o$ ea, a'"lt o%an o resents &t AO &n,l"'es sy,oso,&al

$a,tors; $&rst a#e o$ onset o$ AO (&n,l"'&n# any &story o$ a'oles,ent AO); att&t"'es an' ee,tat&ons

a*o"t a+&n# AO later &n l&$e; att&t"'es an' ee,tat&ons a*o"t treat%ent o$ AO later &n l&$e; ,"rrent

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AO les&on tyes; anato%&, '&str&*"t&on (&.e. $a,e ne, tr"n); o+erall t&%e ,o"rse o$ AO (any $lare

 atterns); resen,e o$ a,ne s,arr&n#; resen,e o$ 'ys,ro%&a (ers&stent &n$la%%atory eryte%a or 

yer&#%entat&on); re+&o"s an' ,"rrent res,r&t&on an'or o+er-te-,o"nter (?C) tera&es "se'

$or AO; "se o$ ys&,al %o'al&t&es an'or 'e+&,e tera&es (&.e. $a,&als eels %&,ro'er%a*ras&on

l&#t tera&es o%e "se 'e+&,es); ,"rrent or re+&o"s "se o$ or%onal a#ent(s) (oral ,ontra,et&+es

s&ronola,tone &ntra"ter&ne or &%lante' 'e+&,es &ne,ta*le a#ents); s&#ns an'or sy%to%s o$ an'ro#en e,ess (&.e. &rs"t&s% aloe,&a &rre#"lar %enses %&sse' %enses &na*&l&ty to ,on,e&+e a

,&l'); %e'&,al &story; ,"rrent %e'&,at&ons an' any ?C s"le%ents; '&et; an' re#nan,y

,ons&'erat&ons.

CONCLUSION

e to&,al treat%ent o$ AO &n a'"lt o%en as re,e&+e' l&ttle attent&on "nt&l re,ently. I%ortantly

t&s at&ent o"lat&on &s ,ara,ter&e' *y se,&$&, ,allen#es %any ,a"se' *y te resen,e o$ AO at

a later sta#e &n l&$e &, %ost o%en 'o not ee,t to o,,"r. eel&n#s o$ $r"strat&on an'

e%*arrass%ent are ,o%%on an' te 'es&re $or tera&es tat are e$$e,t&+e an' ell-tolerate'

se,&$&,ally &n t&s o"lat&on &s ,o%%only eresse'.

Dasone 5/ #el al&e' t&,e 'a&ly $or $a,&al AO as *een son to *e e$$e,t&+e an' sa$e &n %ale

an' $e%ale s"*e,ts X12 years o$ a#e &n &+otal ase 3 tr&als an' &n a 12-%ont st"'y &n &, @=0

 er,ent o$ s"*e,ts "se' 'asone 5/ #el t&,e 'a&ly as %onoteray o+er te '"rat&on o$ te

st"'y.1415 More re,ently 'ata analys&s $ro% te ase 3 &+otal tr&als as son #reater e$$&,a,y &n

$e%ale tan &n %ale s"*e,ts.16 e s"*#ro" analys&s 'ata reorte' ere *ase' on $e%ale at&ents

a,t&+ely treate' &t 'asone 5/ #el t&,e 'a&ly s"ort tat t&s a#ent &s e$$e,t&+e ell-tolerate'

an' sa$e &n *ot a'oles,ent an' a'"lt $e%ales an' $"rter s"##ests tat e$$&,a,y %ay *e #reater &nte latter s"*#ro".

1=). Low intrinsic drug acti!ity and dominant !ehicle %place(o' effect in the topical treatment

of acne !ulgaris . C&o" :

Abstract

In 'r"# treat%ent $or a,ne to&,al ro'",ts alone or &n ,o%*&nat&on &t syste%&, ro'",ts are

,o%%only res,r&*e'. It as re,ently o&nte' o"t *y C&o" tat oral tetra,y,l&nes te %ost,o%%only res,r&*e' syste%&, 'r"#s %ay not *e as e$$e,t&+e as ,o%%only ass"%e' *e,a"se tee$$e,t o$ la,e*o ,an aroa, 'r"# e$$e,ts '"r&n# te 4 - 12 ees o$ 'a&ly a'%&n&strat&on. e resent or e+al"ate' te er,ent ,ontr&*"t&on o$ +e&,le (la,e*o) toar' te reorte' e$$&,a,y o$ re'",t&on &n total (&n$la%%atory an' non-&n$la%%atory) les&on ,o"nts o$ = ,o%%only res,r&*e'to&,al rearat&ons at te en' o$ 10 - 12 ees o$ 'a&ly a'%&n&strat&on. ese rearat&ons &n,l"'e'0.1/ tret&no&n 0.1/ a'aalene 5/ 'asone 1/ ,l&n'a%y,&n a ,o%*&nat&on o$ *enoyl ero&'e&t a'aalene or ,l&n'a%y,&n an' a ,l&n'a%y,&n-tret&no&n ,o%*&nat&on. e %ean re'",t&on $ro%'r"#s an' +e&,les ere 42 N 7.1/ an' 23 N 5.0/ rese,t&+ely; te %ean ,ontr&*"t&on o$ +e&,le

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toar' 'r"# e$$e,t as 55 N 15/ (ran#e 35 - =2/). or 5 *enoyl ero&'e rearat&ons e+al"ate'(2 $or 2.5/ an' 3 $or 5.0/) te&r rese,t&+e %eans ere 40 N 9/ an' 25 N 15/ an' +e&,le-toar'-'r"# ,ontr&*"t&on as 5= N 31/ (ran#e 9 - =9/). e resent or sos te #reat&%ortan,e o$ +e&,le e$$e,ts &n to&,al teray; &n so%e ,ases t&s e$$e,t aroa,e' 90/. e otent&al s&#n&$&,an,e o$ te a*o+e $&n'&n#s &n te 'e+elo%ent o$ %ore e$$e,t&+e to&,al ant&-a,ne'r"#s as '&s,"sse'.

Is "apsone +el Safe and Effecti!e for the Treatment of  Acne

ulgaris-

A%y atel A-B

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A BE:ECIOE EOIDECE ABED MEDICIE 8EOIE

In art&al "l$&ll%ent o$ te 8e!"&re%ents or 

e De#ree o$ Master o$ B,&en,e

In

>ealt B,&en,es ys&,&an Ass&stant

Deart%ent o$ ys&,&an Ass&stant Bt"'&es&la'el&a Colle#e o$ ?steoat&, Me'&,&ne

&la'el&a ennsyl+an&a

De,e%*er 142012

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A.STRACT

?JECIOE< e o*e,t&+e o$ t&s sele,t&+e EM re+&e &s to 'eter%&ne eter or not

'asone #el &s sa$e an' e$$e,t&+e $or te treat%ent o$ a,ne +"l#ar&s.

BDY DEBI@< A re+&e o$ tree En#l&s lan#"a#e st"'&es "*l&se' &n 2007. In,l"'es to

ran'o%&e' 'o"*le-*l&n' ,ontrolle' tr&als an' one oen la*el non,o%arat&+e st"'y.

DAA B?8CEB< 8an'o%&e' ,ontrolle' tr&als ,o%ar&n# 'asone #el to +e&,le #el ,ontrol

ere $o"n' "s&n# "*Me' an' Co,rane 'ata*ase.

?C?MEB MEAB8ED< B",,ess on te @lo*al A,ne Assess%ent B,ore (@AAB) an'

re'",t&on &n a,ne les&on ,o"nts

8EB:B< e to ran'o%&e' ,ontrolle' tr&als an' te oen-la*el non,o%arat&+e st"'y

soe' tat 'asone #el as e$$e,t&+e &n te treat%ent o$ a,ne +"l#ar&s. 8es"lts $ro% te Draelos

et al an' 8a&%er et al st"'&es soe' at&ents a' s",,ess on te @AAB an' a' a re'",t&on &n

a,ne les&on ,o"nts. e :",y et al st"'y soe' tat at&ents a' a re'",t&on &n a,ne les&ons

,o"nts. All tree st"'&es also 'e%onstrate' tat 'asone #el as sa$e en "se' to treat a,ne

+"l#ar&s.

C?C:BI?B< e res"lts o$ te ran'o%&e' ,ontrolle' tr&als an' oen-la*el

non,o%arat&+e st"'y &n'&,ate tat 'asone #el $or te treat%ent o$ a,ne +"l#ar&s &s sa$e an'

e$$e,t&+e.

TEY ?8DB< Dasone a,ne.

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atel< Dasone A,ne O"l#ar&s

I/TR0"1CTI0/

A,ne +"l#ar&s &s a ,o%%on 'er%atolo#&, ,on'&t&on tat resents &n a'oles,en,e an' &s

,ara,ter&e' *y &n$la%%atory les&ons (a"les an' "st"les) an' non-&n$la%%atory les&ons

(,o%e'ones).1

A,ne +"l#ar&s ,an *e ,ron&, $or so%e &n'&+&'"als *"t sel$-l&%&t&n# &n oter ,ases.

A,ne +"l#ar&s ten's to *e %ore se+ere &n %ales tan $e%ales. Contr&*"t&n# $a,tors to 'e+elo&n#

a,ne &n,l"'e stress #enet&,s an' en+&ron%ent. A,ne +"l#ar&s %ay ne#at&+ely &%a,t *o'y

&%a#e sel$-estee% an' %oo'.2B",,ess$"l an' ro%t treat%ent o$ a,ne +"l#ar&s ,an &%ro+e an

&n'&+&'"alLs !"al&ty o$ l&$e.

2

In te n&te' Btates a,ne &s te %ost ,o%%on s&n '&sor'er a$$e,t&n# 40 to 50 %&ll&on

&n'&+&'"als.3

e re+alen,e o$ a,ne +"l#ar&s eas '"r&n# te %&''le to late teena#e er&o' an'

ten stea'&ly 'e,reases. e &n,&'en,e o$ a,ne +"l#ar&s &s 30/ to 60/ o$ 10-12 year ol's an'

=0/ to 95/ o$ 16-1=-year ol's tat are a$$e,te'.4

e '&re,t ,osts asso,&ate' &t a,ne +"l#ar&s

s"rass [2.2 *&ll&on ea, year &n te n&te' Btates.5

D"e to te n"%ero"s &n'&+&'"als a$$e,te' *y

a,ne +"l#ar&s t&s ,on'&t&on &s ,o%%only en,o"ntere' &n te s,oe o$ A ra,t&,e. It &s

&%ortant to *e a*le to ,orre,tly '&a#nose an' treat a,ne +"l#ar&s.

e ato#enes&s o$ a,ne +"l#ar&s &n,l"'es %any $a,tors an' te ser&es o$ e+ents &n te

 ro,ess o$ 'e+elo%ent o$ a,ne are "n,lear.6

A,ne 'e+elo%ent &s &n&t&ate' '"r&n# %enar,e

en tere &s &n,reas&n# se*"% ro'",t&on &n te se*a,eo"s #lan's.6

D"r&n# %enar,e te

a'renal #lan's o+ar&es an' testes se,rete an'ro#ens. &s s"*se!"ently lea's to an &n,rease &n

se*"% ro'",t&on ,a"s&n# a&r $oll&,les to *e l"##e' &t o&l an' 'ea' s&n ,ells tat $"rter 

st&%"late te 'e+elo%ent o$ a,ne.6

?ter non $a,tors tat ,ontr&*"te to a,ne +"l#ar&s are

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atel< Dasone A,ne O"l#ar&s *

&n$la%%at&on $oll&,"lar yerrol&$erat&on an' ro&on&*a,ter&"% a,nes.6

Co%%on lo,at&ons $or 

a,ne to 'e+elo &n,l"'e te $a,e ne, ,est so"l'ers an' *a,.

A,ne +"l#ar&s ,an *e treate' &t a +ar&ety o$ %e'&,at&ons or s&%ly sel$-,are.

reat%ent o$ a,ne &ll el to $&#t *a,ter&al &n$e,t&ons a,,elerate s&n t"rno+er re'",e

&n$la%%at&on an'or re'",e o&l ro'",t&on. reat%ent ot&ons +ary &t ea, at&ent 'een'&n#

on te se+er&ty o$ a,ne. Bo%e ot&ons &n,l"'e a,,"tane tret&no&n aela&, a,&' *enoyl ero&'e

s"l$er sal&,y,l&, a,&' resor,&nol or ro"t&ne $a,e as&n# &t %&l' soa.4

Ant&*&ot&,s tat ,an *e

"se' $or a,ne &n,l"'e tetra,y,l&ne 'oy,y,l&ne erytro%y,&n tr&%etor&% an' ,l&n'a%y,&n.4

ro%t treat%ent &s ,r",&al *e,a"se a,ne +"l#ar&s ,an ,a"se sy,olo#&,al or so,&al 'ys$"n,t&on

an' lon#-last&n# 'e$or%&ty.

e treat%ent ot&ons tat are l&ste' a*o+e are all s",,ess$"l ays o$ treat&n# a,ne.

Dasone &s a s"l$one tat as ant&-&n$la%%atory an' ant&%&,ro*&al roert&es. Dasone as *een

"se' orally $or te treat%ent o$ a,ne *"t &s l&%&te' &n "se '"e to te otent&al $or syste%&,

a*sort&on lea'&n# to to&,&ty. 8e,ently to&,al 'asone #el as 'e+eloe' $or treat%ent o$ 

a,ne &, o"l' o$$er te sa%e ant&%&,ro*&al an' ant&-&n$la%%atory a'+anta#e &t %&n&%al

syste%&, a*sort&on. "s 'asone #el o$$ers a ne treat%ent ot&on $or a,ne +"l#ar&s.

0.2ECTIE

e o*e,t&+e o$ t&s sele,t&+e EM re+&e &s to 'eter%&ne eter or not RIs 'asone

#el sa$e an' e$$e,t&+e $or te treat%ent o$ a,ne +"l#ar&sVS

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atel< Dasone A,ne O"l#ar&s /

3ET40"S

&s re+&e &n,l"'es to ran'o%&e' ,ontrolle' tr&als an' one oen-la*el non-

,o%arat&+e st"'y. e &nter+ent&on "se' as 'asone #el 5/. e treat%ent #ro"s re,e&+&n#

'asone #el ere ,o%are' to tose re,e&+&n# +e&,le #el ,ontrol treat%ent. e o"lat&on &n

tese st"'&es ,ons&ste' o$ %en an' o%en o+er te a#e o$ 12 years &t a,ne +"l#ar&s. e

o"t,o%es %eas"re' ere tose o$ at&ent-or&ente' e+&'en,e. e e$$&,a,y an' sa$ety o$ 'asone

#el $or te treat%ent o$ a,ne +"l#ar&s as %eas"re' tro"# s",,ess on te @AAB (#lo*al a,ne

assess%ent s,ore) an' re'",t&on &n a,ne les&on ,o"nt. Ba$ety o$ 'asone #el as se,&$&,ally

e+al"ate' tro"# a'+erse e+ents an' ys&,al ea%&nat&on $&n'&n#s.

e tree st"'&es &n t&s re+&e ere resear,e' "s&n# "*Me' an' Co,rane 'ata*ase

 *y te a"tor. Teyor's "se' &n l&terat"re sear, ere R'asoneS an' Ra,neS. All art&,les ere

 "*l&se' &n En#l&s &n eer-re+&ee' o"rnals &n 2007. Art&,les ere sele,te' *y te a"tor 

 *ase' on te&r rele+an,e an' o"t,o%e to te at&ent. In,l"s&on ,r&ter&a ere ran'o%&e'

,ontrolle' 'o"*le-*l&n' st"'&es *ase' on an o"t,o%e &, as &%ortant to te at&ent. Bt"'&es

ere e,l"'e' &$ tey &n,l"'e' at&ents "n'er te a#e o$ 12 years ol'. a*le 1 'e%onstrates te

'e%o#ra&,s o$ te st"'&es &n,l"'e'. Btat&st&,s &n,l"'e' &n te st"'&es ere relat&+e r&s 

re'",t&on (888) a*sol"te r&s re'",t&on (A88) relat&+e r&s &n,rease (88I) a*sol"te r&s 

&n,rease (A8I) n"%*er nee'e' to treat () n"%*er nee'e' to ar% (>) an' -+al"es.

ot Draelos et al an' 8a&%er et al st"'&es ere 'es&#ne' &n a s&%&lar ay. at&ents ere

ran'o%ly ass&#ne' 'asone #el or +e&,le #el an' ten &nstr",te' to aly a t&n layer o$ 'asone

or +e&,le #el to te a,ne-a$$e,te' areas $or 12 ees. In :",y et al st"'y at&ents al&e'

'asone #el to a,ne-&n+ol+e' areas $or 12 %onts. In t&s st"'y &$ a,ne ,leare' " &n a art&,"lar 

area treat%ent ,o"l' *e '&s,ont&n"e' *"t &$ a,ne re,"rre' ten 'asone #el as real&e'.

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atel< Dasone A,ne O"l#ar&s 4

01TC03ES 3EAS1RE"

?"t,o%es %eas"re' ere tose o$ at&ent-or&ente' e+&'en,e tat %atters. Draelos et al

an' 8a&%er et al st"'&es assesse' e$$&,a,y *ase' on s",,ess rates on te @AAB $ro% 0 to 4

(0none 1%&n&%al 2%&l' 3%o'erate4se+ere) an' re'",t&on $ro% *asel&ne &n a,ne les&on

,o"nts. B",,ess on te @AAB &s 'e$&ne' as a s,ore o$ 0 or 1. at&ents ent tro"# a

'er%atolo#&, ea%&nat&on at *asel&ne an' ees 2 4 6 = an' 12. At tese +&s&ts a @lo*al A,ne

Assess%ent B,ore as re,or'e'. In a''&t&on at *asel&ne an' ee 12 &n$la%%atory non-

&n$la%%atory an' total les&ons ere ,o"nte'. e :",y et al st"'y assesse' e$$&,a,y *ase' on

re'",t&on o$ a,ne ,o"nt les&ons '"r&n# a 'er%atolo#&,al ea%&nat&on at *asel&ne an' %onts 1 3

6 9 an' 12.

Anoter o"t,o%e %eas"re' as sa$ety o$ 'asone #el. &s as e+al"ate' *y te a'+erse

e+ents an' ys&,al ea%&nat&on $&n'&n#s. All tree st"'&es assesse' at&ents $or 'ryness

 eel&n# an' eryte%a. A''&t&onally *loo' as 'ran $or ro"t&ne la*oratory tests an' at&ents

ere s,reene' $or @6D 'e$&,&en,y.

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atel< Dasone A,ne O"l#ar&s 5

a*le 1< De%o#ra&,s Cara,ter&st&,s o$ &n,l"'e' st"'&es

Bt"'y ye \ ts A#e In,l"s&on Cr&ter&a E,l"s&onCr&ter&a

D Inter+ent&on

Draelos6

(2007)

Do"*le

 *l&n'8C

3010 Q 12

years ol'

- Atleast 12 years

ol' &t a ,l&n&,al'&a#nos&s o$ a,ne+"l#ar&s&n+ol+&n# $a,e- 20-50&n$la%%atoryles&ons an' 20-100non&n$la%%atoryles&ons a*o+e te%an'&*"lar 

 *asel&ne

- Be+ere ,yst&,

a,ne or a,t&+e'e+elo&n#no'"les- se o$ 'r"#stat a$$e,t a,ne- Aller#y to'asone or s"l$a 'r"#s- re#nant or n"rs&n# o%en

503 'asone #el

5/ t&,e'a&ly or +e&,le #el,ontrol

8a&%er 2

(2007)

Do"*le *l&n'8C

1306 Q12 yearsol'(s"*-#ro" resente'&n t&sst"'y &s12-15years ol')

- 12 years or ol'er &t a,ne+"l#ar&s;- resen,e o$ 20-50 &n$la%%atoryles&ons an' 20-100non&n$la%%atoryles&ons a*o+e te%an'&*"lar l&neat *asel&ne

 A 22 'asone #el5/ t&,e'a&ly or +e&,le #el,ontrol

:",y1

(2007)

?enla*elnon,o%- arat&+e

506 Q12 yearsol'

- 12 years or  ol'er &t a,l&n&,al '&a#nos&so$ %o'erate to%o'eratelyse+ere a,ne

+"l#ar&s 'e$&ne'as at least 20&n$la%%atoryles&ons at *asel&ne

- Be+ere ,yst&,a,ne a,ne,on#lo*ate or a,t&+e'e+elo&n# no'"les- se o$ 'r"#s

tat a$$e,t a,ne- Aller#y to'asone or s"l$a 'r"#s- re#nant or n"rs&n# o%en

166 'asone #el5/ t&,e'a&ly

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atel< Dasone A,ne O"l#ar&s

RES1LTS

&s EM re+&e as 'one on to ran'o%&e' ,ontrolle' tr&als an' one oen-la*el non-

,o%arat&+e st"'y. e res"lts &n tese re+&es ere resente' as '&,oto%o"s 'ata. Data $ro%

te st"'&es as analye' &t te &ntent&on to treat. e &n,l"s&on ,r&ter&a $or all tree st"'&es

as s&%&lar. All art&,&ants ere at least 12 years ol' &t a ,l&n&,al '&a#nos&s o$ a,ne +"l#ar&s

an' a' te resen,e o$ at least 20 &n$la%%atory les&ons at *asel&ne. e Draelos et al an' :",y

et al st"'&es a' s&%&lar e,l"s&on ,r&ter&a ereas te 8a&%er et al st"'y '&' not a+e an

e,l"s&on ,r&ter&a note'. E,l"s&on ,r&ter&a &n,l"'e' se+ere ,yst&, a,ne a,t&+e'e+elo&n#

no'"les re#nant or n"rs&n# o%en aller#y to 'asone or s"l$a 'r"#s or te "se o$ oter 'r"#s

tat a$$e,t a,ne.

In te st"'y 'one *y Draelos et al at&ents treate' &t 'asone #el a' s&#n&$&,antly

#reater re'",t&on &n &n$la%%atory non-&n$ la%%atory an' total les&on ,o"nts $ ro% *asel&ne to 12

ees an' a,&e+e' s",,ess on te @AAB. e relat&+e r&s re'",t&on (888) as 23/ an'

a*sol"te r&s re'",t&on (AA8) as =.3/. e n"%*er nee'e' to treat () as 13 at&ents.

&s &%l&es tat 13 eole nee'e' to *e treate' &t 'asone #el &n or'er to &%ro+e a,ne

+"l#ar&s &n one at&ent. e '&$$eren,e &n ,ontrol an' eer&%ental #ro" as a -+al"e less tan

0.001 %a&n# &t stat&st&,ally s&#n&$&,ant.

In te st"'y 'one *y 8a&%er et al 'asone #el as %ore e$ $ e,t&+e tan +e&,le #el. At

ee 12 at&ents a,&e+e' @AAB s",,ess an' re'",t&on &n a,ne les&on ,o"nts $ro% *asel&ne. e

relat&+e r&s re'",t&on (888) as 42/ an' a*sol"te r&s re'",t&on as 11.9/. e n"%*er 

nee'e' to treat as 9 at&ents. "s 9 at&ents nee'e' to *e treate' &t 'asone #el to &%ro+e

a,ne +"l#ar&s &n one at&ent. est&n# as stat&st&,ally s&#n&$&,ant &t a -+al"e less tan 0.001.

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atel< Dasone A,ne O"l#ar&s B

In te oen-la*el non-,o%arat&+e st"'y 'one *y :",y et al tere as a re'",t&on &n

a,ne ,o"nt les&ons $ro% *asel&ne to 12 %onts &t te "se o$ 'asone #el. In$la%%atory les&ons

'e,rease' te #reatest *y 5=.2/ an' non-&n$ la%%atory les&ons 'e,rease' *y 19.5/. otal a,ne

les&on ,o"nts 'e,rease' *y 49.0/. e test as stat&st&,ally s&#n&$&,ant &t a -+al"e o$ less

tan 0.001. Ta(le  sos te e$$ &,a,y o$ 'asone #el &n te treat%ent o$  a,ne +"l#ar&s &n to o$ 

te tree st"'&es. e st"'y 'one *y :",y et al &s not &n,l"'e' &n Ta(le  *e,a"se &t '&' not "se

te @AAB s,ore to e+al"ate e$$e,t&+eness.

Ta(le . Cl&n&,al e$$&,a,y o$ 'asone #el &n te treat%ent o$ a,ne +"l#ar&s

Bt"'y EE8  (Dasone#el;In'&+&'"alsa,&e+&n#s",,ess on@AAB)

CE8 (Oe&,le#el,ontrol;In'&+&'"alsa,&e+&n#s",,ess on@AAB)

 -+al"e 888 A88

Draelos

et al(2007)

44.2/ 35.9/ 0.001 23/ =.3/ 13

8a&%er et al(2007)

40.1/ 2=.2/ 0.001 42/ 11.9/ 9

:",yet al(2007)

- - - - - -

EE8 eer&%ental e+ent rate CE8 ,ontrol e+ent rate 888 relat&+e r&s re'",t&onA88 a*sol"te r&s re'",t&on n"%*er nee'e' to treat

e &n,&'en,e o$ a'+erse e+ents as also ,al,"late' *y ea, st"'y &n re#ar's to te sa$ety

o$ 'asone #el. In te st"'y 'one *y Draelos et al *ot 'asone #el an' +e&,le #el treate'

#ro"s eer&en,e' s&%&lar rates o$ a'+erse e+ents. at&ents treate' &t 'asone #el a' an

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atel< Dasone A,ne O"l#ar&s

&n,&'en,e o$ 5=.2/ an' at&ents treate' &t +e&,le #el a' an &n,&'en,e o$ 5=.6/ &n ter%s o$ 

a'+erse e+ents. Eryte%a o,,"rre' &n 16.3/ o$ 'asone treate' at&ents an' 16.1/ o$ +e&,le

#el treate' at&ents. e relat&+e r&s &n,rease (88I) as 1.2/ an' te a*sol"te r&s &n,rease

(A8I) as 0.2/. e n"%*er nee'e' to ar% (>) as 500 at&ents. "s 500 at&ents nee'

to *e treate' &t 'asone #el $or one erson to a+e eryte%a as an a'+erse e+ent.

In te st"'y 'one *y 8a&%er et al eryte%a as one o$ te %ost ,o%%on a'+erse e+ents

o,,"rr&n# at ee 12. e relat&+e r&s &n,rease (88I) as -11.4/ an' a*sol"te r&s &n,rease

(A8I) as -4.3/. e n"%*er nee'e' to ar% (>) as 23 at&ents.

e st"'y ,on'",te' *y :",y et al $o"n' 6=/ o$ at&ents eer&en,e' at least one

a'+erse e+ent. A*o"t 1.6/ o$ at&ents eer&en,e' eryte%a at al&,at&on s&te. Eryte%a as a

,o%%on a'+erse e+ent &n all tree st"'&es. Ta(le 6 sos te &n,&'en,e o$ eryte%a &n at&ents

treate' &t 'asone #el +ers"s +e&,le #el treate' #ro"s.

Ta(le 6. In,&'en,e o$ eryte%a &n 'asone #el #ro" +ers"s +e&,le #el ,ontrol #ro".

Bt"'y EE8  ('asone #el)

CE8 (+e&,le #el,ontrol)

88I A8I >

Draeloset al(2007)

16.3/ 16.1/ 1.2/ 0.02/ 500

8a&%er et al(2007)

33.4/ 37.7/ -11.4/ -4.3/ -23

:",y

et al(2007)

1.6/ A A A A

EE8 eer&%ental e+ent rate CE8 ,ontrol e+ent rate 88I relat&+e r&s &n,reaseA8I a*sol"te r&s &n,rease > n"%*er nee'e' to ar% A not al&,a*le

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atel< Dasone A,ne O"l#ar&s C

"ISC1SSI0/

Dasone as son to *e e$$e,t&+e $or te treat%ent o$ a,ne +"l#ar&s years a#o *"t as

not &'esrea' &n "se '"e to &ts syste%&, to&,&ty. Dasone as ant&%&,ro*&al an' ant&-

&n$la%%atory roert&es. Dasone as non to ,a"se a'+erse e%olyt&, rea,t&ons %ore

,o%%only &n at&ents &t @6D 'e$&,&en,y.6

e to ran'o%&e' ,ontrolle' tr&als an' one oen-la*el non,o%arat&+e st"'y soe'

tat 'asone #el 5/ &s sa$e an' e$$e,t&+e $or te treat%ent o$ a,ne +"l#ar&s. o&,al 'asone #el

as %&n&%al syste%&, a*sort&on as note' *y te st"'&es '&s,"sse'. A'+erse e+ents an' ro"t&ne

 *loo' la*oratory +al"es ere %on&tore' on at&ents '"r&n# te st"'y &, soe' s&%&lar 

res"lts *eteen te 'asone #el treate' #ro" an' +e&,le #el treate' #ro". A %aor ,on,ern

as at&ents '&a#nose' &t @6D 'e$&,&en,y *"t no %ean ,an#e $ro% *asel&ne as seen &n te

e%atolo#y res"lts.

e st"'y 'one *y Draelos et al soe' a &#er er,enta#e o$ eole a+&n# %&n&%al to

no a,ne at te en' o$ te treat%ent &n at&ents treate' &t 'asone #el. In a''&t&on tose treate'

&t 'asone #el a' #reater s",,ess on te @AAB an' a re'",t&on &n a,ne les&on ,o"nts.

Eryte%a as a ,o%%on a'+erse rea,t&on seen &n *ot #ro"s tat ere treate' *"t 'e,l&ne'

&t te ,o"rse o$ treat%ent. In te st"'y ,on'",te' *y 8a&%er et al 'asone #el also ,a"se'

&%ro+e%ent o$ a,ne *ase' on @AAB s",,ess an' re'",t&on &n a,ne ,o"nt les&ons. @reatest

&%ro+e%ent as seen &n &n$la%%atory les&ons. In te st"'y 'one *y :",y et al &t &s '&$$&,"lt to

assess e$$&,a,y &to"t a ,ontrol #ro". >oe+er t&s st"'y '&' assess te "se o$ 'asone #el $or 

tel+e %onts rater tan only tel+e ees.

e st"'&es &n t&s re+&e a+e so%e l&%&tat&ons. e st"'&es 'one *y Draelos et al an'

8a&%er et al ere tel+e ees lon# &, %ay not *e eno"# t&%e to toro"#ly assess

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atel< Dasone A,ne O"l#ar&s6

e$$&,a,y o$ 'asone #el. or %any at&ents a,ne ,an *e a ,ron&,ally 'e*&l&tat&n# ,on'&t&on

ere a lon#er treat%ent er&o' %ay *e nee'e'. Also te st"'y 'one *y 8a&%er et al only

$o,"se' on a s"*#ro" o$ art&,&ants $ro% 12 to 15 years o$ a#e. E+en to"# a,ne +"l#ar&s &s

%ore ,o%%on &n yo"n# teena#ers an' a'oles,ents %any ol'er &n'&+&'"als are also a$$e,te' an'

so"l' a+e *een reresente'. In a''&t&on te st"'y 'one *y :",y et al la,e' a ,ontrol #ro".

:a, o$ a ,ontrol #ro" ,an l&%&t $&n'&n#s an' *e &n,on,l"s&+e a*o"t te e$$&,a,y an' sa$ety o$ 

'asone.

C0/CL1SI0/

e tr&als re+&ee' &%ly tat 'asone #el &s sa$e an' e$$e,t&+e $or te treat%ent o$ a,ne

+"l#ar&s. at&ents &n all tree st"'&es soe' &%ro+e%ent &n a,ne +"l#ar&s en aly&n#

to&,al 'asone #el. It as also s"##este' $ro% tese st"'&es tat 'asone #el &s ell-tolerate'

as &t 'oes not ,a"se s&#n&$&,ant a'+erse e+ents. A''&t&onally 'asone #el as a ra&' onset o$ 

a,t&on &, tr"ly %atters to te at&ent. Dasone #el ro+&'es a ne treat%ent ot&on $or 

%e'&al ro+&'ers an' tose '&a#nose' &t a,ne +"l#ar&s. Alto"# tese st"'&es 'o ,on,l"'e te

"se o$ 'asone #el &s sa$e an' e$$e,t&+e %ore tr&als so"l' *e 'one to assess te sa$ety o$ "s&n#

'asone #el o+er a ,ron&, t&%e er&o'. 8e#ar'less o$ te nee' $or a''&t&onal st"'&es 'asone

#el &s a sa$e an' e$$e,t&+e ay o$ treat&n# a,ne +"l#ar&s.

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Dapsone gel 5% is an effective, safe, novel topical treatment of

acne vulgaris

David Wilson, MD, The Educational & Research Foundation, nc., Forest, !", #nited $tates

ames 'erndon, MD, $tephens and "ssociates, (arrollton, T), #nited $tates David Whiting,MD, Dallas "ssociated Dermatologists, Dallas, T), #nited $tates "lan $halita, MD, $tate

#niversit* of +e -or, /rool*n, +-, #nited $tates