Clinical trial NCT03352323
Conditions: Rosacea Erythema
Sponsor: Padagis LLC
Start date: 2017-10-18; Completion date: 2018-03-30
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
the study will measure the decrease in redness on the face of rosacea subjects

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Oxymetazoline
Intervention descriptions: intervention 1: RLD

Protocol documents:
Prot_001.pdf: 
 
 
NCT03352323 
 
09-13-2017 











































































































SAP_000.pdf: 
 
 
NCT03352323 
 
09-13-2017 


 
S T A TI S TI C A L A N A L Y SI S P L A N 
 
R H O F A D E ™ ( o x y met az oli ne h y dr oc hl ori de) Cre a m, 1 %      Pr ot oc ol N o.  P R G- N Y - 1 7- 0 1 3 
  
 
  
                  Perri g o 
                         Pa ge 1 of 5 8 
            
S T A TI S TI C A L A N A L Y SI S P L A N                 
A n E val uati o n of t he Re d ucti o n i n Er yt he ma b y R H O F A D E ™ ( o x y metaz oli ne h y dr oc hl ori de) 
T o pical Crea m, 1 % ( Aller ga n) i n A d ult Patie nts wit h M o derate t o Se vere Persiste nt Facial 
Er yt he ma Ass ociate d wit h R osacea, 
 
 
 
 
 
Pr ot oc ol N u m ber: P R G- N Y - 1 7- 0 1 3 
 
 
 
S p o n s or: 
Perri g o 
 
1 7 0 1 Bat h gate A ve. 
Br o n x, N Y 1 0 4 5 7 
 
 
 
 
 
 
 
 
 
 


 
S T A TI S TI C A L A N A L Y SI S P L A N 
 
R H O F A D E ™ ( o x y met az oli ne h y dr oc hl ori de) Cre a m, 1 %      Pr ot oc ol N o.  P R G- N Y - 1 7- 0 1 3 
  
 
  
                  Perri g o 
                         Pa ge 2 of 5 8 
 
S A P  Fi n al Versi o n A p pr o v als 
 
 
 
A n E val uati o n of t he Re d ucti o n i n Er yt he ma b y R H O F A D E ™ ( o x y metaz oli ne 
h y dr oc hl ori de) T o pical Crea m, 1 % ( Aller ga n) i n A d ult Patie nts wit h M o derate t o Se vere 
Persiste nt Facial Er yt he ma Ass ociate d wit h R osacea,
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 




 
S T A TI S TI C A L A N A L Y SI S P L A N 
 
R H O F A D E ™ ( o x y met az oli ne h y dr oc hl ori de) Cre a m, 1 %      Pr ot oc ol N o.  P R G- N Y - 1 7- 0 1 3 
  
 
  
                  Perri g o 
                         Pa ge 4 of 5 8 
List  of A b bre vi ati o ns a n d Defi niti o n of Ter ms 
A Da M  
A nal ysis Dataset M o del  
A E  
A d verse E ve nt  
A N O V A  
A nal ysis of Varia nce  
 
 
C  
Celsi us  
C DI S C  
Cli nical Data I nterc ha n ge C o ns orti u m  
 
 
C R O  
Cli nical Researc h Or ga nizati o n  
e C R F  
electr o nic Case Re p ort F or m  
e C T D 
electr o nic C o m m o n Tec h nical D oc u me nt  
F  
Fa hre n heit  
F D A  
F o o d a n d Dr u g A d mi nistrati o n  
g  
Gra m  
I C F  
I nf or me d C o nse nt F or m  
I C H 
I nter nati o nal C o nfere nce o n Har m o nizati o n 
L O C F  
Last O bser vati o n Carrie d F or war d  
M A OI  
M o n oa mi ne o xi dase i n hi bit or  
Me d D R A  
Me dical Dicti o nar y f or Re g ulat or y Acti vities  
mI T T  
m o difie d I nte nt -t o-Treat  
m L  
Milliliter  
P D  
Pr ot oc ol De viati o n  
P P  
Per -Pr ot oc ol  
 
 
S A E  
Seri o us A d verse E ve nt  
S A P  
Statistical A nal ysis Pla n  
S A S  
Statistical A nal ysis S oft ware  
S D T M  
St u d y Data Ta b ulati o n M o del  
 
 
 


 
S T A TI S TI C A L A N A L Y SI S P L A N 
 
R H O F A D E ™ ( o x y met az oli ne h y dr oc hl ori de) Cre a m, 1 %      Pr ot oc ol N o.  P R G- N Y - 1 7- 0 1 3 
  
 
  
                  Perri g o 
                         Pa ge 5 of 5 8 
T A B L E O F C O N T E N T S 
1. I N T R O D U C TI O N ....................................................................................................................... 8  
2. O B J E C TI V E S .............................................................................................................................. 8 
3. O V E R A L L S T U D Y D E SI G N ..................................................................................................... 8  
4. R A N D O MI Z A TI O N A N D B LI N DI N G.................................................................................... 1 2  
5. S A M P L E SI Z E .......................................................................................................................... 1 2  
6. S T U D Y E N D P OI N T S ............................................................................................................... 1 2  
7. S T U D Y P O P U L A TI O N S .......................................................................................................... 1 2  
8. S T A TI S TI C A L A N A L Y SI S M E T H O D S ................................................................................. 1 3  
8. 1 Baseli ne C haracteristics ...................................................................................................... 1 4  
8. 1. 1 Pati e nt Dis p ositi o n ...................................................................................................... 1 4  
8. 1. 2 De m o gra p hic a n d Ot her Baseli ne C haracteristics ....................................................... 1 4  
8. 1. 3 Me di cal Hist or y ........................................................................................................... 1 5  
8. 1. 4 C o nc o mita nt Me dicati o ns ........................................................................................... 1 5  
8. 2 Ef ficac y A nal yses................................................................................................................ 1 5 
8. 2. 1 A nal yses  o n 
Assess me nts ..................................................................... 1 5  
8. 2. 2 A nal yses  o n  
 Assess me nts .............................................................................. 1 5 
8. 2. 3 E x pl orat or y A nal yses 
 ....................................... 1 6 
8. 3 Saf et y A nal ysis ................................................................................................................... 1 7  
8. 3. 1 A d verse E ve nt s ............................................................................................................ 1 7 
8. 3. 2 Vita l Si g ns ................................................................................................................... 1 8 
8. 3. 3 Pre g na nc y Test ............................................................................................................ 1 8  
8. 4 M ul ti ple C o m paris o ns ......................................................................................................... 1 8 
8. 5 Met h o ds f or Ha n dli n g Missi n g Data ................................................................................... 1 8  
8. 6 I nt eri m A nal yses ................................................................................................................. 1 8  
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 


 
S T A TI S TI C A L A N A L Y SI S P L A N 
 
R H O F A D E ™ ( o x y met az oli ne h y dr oc hl ori de) Cre a m, 1 %      Pr ot oc ol N o.  P R G- N Y - 1 7- 0 1 3 
  
 
  
                  Perri g o 
                         Pa ge 6 of 5 8 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
S T A TI S TI C A L A N A L Y SI S P L A N 
 
R H O F A D E ™ ( o x y met az oli ne h y dr oc hl ori de) Cre a m, 1 %      Pr ot oc ol N o.  P R G- N Y - 1 7- 0 1 3 
  
 
  
                  Perri g o 
                         Pa ge 7 of 5 8 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 




 
S T A TI S TI C A L A N A L Y SI S P L A N 
 
R H O F A D E ™ ( o x y met az oli ne h y dr oc hl ori de) Cre a m, 1 %      Pr ot oc ol N o.  P R G- N Y - 1 7- 0 1 3 
  
 
  
                  Perri g o 
                         Pa ge 9 of 5 8 
( Aller ga n) i n patie nts 
wit h 
m o der ate t o se vere persiste nt ( n o n-tra nsie nt) facial er yt he ma 
ass ociate d 
wit h r osacea.  
  
  
  
  
  
  
 
 
. 
Bef ore a n y st u d y-s pecific pr oce d ures are perf or me d, all patie nts will rea d a n d si g n t he I R B-
a p pr o ve d i nf or me d c o nse nt f or m (I C F). 
A p pr o xi matel y 5 0 eli gi ble patie nts, 1 8 years of a ge a n d ol der, will be e nr olle d i n t he st u d y. 
Eli gi ble patie nts will c o m plete f o ur cli nic visits as f oll o ws: 
 Visi t 1: Scree ni n g ( Da y - 2 8 t o - 1) 
 Visi t 2: Baseli ne ( Da y 1) 
 Visi t 3: I nteri m Visit ( Da y 7 ± 2) 
 Visi t 4: E n d of St u d y ( Da y 1 5 ± 2) 
T he st u d y pr o d uct will be a p plie d t o t he e ntire face (f ore hea d, n ose, eac h c hee k, a n d c hi n) 
a v oi di n g t he e yes a n d li ps. St u d y pr o d uct will be a p plie d i n t he cli nic at Visits 2, 3, a n d 4. 
Patie nts will be i nstr ucte d t o a p pl y t he st u d y pr o d uct at h o me o nce dail y, at a p pr o xi matel y t he 
sa me ti me of da y, o n n o n- visit da ys. 
 
. E val uati o ns will be perf or me d i n 
acc or da nce wit h t he st u d y sc he matic. Safet y assess me nts will i ncl u de vital si g n meas ure me nt 
a n d uri ne pre g na nc y test (f or all w o me n of c hil d beari n g p ote ntial). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
S T A TI S TI C A L A N A L Y SI S P L A N 
 
R H O F A D E ™ ( o x y met az oli ne h y dr oc hl ori de) Cre a m, 1 %      Pr ot oc ol N o.  P R G- N Y - 1 7- 0 1 3 
  
 
  
                  Perri g o 
                         Pa ge 1 0 of 5 8 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
. 


 
S T A TI S TI C A L A N A L Y SI S P L A N 
 
R H O F A D E ™ ( o x y met az oli ne h y dr oc hl ori de) Cre a m, 1 %      Pr ot oc ol N o.  P R G- N Y - 1 7- 0 1 3 
  
 
  
                  Perri g o 
                         Pa ge 1 1 of 5 8 
      Fi g ure 1 St u d y Sc he m atic 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
S T A TI S TI C A L A N A L Y SI S P L A N 
 
R H O F A D E ™ ( o x y met az oli ne h y dr oc hl ori de) Cre a m, 1 %      Pr ot oc ol N o.  P R G- N Y - 1 7- 0 1 3 
  
 
  
                  Perri g o 
                         Pa ge 1 2 of 5 8 
4. R A N D O MI Z A TI O N A N D B LI N DI N G 
Pati e nts will be assi g ne d t o treat me nt i n a n o pe n-la bel fas hi o n. At Visit 2, eli gi ble patie nts will 
be assi g ne d a ra n d o miz ati o n n u m ber i n asce n di n g se q ue ntial or der, starti n g wit h t he l o west 
n u m ber a vaila ble. 
T his is a n o pe n-la bel st u d y. 
5. S A M P L E SI Z E 
T he sa m ple size of a p pr o xi matel y 5 0 patie nts was dee me d a p pr o priate t o meet t he o bjecti ves of 
t he st u d y. 
6. 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
  
  
 
 
 
 
 
7. S T U D Y P O P U L A TI O N S 
Per- Pr ot oc ol ( P P) P o p ul ati o n  
T he P P p o p ulati o n will i ncl u de all ra n d o mize d patie nts w h o: 


 
S T A TI S TI C A L A N A L Y SI S P L A N 
 
R H O F A D E ™ ( o x y met az oli ne h y dr oc hl ori de) Cre a m, 1 %      Pr ot oc ol N o.  P R G- N Y - 1 7- 0 1 3 
  
 
  
                  Perri g o 
                         Pa ge 1 3 of 5 8 
 Meet all i ncl usi o n a n d e xcl usi o n criteria. 
 C o m plete t he fi nal st u d y visit wit hi n t he pr ot oc ol wi n d o w of Da y 1 5  
 
 
 Ha ve 
n o si g nifica nt pr ot oc ol de viati o ns ( P Ds) t hat 
w o ul d affect treat me nt 
e val uati o n. 
 A p pl y t he st u d y pr o d uct a p pr o priatel y 
 
. 
 D o n ot miss t he sc he d ule d a p plicati o ns f or m ore t ha n o ne c o nsec uti ve da y. 
 
 
 
 
 
 
M o difie d I nte nt- t o- Tre at ( mI T T) P o p ul ati o n 
T he mI T T p o p ulati o n will i ncl u de: ra n d o mize d patie nts w h o: 
 Mee t all i ncl usi o n/e xcl usi o n criteria. 
 A d mi nister at least o ne d ose of assi g ne d pr o d uct. 
 Ha ve at l east o ne p ost- baseli ne e val uati o n. 
Patie nts disc o nti n ue d earl y f or reas o ns ot her t ha n lac k of treat me nt effect or w orse ni n g c o n diti o n 
will be i ncl u de d i n t he mI T T p o p ulati o n usi n g last o bser vati o n carrie d f or war d ( L O C F). 
S afet y P o p ul ati o ns  
T he Safet y p o p ulati o n will i ncl u de all patie nts w h o are ra n d o mize d a n d recei ve d st u d y pr o d uct. 
8 . S T A TI S TI C A L A N A L Y SI S M E T H O D S 
Data 
will  be s u m marize d wit h res pect t o de m o gra p hic a n d baseli ne c haracteristics a n d safet y 
var ia bles. 
F or cate g orical varia bles, t he n u m ber a n d perce nta ge of eac h cate g or y wit hi n a para meter will be 


 
S T A TI S TI C A L A N A L Y SI S P L A N 
 
R H O F A D E ™ ( o x y met az oli ne h y dr oc hl ori de) Cre a m, 1 %      Pr ot oc ol N o.  P R G- N Y - 1 7- 0 1 3 
  
 
  
                  Perri g o 
                         Pa ge 1 4 of 5 8 
calc ulate d f or n o n- missi n g data. F or c o nti n u o us varia bles, statistics will i ncl u de n, mea n, sta n dar d 
de viati o n, me dia n, mi ni m u m a n d ma xi m u m val ues. 
All statistical a nal yses will be c o n d ucte d usi n g S A S ® , Versi o n 9. 4 or hi g her. Datasets will be pre pare d 
usi n g hea di n gs fr o m Cli nical Data I nterc ha n ge C o ns orti u m ( C DI S C), St u d y Data Ta b ulati o n M o del 
(S D T M) i m ple me ntati o n f or h u ma n cli nical trials, a n d A Da M ( A nal ysis Dataset M o del). 
8. 1 B aseli ne C h ar acteristics 
8. 1. 1 P atie nt Dis p ositi o n 
T he patie nt dis p ositi o n i nf or mati o n will be s u m marize d. T he n u m ber of patie nt s ra n d o mize d, treate d 
wit h st u d y me dicati o n will be ta b ulate d. I n a d diti o n, c o m pleti o n stat us a n d pri mar y reas o n f or 
wit h dra wal will be s u m marize d. 
8. 1. 2 De m o gr a p hic a n d Ot her B aseli ne C h ar acteristics 
Basel i ne c haracteristics will be e val uate d se paratel y f or t he P P, mI T T, a n d Safet y p o p ulati o ns. 
T he f oll o wi n g baseli ne de m o gra p hics ( deter mi ne d fr o m t heir i nitial st u d y visit) 
will be 
e val uate d: 
 A ge ( years) 
 Se x ( M ale/ Fe male) 
 Et h ni cit y ( His pa nic/ n o n- His pa nic) 
 Race ( W hite, Blac k/ Africa n A merica n, Nati ve Ha waiia n or Ot her Pacific Isla n der, 
Asia n, A merica n I n dia n, or Alas ka Nati ve) 
 Basel i ne n u m ber of i nfla m mat or y lesi o ns (i.e., pa p ules a n d p ust ules) 
 
 
 
 
 
 
 
S u m mar y ta bles will be prese nte d. C o nti n u o us varia bles will be s u m marize d usi n g descri pti ve 
statistics ( n u m ber of o bser vati o ns, me dia n, mi ni m u m, ma xi m u m, mea n, a n d S D). Cate g orical 
varia bles will be s u m marize d usi n g fre q ue ncies a n d perce nta ge.  
All data will be liste d b y patie nt. 


 
S T A TI S TI C A L A N A L Y SI S P L A N 
 
R H O F A D E ™ ( o x y met az oli ne h y dr oc hl ori de) Cre a m, 1 %      Pr ot oc ol N o.  P R G- N Y - 1 7- 0 1 3 
  
 
  
                  Perri g o 
                         Pa ge 1 5 of 5 8 
8. 1. 3 Me dic al Hist or y 
At Visi t 1, patie nts will be q uesti o ne d a b o ut pers o nal me dical hist or y, i ncl u di n g r osacea hist or y. 
Me dical hist or y data will be liste d b y patie nt. 
8. 1. 4 C o nc o mit a nt Me dic ati o ns 
At Visit 1, patie nts will be q uesti o ne d a b o ut me dicati o n use 
. At all 
s u bse q ue nt visits, patie nts will be q uesti o ne d a b o ut o n g oi n g or ne w c o nc o mita nt me dicati o n use. 
All pri or a n d c o nc o mita nt me dicati o ns ta ke n sin ce scree ni n g u ntil t he e n d of t he st u d y will be 
liste d b y patie nt. 
8. 2 Effi c ac y A n al ys es 
8. 2. 1 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
  
 
 
8. 2. 2 
 
.  


 
S T A TI S TI C A L A N A L Y SI S P L A N 
 
R H O F A D E ™ ( o x y met az oli ne h y dr oc hl ori de) Cre a m, 1 %      Pr ot oc ol N o.  P R G- N Y - 1 7- 0 1 3 
  
 
  
                  Perri g o 
                         Pa ge 1 6 of 5 8 
 
 
 
 
8. 2. 3 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
S T A TI S TI C A L A N A L Y SI S P L A N 
 
R H O F A D E ™ ( o x y met az oli ne h y dr oc hl ori de) Cre a m, 1 %      Pr ot oc ol N o.  P R G- N Y - 1 7- 0 1 3 
  
 
  
                  Perri g o 
                         Pa ge 1 7 of 5 8 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8. 3 S afet y A n al ysis 
Safet y a nal ysis will be c o n d ucte d o n safet y p o p ulati o n.   
8. 3. 1 A d verse E ve nts 
All t he a d verse e ve nts ( A Es) re p orte d t hr o u g h o ut t he st u d y will be c o de d a n d classifie d 
acc or di n g t o t he Me d D R A ( Me dical Dicti o nar y f or Re g ulat or y Acti vities) c o di n g dicti o nar y 
( Versi o n 2 0. 0 or hi g her). Eac h a d verse e ve nt is t o be e val uate d f or date of start a n d e n d, 
seri o us ness, se verit y, ca usal relati o ns hi p wit h t he st u d y dr u gs, acti o n ta ke n a n d o utc o me. 
All A Es will be liste d b y patie nt. 
A s u m mar y ta ble of t he n u m ber a n d perce nt of patie nts wit h A Es b y s yste m or ga n class, 
preferre d t er m will be prese nte d. Eac h patie nt will be c o u nte d o nl y o nce wit hi n eac h preferre d 
ter m. 
A fre q ue nc y s u m mar y ta ble of t he n u m ber of A Es b y s yste m or ga n class, preferre d ter m, se verit y 
will be prese nte d. Se verit y will be classifie d as “ Mil d”, “ M o derate”, or “ Se vere”. 
Si milarl y, a fre q ue nc y s u m mar y ta ble of t he n u m ber of A Es b y s yste m or ga n class, preferre d 
ter m, a n d relati o ns hi p t o a st u d y dr u g will be prese nte d. Relati o ns hi p t o a st u d y dr u g will be 
classifie d as “ N ot Relate d”, “ U nli kel y”, “ P ossi ble”, “ Pr o ba bl y”, “ Defi nitel y”.  


 
S T A TI S TI C A L A N A L Y SI S P L A N 
 
R H O F A D E ™ ( o x y met az oli ne h y dr oc hl ori de) Cre a m, 1 %      Pr ot oc ol N o.  P R G- N Y - 1 7- 0 1 3 
  
 
  
                  Perri g o 
                         Pa ge 1 8 of 5 8 
8. 3. 2 Vit al Si g ns 
T he patie nt’s vital si g ns will be rec or de d 
 
 at eac h visit. 
Descri pti ve s u m maries ( n u m ber of o bser vati o ns, mea n, sta n dar d de viati o n, mi ni m u m , me dia n 
a n d ma xi m u m) will be pr o vi de d b y visit. 
All data will be liste d b y patie nt. 
8. 3. 3 Pre g n a nc y Test 
All fe males of c hil d beari n g p ote ntial will ha ve a uri ne pre g na nc y test perf or me d at Visits 1, 2, 
a n d 4.  
Pre g na nc y test res ults will be liste d b y patie nt. 
8. 4 M ulti ple C o m p aris o ns 
N o m ulti ple c o m paris o n a dj ust me nt will be ma de i n t his st u d y. 
8. 5 Met h o ds f or H a n dli n g  Missi n g D at a 
F or de m o gra p hic a n d baseli ne c haracteristics, eac h varia ble will be a nal yze d usi n g all a vaila ble 
data. Patie nts wit h missi n g data will be e xcl u de d o nl y fr o m a nal yses f or w hic h data are n ot 
a vaila ble. 
8. 6 I nteri m A n al yses 
T here  is n o i nteri m a nal ysis pla n ne d i n t his st u d y.