## T QM



# IConsumer Product9

Gornpany fncorporated 12 Spiglman Road Fairiield, New Jersey fli Op4

(201) 808-7111 FAK: (201) 808-7234 

### FiNA,L REPORT

CLTENT:

ATTENTTON: lnformatifln Scrvices Nlanager

TEST: Repeateel Tnsuit Patch Test

TEST MATSRIAL:

EXPER[MiENT RERERENCE NU1tiY6ER;



### Geral N. Wachs, h4.D., F.A C.P. Mi;dicxl DirCtitor

-~

7oY r li N Ex utive Vice Presidenl Cliaical Evalualiotls z

/ 

# f
~G•~irc~~~ 

# t 1C `lr

;

•~ 

# =t I3awn M. Serkcnhush, H.S Quality Assurance Unit

oate Acr ,$ust 17 1943

. .TFhe 7hlsreport fSsuL*miNOtl PGr thn exdusfveuse pf tho paraon, par:nershlp, orcorppra!ipn to whom it is addrassed, entl nNthqr {ti9report nor 1hB rnreme ol ihese LaGOratortes nur oi eny mpmbor ot h's statt, rnay bB u5etl im mnnection with 4he advertlsinH or saie o# anY product or pracess wimoutwrltt9n suthurizrtion.T1tC ubjactive of the Qivality As.surance Unit (QAU) is [o mottitor the conduct and mporting of clinical laboratory studies- The QACi niaintaitts copies of study protaculs and standard operating procedures and has inspected this study on the da[c(s) listcd 1x;louc Studies lasting six months or more arc inspected at tinte intervals to assure the integrity of the study. The findings o£ thcsc imtpections have baen reported to managcmcnt and the Ctinical Director. All maicrials and data pertinent to this study 4vi71 be su7red in the Archives E`aciiity unless othcrwis: requexted by rhe sponsor.

DatesoCiuspeetxutns: Auguat 16, 1993 August 17, 1993

Senior personnet involwedt

7oy Frank, RN. - Executive Vicc President Clinic:;tt Hvaluations

13everly Pin.sky - t,tinical I,aboxatory Supervisoc

Clliver Shapirn, M.S, - Director of Quality Assnrattce and Regulatory Compliance

The r_epresentative signaturct nC thn Quafity Assuiatice Unit on tkte. 1"ront pagn signifies that this siudy has been perfornted 

### ui aecordanrc: aith standard operating procedures and study pron}eol s.s vvell Ggs govcrnmcnt reouiations tegardin sueii procedures "d protocols as outlined in the Federal Rcgistcr (VoL 46, No. 17 of "['uesday, lanuary 2;, L9811

StAclnt[9n FZot7d - Pairfield. NewJcrscy0<004 a("-ant) 808-7t t I • I`aC 120l} 808-7234Page 3

Objective: To determine by epidermal contact thc primary or cumulativc irritation ar,d/or sensitiza6on ps>tential of a test matefial.

Participants: A panel contprised af fifty-seven (57) subjects, ranring in age froni 17 to 75 years, wtto qualified were $elected ffiar this study. Fifty-two (52) subjeCts compieted this evalaation. The remaining subjects disc:ontinqed their participstion for variuus reasons, none of wlticll were related to the use of the test maEerial.

Tha criteria for seieetion was:

1. Willingness to cooperate, 2. Absence of any vis?ble skin disease which mi ht be confosed with skin reactions from the test matcriat, 

### 3- Avoidance of usc of titpical or systeniic steroids andlor antihistamines for several days prior to study inifiation; 4. Dependabitity and intelligence in following directions, and 5. Reading, understanding and signinff an informed consent contrnct

Test 7Vlaterlal:

Study Schedule: Indtillton Date ComPietion Date
fuly 7, 1993 August 13, 1993

Methadolog}': As inskticted, prior h: the inft"rstiott of tftis study, the tCst materiat was dilutcd hy a Fuctor of five: from an activit y o uf approximately 25% to 5'

~~ . The upper back €x tween thc scapulae served as the treatment site.. Approximatcly 0,2 mT of the test material was applied to the 1" x 7" gauze portion of a Raadi-BandagcO adhesive dressing.* This wastlten appTied to the appropriate treatment site to form a 5emi

### occluded patch.
This procedura was followed thrce fimes per week: Monday, Wedr,esday, and Friday far a total of ten applications. If a participant was unablc to rc:port for an a_ssigned test day, one (l) makeup day was permitted. This day was added to the Induction Period. Tttc sitc was tnarked to eneure the centXnuity of patch appllcatinn. The participants were instructed to remove this patch after twenty-foun cours. The avaluation of this site was rttade just prior to re-application.
*Manufactttred by professional ;vledical Productc, Ync.., Grecnwnod, SC

# PaAe 4

t4lethotlology (continued): Rest penods consisted of twenty-lirur tiours ir}llowing the Tuestlay

and Thurs0ay renroval and forty-sight hours following the 5aturday rBmUVaI,


# At tlfe conclusion of a rest perioc# of approximatcly fourtecn days to[lowing the renth applicatic,n, a rhalicnge pareh wa-

~ 

# applied tn the originat site and to a virgin site, Cach site tvas cvaluated at twenty four and forty-eiaht it0urs after application, The SFolar forearm scrvcd as thc vir g gan tcst sitc,

Evatt ation Key; 0

1+ 2±

3+ 4+ 

# No visihlc rcaction 1!-iild crythcma WeIS-detined erythema, possibte presence ot 6arely perceptible ederna Erytlienia aiid edena Erythenra and edetnu ivith vesicuiation and uloeratiort

ttesults; The resvtts ot' each participarrt are app2nded, t?hservations

remained nil
, pativc throuphitut thc tust interval,



# Sumnaary; [[nder the conditions of tltis study, test matorial, ,

does not indic<<tc a potcntiat far dermal irritatian or sensitiLation,

### Pa4e 5

Tabte 1
Indiyidual Rcsul[s

p



### Snbject

Numhcr --------°---inducFlon Exposut

- es------ ------

1 2 i 4 5 6 7 8 9 10 C3ri

~ 

### inal 3ite 24 48 virgin

Sitc 24 48

1 0 fi Ci 0 0 U 0 0 a 0 0 0 0 0 2 0 0 0 () U t} 0 a 0 Om 0 0 0 0 3 0 0 0 0 0 0 0'n 0 0 0 0 l) 0 0 

### 4 tl (I C 0 0 0 0 (l 0 Ci 0 Q U 0 5 0 0 0 0 0 0 (l 0 0 0 0 p 0 4 

### 6 Sa (? Ci 0 tl Cl 0 Q 0 0 0 (I 0 0 7 0 [l El tl lf 0 0 C) (tni 0 0 G ;] t1 $ 0 0 0 U fJ {) i) (l 0 U l} U 0 U 9 U 0 0 0 u 0 G 0 0 Om [) 0 0 U 10 0 {) G iJ 0 0 0 0 0 f? 0 0 U 0 

### 11 i) 4n' U 0 tl (a 0 0 0 a 0 0 0 0 12 a c) 0 0 0 0 0 0 CS 0 0 Q 0 U 

### 13 [) G 0 t} 0 0 U a C) 0 n 0 o U 14 4 0 0 0 0 0 0 0 4 G [t U 0 0 

### I 15 U 0 0 Uni 0 0 0 0 0 0 CI 41 [t 13

16 {) 0 0 U [Y 0 0 0 G 0 D G 0 l7 

### 17 {l 0 0 0 1 {l {l 0 0 0111 {} 0 i7 tl 1B 0 0 U G 0 U 0 U O 0 0 G 0 Q lSt a G U Uni 0 {} {? 0 U cl {t q



### 20 iT 0 0 U 0 U 0 U 0 C) U U 0 U 21 C p U 0 0 0 Q () (} 0 b 0 0 0 22 0 0 0 0 U 0 Uni 0 0 f} t) U 0 Q 23 0 0 0 0 0 0 0 (} 0 C7 (? 0 U 0 24 0 U t} t) 0 f) G 0 p tt 0 0 0 G 

### 25 0 0M 0 (f t} 0 Cl O tt 0 tJ 0 0 4 26 0 0 0 Cl 0 tl 0 0 Q 0 U [) p u 27 ti 0 U G
, 0 0 0 0 tl 0n? 0 D 0 {1 Z$ 0 ;} ii fJ 4 0 D On+ 0 U 0 0 f? Ci 29 0 G 0 ll 0 U U tJ (1 {.? U 0 0 0 30 Cl 0 0 pm U 0 0 0 U i) G p {Y 0


### ni = Iviakeup day ~

I

### Paue 6

Table 1 (confinucd)

Individual Resulis

. ~



### Subject Nuaxbcr -------------Induclion ETpusures--------------

l 2 3 4 5 fr 7 $ 9 f(} O[iginal 

### Sica 24 48 Virgin



### Sitc 24 49

31 0 t) t) 0 0 0 (l t} Cf 0 Q 0 LY t) 

### 32 ----------------------- ------- D1D NDT C(}NIPLETE STLR)Y ------------------ -°--- 33 0 0 0 0 0 0 {) {} It 0 (s 0 0 Cr 34 0 0 0 (i r_1 t) 0 I) 0 1 TI t} fi 0 0 0 35 0 0 0 0 Q i} (l tiM 0 0 0 fi 0 i:I 

### 36 U ----------------------------DTTa N{)T t^t=1MPLHTE STUDY-------------------- 37 0 0 U t} 0 0 U 0 c) 0 0 {I 0 0 

### 38 0 4 tl 0 0 0 4 {} [J CI 0 0 U ) 39 U iI 0 0 0 U fl l} 0 0 Li tl 0 [> 40 0 0 U 0 {) U Ct !} 0 0 [} t} 0 0 41 0 (} 0 t7m {i 0 0 U 0 () t} 0 0 {} 

### 42 0 0 0 U 0 0 {} 0'n 0 (} 0 i i J 0 43 {} 0 0 111 ----------------DiD NCtT C(iMPLETE STUi)Y ------------------ — 44 El U 0 0 11 [I 0 0 0 U t) 0 0 [{ 45 0 0 0 t} U G! i} 0 (} 0 0 0 0 0 

### 46 0 {l U 0 0 {} 0 0 0 (l 0 [} t) (} 47 G t) 0 (} (} 0 {"} {} 0 0 [t t) 0 0 

### 48 (} U 0 [} 0 U 0 U {) Q [l i} U 0 =19 Om Ci 0 t) ---------------DID NOT C[)MPLETE S'I'UDY --------------- 50 0 t} U G 0 0 {} 0 0 0 tJ 0 0 0 51 t) tI 0 (l [7 0 0 t) [l 0 0 c) 0 U S2 o (t 0 a 0 0 0 Un , 0 n U 0 0 t? 

### 53 0 Ct cJ (}n' 0 0 ct (I 0 0 [? 0 U () 54 (} t} 0 t} () 0"' Q C! 0 --DID NqT Ct3IvIPLF..TE STUIJY-- 55 [i {Y t] (} 0 0 U 0 Q {} f) 0 ti t} 

### 56 0 0 (J 0 U 0 U 0 0 t3 ll C} U t} 57 0 tt U 0 0 r}m (} p {} (} 0


### m - hiakcuP dayPauc 7

Table 2
Suhiec[ flaia

Initials a1

~ >e: SCa



### SC 59 JFi 52 LF

~ i 45 MS 59 PNI 4E KD 25 NSL 3() DA 54 YE? (7 BM 44 PO 37 

### 1L 46 n11P 33 AB 42 

### FR 36 SB 28 I S 49 KR 36 4}I? 60 

### SR 3G DV 50 JV ^t3 ChT
2 4 {, }i 3? 

### MC 35 R7_ 54 

### IS 58 PL a'3 CB 69 I7B 33Page $

Table 2 (cl5ntinUOd) Subjcct Data

i itiaIS A

~ ue 'Sex

MC S3 EC 58 PS 24 CR 4) IM 45 L' W 18 DC 43 PM 29 HP 55 DG 44 Dbi 32 MiC 43 B P 52 LS 26 R4W 75 JR 69 N4G 33 WH 29 AS 21 AG 72 SG 47 FL 65 NG 61 KD 32 MP 35 DH 56 V im 31