Transcript
Page 1: Academy of Dermatology 65 Academy of Dermatology 63 Annual … 2008 Undera… Irritation.pdf · 2015. 10. 22. · subsequent non-contact SIAscopy evaluation, AP efficacy (Post-trt

Lola

Kel

ly S

mal

ls, P

hD, M

BA, L

aurie

Els

tun,

MS,

Am

y C

apre

tta,

BS,

Pau

la H

artw

ig, B

S, M

icha

el T

hom

as, M

BA, D

avid

Sw

aile

, PhD

, P&

G B

eaut

y, C

inci

nnat

i, O

hio

USA

INTR

OD

UC

TIO

NPr

escr

iptio

n (R

x) a

ntip

ersp

irant

(AP)

pro

duct

s are

wid

ely k

now

n to

indu

ce ir

ritat

ion

(ery

them

a, st

ingi

ng, b

urni

ng)

due

to t

he h

ighl

y ac

idic

natu

re o

fth

e A

P ac

tive

in

vehi

cles

that

are

not

opt

imiz

ed t

o bu

ffer

the

skin

rea

ctio

ns.

This

axill

ary

skin

irr

itatio

n lim

its p

atien

t com

plian

ce, t

hus

impe

ding

pro

duct

effi

cacy

. Pre

viou

sly, w

e sh

ared

da

ta

from

tw

o w

ell-c

ontro

lled

clini

cal

stud

ies

that

es

tabl

ished

th

e pr

escr

iptio

n st

reng

th A

P ef

ficac

y fo

r an

OTC

AP

com

pare

d to

a R

xA

P1 . Th

is pr

escr

iptio

n st

reng

th w

etne

ss p

rote

ctio

n O

TC A

P w

as f

orm

ulat

ed t

o be

gen

tle t

o th

e sk

in b

y de

liver

ing

skin

-soo

thin

g be

nefit

s vi

a pe

trolat

um a

nd d

imet

hico

ne. I

n th

ese

clini

cal

stud

ies

we

dem

onst

rate

th

e ut

ility

of

no

n-co

ntac

t SI

ASc

opy

(Spe

ctro

phot

omet

ricIn

tracu

tane

ous

Ana

lysis,

NCS

), an

imag

e an

alysis

met

hod

that

m

aps s

kin

chro

mop

hore

s(he

mog

lobi

n, e

umela

nin,

der

mal

colla

gen)

2, 3

, 4, t

o ex

amin

e th

e re

gion

al di

strib

utio

n an

d co

ncen

tratio

n of

hem

oglo

bin

in a

xilla

ry s

kin

treat

ed

with

a m

ild O

TC A

P an

d an

irrit

atin

g pr

escr

iptio

n A

P.

Ove

rall,

th

ese

data

de

mon

stra

te

that

no

n-co

ntac

t ch

rom

opho

rem

appi

ng v

ia SI

Asc

opy

is an

effe

ctiv

e to

ol

for

the

asse

ssm

ent

of

axill

ary

irrita

tion

and

is co

nsist

ent

with

exp

ert

clini

cal

irrita

tion

asse

ssm

ents

, an

d su

bjec

t self

-per

ceiv

ed d

ata.

Add

ition

ally,

the

mild

er “

Soft

Solid

”O

TC A

P m

ay in

crea

se su

bjec

t co

mpl

iance

, lea

ding

to a

mor

e co

nsist

ent t

reat

men

t reg

imen

as

com

pare

d to

the

mor

e irr

itatin

g Rx

A

lum

inum

Chl

orid

e A

P.

Curr

ently

, th

e im

age

analy

sis

met

hod

wor

ks

well

in

sh

aved

un

dera

rm s

kin.

Th

e m

etho

d ha

s no

t be

en o

ptim

ized

for

uns

have

d sk

in.

In

clini

cal

trials

, ex

pert

irrita

tion

asse

ssm

ent

is alw

ays

reco

mm

ende

d in

co

njun

ctio

n w

ith

imag

e an

alysis

m

etho

ds.

Ackn

owle

dgem

ents

:Im

age

Ana

lysis

by

Mic

hael

Mar

mor

& K

ukiz

oM

iyam

oto.

Eva

luat

e th

e ut

ility

of n

on-c

onta

ct S

IAsc

opy

for t

he a

sses

smen

t of a

xilla

ry ir

ritat

ion

via

chro

mop

hore

map

ping

of

hem

oglo

bin

with

com

paris

on t

o ex

pert

clini

cal a

nd

subj

ect p

erce

ived

irrit

atio

n in

axi

llary

ski

n tre

ated

with

a m

ild p

resc

riptio

n st

reng

th

wet

ness

pro

tect

ion

OTC

AP

and

an ir

ritat

ing

pres

crip

tion

AP.

OBJ

ECTI

VE

MET

HO

DS

Two

well

-con

trolle

d, r

ando

miz

ed a

nd b

linde

d pa

ired

com

paris

on c

linica

l st

udies

w

ere

cond

ucte

d to

eva

luat

e ax

illar

y irr

itatio

n an

d A

P ef

ficac

y of

a R

x A

P co

ntain

ing

6.25

% A

lum

inum

Chl

orid

e ve

rsus

an

OTC

anh

ydro

us, A

lum

inum

Tric

hlor

ohyd

rex

GLY

AP.

The

stu

dy w

as c

ondu

cted

for

7-d

ays

in h

ealth

y fe

male

s (n

=19

), w

ith

treat

men

ts a

pplie

d 1X

/day

in

the

even

ing.

Th

e pa

nelis

ts w

ere

evalu

ated

for

irr

itatio

n at

eac

h vi

sit.

If a

pan

elist

had

an

irrita

tion

scor

eof

2 o

r ab

ove

(Sca

le:

0=N

one

to 3

=E

xtre

me)

, pro

duct

app

licat

ion

was

disc

ontin

ued

for

subj

ect

safe

ty

and

the

high

est i

rrita

tion

and

imag

e sc

ores

for t

hat p

aneli

st w

ere

carr

ied fo

rwar

d fo

r th

e an

alysis

. St

udy

mea

sure

men

ts:

Dail

y hi

gh

reso

lutio

n im

age

capt

ure

for

subs

eque

nt n

on-c

onta

ct S

IAsc

opy

evalu

atio

n, A

P ef

ficac

y (P

ost-t

rt 6)

, dail

y ex

pert

irrita

tion

scor

ing,

and

dail

y su

bjec

t sel

f-rep

orte

d sy

mpt

oms.

The

data

wer

e as

sess

ed

usin

g m

ixed

mod

els o

r the

mar

gina

l hom

ogen

eity

test

.

RESU

LTS

CO

NC

LUSI

ON

S

Ref

eren

ces

1.Th

omas

M, K

elly

Sm

alls L

R, L

eaze

r TM

, Fin

n E

, Elst

un L

T,

Har

twig

P, S

wail

e D

, Cap

retta

A. A

ltern

ativ

e To

pica

l Tre

atm

ent t

o an

Alu

min

um C

hlor

ide

Ant

iper

spira

nt th

at P

rovi

des P

resc

riptio

n St

reng

th E

ffica

cy w

ith S

igni

fican

tly L

ess I

rrita

tion.

Am

eric

an

Aca

dem

y of

Der

mat

olog

y 65

thA

nnua

l Mee

ting,

200

7.

2.M

atts

, PJ,

Fink

, B, ,

Gra

mm

er, K

, Bur

ques

t, M

. Col

or h

omog

eneit

y an

d vi

sual

perc

eptio

n of

age

, hea

lth, a

nd a

ttrac

tiven

ess o

f fem

ale

faci

al sk

in. J

Am

Aca

dD

erm

atol

2007

; 57:

977

-84.

3.

Mat

ts P

J, Ca

rey

J, Co

tton

SD. C

hrom

opho

rem

appi

ng: a

new

te

chni

que

to c

hara

cter

ized

age

ing

hum

an sk

in, i

nviv

o, A

mer

ican

A

cade

my

of D

erm

atol

ogy

63rd

Ann

ual C

onfe

renc

e, 20

05.

4.K

imba

ll A

, Mat

ts, P

J. Ch

arac

teriz

ing

Hyp

er-p

igm

ente

d Fa

cial

Lesio

ns U

sing

Clin

ical

Eva

luat

ion

and

a N

ew C

hrom

opho

re-

Map

ping

Tec

hniq

ue.

Am

eric

an A

cade

my

of D

erm

atol

ogy

64th

Ann

ual M

eetin

g, 2

006.

Ch

rom

op

ho

reM

app

ing

of

Hem

og

lob

in f

or

the

Ass

essm

ent

of

Axi

llary

Irri

tati

on

: C

om

par

iso

n o

f O

TC a

nd

Pre

scri

pti

on

An

tip

ersp

iran

ts

This

wor

k w

as f

unde

d by

P&

G B

eaut

y.CO

NC

LUSI

ON

S

01234567

Visi

t 1Vi

sit 2

Visi

t 3Vi

sit 4

Visi

t 5Vi

sit 6

Visi

t 7

Mean Change from Baseline Hemoglobin Value (higher= more irritation)

A (F

emal

e O

TC A

nhyd

rous

"S

oft S

olid

")C

(Rx

AlC

l3 A

P)

p=0.

0337

p=0.

0001

p=0.

0011

p=0.

0003

p<0.

0001

Rx

Alu

min

um

Ch

lori

de

AP

An

hyd

rou

s “S

oft

So

lid”

OTC

AP

Ori

gin

al Im

age

NC

S H

emo

glo

bin

Map

Ori

gin

al Im

age

NC

S H

emo

glo

bin

Map

Female Underarms

0

0.51

1.52

2.53

3.54

Vis

it 1

Vis

it 2

Vis

it 3

Vis

it 4

Vis

it 5

Vis

it 6

Vis

it 7

Mean Subject Perceived Irritation Score (higher= more irritation, Scale- 0-10)

A (F

emal

e O

TC A

nhyd

rous

"So

ft S

olid

")C

(Rx

AlC

l3 A

P)

p=0.

0148

p=0.

0138

p=0.

0114

p=0.

0104

p=0.

0146

Non

-con

tact

chr

omop

hore

map

ping

of h

emog

lobi

n in

dica

ted

that

ther

e w

as si

gnifi

cant

ly (p

<0.

05) m

ore

irrita

tion

for t

he

Rx A

P as

com

pare

d to

the

OTC

AP

(Visi

ts 3

-7).

Add

ition

ally,

the

hem

oglo

bin

data

wer

e co

nsist

ent

with

sig

nific

ant

findi

ngs

(p<

0.05

) for

exp

ert c

linica

l visu

al irr

itatio

n sc

ores

(Visi

ts 3

-7) a

nd s

ubjec

t self

-ass

essm

ents

(p<

0.05

, Visi

ts 3

-7).

Subj

ect p

erce

ptio

n da

ta in

dica

ted

that

the

irrita

tion

from

the

Rx A

P m

ost o

ften

felt

like

stin

ging

and

bur

ning

. Fo

r sub

ject

sa

fety

, tre

atm

ent w

as d

iscon

tinue

d at

leve

l 2 ir

ritat

ion

(Sca

le:0-

3): n

=7

on R

x A

P an

d n=

0 on

Anh

ydro

us O

TC A

P.

Subj

ect S

elf P

erce

ived

Irrit

atio

n Sc

ore

by V

isit

Imag

e An

alys

is-C

hang

e fro

m B

asel

ine

Hem

oglo

bin

Valu

es

01020304050607080

Visi

t 1Vi

sit 2

Visi

t 3Vi

sit 4

Visi

t 5Vi

sit 6

Visi

t 7

% of Subjects Unfavorable Irritation Comments(higher= more unfavorable)

A (F

emal

e O

TC A

nhyd

rous

"So

ft So

lid")

C (R

x Al

Cl3

AP)

p=0.

0007

p=0.

0038

p=0.

0024

p=0.

0038

p=0.

0079

Subj

ect S

elf-P

erce

ived

Irrit

atio

n U

nfav

orab

le C

omm

ents

Exp

ert V

isua

l Irr

itatio

n As

sess

men

t by

Visi

t

0

0.2

0.4

0.6

0.81

1.2

1.4

Visi

t 1Vi

sit 2

Visi

t 3Vi

sit 4

Visi

t 5Vi

sit 6

Visi

t 7

Mean Expert Visual Irritation Score(higher= more irritation, Scale- 0-3)

A (F

emal

e O

TC A

nhyd

rous

"So

ft So

lid")

C (R

x Al

Cl3

AP)

p=0.

0124

p=0.

0018

p=0.

0003

p=0.

0007

p=0.

0004

P100

0

Recommended