Presentation Dermacool final - Zoovet · D0 D7 D15 3 2 1 0 0 4 8 12 16 D0 D7 D15 No. of feet...
-
Upload
dangkhuong -
Category
Documents
-
view
220 -
download
0
Transcript of Presentation Dermacool final - Zoovet · D0 D7 D15 3 2 1 0 0 4 8 12 16 D0 D7 D15 No. of feet...
Efficacy of a soothing astringent topical spray Efficacy of a soothing astringent topical spray for the management of for the management of MalasseziaMalassezia
pododermatitis in dogspododermatitis in dogs
Dermacool®
A preliminary openA preliminary open--label clinical triallabel clinical trial
D.N.D.N. CarlottiCarlotti11, C.A., C.A. RèmeRème22
11DermatologyDermatology Veterinary Clinic, BordeauxVeterinary Clinic, Bordeaux--MerignacMerignac, France, France22VIRBACVIRBAC Laboratories, Carros, FranceLaboratories, Carros, France
47th BSAVA Congress, Birmingham, April 200447th BSAVA Congress, Birmingham, April 2004
Study rationale
Solutions for localised pedal dermatitisSolutions for localised pedal dermatitis
•• ≠≠ systemicsystemic azolesazoles (generalised, severe)(generalised, severe)•• azoleazole +/+/-- chlorhexidine shampoochlorhexidine shampoo•• azoleazole lotion, creamlotion, cream•• chlorhexidine soakschlorhexidine soaks
OpportunisticOpportunistic MalasseziaMalassezia
Primary diseasePrimary disease
Malassezia Malassezia overgrowthovergrowth
moisturemoisture, , surface lipidssurface lipidsepidermal barrierepidermal barrier
may prove may prove impractical orimpractical or
labourlabour--intensiveintensiveor shortor short--acting acting
Test an alternative “easy spot therapy” Test an alternative “easy spot therapy” using a leaveusing a leave--on residual spray, on residual spray, azoleazole-- && chlorhexchlorhex..--free, with both antiseptic and environment modifying propertiesfree, with both antiseptic and environment modifying properties
+ need to preserve + need to preserve sustained susceptibility sustained susceptibility to these key antifungal to these key antifungal
agents agents
P.J
asm
in
Animals
RecruitmentRecruitment•• Referral veterinary practice (Dr Carlotti,Referral veterinary practice (Dr Carlotti, DipDip ECVD)ECVD)
Inclusion criteriaInclusion criteria•• male & female dogs of any breed and agemale & female dogs of any breed and age•• presenting with presenting with erythematous feet (interdigital area)erythematous feet (interdigital area)•• MalasseziaMalassezia overgrowth evidenced by cytologyovergrowth evidenced by cytology
Exclusion criteriaExclusion criteria•• Parasitic pododermatitisParasitic pododermatitis•• Bacterial infectionBacterial infection•• ParonychiaParonychia•• Poor conformation, foreign body, granuloma, Poor conformation, foreign body, granuloma, neoplasianeoplasia•• Under or requiring immunomodulating therapyUnder or requiring immunomodulating therapy
Treatment
DermacoolDermacool®® BID for 15 daysBID for 15 days
spray on the lesionsspray on the lesions
contains:contains:•• PCMXPCMX & benzalkonium chloride& benzalkonium chloride
antisepticantiseptic•• MentholMenthol
soothing, relievingsoothing, relieving•• HamamelisHamamelis extractsextracts
drying, healingdrying, healing
D.N
. Car
lotti
NB: No other treatmentNB: No other treatment
Evaluation
D0 D7 D15
Scoring for pedal signsScoring for pedal signs
Lesions / signsLesions / signs•• erythemaerythema•• keratoseborrhoeic statuskeratoseborrhoeic status•• hyperpigmentationhyperpigmentation•• prurituspruritus
ScaleScale0/ none0/ none1/ mild1/ mild2/ moderate2/ moderate3/ severe3/ severe
Aggregate clinical scoreAggregate clinical score
ΣΣ scores / foot scores / foot (0(0--12)12)
Yeast quantitationYeast quantitation
Cellophane tape testCellophane tape test HeatHeat--fix,fix, DiffDiff--QuikQuik®® Counting / 30Counting / 30 hpfhpf (x1000, oil immersion)(x1000, oil immersion)
D. P
in
D. P
in
D. P
in
Results: baseline
•• Dog breeds: Labrador, West Highland White Terrier, BoxerDog breeds: Labrador, West Highland White Terrier, Boxer•• Age range: 2Age range: 2--8 years8 years•• Underlying disease: atopy, food allergy, idiopathicUnderlying disease: atopy, food allergy, idiopathic•• Statistical units of analysis: 16 feetStatistical units of analysis: 16 feet
0
4
8
12
16
erythema KSD Pigment Pruritus
Sign
Nb o
f fee
t 3210
Sign severity on D0Sign severity on D0
AggregAggreg. clinical score . clinical score ≥≥ 5 for 5 for 12 feet/16 12 feet/16
Yeast counts on D0Yeast counts on D0
0
10
20
30
40
50
60
70
80
90
Mea
nno
.of M
alas
sezi
a/ 3
0hp
f1 dot = 1 foot
Results: baseline
Variability of Variability of Malassezia Malassezia counts between microscopic fields on D0counts between microscopic fields on D0
0
10
20
30
40
50
60
70
80
90
100
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
Foot
Num
ber o
f Mal
asse
zia
/hpf Need to count 30 Need to count 30
fields per foot to be fields per foot to be representativerepresentative…but tremendous work…but tremendous work
30 fields x 16 feet x 3 30 fields x 16 feet x 3 examination time points examination time points = 1440 fields counted !!!= 1440 fields counted !!!
Results: baseline
Correlation between clinical signs and Correlation between clinical signs and Malassezia Malassezia counts on D0counts on D0
0
10
20
30
40
50
60
70
80
90
0 2 4 6 8 10 12
Aggregate clinical scoreAggregate clinical score
Mea
nM
ean
no.
no. o
f of M
alas
sezi
aM
alas
sezi
a/ 3
0/ 3
0hp
fhp
f
Pearson r² = 0.2, NSPearson r² = 0.2, NS
Weak correlationWeak correlation
Signs also depend Signs also depend on underlying disease on underlying disease (allergy), reaction of the (allergy), reaction of the animal (foot licking)animal (foot licking)
Yeast overgrowth Yeast overgrowth depends on microdepends on micro--ecosystem conditionsecosystem conditions
Results over the study period
Clinical signs: globalClinical signs: global
Examination time point (day)Examination time point (day)
Mea
n ag
greg
ate
clin
ical
sco
re (
Mea
n ag
greg
ate
clin
ical
sco
re ( ±±
SE)
SE)
012345678
0 7 15
RM ANOVARM ANOVA, p < 0.0003, p < 0.0003
Decrease from D7 onwardDecrease from D7 onward
Clinical score Clinical score ≥≥ 55
•• D0: 12 feet /16D0: 12 feet /16
•• D7: 1 foot /16D7: 1 foot /16
•• D15: 3 feet /16D15: 3 feet /16
Mean reduction: 43%Mean reduction: 43%
Results over the study period
Clinical signs: splitClinical signs: split
0
4
8
12
16
D0 D7 D15
3210
0
4
8
12
16
D0 D7 D15
No.No.
of fe
etof
feet
PruritusPruritusErythemaErythema
SeveritySeverity
Erythema: progressive reduction, still 6 feet / 16 with high scoErythema: progressive reduction, still 6 feet / 16 with high score on D15re on D15
Pruritus: rapid reduction, still significant for 3 feet / 16 onlPruritus: rapid reduction, still significant for 3 feet / 16 onlyy
Results over the study period
Clinical signs: splitClinical signs: split
KSDKSDHyperpigmentationHyperpigmentation
HyperpigmHyperpigm.: progressive reduction (chronicity).: progressive reduction (chronicity)
KSDKSD: low incidence and severity, little affected: low incidence and severity, little affected
0
4
8
12
16
D0 D7 D150
4
8
12
16
D0 D7 D15
3210
No.No.
of fe
etof
feet
SeveritySeverity
Results over the study period
MalasseziaMalassezia countscounts
0
10
20
30
40
50
60
70
80
90
100
0 7 15
Mal
asse
zia
Mal
asse
zia
coun
t /co
unt /
hpf
hpf
Pooled data (16 feet x 30 microscopic fields / time )Pooled data (16 feet x 30 microscopic fields / time )
Examination time point (day)Examination time point (day)
RM ANOVARM ANOVA, p < 0.0001, p < 0.0001
Huge decrease from D7Huge decrease from D7
Mean counts (±Mean counts (± SDSD) / 16 feet) / 16 feet
•• D0: 22.3 (± 21.5)D0: 22.3 (± 21.5)
•• D7: 0.8 (± 1.2)D7: 0.8 (± 1.2)
•• D15: 0.1 (± 0.1)D15: 0.1 (± 0.1)
No. of feet for which mean No. of feet for which mean yeast count < 1yeast count < 1 hpfhpf / 30 fields/ 30 fields
•• D0: 0 / 16D0: 0 / 16
•• D7: 13 / 16D7: 13 / 16
•• D15: 16 / 16D15: 16 / 16
ConclusionsDermacoolDermacool®® spot therapy proved valuable spot therapy proved valuable in vivoin vivo to control signs and yeast to control signs and yeast proliferation associated with proliferation associated with MalasseziaMalassezia pododermatitispododermatitis
Convenient, well tolerated (no adverse event)Convenient, well tolerated (no adverse event)
MultiMulti--targeting: yeast killing + soothing, drying effects (“ seed & grtargeting: yeast killing + soothing, drying effects (“ seed & ground”)ound”)
Sustained release (Sustained release (encapsulationencapsulation technology: Spherulitestechnology: Spherulites®®) )
Need to address underlying allergic condition to achieve completNeed to address underlying allergic condition to achieve complete efficacye efficacy
OpportunisticOpportunistic MalasseziaMalassezia
AllergyAllergy
Malassezia Malassezia overgrowthovergrowth
epidermal lipidsepidermal lipidsTEWL TEWL moisturemoisture
inflammation, scratching inflammation, scratching epidermal barrierepidermal barrier
HamamelisHamamelis extractsextracts
MentholMenthol
PCMXPCMX ++ BenzalkBenzalk.. ChlChl..
DermacoolDermacool®® sprayspray