Untitled - Clarion Medical Technologies

Evaluation
of the SilkPeel"
System
in Treating
ErythematoteIangiectatic
andPapulopustular
Rosacea
Tejas D. Desai, DO; Lawrence S. Moy, MD; William Kirby, DO;
Alpesh D. Desai, DO; Francisca Kartono. BS: Leah Roscoe
Wepresenta studydesignedto evaluatethe efficacyof the SilkPeel
systemin the treatmentof erythematotelangiectatic
and papulopustular
rosacea.The
SilkPeel
systemis an innovative
formof microdermabrasion
that exfoliates
uniformlyand simultaneously
allowssurfacepenetration
of topicalinfusion
agents,
whichoptimizes
therapywhilemaintaining
structural
integrity.
Thirtyqualifiedpatientswith
erythematotelangiectatic
or papulopustular
rosacea
asdefinedby the National
Rosacea
Society
underwentSilkPeel
treatments
bimonthlyfor 12weeks.
papules,
Significant
clinicalreductions
in erythema,
andpustules
werenotedasearlyasweek4 for allpatients(P<.03).
osaceais a chronic inflammatorydermatitis basedtaxonomy becauseno histologic or laboratory markthat commonly consistsof facial erythema ers are availablefor diagnosis.More etiologic factorshave
with visrbletelanglectases,
papules,pustules, been studied and identified in rosacea.Nevertheless,
the
and sebaceous
hyperplasialeadingto rhino- exactpathogenesis
of this condition has yet to be discovphl*u. A comblnationof thesefeaturesis the eredand is poorly understood.
norm, making classi[icatron
difficult ar rimes.Additionally,
Studiesto establishthe efficacyof treatmentsor combidiagnosticcriteriahavenot beenelucidatedand constantly nations of treatments for each rosaceasubtlpe still are
are evolving.In 2002, the National RosaceaSocietystan- needed. Current treatmentsinclude avoiding triggers that
dardizedrosaceainto 4 subtypes:erythematotelangiectaric,complicaterosacea,topical agents,oral antibiotics,and
papulopustular,
phlrnatous,and ocular.rThis is a clinically laser and light therapies.Overall, a minimum of 4 to
6 weeks of therapy is requlred before a patient may begin
Drs. ID. Desai and Ku'by are Co-ChieJResidents,Westent to seeimprovement. Most rosaceatreatmentsare aimed at
U niver sity/Pacific Lotrg Beach D ennatologt Progr am, Torr ance,
decreasing
the inflammationassociated
with the disease.2-6
California. Dr. Moy is a Dermatologist, Marinttan Beaclr Conventionaltherapiesalso have been shown to induce
Laser and Sltin Institute, CaliJonia. Dr. A.D. Desai is a
long-term effects;antibioticspromote resistanceand varDermatologist,Dennatologyand SldnLaserCente4 SanMattos,
lous topical agents can cause local skin irritation.
Texas.Ms. Kartono is a Medical Snrdent,WestentUniversityoJ Rosaceadisrupts facial aestheticsand symmetry,which
Health Sciatces,Pomona,
CaliJontia.Ms. Roscoeis an Aestl.rctician, leads to psychosocial implications that may affect a
CoastDermatologyClinic, Ton'ance.
patlents quality of 1ife.Consequently,displeasedpatients
The authorsreportno actual or potentialconJlictoJ interest itt
return to their dermatologists requesting alternative
relationto this article.
treatmentmodalities.
VoL. 19 NO. I . JANUARY
2006. Cosmetic Dermatology
5l
SrlxPser Sysreu roR TnsRrrNcRosRcee
Microdermabrasion
has becomea popular dermatologic
office procedure for a vaiety of conditions. However, the
true benefits of traditional microdermabrasionare limited,
and the proceduremay not produceconsisrentresults.The
SilkPeelsystemis an innovative therapy that exfoliatesuniformly and simultaneously allows surface penerration of
topical infusion agents for the treatment of specific skin
disorders.lt slnchronizesmicrodermabrasion
2n61rlali.'o^'
of soluble medicationsto optimize therapy
Resultsof an isolated histologic study reveal rhat the
SilkPeelsyslem abradesevenly to a depth of approximately 30 to 35 pm within the epidermisof preauricular
skin (L.S.M.,T.D.D.,unpublisheddata,2005).This studl'
aiso has shown that various soiutionspenetratethe stratum corneum during the SiikPeelprocedure,which produces cellular vacuolization of keratinocytes in the
epidermis and dermal edema. Penetration of selected
solutions is evident. Keratinosomes,the struciures
responsiblefor producing the hydrophobicbarrier of skin
beyond the epidermal deeperlayers,are left untouched;
thus, the integrity of the skin structure rs maintalned
becausethe SilkPeelsystemdoesnot seemto abradepast
35 pm of the epidermis.Thereare no reportsin the literature of clinical trials evaluatingthe efficacyof a mrcrodermabrasion system used as monotherapy for the
treatmentof rosacea.The SilkPeelsystemmay be an effective treatmentalternativefor this condition.
Microdermabrasiongenerally is not considered as a
treatmentoption for patientswrth rosaceabecausedeep
epidermal penetration causes increased angiogenesis,
inflammatlon,and reactiveoxygenspecies,therebl'worsening the clinical outcome.T-rrr
Traditional microdermabrasion systemshave been reported [o penetrateas
deepas 100 pm usingpressures
of up to t2 ro 20 psi.rrrr
At these depths and pressures,epidermal layersbeyond
the granular layer may be affected,causing the loss of
Langerhanscells immunocompetence,desmosomes,and
g a p junc t ions and c a u s i n g a n i n c re a s ei n v ari ous
cytokinesresponsiblefor cell cycleregulationand wound
healing. In addition, a minrmum of 5 to 10 days is
required for renewalof deeperlevelsof the epidermis.
In contrast,the SilkPeelsystemabradesto a depth of
20 to 35 pm (the approximatedepth of the upper granular layer) and transferssolutions at an averagefluid infusion of l0 to 12 ml-/min, with vacuum pressureof 3 to
4 psi. This achievesa characteristi.cbarrier recovery
sequenceof no more than 72 hours. Furthermore, the
SilkPeelsystemdoesnot causeintenseerythema,inflammation, granulomaformation,hypopigmentation,postinflammatory hyperpigmentation, and the potential for
vesiculation,a1lof which are effectsof traditional micro(L.S.M.,T.D.D.,unpublisheddata,2005).
dermabrasion
52
Cosmetic Dermatology . JANUARY
2006. VOL. 19NO. I
METHODS
Thirty qualified patientsrvith erythematotelangiectatic
or
papulopustular rosaceaas defined by the National
Rosacea Societyr underwent SilkPeel treatments
pntpr i no
hi m nnthl v
the
c tr r dv
"..'."......,/fnr I ) r v eel <c R pfnr p
approvalfrom the InstrtutionalReviewBoard was
obtained, and the patients provided written informed
consent.Patientsolder than 65 yearswere excludedfrom
the study Patientswere allowed to withdraw from the
study at any time and were not permitted to use overthe-counterproductsduring the study perlod without the
approvalof an inr.estigator.
P ati entsw i th c;sts or tenderor overtl yw eepyl esi o ns
were excluded from the study to prevent complications
such as severepain and infection. Furthermore,patienis
with symptomatic erythematotelangiectatic
rosacearvho
complained of a burning sensationwere excluded, as
were patientswho used astringents,toners.and other
products containing sodrum lauryl sulfates,menthol, or
camphor becauseof the potential for adversereactions.
Exclusion criteria also included the use of prescription
medicatlonsfor rosaceawithin 4 weeks from the start of
the study; patlents rn hyperestrogenicstates(eg, pregnancl',oral contraceptiveuse, estrogentherapy);patients
(eg,
w i th faci aler)themaresul ti ngl rom vari ousdi seases
svstemiclunrrs ervthematosus)or certain medications
(es ni aci n): and nati ents w i th moderate to seve r e
rhytldes. In addition, patientswith undiagnosedlesions,
skln cancers(eg, atypicalnevi), and activeherpesinfectron were excluded.
The solutionsof choice consistedof 2oloerythromycin
fo decreaseexisting and potential inflammation and 2o/o
sallcylicacid to further aid exfoliation.The solutronswere
prepared in sterile water and obtained from our pharmac;r Patientswere permitted to use a sunblock, moisl ttr i z er
enl t
oentl e
el eens er
thr nr r ohnr r t
thp
c tr r dv
T he
SllkPeelsystemwas apphedto the faceof eachpatient at
each vlsrt, and each patient inltrally received a gentle
abrasionwlth a fluid infusion of 10 to 12 mUmin and a
vacuum pressureof 3 to 4 psl. Theseparameterswere tailored to achievea favorableclinical end point.
Adverseeffectswere documentedat eachvisit to ensure
quallty assurance.Informed consentoutlining the details
of the study was receivedfrom each patient prior to the
studyrCondltionsunder whlch patientswere permittedto
withdraw from the study were fully explalned.At any
tlme during the study, investigatorswere permitted to
releasepatientswho did not abrdeby study protocolsor
who desiredto lvlthdraw: Reasonsinvestigatorsreleased
patientsfrom the study lncluded inability to keep scheduled ireatmentappointments,pregnancy,and use of cosmetlc agents that may have presentedas confounding
SnxPrnl Sysrenr FoR TREATTNG
RosACEA
erythematotelangiectaticrosacea, and
14 patients (70'k) had papulopustular
rosacea.Three patients became pregnant
and were subsequentlydisqualified. The
OE
CL O' 5U
O tr
rc
remaining 7 patlentswere lost to follow-up
c,6 ::
g)>
zv
for various reasons. The mean age for
Ee 1q
all patients was 42.I years (range, 31oc!
61 years).All of the study participanrswere
s
8Fi
white,
and most were of lrish descent.
0
Baseline
Week4
Week8
Clinical reduction in erythema, papules,
Week12
and pustules was noted in all pati.entsas
Figure 1. Percentageimprovement in erythematotelangiectaticrosaceaafter 12 weeks earlyas 4 weeks,with statisticallysignificant
(P<.03) reductionby 12 weeks.By the end
of b i m o n t h l y S i l k P e e l tr
' . e a tm e n ts.
of the study, patients with erythemarorelanfactors in skin improvement. None of the participants giectaticrosaceahad a meanof 4I.7ok improvemenrin erywrthdrew or were releasedfrom the study becauseof thema(Figure1); patientswith papulopusrularrosacea
had
unsatisfactoryresults.
a mean 690/odecreasein papules and 55o/odecreasein pusA quantlficationschemewas used at baselineand at 4, tules. The degree of erythema was defined as an overall
B, and 12 weeks by one investigatorwho graded ery- reduction percentage.Percentageof improvement was
th em a lev els . G r a d i n g [o r e ry rh e m a ro re l a n gi ecLaticalculated
c
as (end point score- baselinescore)/baseline
rosacea was quantified clinically on a 4-point scale score- 100o/o
. A meanof the percentages
at eachend point
(l=trace erythema; 2=mild erythema; 3=moderareery- was taken as the reportedvalue at 4,8, and 12 weeks.
thema; 4=severeeryrhema). For the papulopustular Patientshad a mean startingscoreof 2.8 and a mean endgroup, lesions were divided into the gross number of treatmentscoreof 2. A wide spectrumof erythemaalong
papulesand pustules.PatientsreceivedSilkPeeltreatment the scoring scalewas observed.
on the entire face;no control siteson the facewere used
More patientshad papules(meanstarringcount, 7.1)
for comparison when grading improvement. However, than pustules(meanstaningcounr,3.1). Not all patients
digital photographswere raken ar eachvisit and used as enrolled in the papulopustulargroup had pustules,but
comparisonfor grading subsequentimprovement.physi- papuleswere noted ln all patients.The range of papules
cian and patient global improvement was rated at was 1 to 9, and the rangeof pustuleswas I to 5. At week
baselineand at 4,8, and 12 weeksusing a 5,poinr scale 12, the end-treatment
papulecount decreased
to 2.2, and
(0 = no im pr ov em e n r. 1 = s l i g h r i mp ro v e ment; 2=mild improvemenr;3=moderate
8
improvement; 4=marked improvement).
7
Percentageof improvement was calculated
as (end point score- baselinescore)/baseo
line score- 100o/o.
A mean of the percento_
ages at each end point was taken as the
45
.Es oo
reportedvalue at 4, B, and 12 weeks.Physician grading for improvement was performed by one invesrigarorand did not
include erythema. Patient satisfaction
scoreswere evaluatedon a 4-point scaleat
the studys end (0=dissatisfied;l=fair;
2=good; 3=excellenr).Patient sarisfacrion
scorestook into consideratlontherapeutic
efficacy, adverse effects, tolerability, and
overallqualrty of life.
I
f
It
0) +
4,
G5
o
=
2
1
0
B asel i ne
Week 4
tr
Pustules
We e k 8
I
We e k i 2
Papules
RESULTS
Twenty patients completed the l2-week
study. Six patienrs (30olo)presentedwirh
F ig u r e 2, Mean reducti on of papul es and pustul es after 12 w eeks of bi monthl y
SilkPeel*treatments.
VOL.19 NO. I . JANUARY
2006. Cosmetic Dermatology
53
SnxPeer Sysreu ron TmerrNc RosRcre
s70
c
0 an
Etu
o 5u
ct
exacerbation of erythema with an averuge
resolutiontime of 3 to 6 hours. None of the
study participants experienced extreme
pruritus, erythema,or other adverseeffects.
COMMENT
Studies to enhancetransdermal drug delivery processessuch as iontophoresis and
i40
o!
sonophoreslshave been equivocal.13The
'E 30
1ow permeability of the stratum corneum
o
resides in its hydrophobic nature, which
Br o
consistsof ceramides,cholesterol,and free
d
fatty acids.raThe SilkPeelsystemtemporarci ro
z
ily inhibits extracellular processing,preventi.nglipid precursors from transforming
B ase lin e
Week4
Week8
Week12
into the hydrophobic barrier. Histologic
Patient
Physician
I
I
samples taken during the SilkPeel procedure show that solutions penetratethe straFigure 3. Physicianand patient evaluation of global improvement from baseline.
tum corneum and thus produce dermal
edemaand vacuolization of keratinocytesin
the end-treatmentpustule count decreasedto I.4. Mean the epidermis(L.S.M.,T.D.D.,unpublisheddata,2005).
reductionin papule and pustulecountsare shown in Fig- Under ideal conditions, one proposed mechanism of
ure 2. No clinical exacerbations
were reportedduring the action for the SilkPeel system involves the disruption of
treatment period. Male patients in both groups took desmosomesin the corneal and often the granular layers,
longer than femalepatientsto reacha clinical end point. while the keratinosomes,desmosomes,
and gapjunctions
Patient and physician global improvement assessments of deeper layers are left untouched. This preserves
were closely correlated(Figure 3). There was an overall hydrophobic barrier function, epidermal scaffolding, and
tendency toward improvement,with a 53.8o/oimprove- intercellular communicati.on. Furthermore, according to
ment rating among patients and a 74o/oimprovement rat- the domain mosaicmodel, the hydrophobic barrier coning among physiciansat week 12.
tains discontinuous aqueous pores arranged in the lacuPhotographstaken throughout the course of the study nae that have the potential to transform into continuous
confirmed an overall improvement (Figures 4 and 5). pores. lnterconnectionsbetween adjacent lacunae are
Patientsprovided positive feedbackregarding tolerability, formed by prolonged permeability, which promotes consatisfaction, and overall quality of life (Figure 6). The tinuity and thereby allows hydrophilic materials to penemost commonlv reported adverse effect was a rranslenr trate the stratum corneum.r5 A subclinical SilkPeel
Figure4. A 57-year-old
womanwith longstanding
rosacearefractoryto standardformsof therapybefore(A)and
erythematotelangiectatic
(B)
after 12weeksof bimonthlySilkPeel"
treatments.
54
Cosmetic Dermatology . JANUARY
2006. VOL.19 NO. I
StmPen Sysrnu FoR TREATTNG
RosAcEA
Figu r e 5 . A 4 2 - y e a r - o ldwo m a n with lo n g sta n d in g p a p u lopustul ar rosacea refractory to standard modes of therapy before (A) and
after (B) l2 weeks of bimonthlv SilkPeel-treatments.
treatment (i.e,using one pass for patients with sensitive
skin or spot suction treatments)may act as the permeable
stimulus necessaryfor continuity within the lacunaeso
that a clinical end point can be reachedeven rhough rhe
hydrophobic barrier persists. What makes microdermabrasioneffectivemay have norhing to do wirh abrasion; the vehicle'ssuction with concurrentsolution flow
may provide the impetus for a unique treatment.
Ficks first law of diffusion sraresrhar absorptionof a
substanceacrossbarriers is directly proportional to the
concentrationdifferenceacrossthat barrier.This law can
be representedby the equationJ=KpCv,where Kp is rhe
permeabilitycoefficientand Cv is rhe concenrrarionof rhe
drug in any given vehicle. However, the permeability
coefficientKp is a function of rhe partitlon coefficienrKm,
the diffusion coefficientD, and the length of the diffusion
p a thway L. T his e q u a ti o n m a y b e re w ri tten as
J=(DKm/L)Cv.Theoretically,the mechanismof action of
the SilkPeelsystemincreasesthe diffusion coefficientD
and may causethe dlffusion pathway L to approximate
zero, which createsthe potential for inflnite absorption.
Therefore,though the SiikPeelsysremadministersmedications in a solution form that is diluted, only small
quantitiesare required for increasedabsorption.Furthermore, the SilkPeelsystem minimizes the distancesthat
medicinal solutions have to travel. which makes it an
attractivevehicle.
Tiaditionai microdermabrasionuses the mechanics of
vacuum pressureand abrasives.Aluminum oxide microcrystalscommonly are used, but other types of substances
servethe samefunction. Theseinsoluble microcrystalsare
about I00 pm in size and are insrrumentalin the utility of
lhe system.]6-ro
Dependingon the circumstance.
patients
may receive fulI-thickness microdermabrasiontherapy
from the corneallayer to the basalcell layer.o10.20-22
This
can result in severalconsequencesif each epidermal layer
(specifically,
the spinous and basal cell layer) is affected.
The spinouslayeris rich in desmosomes,
and lossof cohesion between keratlnocyteswtll occur if abrasionis too
aggressive.
Spinouslayerdepletlonalsomll make the epidermis more prone to mechanrcalstresses.
Gap junctions
alsomay be affected,leadingto a lack of intercellularcommunication. The basal cell layer is seldom affected,but
when destroyed,terminal differentiationand signalingwill
not transpire,and abundant Langerhanscells will not execute adequateimmune surveillance.In addition, high
molecularweightmicrodermabrasion
particlesmay remain
dormant on the skin, causing granuloma formation and
eye changes,such as conjunctivitis,keratitis, and even
I
Excellent
I
cood
I
rait
I
Dissatisfied
Fi gure 6. P ercentage of pati ents rati ng thei r sati sfacti on a s
excellent, good, fair, or d issatisfied afer 12 weeks of bimonthly
SilkPeel'"treatments.
VOL.19 NO. I . JANUARY
2006. Cosmetic Dermatology
55
-
SrlxPmr Sysreu roR TReenNc Rosacsa
blindness. An unusual case of urticaria also has been attributable to the superficial exfoliation of the stratum
reportedas a resultof deepmicrodermabrasion.2r
corneum and the excellentdelivery of erythromycin to the
Rosacea
hasdeepdermalcomponenrs;thus,it is difficult deeperlevels of the epidermis and dermis. This combinato penetratethe stratumcorneumof patientswith rosacea tion discouragesinterferencewith the dermal vasculature,
using conventionalvehicleswithout harming the epider- while erythromycin theoretically inhibits angiogenic
mis. ct-Hydroxyacids (eg, low-percentage
glycolic acids) growth factorssuch as fibroblast growth factor-l, vascular
havebeen usedas keratolyticsbut commonly causeirrita- endothelialgrowth factor,and other cytokines.26
tion and may penetrateto the dermis.scr-Hydroxyacids
Overall patient satisfactionwith the SilkPeel system
dimlnish cellularcohesionat the lowestlevelsof the stra- was favorable.Only 5oloof patientswere dissatisfiedwith
tum corneum whereas B-hydroxy acids such as salicylic the overall results of the SilkPeelsystem.In facr, most
acid removelayer by layer from the outermost level down- patients preferred the SilkPeelsysremro rheir previous
ward.15Therefore,salicylicacid applicationscan produce rosaceatreatments.Compliancewas excellentbecausethe
favorable results for patients with sensltive skin such as procedurewas performedon-siteand resultedin minimal
thosewith rosacea.
downtime and no side effects.
Another advantageof salicylic acid is irs inherently
acidic nature, acidity malntainsbarrier homeostasis,
pro- CONCLUSION
motes differentiation,and hastensthe recoveryof kerat- Perhapsthe only limitation of the SilkPeelsystemis rrear2' Lower pH favorssequentialenzymaticsteps ing agedskin with multiple rhytides.
inocytes.2j
Looseor slack skin
that lead to the formation of mature stratum corneum. posesa dilemma becauseproper procedureis difficult to
Once SilkPeel treatments have strlpped rhe stratum perform in such cases.Treatmentsmay be cost-effective
corneum,salicylicacid may acceleraterecoveryof barrier long term, especiallyif patientscontinue to stay disease
function. Certai.nbacteria, including Propionibacteriuntfree during eachprocedure,as was the casein our study.
acneswhich has been shown to contribute to rhe signs The SilkPeelsystem ailows the operator to modify the
and symptoms of rosaceathrough direct invasion or by vacuum pressure,floq and choice of solutions. Future
galvanizing the inflammatory process, cannot thrive at trends are being investigatedfor alternative therapies,
low pH levels.
though principles of barrier function may offer a distincTopical erythromycrn has been show to act as an tive advantage.The SilkPeel system can be used as
antimicrobial and anti-inflammatoryagent in rhe treat- monotherapy for patients with erythematotelangiectatic
ment of rosacea.In a study by Mills and Kligman,2+ and papulopustularrosacea.
reduction of erythema and suppressionof papules and
pustules occurred in i3 of 15 parients (87ok) after Acknowledgment-We thanh Raul Hipolito Jor his help
4 weeks of twice-daily treatments with a combined with the photographsand t'or his continuedsupport oJ
2olosalicylic acid and 2o/oerythromycin solution. CIin- this worh.
damycin, tetracycllne, and sulfur solutions were not
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