Photographic standardization of dry skin

j. Soc.Cosmet. Chem.,35, 423-437 (December1984) Photographic standardization of dry skin j. c. SEITZ, R. L. RIZER, andT. S. SPENCER,Dermal Research D...
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j. Soc.Cosmet. Chem.,35, 423-437 (December1984)

Photographic standardization of dry skin j. c. SEITZ, R. L. RIZER, andT. S. SPENCER,Dermal Research Department, S. C. Johnson andSon,Inc., 1525 HoweStreet, Racine, WI 53403.

Received July 13, 1984. Presented at theSCCAnnualScientific Meeting,New York, December 1983. Synopsis

Photographic reference standards weredeveloped to visuallyquantitatechanges in scaling,cracking,and erythema, themajorvisiblesymptoms of dry, chapped skin.Thesestandards wereshownto bereasonably precise whenusedby threeindependent readers to gradea setof dryskinclinicalslides.A pairedcomparison of replicatescoresfor eachjudge showedeither no significantdifferences or singleisolateddifferences dependent on the familiarityof the readerwith the scale.Uniformityof scoringbetweenreaderswas evaluated by analysis of variance.No significant difference wasobserved betweenthe two readersmost familiarwith the scale.A third inexperienced readerdifferedin scoring.However,all scoringtrendsfor this readerweredirectionallyin agreementwith the moreexperienced readersusingthe samescale.The reference standards permitthe useof clinical35-mmslidesfor bothdocumentation andquantification of

dry skin.Additionally,thephotographic reference standards permitblinded,independent evaluations of dry skin by independent readerswith lesssubjectivebias.

INTRODUCTION

In clinicalstudiesof dry skin, a needexistsfor photographic reference standards that arereasonably precise,easyto use,consistent from readerto reader,andcandocument the relativeefficacyof varioustopicaltreatments(1). Currently,in vivoevaluations of dry skin involvea varietyof narrativeordinalscaleswith semi-quantitative worddescriptorsto definethe degreeof dry skin severity.Kantoret al. (2) use 1 to 9 point scalesto quantifyscaling,cracking,and erythema,while Stanfieldet al. (3) employa ten-pointscalecombiningscaling;cracking,anderythema.Earlierdescriptions of dry skin havebeenproposedby severalauthors,and their definitionsdemonstrate that dry skinmeansdifferentthingsto differentobservers (4-7). Basically,existingscales and descriptions of dry skinrelyon the subjective judgementof theclinician,firstto classify the disorder,and thento recallfrommemorythe full rangeof dry skinobserved across manydaysand manystudiesto evaluatethe performance of a product. In the presentstudy, a zero to 10 grading systemwas developedfor scalingand cracking,anda zeroto 4 gradingsystemfor erythema.Thesegradingsystems arebased on photographic reference standards representing a spectrum of normalto severely dry, chappedskin on the dorsalaspectof the hand. Three independent readerswerethen testedfor accuracy and reproducibility usingthe photoreference standards to gradea setof clinicalslidestakenduring recentdry skin studies. 423

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JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS

MATERIALS

AND

METHODS

SUBJECTS

One hundredtwenty-twofemalesubjects,ages21 to 60, who wereproneto develop dry skin on the handswerephotographed during a dry skin studyin Tucson,Arizona. A secondgroup of 161 femalesubjects,ages21 to 55, underwenta soapand water challenge(6 washingsper day for 1 week) to induceseverelydry, chappedskin on the handsduring a hand lotion efficacystudyin ChicagoHeights, Illinois. 35-mm

MACRO-PHOTOGRAPHY

OF THE

HANDS

A Nikon F3 camera with a Micro-Nikor 105-mm macro lens, motor drive, bulk back,

right angle view finder, and shutter cable releasewas inversetripod mountedand bubbleleveled.The camerawasadjustedto a height of 60 cm from the table top to the film plate mark on the camerabody.

Two Novatron334 strobes(Novatronof Dallas,Dallas,TX) weresetperpendicular to the cameraat a 30-degreeincident angle, 1.5 metersfrom the centerof the field of view. Fill lighting was accomplished with a third Novatronstrobeset perpendicular to the main strobesat a 30-degreeangle, 1 meter from the field of view. The strobes were interconnectedto the synchronization terminal on the cameraand were balanced to f/16 with a Minolta FlashMeter III. Subjects'handswere photographed againsta blackvelvetbackground on an 8-degreeincline(Figure1). KodakEktachrome64 film wasusedat a shutterspeedof 1/80 of a second(8). All photographicprocessing was

Figure 1. 35-mm cameraand lighting systemfor macro-photography of the hands.

PHOTOGRAPHIC

STANDARDS

FOR DRY

SKIN

425

donein-houseon a commercial KodakE-6 processor according to the KodakE-6 Process Manual.Test film stripswererun to assurethe correctcolorbalanceand densityfor the Ektachrome64 film. For the Chicagoand Tucsonstudiesall film wasdeveloped in onebatchto furtherreducethe possibilityof subtlechangesin colorbalance. DETERMINATION

OF PHOTOGRAPHIC

STANDARDS

Photographic standards wereselected by reviewingover 1000 slidestakenduringthe ChicagoHeightsand Tucsonstudies.The normaland mostseverecases of dry skin werearbitrarilyassigned scoresof 0 and 10 respectively. Intermediategradesof untreateddry skin were selectedby an iterativeprocedureinvolvingtwo independent readers.Setsof six slidesincludingthe normaland mostseverecaseswerescoredby eachreader.Averagedscores for intermediate slidesthat deviatedfroman idealspacing of 0, 2, 4, 6, 8, and 10 (erythema0, 1, 2, 3, and 4) werereplacedand the scoring procedure wasrepeated. The setof slidesfinallychosen, portraying a rangefromnormal to severely dry, chappedskinwith overtscaling,cracking,anderythema,elicitedthe most consistentgrading response (Figures2-18). READER

REPRODUCIBILITY

Singlereaderreproducibility with the photographic reference scalewastestedfor each of threejudges.Eachjudgescoreda set of 46 randomlysorted,blind encodedslides

162

Figure 2. Scaling--Grade 0.

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223 Figure 3. Scaling--Grade2.

230 Figure4. Scaling--Grade 4.

PHOTOGRAPHIC

•,8

I

STANDARDS

FOR DRY

SKIN

427

i,i

140 .. .

Figure 5. Scaling--Grade 6.

•,8

I

I

Figure 6. Scaling--Grade 8.

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271

Figure 7. Scaling--Grade 10.

231 Figure 8. Cracking--Grade 0.

PHOTOGRAPHIC

STANDARDS

FOR DRY SKIN

OLZ' Figure 9. Cracking--Grade 2.

/47 Figure 10. Cracking--Grade 4.

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252 Figure 11. Cracking--Grade 6.

137 Figure 12. Cracking--Grade8.

PHOTOGRAPHIC

STANDARDS

FOR DRY SKIN

431

282 Figure 13. Cracking--Grade 10.

65

Figure 14. Erythema--Grade0.

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35

Figure 15. Erythema--Grade 1.

Figure 16. Erythema--Grade2

PHOTOGRAPHIC

STANDARDS

FOR DRY SKIN

Figure 17. Erythema--Grade 3.

•8

I

it

172 Figure 18. Erythema--Grade 4.

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taken from the Tucsonand ChicagoHeights studies.These test slideswere viewed side-by-sidewith the photographicstandards on Kodak 5600 projectorswith 102-mm Ektanar C lenses. The identical slides were resorted and rescored between one and three

dayslater. The replicatescoresfor eachjudgewereevaluatedby pairedcomparison. READER

UNIFORMITY

Multiple readeruniformity with the photographicreferencescalewas testedby an analysisof variancecomparingthe samethreejudges'scoringof an identicalsetof 46 slides(23 subjects).

RESULTS

A pairedcomparisonof scoresfor eachof the 3 readersshowedno significantdifferences betweenreadingpasses for Reader1, who wasthe mostfamiliarwith the photoscales. Isolatedsignificantdifferences wereobserved for Reader2, whohadminimalexperience scoringslideswith the scale(pass1 vs pass2 for crackingon slidesof the right hands), and Reader3, with no previousexperience(pass1 vs pass2 for scalingon slidesof the left hands) (Table I).

No significantdifferences werefoundbetweenReaders1 and 2, who weremostfamiliar with the scales.The newand inexperienced Reader,number3, showeda widervariance on all scales.Figures19-21 showthe meanscoresfor eachreaderplotted againstthe total numberof subjects.A wide rangeof dry skin conditionswererepresented in the slide set as shownby the wide fluctuationsin the curves.

DISCUSSION

The clinicalevaluationof dry skinrequiresquantitative,objectivetechniques to describe the visualassessments of the investigator.Until recently,however,investigators have offeredno explicit definitionof dry skin which will improvethe validity and reproducibilityof bioefficacytesting.The photographic reference standards help to visually

Table

I

Photographic Scores? of Dry Skin for ThreeIndependent Readers Reader

Scaling Pass 1

1 2

3

Pass 2

Cracking Pass 1

Pass 2

Erythema Pass 1

2.7

Right 3.3ñ 1.6 3.6ñ 1.6 2.5ñ 1.9 2.8ñ 2.0* 2.9 - 1.1

2.9 2.9

ñ ñ

1.2 1.3

Right3.7 + 2.5 3.7 ñ 2.6 2.2 3.0ñ 3.0 2.7 + 2.4 2.8 4. 1.1 3.1 4. 2.0 3.7 4. 2.1' ___2.6 2.0 ñ 1.7 3.0 ñ 1.3

2.9 ñ 3.1ñ

1.0 1.0

Left Left

3.4 ñ 1.2 3.1 ñ 1.5

3.4 ñ 1.2

3.4 ñ 1.7

2.9 -

1.2

2.1 ñ 1.5

2.9 ñ 1.2

2.2 ñ 1.4

2.9 4- 1.2

2.9 ñ 1.2

Left

? = Mean ___standard deviation.

* = Significantdifferenceby pairedcomparison betweenreadingpasses (c• < 0.05). n = 46.

Pass 2

Right 3.6- 1.8 3.6- 1.8 3.3- 1.7 3.3- 1.8 2.7ñ 1.2

4. 1.2

2.9ñ

1.1

PHOTOGRAPHIC

STANDARDS FOR DRY SKIN

435

5-

t

2

2



5

6

7

8

9

t0

tt

SUBJECT

AVERAGE

READER

t2

t2

t•

t5

t6

t7

t8

NUMBER

SCORES

t9

20

2t

22

22

•READER 1 0 READER 2 --&-READER 3

Figure 19. Parallelismof readerscoringof scaling.

5-

SUBJECT AVERAGE

READEP

NUMBER

SCORES

Figure 20. Parallelismof readerscoringof cracking.

• 0 --&--

READER READER 2 READER 3

2•

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JOURNAL OF THE SOCIETY OF COSMETICCHEMISTS

0 ..• t

2

3

•• 5

6

7

8

9

•0

tt

t2

t3

•' •

•5

t8

t7

•8

t9

SUBaECT NUMBER

AVERAGEREADER SCORES

20

U 0

--&--

2t

22

23

2•

READER • READER 2

READER3

Figure 21. Parallelismof readerscoringof erythema.

quantitate changes in scaling, cracking, anderythema, thesymptoms ofdry,chapped skin.

The gradingsystem, anchored to photographic reference standards, wasconsistent within and betweenreaders.Reader 1, who was thoroughlyfamiliar with the photo

reference standards, demonstrated the bestreproducibility onsuccessive readingpasses. Readers 2 and3, with minimalor no previous experience, wereableto achieve good

reproducibility on repeated reading passes usingthephotographic scales. Although Reader 3 exhibited thehighest variation between readers, thescores weredirectionally correct overall subjects compared to Readers 1 and2. Theresults fromReaders 2 and 3 suggest thatsometrainingandfamiliarization withthescales arerequired. In summary, photographic reference standards provide a visualdefinition of scaling, cracking, anderythema. These standards permittheuseof clinical slides forboth documentation andquantification of a subject's dryskinstatus throughout thecourse of treatment. Moreover, photoreference standards permitblinded,independent evaluations of dry skinby independent readers with lesssubjective bias.Finally,these

photographic reference standards should provide a valuable teaching aidforclinicians andinvestigators whostudythesymptomatology ofvarious levels ofdryskin.

ACKNOWLEDGEMENT

The authorsthankDr. HarrySmith,Jr. for statistical advice.

PHOTOGRAPHIC

STANDARDS FOR DRY SKIN

437

REFERENCES

(1) C. H. Cook, R. L. Centher,and S. E. Michaels,An achegradingmethodusingphotographic standards,Arch. Dermatol.,115, 571-575 (May 1979). (2) I. Kantor, W. G. Ballinger,and R. C. Savin,Severelydry skin: Clinicalevaluationof a highly effectivetherapeutic lotion, Cutis,30, 410-424 (September 1982). (3) J. W. Stanfield, J. Levy,A. A. Kyriakopoulos, andP.M. Waldman,A newtechnique forevaluating bath oil in the treatmentof dry skin, Cutis,28, 458-460 (October1981).

(4) M. E. Chernosky, Clinicalaspects of dryskin,J. Soc.Cosmet. Chem.,27, 365-376 (August1976). (5) F. DanielsandJ. C. van der Leun, Problemsin quantifyingskin reactions, Arch.Derre.,97, 553565 (May 1968). (6) A.M. Kligman,Regression methodforassaying theefficacy of moisturizers, Cosmet. andTodet.,93, 27-35 (April 1978).

(7) T. B. Fitzpatrick,"Fundamentals of Dermatologic Diagnosis,"in Dermatology in General Medicine, 2nd ed., T. B. Fitzpatrick,A. Z. Eisen, K. Wolff, I. M. Freedberg,and K. F. Austin, Eds. (McGraw-Hill, New York, 1979), Part Two, pp 10-37.

(8) ClinicalPhotography, PublicationNumberN-3, (EastmanKodakCo., Rochester, New York, 1972), pp 21-64.

Editor'sNote:The authorswishto notethat colorreproduction of standards mightbe affected by mechanical reproduction andby the paperusedin printing.

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