P6261The burden imposed by atopic dermatitis on families: Creation of aspecific questionnaire

Cecile Meni, MD, Dermatologyst, Boulogne Billancourt, France; Antoine Toulon,MD, Hopital Necker, Paris, France; Charles-Remy Taieb, MD, MBA, CREES PFSA,Boulogne Billancourt, France; Christine Bodemer, MD, Hopital Necker, Paris,France; St�ephanie Merhand, PhD, French Eczema Association, Nantes, France

Background: The notion of individual burden, associated with the disease, has beenintroduced recently to determine the ‘‘disability’’ caused by the pathology in thebroadest sense of the word (psychological, social, economic, physical).

Methods: The ABS questionnaire (Atopy Burden Score Q) consists of 19 items,structured around 5 components. It was distributed to a random sample of familiesconsulting at the Necker Hospital, staying at the Av�ene Hydrotherapy Center, andmembers of the patient association. The ABS was accompanied by SF12 and PGWBI,to confirm internal and external validation, and by the PO-SCORAD to assess thelevel of severity.

Results: 58 Q were considered evaluable. 51% of the atopic children were girls. ThePO-SCORAD established the level of severity of the AD: 14%, 50% and 36% ofchildren had mild, moderate or severe AD respectively. Internal validity wasmeasured by Cronbach’s alpha, which is equal to 0.81, reflecting a good homoge-neity of the 19 items. The mean PGWBI score is 51.826 14.28. The score reflectingthe most important deterioration is found among parents of children with severeatopy. In contrast, the scores associated with moderate and mild atopy are notcorrelated with severity. Families’ QoL, measured using the SF12, revealed nodeterioration in the physical component. The ABS score is correlatedwith the scoresof the Q used, thus confirming external validity. The mean score calculated from theABS is 48.176 18.36. The score increases with the severity of the AD. A statisticallysignificant difference is observed between the 3 severity groups (ie, mild, moderateand severe), with scores of 30.63 6 10.89, 42.55 6 15.72, and 62.62 6 13.59,respectively. Each of the 5 components is also correlated with the severity of AD,which opens the door for more detailed analyses of sensitivity to change.

Discussion: The internal and external validity of our Q were confirmed. ABS iscorrelated with the severity of AD. Hence, we have a short, easy-to-use, validatedtool for assessing the burden imposed by atopy on families. It is now necessary toevaluate the correlation between this burden and treatment. This is currently beingdone as part of a program aimed at evaluating the therapeutic education andtreatment of children in hydrotherapy centers. Following cultural and linguisticvalidation, the ABS is now available in US English, Spanish, German and Italian.

APRIL 20

onsored by Eau Thermale Avene.

45% is sp

P6610Use of in vitro methods to quantify the ability of moisturizing products tohydrate skin and provide a water vapor barrier: Development of amoisturization index for persons with atopic dermatitis

Anthony Geonnotti, PhD, Johnson & Johnson Consumer Companies, Inc,Skillman, NJ, United States; Armando R. Garcia, Surface Measurement Systems,Ltd., Allentown, PA, United States; Daniel Burnett, PhD, Surface MeasurementSystems, Ltd., Allentown, PA, United States; Julie Hirsch, PhD, Johnson &Johnson Consumer Companies, Inc, Skillman, NJ, United States; MichaelMoeller, MS, PhD, EMD Millipore Corporation, Danvers, MA, United States;Pablo Crespo Bosque, Johnson & Johnson Consumer Companies, Inc, Skillman,NJ, United States; Robert Yates, Johnson & Johnson Consumer Companies, Inc,Skillman, NJ, United States

Topical moisturizing products aim to restore compromised skin by augmenting itsnatural water content and barrier properties. In theory, products that restoreoptimal hydration and resist moisture loss will facilitate the natural processes of skinregeneration and repair. These products are especially useful in patients who sufferfrom atopic dermatitis or other skin barrier disruptions. However, traditionalmethods to assess the moisturizing and barrier ability of commercial lotions, such astransepidermal water loss (TEWL), are highly variable and require the recruitment ofhuman volunteers. To address these concerns, we have created objective, instru-mental methods to measure a formulation’s ability to increase and stabilize the waterconcentration within the stratum corneum. We tested 6 commercially availablemoisturizing lotions commonly used by patients with atopic dermatitis. Sorptionisothermswere used to quantify the humectancy, or water affinity, of formulations atbiologically relevant environmental conditions. Tested products showed significantand substantial differences in their ability to mimic the skin’s natural moisturizingfactors to increase and stabilize water content at physiologic temperature andhumidity levels. For example, a colloidal oatmeal cream was able to absorb over 12times the amount of water as a popular anhydrous ointment. Products with higherwater affinities can increase the water content of the stratum corneum by a greateramount and resist water loss for longer lengths of time. Additionally, we quantifiedthe ability of a thin (200 micron) layer of each product to block water vaportransport through a novel synthetic membrane optimized to mimic the permeabilityof human skin. All products provided a partial barrier to water loss; however, therewere significant differences in water flux reduction rates, ranging from 25% to 95%.Even slight increases of the skin’s barrier will increase tissue hydration and create anenvironment conducive to tissue repair. Testing resulted in a unique ‘moisturizationindex’ for each lotion. To be maximally effective, topical treatment products shouldoptimize both modes of skin hydration while maintaining acceptable user aes-thetics. These new biophysical measurements will enable the creation of superiorproducts for the treatment of atopic dermatitis, as well as provide clinicians andconsumers with objective information to compare products.

ponsored by Johnson & Johnson Consumer Companies, Inc.

100% is s

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DERMATITIS, CONTACT, ALLERGIC AND IRRITANT

P6044A global patch test grader training program

Jeffrey Berg, Hill Top Research, St. Petersburg, FL, United States; James Bowman,MS, Hill Top Research, St. Petersburg, FL, United States; Micah Humphrey, HillTop Research, St. Petersburg, FL, United States; Robert Harper, PhD, Hill TopResearch, St. Petersburg, FL, United States

Patch testing is the fundamental methodology and standard for assessing humancutaneous irritation and sensitization. The principal evaluation tool for skinresponses is visual assessment by a trained evaluator. Therefore, it is essential toestablish accuracy and reproducibility of skin patch test graders involved in skingrading at multiple sites. The training program involved 13 graders from Canada,United States, and India. A dermatologist provided medical insight into theobserved reactions. This was a single center, grader-blinded, randomized study in33 healthy male and female subjects 18 to 65 years of age with Fitzpatrick skintypes I to VI. Ten patches were applied to subjects’ backs for 24 hours perapplication for 4 consecutive days. Patches contained surfactants known to elicitskin responses, along with a low irritancy control. On days 2 to 4, subjectsreturned to the test facility, had patches removed, sites evaluated and a fresh setof patches applied. Day 5, the last day of the program, consisted of graderevaluations of each subject. The scoring scale used was one that is commonlyused for scoring Human Repeat Insult Patch Tests. More than 600 individualpatch site reactions were used in the analysis, and 1 evaluator served as themaster grader for analysis purposes. Friedman rank sum analyses showed that allgraders ordered the test materials the same, from the least irritating to the mostirritating. The results of the multiple comparison test indicated similar productdifferentiation for all graders. Additional analyses consisted of correlation, percentagreement and kappa comparing each evaluator to the master grader. Allcorrelation coefficients were [0.75, all kappa scores were [0.6 and percentagreements ranged from 67% to 73%. Evaluators scored each test site twice andanalyses were conducted to evaluate the repeatability of each patch grader. Forthese analyses the correlation coefficients were [0.8, with most being over 0.9,all kappa scores were[0.7 and percent agreements ranged from 77% to 88%. Weconclude that this exercise provides an excellent training mechanism and servesas a continuing education and certification process for skin irritation graders. Theresults of this training session provide reassurance to investigators, sponsors, andregulatory authorities worldwide that consistent and reproducible data will begenerated from patch test drug trials using skin graders certified using thisprogram.

cial support: None identified.

Commer

P7098Alitretinoin: A new systemic treatment in the management of chronichand eczema

Antonella Tammaro, Sant’Andrea Hospital, Rome, Italy; Angelo MassimilianoD’Erme, University of Florence, Florence, Italy; Gabriella De Marco, Sant’AndreaHospital, Rome, Italy; Massimo Gola, University of Florence, Florence, Italy;Nicola Milanesi, University of Florence, Florence, Italy; Severino Persechino,Sant’Andrea Hospital, Rome, Italy

Background: Hand eczema is an inflammatory skin condition caused by theconcurrence of endogenous and exogenous factors in predisposing patients. Thisdermatitis shows an high prevalence (12% in Europe, and 16% in the USA). Clinicalmanifestations are characterized by erythema, vesicles, papules, and oedema in theacute phase; in the chronic one the main features are lichenification and hyper-cheratosis. First line therapies in hand eczema are usually topical treatments but, inpatients with chronic course of this dermatitis, systemic therapies are necessary.Oral alitretinoin is the only endogenous retinoid approved for the treatment ofchronic hand eczema . The aim of our study was to evaluate the efficacy andtolerability of this new drug in the treatment of chronic severe hand eczema.

Methods: We enrolled 30 patients of both sexes and aged between 30 and 65 yearsaffected by chronic severe hand eczema (evaluated by PGA Score- Physician’s GlobalAssessment) unresponsive to topical corticosteroids therapies. Each patient wasadministered with oral alitretinoin 30 mg daily for a period of 4 months, assessingthe efficacy and tolerability of this treatment with monthly control visits, evaluationof PGA score and routine blood test to exclude adverse effects (hyperlipidemia,hypertransaminasemia, low TSH levels). Patientswere considered responders if theywere rated as ‘‘clear’’ or ‘‘almost clear’’ on PGA score at the end of treatment.

Results: On the total of 30 patients, 28 cases obtained a great improvement of thecutaneous lesions, rating as clear or almost clear on PGA score, without significantadverse effects except for mild headache at the beginning of the treatment. Only 2patients had to reduce the dosage of alitretinoin from 30mg to 10 mg daily forincreased cholesterol and triglycerides levels.

Discussion: Chronic hand eczema is an invalidant pathology causing a reduction ofquality of life and important limitations for the daily activities. The data of our studyabout therapy with oral alitretinoin show the efficacy of this new molecule not onlyin the improving of cutaneous lesions but also in the prevention of the eczemarelapses.

cial support: None identified.

Commer

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