P6662Treatment of cutaneous dystrophic calcification with intralesional sodiumthiosulfate

Ryan Arakaki, Harvard Medical School, Boston, MA, United States; DanielaKroshinsky, MD, MPH, Massachusetts General Hospital, Department ofDermatology, Boston, MA, United States

Sodium thiosulfate is a medication that has traditionally been used intravenouslyfor the treatment of cyanide poisoning and the prevention of neurotoxicity fromchemotherapy. In 2004, the use of sodium thiosulfate was first published for thetreatment of calciphylaxis and its use since this time has gradually become morewidespread, with approximately 40 cases of calciphylaxis treated with intrave-nous sodium thiosulfate published in the literature. The mechanism of action forthis medication is currently unknown, but current hypotheses include a combi-nation of enhancement of calcium solubility, calcium chelation, neutralization ofreactive oxygen species, and increased production of hydrogen sulfide which is amolecule with known vasodilatory and antiinflammatory effects. Sodium thiosul-fate is not without risks, as hypotension, gastrointestinal intolerance, andmetabolic acidosis are known to occur with intravenous administration. Thereis also a concern for patients developing osteoporosis when receiving extendedtreatment courses of this medication. Given the systemic side effects of thismedication, a method of locally administering the medication could be of benefit.Case reports in the literature have documented the use of sodium thiosulfate as atopical treatment for calcified lesions, usually requiring 12 to 15 weeks forimprovement. Based on the reports of the topical use of this medication, weevaluated the use of sodium thiosulfate as an intralesional injection. We reporthere the intralesional administration of sodium thiosulfate mixed with normalsaline for dystrophic calcifications secondary to dermatomyositis. The patient wasa 72-year-old man with a history of dermatomyositis who had developed painfulcalcified subcutaneous nodules over the area of his sacrum bilaterally. The patientwas treated with 3 rounds of intralesional sodium thiosulfate at a concentrationof 250 mg/mL to lesions only on one side. After 3 weeks, a decrease in theamount of induration and pain on the injected side was noted. In addition toimprovement that was noted clinically, there was also a decrease in the extent ofsubcutaneous calcification on the treated side noted on follow-up radiographicstudies.

APRIL 20

cial support: None identified.

Commer

DERMATITIS, ATOPIC

P6654A colloidal oatmeal OTC cream is as clinically effective as a prescriptionbarrier repair cream for the management of mild to moderate atopicdermatitis in African American children

Christopher Nunez, PhD, Johnson & Johnson Consumer Companies, Inc, MorrisPlains, NJ, United States; Daniel Hogan, MD, Hill Top Research, St. Petersburg, FL,United States; Micah Humphrey, Hill Top Research, St. Petersburg, FL, UnitedStates; Paul Zhang, PhD, Johnson & Johnson Consumer Companies, MorrisPlains, NJ, United States; ToniAnne Lisante, Johnson & Johnson ConsumerCompanies, Morris Plains, NJ, United States; Uday Doshi, PhD, Johnson &Johnson Consumer Companies, Morris Plains, NJ, United States

Background: Atopic dermatitis (AD) is a chronic inflammatory skin conditioncharacterized by intense pruritus. AD affects approximately 10% of children in thegeneral population with a higher prevalence observed in African American (AA)children (Shaw et al). Previous studies suggest that AAs are more likely to seekmedical care for AD management and thus could benefit from education on cost-effective approaches for treating mild to moderate AD (Janumpally et al). The recentformulation of an over-the-counter cream (colloidal oatmeal) presents a novelapproach for addressing this dermatological condition.

Methods: As part of a larger trial examining the efficacy and safety of colloidaloatmeal, this investigation studied 49 AA children, ranging from 2 to 15 years of agewith mild to moderate AD. Patients were randomly assigned to colloidal oatmeal or aprescription barrier repair cream (BRC) and were instructed to use assignedproducts twice daily or as needed for 3 weeks. Assessments of AD severity andimprovement were made by the investigator using the Eczema Area and SeverityIndex (EASI) at baseline and days 7, 14, and 21. Subjective assessment of itch wasmade via questionnaires at each time point using a 10 point scale (1 ¼ very itchy,10 ¼ not itchy at all).

Results: Based on the analyses of the change from baseline in EASI scores at day 21,colloidal oatmeal and BRC performed clinically equivalent, with the 95% CI of thetreatment difference reported as [-0.37, 0.69]. Colloidal oatmeal did provide rapidimprovement in AD symptoms by day 7 (% change from baseline in EASI: 62.9% vs53.7% for BRC and subjective ratings of itch by day 7 (% change from baseline in itch:43.1 % vs 33.3% for BRC). Both treatments were well tolerated in the study.

Conclusion: The results from this investigation suggest that colloidal oatmeal was atleast as effective as BRC and provided rapid improvement in AD symptoms by day 7based on Investigator and subjective assessments. Colloidal oatmeal cream provideda safe, cost-effective OTC treatment approach for managing mild to moderate AD inthe population studied.

y was sponsored by Johnson & Johnson Consumer Companies,

This stud Inc.

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P6980A new methodology to map the relative mildness potential of personalcleansing products

Min Liu, Unilever R&D, Trumbull, CT, United States; Diana Marrero, UnileverR&D, Trumbull, CT, United States; Heather McGuiness, Unilever R&D, Trumbull,CT, United States; K. P. Ananthapadmanabhan, Unilever R&D, Trumbull, CT,United States; Leonel-Maximo Mollica, Unilever R&D, Trumbull, CT, UnitedStates; Shuliang Zhang, Unilever R&D, Trumbull, CT, United States; VasuVasudevan, Unilever R&D, Trumbull, CT, United States

Assessment of a large number of personal cleanser products by high throughputmethods is desirable for product optimization, particularly as ultramild cleansersnow contain a variety of factors important for mildness (eg, mild surfactants,emollients, and humectants, etc). Traditional approaches to measure irritationpotential of personal cleansing products include squamometry (SQM) and corneo-surfametry (CSM). SQM is a technique where the outer layers of the stratumcorneum (SC) are treated with products, collected, and treated via a dye stainingprocess. Samples are then measured by colorimetric assessment to determinerelative amounts of corneocytes released from skin. CSM relies on the collection ofoutler layers of (SC) with cyanoacrylate tape strips. Samples are incubated in thetreatment solution, rinsed and then stained using dyed and analyzed to predict therelative mildness via measuring the dye substantivity. A new methodology, ormodified corneomsurfametry (MCSM) has been developed that combines the CSMcollection procedure and the SQM treatment principles to deliver a high throughputex vivo screening methodology to map the relative technical mildness of personalcleansing products. The relative ranking of products using the modified CSM showsgood correlation to in vivo clinical mildness performance. The method differs fromSQM and CSM in that the ex vivo treatment time is reduced to 10 minutes and thetreatment and analysis are carried out in a 96-plate well format. The MCSM methodhas been validated by using a range of surfactants, which have been tested in both invitro protein and lipid damage tests and in in vivo clinical studies. Results clearlydemonstrate the potential of the new MCSM technique as a rapid assessment of therelative mildness of full formulated systems.

ponsored by Unilever.

100% is s

P6999A validation of a novel technology in body wash for consumer preferredsensories with ultramild surfactants and effective skin conditioning

Leonel-Maximo Mollica, Unilever R&D, Trumbull, CT, United States; Jamie Miller,Unilever R&D, Trumbull, CT, United States; Jamie Regan, Unilever R&D,Trumbull, CT, United States; Kathryn Vetro, Unilever R&D, Trumbull, CT,United States; Shuliang Zhang, Unilever R&D, Trumbull, CT, United States;Vasu Vasudevan, Unilever R&D, Trumbull, CT, United States

Mild personal liquid cleansing products can be broadly segmented into 2 body washcategories: mild products with relatively low skin conditioning benefits, and harshsurfactant systems with high skin conditioning benefits. Milder body washes,particularly those with high levels of emollients/occlusives, do not always haveoptimal consumer-desired sensory properties, in particular lather and clean rinse.Our research has identified that adding an ultramild amino acidebased surfactantpreviously used in facial cleansing, specifically acyl-glycinates can improve both themildness and sensory properties in a body wash simultaneously. The mildness of thenew cleanser system has been evaluated in a number of in vitro protein and lipiddamage assessment tests, and in vivo clinical studies such as the standard forearmcontrolled application test (FCAT) and leg controlled application tests (LCAT). Invitro assessment shows that the acyl glycinate surfactant is mild towards bothproteins and lipids, unlike other standard body wash surfactants, which test as mildin only 1 of the 2 SC components (protein or lipid). Tests with fully formulatedsystems show that introduction of the new amino acidebased surfactant improvesmildness as measured by a modified corneosurfametry method, as well as thestandard clinical methods. Consumer testing of the prototypes shows that the abovechanges also result in enhancements in both sensory and consumer perceivedmoisturized feel.

ponsored by Unilever R&D.

100% is s

J AM ACAD DERMATOL AB73