Efficacy and safety of a natural cream-to-powder formulation on diaper-wearing infants and children

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P7948 Diffuse erythrodermic eczematous dermatitis secondary to subcutaneous insulin treatment Ashley De La Cerda, MD, Scott and White Department of Dermatology, Temple, TX, United States Diabetes mellitus has become a national epidemic, with [26 million Americans affected. Most patients are managed with subcutaneous insulin replacement therapy or oral hypoglycemics. There are numerous cutaneous manifestations of the disease and cutaneous side effects to the medications used to treat it. We report a rare case of a patient who developed a diffuse, pruritic erythematous scaly eruption 2 months after beginning subcutaneous insulin therapy with insulin glargine and insulin lispro. Multiple tissue biopsies were consistent with an eczematous drug eruption. The dermatitis cleared over weeks with discontinuation of the insulin, only to reappear with subsequent administration during hospital admissions. Upon review of the literature, there have been 2 previously reported cases of a delayed type IV hypersensitivity drug eruption secondary to preservatives found in subcutaneous insulin. Patch testing to the components in the insulin can confirm the diagnosis. It is important to consider insulin as a culprit for erythroderma, because it is often overlooked in patients on numerous medications and there are insulin preparations available without the possible offending preservatives. Commercial support: None identified. P8634 Effect of pseudoceramide cream on irritant hand dermatitis in health care workers Marty O. Visscher, PhD, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, United States; Andrew DiMuzio, Kao, USA InC, Cincinnati, OH, United States; Jennifer Jones, Cincinnati Children’s Hospital, Cincinnati, OH, United States; Lisa Adams, Kao Usa Inc, Cincinnati, OH, United States; Ward Billhimer, MS, Kao USA, INC, Cincinnati, OH, United States Routine hand hygiene reduces hospital acquired infections. However, repetitive hand hygiene is a significant factor in the development of irritant contact dermatitis in health care workers (HCW). Damaged hands have higher bacterial counts and increased susceptibility for penetration by irritants and microorganisms. Maintenance of skin integrity is important for patients and workers. The objective was to determine the effects on hand skin condition of a pseudoceramide test cream, designed for moisture barrier repair and substantivity, relative to the hospital provided lotion among intensive care HCWs in a monitored use study. Sixty-three subjects participated in the randomized controlled parallel group trial. Assignment of the test cream or hospital lotion was stratified by baseline knuckle dryness scores; application was 33 daily. The primary outcome was skin condition measured as expert visual scoring of dryness and erythema, digital imaging and analysis, stratum corneum integrity (TEWL), and skin hydration (capacitance) after 1, 2, and 4 weeks. Data were analyzed using linear mixed models with repeated measures. There was significant irritant dermatitis at baseline as over 60% of HCWs had knuckle dryness and erythema scores of 2. After 4 weeks, hands treated with the test cream were significantly less dry and irritated versus the hospital lotion as well as lower dryness on the knuckles and dorsum of both hands (P \.05) and as lower erythema on the knuckles of both hands and the left dorsum (P \.05). Skin treated with the test cream had a more competent stratum corneum barrier, than that of the hospital lotion group (P \.05) as evidenced by lower TEWL. For the test cream and hospital lotion, respectively, TEWL values were 26.2 and 21.6 g/m 2 /hr at baseline and 21.6 and 25.6 g/m 2 /hr at week 4. Hand skin of the test cream group was more hydrated than the hospital lotion group, as evidenced by higher Corneometer readings, for both dorsum and the left hand knuckles (P \.05). Mean daily usages were 4.5 and 4.8 times for test and hospital lotion, respectively. In addition, application of the highly substantive test cream 4-5 times daily significantly reduced the severity of irritant contact dermatitis in HCWs. Subjects reported the test cream as protective and moisturizing, characteristics that likely impact compliance. Supported by Kao USA, Inc. P8311 Efficacy and safety of a natural cream-to-powder formulation on diaper-wearing infants and children Hemali Gunt, PhD, MS, Burt’s Bees Inc, Durham, NC, United States; Abena Antwi, Burt’s Bees Inc, Durham, NC, United States; Celeste Lutrario, Burt’s Bees Inc, Durham, NC, United States; Stanley Levy, MD, Chapel Hill Dermatology, Chapel Hill, NC, United States Background: The SC’s function is to reduce water loss, repel water, protect deeper layers of the skin from injury, and from microbial infections. In infants, this layer of the skin is much thinner and more easily disrupted. Diaper rash or irritant diaper dermatitis develops when skin is exposed to prolonged moisture, increased skin pH caused by urine and feces, and intertriginous occlusion, resulting in breakdown of the SC. Hence, any treatment that keeps the skin surface dry helps alleviate this condition. Most common remedies include moisture-absorbing powders, such as talc, or barrier creams blocking moisture from reaching the skin. A natural skin barrier cream was developed that keeps the skin dry and provides moisture protection. Objective: To evaluate the safety and efficacy of a natural cream-to-powder formulation in diaper wearing infants and children. Methods: A 4-week use safety and efficacy study was conducted on 53 diaper- wearing subjects ranging in ages from 2 months to 3 years. Erythema, dryness, and edema were evaluate and clinical graded by a pediatrician at baseline and after 4 weeks of product use. In a separate panel of 20 adult females, wetness protection was evaluated in vivo using dye exclusion method. The test product was applied to volar forearm, followed by dye application and skin staining evaluation. Results: The 4-week use safety and efficacy study showed that the natural cream-to- powder formulation did not cause any irritation or sensitization on pediatric subjects. Dye exclusion revealed significant barrier against wetness on adult forearms. Conclusion: The natural cream-to-powder formulation was proven to be safe in pediatric subjects. The dye exclusion method was able to demonstrate the wetness protection property of the natural cream-to-powder formulation. Sponsored 100% by Burt’s Bees Inc. P8496 Impact of co/cross-reactants on available alternative hair dyes in p-phenylenediamine allergic patients Gurbir Dhadwal, MD, Department of Dermatology and Skin Science, University of British Columbia, Vancouver, Canada; Gillian de Gannes, MD, Department of Dermatology and Skin Science, University of British Columbia, Vancouver, Canada Background: P-phenylenediamine (PPD) is a common component of permanent and semipermanent hair dyes. However, it is also a common allergic contact allergen. Published rates of sensitization to PPD, amongst patients presenting for patch testing, range between 2% and 12%. Given the rates of sensitization, hair dyes containing alternatives to PPD have been developed. Here we attempt to determine if co/cross-reactants found in these alternative hair dyes will limit their use by PPD allergic patients. Methods: We retrospectively reviewed all patch test results of patients presenting to the Vancouver Patch Test Clinic between November 2008 and June 2013. All patients were tested to the North American Contact Dermatitis Group standard screening series and other standard sets of allergens as clinically indicated, such as a hairdressing tray. Data was collected for all positive reactions to PPD and those results were further analyzed to find all co/cross-reactants. The American Contact Dermatitis Contact Allergen Management Program (CAMP) database was then queried with PPD along with each of the most common co/cross reactants for available hair dyes without those ingredients. Results: 1319 patch tests were performed during the study period. 95 patients were found to be patch test positive to PPD. Of those 95 patients, 74 (78%) had at least 1 other positive reaction. The 10 most common co/cross reactants were nickel (31%), ammonium persulfate (23%), cobalt (ii) chloride hexahydrate (20%), p-toluenedi- amine sulfate (19%), 4-aminophenol (18%), fragrance mix 1 (15%), toluenediamine base (12%), fragrance mix 2 (9%), myroxylon pereirae resin (9%) and glyceryl thioglycolate (9%). The CAMP database contained 180 PPD-free dyes. Nickel, cobalt, ammonium persulfate, or glycerly thioglycolate were not found to be components of the PPD-free dyes. Cross-reacting to 4-aminophenol restricted available dyes to 52. Cross reacting to toluenediamine compounds restricted the available dyes to 19, none of which were dark in color. Positivity to any of the fragrances restricted the availability to 1 nonpermanent dye. Conclusions: Patients who are allergic to PPD are commonly allergic to other chemicals. Patients that are PPD allergic and also react to toluenediamine or fragrances are severely restricted in their choice of hair dye. The clinic relevance of fragrance allergy in patients wishing to dye their hair is unclear and likely warrants additional investigation. Commercial support: None identified. AB68 JAM ACAD DERMATOL MAY 2014

Transcript of Efficacy and safety of a natural cream-to-powder formulation on diaper-wearing infants and children

Page 1: Efficacy and safety of a natural cream-to-powder formulation on diaper-wearing infants and children

P7948Diffuse erythrodermic eczematous dermatitis secondary to subcutaneousinsulin treatment

Ashley De La Cerda, MD, Scott and White Department of Dermatology, Temple,TX, United States

Diabetes mellitus has become a national epidemic, with [26 million Americansaffected. Most patients aremanagedwith subcutaneous insulin replacement therapyor oral hypoglycemics. There are numerous cutaneous manifestations of the diseaseand cutaneous side effects to themedications used to treat it.We report a rare case ofa patient who developed a diffuse, pruritic erythematous scaly eruption 2 monthsafter beginning subcutaneous insulin therapy with insulin glargine and insulinlispro. Multiple tissue biopsies were consistent with an eczematous drug eruption.The dermatitis cleared over weeks with discontinuation of the insulin, only toreappear with subsequent administration during hospital admissions. Upon reviewof the literature, there have been 2 previously reported cases of a delayed type IVhypersensitivity drug eruption secondary to preservatives found in subcutaneousinsulin. Patch testing to the components in the insulin can confirm the diagnosis. Itis important to consider insulin as a culprit for erythroderma, because it is oftenoverlooked in patients on numerous medications and there are insulin preparationsavailable without the possible offending preservatives.

AB68

cial support: None identified.

Commer

P8634Effect of pseudoceramide cream on irritant hand dermatitis in health careworkers

Marty O. Visscher, PhD, Cincinnati Children’s Hospital Medical Center,Cincinnati, OH, United States; Andrew DiMuzio, Kao, USA InC, Cincinnati, OH,United States; Jennifer Jones, Cincinnati Children’s Hospital, Cincinnati, OH,United States; Lisa Adams, Kao Usa Inc, Cincinnati, OH, United States; WardBillhimer, MS, Kao USA, INC, Cincinnati, OH, United States

Routine hand hygiene reduces hospital acquired infections. However, repetitivehand hygiene is a significant factor in the development of irritant contact dermatitisin health care workers (HCW). Damaged hands have higher bacterial counts andincreased susceptibility for penetration by irritants and microorganisms.Maintenance of skin integrity is important for patients and workers. The objectivewas to determine the effects on hand skin condition of a pseudoceramide testcream, designed for moisture barrier repair and substantivity, relative to the hospitalprovided lotion among intensive care HCWs in a monitored use study. Sixty-threesubjects participated in the randomized controlled parallel group trial. Assignmentof the test cream or hospital lotion was stratified by baseline knuckle dryness scores;application was 33 daily. The primary outcome was skin condition measured asexpert visual scoring of dryness and erythema, digital imaging and analysis, stratumcorneum integrity (TEWL), and skin hydration (capacitance) after 1, 2, and 4 weeks.Data were analyzed using linear mixed models with repeated measures. There wassignificant irritant dermatitis at baseline as over 60% of HCWs had knuckle drynessand erythema scores of 2. After 4 weeks, hands treated with the test cream weresignificantly less dry and irritated versus the hospital lotion as well as lower drynesson the knuckles and dorsum of both hands (P\.05) and as lower erythema on theknuckles of both hands and the left dorsum (P \ .05). Skin treated with the testcream had a more competent stratum corneum barrier, than that of the hospitallotion group (P\.05) as evidenced by lower TEWL. For the test cream and hospitallotion, respectively, TEWL values were 26.2 and 21.6 g/m2/hr at baseline and 21.6and 25.6 g/m2/hr at week 4. Hand skin of the test cream group was more hydratedthan the hospital lotion group, as evidenced by higher Corneometer readings, forboth dorsum and the left hand knuckles (P\.05). Mean daily usages were 4.5 and4.8 times for test and hospital lotion, respectively. In addition, application of thehighly substantive test cream 4-5 times daily significantly reduced the severity ofirritant contact dermatitis in HCWs. Subjects reported the test cream as protectiveand moisturizing, characteristics that likely impact compliance.

d by Kao USA, Inc.

Supporte

J AM ACAD DERMATOL

P8311Efficacy and safety of a natural cream-to-powder formulation ondiaper-wearing infants and children

Hemali Gunt, PhD, MS, Burt’s Bees Inc, Durham, NC, United States; Abena Antwi,Burt’s Bees Inc, Durham, NC, United States; Celeste Lutrario, Burt’s Bees Inc,Durham, NC, United States; Stanley Levy, MD, Chapel Hill Dermatology, ChapelHill, NC, United States

Background: The SC’s function is to reduce water loss, repel water, protect deeperlayers of the skin from injury, and from microbial infections. In infants, this layer ofthe skin is much thinner and more easily disrupted. Diaper rash or irritant diaperdermatitis develops when skin is exposed to prolonged moisture, increased skin pHcaused by urine and feces, and intertriginous occlusion, resulting in breakdown ofthe SC. Hence, any treatment that keeps the skin surface dry helps alleviate thiscondition. Most common remedies include moisture-absorbing powders, such astalc, or barrier creams blocking moisture from reaching the skin. A natural skinbarrier cream was developed that keeps the skin dry and provides moistureprotection.

Objective: To evaluate the safety and efficacy of a natural cream-to-powderformulation in diaper wearing infants and children.

Methods: A 4-week use safety and efficacy study was conducted on 53 diaper-wearing subjects ranging in ages from 2 months to 3 years. Erythema, dryness, andedema were evaluate and clinical graded by a pediatrician at baseline and after 4weeks of product use. In a separate panel of 20 adult females, wetness protectionwas evaluated in vivo using dye exclusion method. The test product was applied tovolar forearm, followed by dye application and skin staining evaluation.

Results: The 4-week use safety and efficacy study showed that the natural cream-to-powder formulation did not cause any irritation or sensitization on pediatricsubjects. Dye exclusion revealed significant barrier against wetness on adultforearms.

Conclusion: The natural cream-to-powder formulation was proven to be safe inpediatric subjects. The dye exclusion method was able to demonstrate the wetnessprotection property of the natural cream-to-powder formulation.

d 100% by Burt’s Bees Inc.

Sponsore

P8496Impact of co/cross-reactants on available alternative hair dyes inp-phenylenediamine allergic patients

Gurbir Dhadwal, MD, Department of Dermatology and Skin Science, Universityof British Columbia, Vancouver, Canada; Gillian de Gannes, MD, Department ofDermatology and Skin Science, University of British Columbia, Vancouver,Canada

Background: P-phenylenediamine (PPD) is a common component of permanent andsemipermanent hair dyes. However, it is also a common allergic contact allergen.Published rates of sensitization to PPD, amongst patients presenting for patchtesting, range between 2% and 12%. Given the rates of sensitization, hair dyescontaining alternatives to PPD have been developed. Here we attempt to determineif co/cross-reactants found in these alternative hair dyes will limit their use by PPDallergic patients.

Methods: We retrospectively reviewed all patch test results of patients presenting tothe Vancouver Patch Test Clinic between November 2008 and June 2013. Allpatients were tested to the North American Contact Dermatitis Group standardscreening series and other standard sets of allergens as clinically indicated, such as ahairdressing tray. Data was collected for all positive reactions to PPD and thoseresults were further analyzed to find all co/cross-reactants. The American ContactDermatitis Contact Allergen Management Program (CAMP) database was thenqueried with PPD along with each of the most common co/cross reactants foravailable hair dyes without those ingredients.

Results: 1319 patch tests were performed during the study period. 95 patients werefound to be patch test positive to PPD. Of those 95 patients, 74 (78%) had at least 1other positive reaction. The 10 most common co/cross reactants were nickel (31%),ammonium persulfate (23%), cobalt (ii) chloride hexahydrate (20%), p-toluenedi-amine sulfate (19%), 4-aminophenol (18%), fragrance mix 1 (15%), toluenediaminebase (12%), fragrance mix 2 (9%), myroxylon pereirae resin (9%) and glycerylthioglycolate (9%). The CAMP database contained 180 PPD-free dyes. Nickel, cobalt,ammonium persulfate, or glycerly thioglycolate were not found to be components ofthe PPD-free dyes. Cross-reacting to 4-aminophenol restricted available dyes to 52.Cross reacting to toluenediamine compounds restricted the available dyes to 19,none of which were dark in color. Positivity to any of the fragrances restricted theavailability to 1 nonpermanent dye.

Conclusions: Patients who are allergic to PPD are commonly allergic to otherchemicals. Patients that are PPD allergic and also react to toluenediamine orfragrances are severely restricted in their choice of hair dye. The clinic relevance offragrance allergy in patients wishing to dye their hair is unclear and likely warrantsadditional investigation.

cial support: None identified.

Commer

MAY 2014