hygiene program for children with atopic dermatitis

1
P1304 Effect of moisturizing treatments on dry skin of whites and African Americans Anthony Geralis, MD, MPH, Unilever R&D, Trumbull, CT, United States; Greg Nole, Unilever R&D, Trumbull, CT, United States; Jamie Regan, Unilever R&D, Trumbull, CT, United States Skin dryness is a commonly observed physiologic condition that transcends any ethnicity. Although skin dryness is common, we know that there are variations in the way it presents on different skin complexions. On white skin, dryness appears visually as a range from fine white lines to severe flaking/fissuring. Ashiness is a manifestation of dryness only seen on darker skin, specifically African Americans in this research. Clinical studies were conducted to determine if the visual differences observed between dry leg skin of African Americans and whites had an effect on instrumental and visual assessments of skin hydration after moisturizer treatment. A 24-hour (single application) and a 5-day (twice-daily application) clinical study, consisting of both African American and white subjects, were conducted. Correlations between visual dryness, as assessed by an expert grader, and instru- mental measurements also were performed for both skin complexions. Results from the 24-hour clinical studies showed no statistically significant differences between populations based on standard dry skin measures: Skicon, Corneometer, and visual dryness grading (0-4 point scale). Overall, both subgroups responded similarly to product treatment, though two interesting trends were observed: (1) in general, the whtie group trended to having higher average skin hydration values, and (2) in visual dryness, lotions with higher emollient loads appeared more responsive on African American skin. Results from the 5-day study showed similar trends, though again not at a statistically significant level. The visual presentation of dry skin varies based on ethnicity. These short- and longer-term moisturization clinical studies showed no statistically significant differences between populations in their response to product treatment; however, observations do suggest that the populations may respond more favorably to different product formulations leading to opportunities for targeted product benefits. Commercial support: 100% sponsored by Unilever HPC. P1305 Emollient body washes: Benefits for dry skin in older subjects Carol Vincent, Unilever R&D, Trumbull, CT, United States; K. P. Ananthapadmanabhan, Unilever R&D, Trumbull, CT, United States; Kumar Subramanyan, Unilever R&D, Trumbull, CT, United States It is known that the incidence of skin dryness (roughness, scaling, and itch) increases with age because of changes in structure of the stratum corneum (SC) and its water holding capacity. The type of cleanser used is a key determinant of the moisture level in the SC, because cleansers can strongly interact with the ‘‘moisture- regulating’’ mechanisms in skin, such as the lipids and the natural moisturizing factors (NMFs). One of the emerging technologies in the cleansing market is to incorporate high levels of emollients into liquid cleansing systems to alleviate the symptoms of dry skin and to mitigate the damaging effects of cleanser surfactants. We present data from one clinical study to show the benefits of an emollient-rich liquid body cleanser on older individuals with dry skin under normal use conditions. Ninety-five subjects 45 to 65 years of age provided informed consent to participate in this institutional review boardeapproved study. Subjects underwent an initial conditioning phase, during which they discontinued the use of all moisturizers and used a marketed syndet bar for daily cleansing. Fifty-five subjects with sufficient leg dryness continued into the product application phase, where the legs where washed with the same cleanser, with and without emollients, once a day for nine consecutive days. A 3-day regression phase, where no product was applied to the legs, followed. Skin was evaluated by an expert clinical grader for dryness and erythema and assessed instrumentally for hydration (conductance and capacitance) and transepidermal water loss (TEWL; measure of SC barrier integrity) during the course of the study. Skin washed with the emollient-rich cleanser was significantly more hydrated and showed significantly lower TEWL values (better preservation of SC barrier) than skin treated with just the cleanser base. The emollient cleanser also resulted in significantly lower visual dryness and skin irritation compared to the cleanser without emollients. The emollient cleanser continued to provide a greater benefit to the skin during the regression phase. The findings from this study suggest that the benefits of emollient-rich body washes do manifest under controlled normal use test conditions, and that these products can provide a significant improvement to older, drier skin compared to body washes without moisturizers. Commercial support: 100% sponsored by Unilever HPC. P1306 New therapeutic antiinflammatory action of a natural PPAR-alfa agonist emollient versus topical steroids in atopic dermatitis Philippe Msika, Laboratoires Expanscience, Epernon, France; Bernard Chadoutaud, Clinreal Online, Toulouse, France; Caroline Baudouin, Laboratoires Expanscience, Epernon, France; Clarence de Belilovsky, Institut Alfred Fournier, Paris, France Objectives: Atopic dermatitis (AD) is a chronic dermatosis requiring permanent skin care. This goal can be achieved by emollients, often in conjunction with topical steroids if needed. In a previous study, an emollient containing a natural patented active ingredient (2% sunflower oleodistillate [SOD]) has demonstrated a 75% corticosteroid sparing effect (steroid class II, desonide 0.05%). In this new European multicenter study, its applications have been compared to those of a more potent steroid (class III, hydrocortisone aceponate cream 1.27mg/g). Methods: During an open comparative study, two groups of 40 children with light to moderate AD have been included by 12 dermatologists. All children received soap- free washing oil. Group A applied the steroid two times a day on affected areas and group B the emollient on lesions and on the entire body two times a day. Children were examined, and Scoring Atopic Dermatitis (SCORAD) scores were established at days 0, 7, and 21. Quality of life questionnaires were filled at days 7 and 21. Results: The mean age of the children was 2.3 and 2.4 years in groups A and B. At day 0, SCORAD was similar in the two groups: 37.2 versus 36.9 (moderate AD). In both groups, improvements were statistically significant versus DO at day 7 (-49% and -48%) and day 21 (-70% and -75%). There were no statistic differences between SCORAD at day 21 (11 vs 9.4). All items of SCORAD improved in the same range except for xerosis which was naturally better improved by the emollient (-81%) than in the steroid group at D21 (-53%; P \.01). This latter result in the steroid group might be attributed to the soap-free washing oil. Investigator assessment stated that the emollient could reduce the frequency of atopic flares (93%) and the intensity of flares (90%), with no statistic difference between the two groups at day 21. Infant Dermatitis Quality Of Life (IDQOL) improved by 65% with the steroid and 72% with the emollient at day 21 (P \.01 vs D0 and no significant difference between two groups). Similarly, the Dermatitis Family Impact Questionnaire (DFIQ) score was reduced by 67% and 75% (idem). Conclusions: For the first time, a cosmetic emollient containing 2% patented SOD has demonstrated therapeutic properties comparable to those of a class III steroid in a 3-week comparative study. The impact on the quality of life tended to be better but did not reach a significant difference. These properties of the tested emollient on AD might rely on its natural agonist PPAR-alfa properties, previously demonstrated in vitro. Commercial support: 100% sponsored by Laboratoires Expanscience. P1307 Hygiene program for children with atopic dermatitis Philippe Msika, MD, Laboratoires Expancience, Epernon, France; Bernard Chadoutaud, Clinreal Online, Toulouse, France; Caroline Baudouin, Laboratoires Expanscience, Epernon, France; Clarence de Belilovsky, Institut Alfred Fournier, Paris, France; Franck Menu, Laboratoires Expanscience, Epernon, France Objectives: During atopic dermatitis (AD), all washing products must preserve the mechanical and biologic skin barrier function, soothe the skin, and even improve other skin cares. For that purpose, a cosmetic baby product hygiene line dedicated to atopic skin has been developed. All three products are perfume and paraben free. They all contain mild vegetal surfactants and sunflower oleodistillate (SOD), a patented molecule which stimulates lipogenesis via agonist PPAR-alfa properties. Methods: Each product has been tested, in open studies, on 100 children, aged [3 months, with light to moderate AD, by dermatologists, pediatricians, and pediatric nurses, during 3 weeks, in France and Spain. Other skin cares (emollients and steroids) were not changed and used as needed. Clinical examination (dryness, erythema, desquamation, and pruritus) and the quality of life assessments Infant Dermatitis Quality of Life (IDQOL) and Dermatitis Family Impact Questionnaire (DFIQ) were performed at days 0 and 21. Study A used a no-rinse cleansing water, used on the face, the body, or the nappy area as needed. Study B used a cleansing cream for hair and body, and study C used a milky bath oil, used either during shower or bath without rinsing. Results: Most of the children (3.6-5.3 yrs old) were included during a flare of AD (study A, 85%; B, 74%; C, 88%) and applied hygiene products on lesional skin (88%/95%/99%). Sisxty-six percent/89%/84% continued their usual emollient during the study period and 19%/48%/38% continued with their topical steroid (7%/14%/11% compared to 1 month earlier). In all three studies, all clinical and quality of life scores improved by at least 50% (P \.01) by day 21. For clinical scores, a comparison between children receiving solely hygiene products and combined to emollient and/or steroid showed no difference. Investigator assessments: The products are adapted to AD hygiene (study A, 95%; B, 99%; C, 86%) and decrease a given AD flare’s intensity (77%/77%/76%) and frequency (63%/74%/64%). For the parents, these products clean the skin softly (98%/100%/91%), especially on lesional skin (82%/98%/83%). They are nonirritating (98%/100%/99%), soothing (80%/88%/83%), hydrating (83%/84%/80%), and the child reacts favorably after application (92%/99%/94%). Conclusion: During ‘‘use-test conditions’’ studies, three specific AD hygiene products containing active patented ingredient (SOD), applied alone or associated to regular cosmetic skin cares and therapies, have demonstrated a [50% improve- ment both for clinical signs and of quality of life. Commercial support: 100% sponsored by Laboratoires Expanscience. AB68 JAM ACAD DERMATOL MARCH 2009

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P1304Effect of moisturizing treatments on dry skin of whites and AfricanAmericans

Anthony Geralis, MD, MPH, Unilever R&D, Trumbull, CT, United States; GregNole, Unilever R&D, Trumbull, CT, United States; Jamie Regan, Unilever R&D,Trumbull, CT, United States

Skin dryness is a commonly observed physiologic condition that transcends anyethnicity. Although skin dryness is common, we know that there are variations in theway it presents on different skin complexions. On white skin, dryness appearsvisually as a range from fine white lines to severe flaking/fissuring. Ashiness is amanifestation of dryness only seen on darker skin, specifically African Americans inthis research. Clinical studies were conducted to determine if the visual differencesobserved between dry leg skin of African Americans and whites had an effect oninstrumental and visual assessments of skin hydration after moisturizer treatment. A24-hour (single application) and a 5-day (twice-daily application) clinical study,consisting of both African American and white subjects, were conducted.Correlations between visual dryness, as assessed by an expert grader, and instru-mental measurements also were performed for both skin complexions. Results fromthe 24-hour clinical studies showed no statistically significant differences betweenpopulations based on standard dry skin measures: Skicon, Corneometer, and visualdryness grading (0-4 point scale). Overall, both subgroups responded similarly toproduct treatment, though two interesting trends were observed: (1) in general, thewhtie group trended to having higher average skin hydration values, and (2) in visualdryness, lotions with higher emollient loads appeared more responsive on AfricanAmerican skin. Results from the 5-day study showed similar trends, though again notat a statistically significant level. The visual presentation of dry skin varies based onethnicity. These short- and longer-term moisturization clinical studies showed nostatistically significant differences between populations in their response to producttreatment; however, observations do suggest that the populations may respondmore favorably to different product formulations leading to opportunities fortargeted product benefits.

AB68

cial support: 100% sponsored by Unilever HPC.

Commer

P1305Emollient body washes: Benefits for dry skin in older subjects

Carol Vincent, Unilever R&D, Trumbull, CT, United States; K. P.Ananthapadmanabhan, Unilever R&D, Trumbull, CT, United States; KumarSubramanyan, Unilever R&D, Trumbull, CT, United States

It is known that the incidence of skin dryness (roughness, scaling, and itch)increases with age because of changes in structure of the stratum corneum (SC) andits water holding capacity. The type of cleanser used is a key determinant of themoisture level in the SC, because cleansers can strongly interact with the ‘‘moisture-regulating’’ mechanisms in skin, such as the lipids and the natural moisturizingfactors (NMFs). One of the emerging technologies in the cleansing market is toincorporate high levels of emollients into liquid cleansing systems to alleviate thesymptoms of dry skin and to mitigate the damaging effects of cleanser surfactants.We present data from one clinical study to show the benefits of an emollient-richliquid body cleanser on older individuals with dry skin under normal use conditions.Ninety-five subjects 45 to 65 years of age provided informed consent to participatein this institutional review boardeapproved study. Subjects underwent an initialconditioning phase, during which they discontinued the use of all moisturizers andused a marketed syndet bar for daily cleansing. Fifty-five subjects with sufficient legdryness continued into the product application phase, where the legs wherewashed with the same cleanser, with and without emollients, once a day for nineconsecutive days. A 3-day regression phase, where no product was applied to thelegs, followed. Skin was evaluated by an expert clinical grader for dryness anderythema and assessed instrumentally for hydration (conductance and capacitance)and transepidermal water loss (TEWL; measure of SC barrier integrity) during thecourse of the study. Skin washed with the emollient-rich cleanser was significantlymore hydrated and showed significantly lower TEWL values (better preservation ofSC barrier) than skin treated with just the cleanser base. The emollient cleanser alsoresulted in significantly lower visual dryness and skin irritation compared to thecleanser without emollients. The emollient cleanser continued to provide a greaterbenefit to the skin during the regression phase. The findings from this study suggestthat the benefits of emollient-rich body washes do manifest under controlled normaluse test conditions, and that these products can provide a significant improvementto older, drier skin compared to body washes without moisturizers.

cial support: 100% sponsored by Unilever HPC.

Commer

J AM ACAD DERMATOL

P1306New therapeutic antiinflammatory action of a natural PPAR-alfa agonistemollient versus topical steroids in atopic dermatitis

Philippe Msika, Laboratoires Expanscience, Epernon, France; BernardChadoutaud, Clinreal Online, Toulouse, France; Caroline Baudouin, LaboratoiresExpanscience, Epernon, France; Clarence de Belilovsky, Institut Alfred Fournier,Paris, France

Objectives: Atopic dermatitis (AD) is a chronic dermatosis requiring permanent skincare. This goal can be achieved by emollients, often in conjunction with topicalsteroids if needed. In a previous study, an emollient containing a natural patentedactive ingredient (2% sunflower oleodistillate [SOD]) has demonstrated a 75%corticosteroid sparing effect (steroid class II, desonide 0.05%). In this new Europeanmulticenter study, its applications have been compared to those of a more potentsteroid (class III, hydrocortisone aceponate cream 1.27mg/g).

Methods: During an open comparative study, two groups of 40 children with light tomoderate AD have been included by 12 dermatologists. All children received soap-free washing oil. Group A applied the steroid two times a day on affected areas andgroup B the emollient on lesions and on the entire body two times a day. Childrenwere examined, and Scoring Atopic Dermatitis (SCORAD) scores were established atdays 0, 7, and 21. Quality of life questionnaires were filled at days 7 and 21.

Results: The mean age of the children was 2.3 and 2.4 years in groups A and B. At day0, SCORAD was similar in the two groups: 37.2 versus 36.9 (moderate AD). In bothgroups, improvements were statistically significant versus DO at day 7 (-49% and-48%) and day 21 (-70% and -75%). There were no statistic differences betweenSCORAD at day 21 (11 vs 9.4). All items of SCORAD improved in the same rangeexcept for xerosis which was naturally better improved by the emollient (-81%) thanin the steroid group at D21 (-53%; P \.01). This latter result in the steroid groupmight be attributed to the soap-free washing oil. Investigator assessment stated thatthe emollient could reduce the frequency of atopic flares (93%) and the intensity offlares (90%), with no statistic difference between the two groups at day 21. InfantDermatitis Quality Of Life (IDQOL) improved by 65% with the steroid and 72% withthe emollient at day 21 (P \.01 vs D0 and no significant difference between twogroups). Similarly, the Dermatitis Family Impact Questionnaire (DFIQ) score wasreduced by 67% and 75% (idem).

Conclusions: For the first time, a cosmetic emollient containing 2% patented SODhas demonstrated therapeutic properties comparable to those of a class III steroid ina 3-week comparative study. The impact on the quality of life tended to be better butdid not reach a significant difference. These properties of the tested emollient on ADmight rely on its natural agonist PPAR-alfa properties, previously demonstratedin vitro.

cial support: 100% sponsored by Laboratoires Expanscience.

Commer

P1307Hygiene program for children with atopic dermatitis

Philippe Msika, MD, Laboratoires Expancience, Epernon, France; BernardChadoutaud, Clinreal Online, Toulouse, France; Caroline Baudouin,Laboratoires Expanscience, Epernon, France; Clarence de Belilovsky, InstitutAlfred Fournier, Paris, France; Franck Menu, Laboratoires Expanscience,Epernon, France

Objectives: During atopic dermatitis (AD), all washing products must preserve themechanical and biologic skin barrier function, soothe the skin, and even improveother skin cares. For that purpose, a cosmetic baby product hygiene line dedicatedto atopic skin has been developed. All three products are perfume and paraben free.They all contain mild vegetal surfactants and sunflower oleodistillate (SOD), apatented molecule which stimulates lipogenesis via agonist PPAR-alfa properties.

Methods: Each product has been tested, in open studies, on 100 children, aged [3months, with light to moderate AD, by dermatologists, pediatricians, and pediatricnurses, during 3 weeks, in France and Spain. Other skin cares (emollients andsteroids) were not changed and used as needed. Clinical examination (dryness,erythema, desquamation, and pruritus) and the quality of life assessments InfantDermatitis Quality of Life (IDQOL) and Dermatitis Family Impact Questionnaire(DFIQ) were performed at days 0 and 21. Study A used a no-rinse cleansing water,used on the face, the body, or the nappy area as needed. Study B used a cleansingcream for hair and body, and study C used a milky bath oil, used either during showeror bath without rinsing.

Results: Most of the children (3.6-5.3 yrs old) were included during a flare of AD(study A, 85%; B, 74%; C, 88%) and applied hygiene products on lesional skin(88%/95%/99%). Sisxty-six percent/89%/84% continued their usual emollient duringthe study period and 19%/48%/38% continued with their topical steroid(7%/14%/11% compared to 1 month earlier). In all three studies, all clinical andquality of life scores improved by at least 50% (P\.01) by day 21. For clinical scores,a comparison between children receiving solely hygiene products and combined toemollient and/or steroid showed no difference.

Investigator assessments: The products are adapted to AD hygiene (study A, 95%;B, 99%; C, 86%) and decrease a given AD flare’s intensity (77%/77%/76%) andfrequency (63%/74%/64%). For the parents, these products clean the skin softly(98%/100%/91%), especially on lesional skin (82%/98%/83%). They are nonirritating(98%/100%/99%), soothing (80%/88%/83%), hydrating (83%/84%/80%), and thechild reacts favorably after application (92%/99%/94%).

Conclusion: During ‘‘use-test conditions’’ studies, three specific AD hygieneproducts containing active patented ingredient (SOD), applied alone or associatedto regular cosmetic skin cares and therapies, have demonstrated a [50% improve-ment both for clinical signs and of quality of life.

cial support: 100% sponsored by Laboratoires Expanscience.

Commer

MARCH 2009