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Emollients as adjunctive therapy in the management of atopic dermatitis: A multicentric clinical study
P725
P727
Topical vehicle preferences in atopic dermatitis patients-evaluating a novel hydrogel vehicle Nathan Trookman, MD, Rocky Mountain Laser Center, Colorado Springs, CO, United States; Ronald Rizer, PhD, Thomas J. Stephens & Associates, Colorado Springs, CO, United States; Rosanne Ford, SkinMedica, Inc, Carlsbad, CA, United States; Ronald Trancik, PhD, SkinMedica, Inc, Carlsbad, CA, United States Atopic dermatitis (AD), the most common skin disease of childhood, is a chronic inflammatory pruritus that can afflict patients into adulthood. Treatment success necessitates strict adherence to topical medication regimens which are offered in a variety of vehicle forms. The vehicle used can substantially affect the active agent’s clinical action, potency, and acceptability to the patient. Preferences regarding vehicle attributes may impact patient acceptability and compliance with treatment. A user preference study was conducted to determine if a new moisturizing aqueous gel (hydrogel) formulation would appeal to AD patients and potentially increase their treatment compliance. This formulation advance has enabled the development of desonide 0.05% into a novel vehicle that is alcohol and surfactant-free, and designed to be mild, free from sensitizing ingredients, and cosmetically elegant. Adult atopic subjects were asked to apply hydrogel vehicle (no active) to various parts of their body and complete a questionnaire on the vehicle, its acceptability for the treatment of AD and how it compares to other vehicle forms they have used in the past. In addition, subjects were asked to rate the importance of various vehicle attributes. A total of 51 subjects with a history of mild-to-moderate AD (mean years with AD 5 15.6) were enrolled and completed the study. Subjects used an average of 2 topical steroid treatments for their AD in the past 5 years. Results from this study showed that the majority of subjects ([84%) found the hydrogel vehicle easy to apply, suitable for use on multiple body areas including hairy areas, comfortable to have on their skin under clothing and make-up, non-greasy, quickly absorbing, and non-drying. 75% of subjects rated this vehicle as superior to other gels they had used and 88% of subjects would be compliant with this vehicle as part of a treatment regimen. 94% would be willing to use products formulated with this vehicle on their children. In conclusion, a novel hydrogel formulation demonstrated attributes that rated important to AD patients and was preferred by a majority of patients to other vehicles used in the past. This advance in vehicle technology offers cosmetic advantages over traditional vehicle forms and may enhance patient compliance and clinical outcome.
Adherence to topical hydrocortisone 17-butyrate 0.1% using different vehicles in adults with atopic dermatitis Mandeep Kaur, MD, Wake Forest University Health Sciences, Winston-Salem, NC, United States; Steven Feldman, MD, PhD, Wake Forest University Health Sciences, Winston-Salem, NC, United States; Adele Clark, PA, Wake Forest University Health Sciences, Winston-Salem, NC, United States; Robin Inabinet, Wake Forest University Health Sciences, Winston-Salem, NC, United States Background: Topical corticosteroids, with or without topical calcineurin inhibitors, are the mainstay of treatment for atopic dermatitis. It is unknown why some atopic dermatitis patients do not respond to topical treatment. Lack of adherence to a medication regimen could be the underlying source of treatment failure. Objectives: To evaluate adherence to topical hydrocortisone 17-butyrate 0.1% using different vehicles in an outpatient clinical setting using adherence data collected by the medical events monitoring system (MEMS) in adult subjects with atopic dermatitis (AD). Methods: In this investigator-blinded prospective study of 30 subjects with mild to moderate atopic dermatitis, approximately 30 male and female adults age $ 18 years will be randomized to one of three topical hydrocortisone 17-butyrate 0.1% preparations (ointment, cream or lipocream) in the manufacturer’s original tube fitted with a MEMS cap to electronically track adherence rates. Subjects will be instructed to apply the medication twice daily (morning and evening) for 2 weeks to all of their AD lesions. Subjects will be informed that they are being monitored, but will not be told that adherence will be monitored through electronic devices. Disclosure of the adherence monitoring will occur at week 2 (or end of treatment), at which time the results of the subject’s adherence behavior will be used to supply individualized treatment options for each subject (feedback session). Results: The findings of this study will be discussed; we anticipate an improvement in subjects who adhered to the medication for atopic dermatitis. Discussion: Implications of this study will be discussed. This study was supported by a grant from Ferndale Laboratories.
100% is sponsored by SkinMedica, Inc.
P726 Safety and efficacy of pimecrolimus cream 1% in the daily practice results of the Elidel Patient Self-Observation (El Paso) study in 3502 patients with atopic dermatitis in Germany Thomas Luger, MD, Department of Dermatology, University of Muenster, Muenster, DE, Germany; Harald Gollnick, MD, Department of Dermatology, University of Magdeburg, Magdeburg, Germany The objective of this 15-week multi-center patient self-observation study was to evaluate the safety and efficacy of a pimecrolimus cream 1%-based regimen in patients with atopic dermatitis (AD) in daily practice. Physicians incorporated pimecrolimus cream 1% into patient’s standard treatment protocols on the basis of their clinical diagnosis. Use of concomitant medication (including topical and systemic corticosteroids, systemic antihistamines, emollients) was allowed. Physicians assessed overall severity of AD and individual symptoms (excoriation, pruritus, lichenification) using a 6-point scale at study visits (start of treatment, two optional visits during the 15-week observation period, end of treatment). Patients recorded their erythema and pruritus as assessed by themselves or their caregivers on a 6-point scale daily. Adverse events were recorded throughout the study. At end of treatment, safety and efficacy was assessed by the physician, based on patients’ daily records of symptoms, and by the patient. A total of 3502 patients (62% female) aged 4 months to 85 years (mean 26.2 6 18.0 years) were recruited by 810 physicians in Germany. Daily records were received from 2985 patients. A complete data set (CRF from all visits, patients daily records) was available from 1220 patients. The percentage of patients with severe or very severe AD decreased from 25% at baseline to 7% at end of treatment, and the percentage of patients with no or mild symptoms increased from 9% to 55%. Likewise, a marked decrease of prevalence and intensity of erythema and pruritus was observed as well as a decrease of cases with lichenification and excoriation. This result was confirmed by the analysis of patients’ daily records. Efficacy of treatment was rated as good or very good in 83.5% of cases by the physician and by 79% of patients. Treatment was well tolerated. Global tolerability was rated as good or very good in 91% of cases by the physician and by 87% of patients. Adverse events (mostly local skin reaction such as irritation, pruritus, redness and worsening of disease) were observed in 220/3502 (6.3%) of patients. At the end-of-treatment visit 67.3% of the patients rated the pimecrolimus cream 1%-based therapy as better than their preceding therapy. Sponsored by Novartis.
AB74
J AM ACAD DERMATOL
P728 Emollients as adjunctive therapy in the management of atopic dermatitis: A multicentric clinical study Andre Rougier, PhD, DDSc, La Roche-Posay, Asnie`res, France; Thomas Luger, MD, University of Muenster, Muenster, Germany Therapy of AD is aimed at counteracting the itching, the inflammatory and immunological changes, and the complications of the disease, as well as reducing dryness. As the barrier function of the skin in patients with AD is impaired, an adjuvant basic therapy is essential in the management of this disease consisting of the regular application of adequate moisturizers. Lipid ingredients of cream bases either prevent loss of skin lipids or attempt to replace them in their function. The aim of this study was to assess the efficacy and tolerance of a commercially available emollient in children with AD (SCORAD \30) under normal conditions of use. One hundred and thirty-one children aged 3-12 years with light to moderate AD where treated twice daily with the emollient containing shea butter, glycerin, canola oil, thermal water for 6 weeks. During the study, subjects were asked: to avoid other body care or hydrating products, cosmeceuticals, etc, to use their usual body hygiene product(s) (soap, syndets, etc), to avoid UV rays exposure, natural or artificial. A class IV topical corticosteroid (weak) was allowed on a skin surface \5%, but the use of antihistamines was prohibited. The overall clinical efficacy was assessed by the dermatologist by the mean of SCORAD at days 3, 0, and 46 as well as tolerance. The parents and children opinions on various items were also recorded. Results showed that after 6 weeks erythema, dryness, pruritus, extention were reduced by 40 to 60% and SCORAD by 50%. Global efficacy and tolerance were found good and excellent by the dermatologist in 76 to 86% of the cases. The skin was found to itch less, hurt less, to be less red and less dry by 80 to 95% of the parents and children. The quality of sleep was improved in 83% of the cases. This study clearly showed the importance of emollient as adjunctive therapy in the treatment of AD. The emollient we have used is well tolerated, reduces both signs and symptoms of AD and can reduce the need of treatments and their related side effects. 100% supported by La Roche-Posay.
FEBRUARY 2007
P727
Topical vehicle preferences in atopic dermatitis patients-evaluating a novel hydrogel vehicle Nathan Trookman, MD, Rocky Mountain Laser Center, Colorado Springs, CO, United States; Ronald Rizer, PhD, Thomas J. Stephens & Associates, Colorado Springs, CO, United States; Rosanne Ford, SkinMedica, Inc, Carlsbad, CA, United States; Ronald Trancik, PhD, SkinMedica, Inc, Carlsbad, CA, United States Atopic dermatitis (AD), the most common skin disease of childhood, is a chronic inflammatory pruritus that can afflict patients into adulthood. Treatment success necessitates strict adherence to topical medication regimens which are offered in a variety of vehicle forms. The vehicle used can substantially affect the active agent’s clinical action, potency, and acceptability to the patient. Preferences regarding vehicle attributes may impact patient acceptability and compliance with treatment. A user preference study was conducted to determine if a new moisturizing aqueous gel (hydrogel) formulation would appeal to AD patients and potentially increase their treatment compliance. This formulation advance has enabled the development of desonide 0.05% into a novel vehicle that is alcohol and surfactant-free, and designed to be mild, free from sensitizing ingredients, and cosmetically elegant. Adult atopic subjects were asked to apply hydrogel vehicle (no active) to various parts of their body and complete a questionnaire on the vehicle, its acceptability for the treatment of AD and how it compares to other vehicle forms they have used in the past. In addition, subjects were asked to rate the importance of various vehicle attributes. A total of 51 subjects with a history of mild-to-moderate AD (mean years with AD 5 15.6) were enrolled and completed the study. Subjects used an average of 2 topical steroid treatments for their AD in the past 5 years. Results from this study showed that the majority of subjects ([84%) found the hydrogel vehicle easy to apply, suitable for use on multiple body areas including hairy areas, comfortable to have on their skin under clothing and make-up, non-greasy, quickly absorbing, and non-drying. 75% of subjects rated this vehicle as superior to other gels they had used and 88% of subjects would be compliant with this vehicle as part of a treatment regimen. 94% would be willing to use products formulated with this vehicle on their children. In conclusion, a novel hydrogel formulation demonstrated attributes that rated important to AD patients and was preferred by a majority of patients to other vehicles used in the past. This advance in vehicle technology offers cosmetic advantages over traditional vehicle forms and may enhance patient compliance and clinical outcome.
Adherence to topical hydrocortisone 17-butyrate 0.1% using different vehicles in adults with atopic dermatitis Mandeep Kaur, MD, Wake Forest University Health Sciences, Winston-Salem, NC, United States; Steven Feldman, MD, PhD, Wake Forest University Health Sciences, Winston-Salem, NC, United States; Adele Clark, PA, Wake Forest University Health Sciences, Winston-Salem, NC, United States; Robin Inabinet, Wake Forest University Health Sciences, Winston-Salem, NC, United States Background: Topical corticosteroids, with or without topical calcineurin inhibitors, are the mainstay of treatment for atopic dermatitis. It is unknown why some atopic dermatitis patients do not respond to topical treatment. Lack of adherence to a medication regimen could be the underlying source of treatment failure. Objectives: To evaluate adherence to topical hydrocortisone 17-butyrate 0.1% using different vehicles in an outpatient clinical setting using adherence data collected by the medical events monitoring system (MEMS) in adult subjects with atopic dermatitis (AD). Methods: In this investigator-blinded prospective study of 30 subjects with mild to moderate atopic dermatitis, approximately 30 male and female adults age $ 18 years will be randomized to one of three topical hydrocortisone 17-butyrate 0.1% preparations (ointment, cream or lipocream) in the manufacturer’s original tube fitted with a MEMS cap to electronically track adherence rates. Subjects will be instructed to apply the medication twice daily (morning and evening) for 2 weeks to all of their AD lesions. Subjects will be informed that they are being monitored, but will not be told that adherence will be monitored through electronic devices. Disclosure of the adherence monitoring will occur at week 2 (or end of treatment), at which time the results of the subject’s adherence behavior will be used to supply individualized treatment options for each subject (feedback session). Results: The findings of this study will be discussed; we anticipate an improvement in subjects who adhered to the medication for atopic dermatitis. Discussion: Implications of this study will be discussed. This study was supported by a grant from Ferndale Laboratories.
100% is sponsored by SkinMedica, Inc.
P726 Safety and efficacy of pimecrolimus cream 1% in the daily practice results of the Elidel Patient Self-Observation (El Paso) study in 3502 patients with atopic dermatitis in Germany Thomas Luger, MD, Department of Dermatology, University of Muenster, Muenster, DE, Germany; Harald Gollnick, MD, Department of Dermatology, University of Magdeburg, Magdeburg, Germany The objective of this 15-week multi-center patient self-observation study was to evaluate the safety and efficacy of a pimecrolimus cream 1%-based regimen in patients with atopic dermatitis (AD) in daily practice. Physicians incorporated pimecrolimus cream 1% into patient’s standard treatment protocols on the basis of their clinical diagnosis. Use of concomitant medication (including topical and systemic corticosteroids, systemic antihistamines, emollients) was allowed. Physicians assessed overall severity of AD and individual symptoms (excoriation, pruritus, lichenification) using a 6-point scale at study visits (start of treatment, two optional visits during the 15-week observation period, end of treatment). Patients recorded their erythema and pruritus as assessed by themselves or their caregivers on a 6-point scale daily. Adverse events were recorded throughout the study. At end of treatment, safety and efficacy was assessed by the physician, based on patients’ daily records of symptoms, and by the patient. A total of 3502 patients (62% female) aged 4 months to 85 years (mean 26.2 6 18.0 years) were recruited by 810 physicians in Germany. Daily records were received from 2985 patients. A complete data set (CRF from all visits, patients daily records) was available from 1220 patients. The percentage of patients with severe or very severe AD decreased from 25% at baseline to 7% at end of treatment, and the percentage of patients with no or mild symptoms increased from 9% to 55%. Likewise, a marked decrease of prevalence and intensity of erythema and pruritus was observed as well as a decrease of cases with lichenification and excoriation. This result was confirmed by the analysis of patients’ daily records. Efficacy of treatment was rated as good or very good in 83.5% of cases by the physician and by 79% of patients. Treatment was well tolerated. Global tolerability was rated as good or very good in 91% of cases by the physician and by 87% of patients. Adverse events (mostly local skin reaction such as irritation, pruritus, redness and worsening of disease) were observed in 220/3502 (6.3%) of patients. At the end-of-treatment visit 67.3% of the patients rated the pimecrolimus cream 1%-based therapy as better than their preceding therapy. Sponsored by Novartis.
AB74
J AM ACAD DERMATOL
P728 Emollients as adjunctive therapy in the management of atopic dermatitis: A multicentric clinical study Andre Rougier, PhD, DDSc, La Roche-Posay, Asnie`res, France; Thomas Luger, MD, University of Muenster, Muenster, Germany Therapy of AD is aimed at counteracting the itching, the inflammatory and immunological changes, and the complications of the disease, as well as reducing dryness. As the barrier function of the skin in patients with AD is impaired, an adjuvant basic therapy is essential in the management of this disease consisting of the regular application of adequate moisturizers. Lipid ingredients of cream bases either prevent loss of skin lipids or attempt to replace them in their function. The aim of this study was to assess the efficacy and tolerance of a commercially available emollient in children with AD (SCORAD \30) under normal conditions of use. One hundred and thirty-one children aged 3-12 years with light to moderate AD where treated twice daily with the emollient containing shea butter, glycerin, canola oil, thermal water for 6 weeks. During the study, subjects were asked: to avoid other body care or hydrating products, cosmeceuticals, etc, to use their usual body hygiene product(s) (soap, syndets, etc), to avoid UV rays exposure, natural or artificial. A class IV topical corticosteroid (weak) was allowed on a skin surface \5%, but the use of antihistamines was prohibited. The overall clinical efficacy was assessed by the dermatologist by the mean of SCORAD at days 3, 0, and 46 as well as tolerance. The parents and children opinions on various items were also recorded. Results showed that after 6 weeks erythema, dryness, pruritus, extention were reduced by 40 to 60% and SCORAD by 50%. Global efficacy and tolerance were found good and excellent by the dermatologist in 76 to 86% of the cases. The skin was found to itch less, hurt less, to be less red and less dry by 80 to 95% of the parents and children. The quality of sleep was improved in 83% of the cases. This study clearly showed the importance of emollient as adjunctive therapy in the treatment of AD. The emollient we have used is well tolerated, reduces both signs and symptoms of AD and can reduce the need of treatments and their related side effects. 100% supported by La Roche-Posay.
FEBRUARY 2007