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Evaluation of efficacy and safety of desloratadine syrup in childhood atopic dermatitis 1
P238
P240
EVALUATION OF EFFICACY AND SAFETY OF DESLORATADINE SYRUP IN CHILDHOOD ATOPIC DERMATITIS Nicola NB Balato, MD, Universita’ Degli Studi Di Napoli Federico II, Napoli, Italy, Francesca Gaudiello, MD, Fabrizio Ayala, MD, Fabio Ayala, MD Atopic dermatitis (AD) is an inflammatory, pruritic, relapsing, chronic skin disease, that constitutes a significant burden to patients and their families. It currently affects 10% to 15% of children in many parts of the world and its prevalence is increasing. AD tipically begins in early childhood and may continue or recur as adult disease. The management of AD is difficult and reflects the lack of knowledge of the complex pathophysiological mechanisms. Oral antihistamines are usually used alone or, more often, in association with different drugs, for therapy of AD symptoms. Desloratadine, a well-experimented non-sedating anti-H1 molecule devoid of cardiac effects, has been proved safe and useful in children. The rationale for the use of an antihistamine such as desloratadine in the treatment of AD is based on its capacity to reduce erythema, skin hyper-reactivity and itching by blocking the H1 receptors, stabilizing the mast cell membrane, and reducing the expression of adhesion molecules and eosinophil number. Aim of this study was to evaluate the effects of desloratadine as syrup to children with AD. Forty children with AD (aging from 6 to 12; both sex) were enrolled to receive desloratadine syrup (dose: 5ml once a day) for 28 days. The following clinical parameters (erythema, edema/papulation, oozing/crusts, excoriations, lichenification, dryness, itching and sleep loss), were determined by SCORAD INDEX, at the visits planned (days 1, 8, 15 and 29). This study confirms desloratadine as an effective and well tolerated antihistamine in the treatment of AD.
TOLERANCE AND EFFICACY OF A MOISTURIZING BODY CREAM FOR CHILDREN AND ADULTS WITH ATOPIC DERMATITIS. Teresa M Weber, PhD, Beiersdorf Inc, Norwalk, CT, United States, Alexandra Kowcz, MBA, Beiersdorf Inc, Norwalk, CT, United States, Ronald Rizer, PhD, TJ Stephens and Associates, Colorado Springs, CO, United States We evaluated the tolerance and efficacy of a soothing, oil-in-water moisturizing cream containing oatmeal. It was developed to help relieve dry, itchy skin, especially in patients with with atopic dermatitis. Product safety was established by a battery of tests, including repeat insult patch, phototoxicity and photoallergy tests, and controlled usage safety tests conducted with atopic children and adults. Tolerance in children was demonstrated in 25 atopic and 25 normal children, aged 2 through 12, whose parents applied the product to the entire body and face. After two weeks of daily use, there were no clinically significant irritation scores. In a similar study of 30 atopic adults, a lack of subjective and objective irritation was also demonstrated. Moisturization efficacy was demonstrated in a study of 30 adults with dry, itchy skin on the lower legs. Subjects applied the cream in the morning and evening, assessing itch intensity before application, and at 2, 10, 30, and 120 minutes after application. Itch was significantly relieved at each post-application time point, and improved significantly throughout the two weeks of product usage. After two weeks, significant moisturization was also observed, by skin hydration meter readings, clinical grading of dryness and cracking, and assessments of coarse and fine flakes, using image analysis of skin surface squame samples. When the product was discontinued for a week, regression of moisturization and itch relief benefits was observed. The subjects’ responses to questions that probed product efficacy and aesthetics were highly favorable. Taken together, these data demonstrate exceptional tolerance and efficacy of the product formulation for dry, itchy skin, especially associated with atopic dermatitis.
Disclosure not available at press time. The study was carried out by the institution grant of Schering Plough, Italy.
Weber and Kowcz are employees of Beiersdorf Inc. 100% sponsored by Beiersdorf Inc
P239 TREATMENT, RESOURCES, AND IMPACT OF ATOPIC DERMATITIS-THE TRIAD STUDY Mark Boguniewicz, MD, National Jewish Medical and Research Center, and University of Colorado School of Medicine, Denver, CO, United States, William Abramovits, MD, Baylor University Medical Center and University of Texas Southwestern School of Medicine, Dallas, TX, United States, Diane Whitaker-Worth, MD, University of Connecticut Health Center, Farmington, CT, United States, Amy Paller, MD, Northwestern University Medical School and Children’s Memorial Hospital, Chicago, IL, United States Background. Atopic dermatitis (AD) increases health care utilization, affects patient quality of life, places a burden on caregivers, decreases patient/parent productivity, and adds to health care costs. While other studies have assessed the total burden of AD and its impacts on quality of life, few studies have examined the effect of specific treatment modalities across a variety of AD-related outcomes. Methods. A prospective, multi-center, open-label study was conducted to evaluate the effect of tacrolimus ointment on AD-related outcomes over 6 months. Adult and pediatric patients were eligible for enrollment only if they had moderate to severe disease based on Rajka and Langeland criteria. Data were collected at baseline (prior to treatment with tacrolimus ointment) and each month for 6 months across the following domains: clinical outcome, health care utilization/out-of-pocket costs, productivity/absenteeism, compliance, physical appearance, and quality of life. Results. Five centers around the country enrolled a total of 40 evaluable patients (18 adult; 22 pediatric patients). The mean age was 23.8; 67.5% were female; 52.5% were Caucasian; 72.5% had moderate disease at baseline. BSA and EASI scores for patients treated with tacrolimus decreased significantly between baseline, month 1, and end of treatment. Over time, patients treated with tacrolimus ointment reported fewer physician visits, fewer prescription medications for AD, and lower out-of-pocket expenses (p ⬍ 0.01). Patient quality of life also improved. Conclusions. Patients treated with tacrolimus ointment had improved outcomes as measured by clinical, resource utilization, and quality of life endpoints. Future evaluations of patient management strategies should incorporate more comprehensive assessments of overall patient outcomes to quantify the outcomes of disease and benefits of specific therapeutic regimens.
PHYSICAL COMPATIBILITY OF TACROLIMUS OINTMENT 0.1% WITH OTHER TOPICAL MEDICATIONS Jacob O Levitt, Mount Sinai Medical Center, New York, NY, United States, Masaru Fujiwara, Fujisawa Pharmaceutical Co., Inc., Osaka, Japan, Shuhei Deguchi, Fujisawa Pharmaceutical Co., Inc., Osaka, Japan, Teruyuki Kitagawa, Fujisawa Pharmaceutical Co., Inc., Osaka, Japan Tacrolimus ointment 0.1% is indicated for moderate to severe atopic dermatitis and is currently widely used for a variety of other inflammatory cutaneous conditions. Given its widespread acceptance, tacrolimus ointment is often used in patients who apply other medicines. In this study, the compatibility of tacrolimus ointment with over thirty topical products was evaluated. Combinations included 1:1 weight ratio of tacrolimus ointment 0.1% and: acyclovir 5% ointment, aclometasone dipropionate ointment 0.1%, amcinonide 0.1% ointment, bacitracin/fradiomycin sulfate, betamethasone valerate ointment 0.12%, betamethasone valerate/gentamicin sulfate ointment 0.12%, calcipotriene cream and ointment 0.005%, clobetasol propionate ointment 0.05%, clotrimazole cream 1%, desonide ointment 0.05%, diflucortolone valerate ointment 0.1%, difluprednate ointment 0.05%, fluticasone propionate cream 0.05%, gentamicin sulfate ointment 0.15, hydrocortisone valerate ointment 0.2%, ibuprofen piconol ointment 5%, mometasone furoate cream 0.1%, prednisolone valerate acetate ointment 0.3%, salicylic acid gel 6%, tazarotene cream 0.05% and 0.1%, tazarotene gel 0.05% and 0.1%, triamcinolone acetonide cream 0.1%, terbinafine hydrochloride cream 1%, and vidarabine ointment 3%. Additionally, tacrolimus ointment 0.1% was mixed in a 1:1 weight ratio of several sunscreen products. Combinations were spread in a colorless glass tube and stored at room temperature (30°C) under 500 lux of fluorescent light (room light) for 24 hours. Both visual appearance and tacrolimus concentration remained unchanged (i.e. approximately 100% potency) for all combinations tested. Of special significance is the compatibility of tacrolimus ointment 0.1% with salicylic acid 6%, low-, mid-, and superpotent steroids, and various antibiotic preparations.
Authors have received compensation from Fujisawa Healthcare, Inc. for their work on advisory boards, as lecturers, and through research grants. Research 100% sponsored by Fujisawa Healthcare, Inc.
Masaru Fujiwara, Shuhei Deguchi, and Teruyuki Kitagawa are employees of Fujisawa Pharmaceutical Co., Inc. 100% is Sponsored by Fujisawa Pharmaceutical Co., Inc.
MARCH 2004
P241
J AM ACAD DERMATOL
P63
P240
EVALUATION OF EFFICACY AND SAFETY OF DESLORATADINE SYRUP IN CHILDHOOD ATOPIC DERMATITIS Nicola NB Balato, MD, Universita’ Degli Studi Di Napoli Federico II, Napoli, Italy, Francesca Gaudiello, MD, Fabrizio Ayala, MD, Fabio Ayala, MD Atopic dermatitis (AD) is an inflammatory, pruritic, relapsing, chronic skin disease, that constitutes a significant burden to patients and their families. It currently affects 10% to 15% of children in many parts of the world and its prevalence is increasing. AD tipically begins in early childhood and may continue or recur as adult disease. The management of AD is difficult and reflects the lack of knowledge of the complex pathophysiological mechanisms. Oral antihistamines are usually used alone or, more often, in association with different drugs, for therapy of AD symptoms. Desloratadine, a well-experimented non-sedating anti-H1 molecule devoid of cardiac effects, has been proved safe and useful in children. The rationale for the use of an antihistamine such as desloratadine in the treatment of AD is based on its capacity to reduce erythema, skin hyper-reactivity and itching by blocking the H1 receptors, stabilizing the mast cell membrane, and reducing the expression of adhesion molecules and eosinophil number. Aim of this study was to evaluate the effects of desloratadine as syrup to children with AD. Forty children with AD (aging from 6 to 12; both sex) were enrolled to receive desloratadine syrup (dose: 5ml once a day) for 28 days. The following clinical parameters (erythema, edema/papulation, oozing/crusts, excoriations, lichenification, dryness, itching and sleep loss), were determined by SCORAD INDEX, at the visits planned (days 1, 8, 15 and 29). This study confirms desloratadine as an effective and well tolerated antihistamine in the treatment of AD.
TOLERANCE AND EFFICACY OF A MOISTURIZING BODY CREAM FOR CHILDREN AND ADULTS WITH ATOPIC DERMATITIS. Teresa M Weber, PhD, Beiersdorf Inc, Norwalk, CT, United States, Alexandra Kowcz, MBA, Beiersdorf Inc, Norwalk, CT, United States, Ronald Rizer, PhD, TJ Stephens and Associates, Colorado Springs, CO, United States We evaluated the tolerance and efficacy of a soothing, oil-in-water moisturizing cream containing oatmeal. It was developed to help relieve dry, itchy skin, especially in patients with with atopic dermatitis. Product safety was established by a battery of tests, including repeat insult patch, phototoxicity and photoallergy tests, and controlled usage safety tests conducted with atopic children and adults. Tolerance in children was demonstrated in 25 atopic and 25 normal children, aged 2 through 12, whose parents applied the product to the entire body and face. After two weeks of daily use, there were no clinically significant irritation scores. In a similar study of 30 atopic adults, a lack of subjective and objective irritation was also demonstrated. Moisturization efficacy was demonstrated in a study of 30 adults with dry, itchy skin on the lower legs. Subjects applied the cream in the morning and evening, assessing itch intensity before application, and at 2, 10, 30, and 120 minutes after application. Itch was significantly relieved at each post-application time point, and improved significantly throughout the two weeks of product usage. After two weeks, significant moisturization was also observed, by skin hydration meter readings, clinical grading of dryness and cracking, and assessments of coarse and fine flakes, using image analysis of skin surface squame samples. When the product was discontinued for a week, regression of moisturization and itch relief benefits was observed. The subjects’ responses to questions that probed product efficacy and aesthetics were highly favorable. Taken together, these data demonstrate exceptional tolerance and efficacy of the product formulation for dry, itchy skin, especially associated with atopic dermatitis.
Disclosure not available at press time. The study was carried out by the institution grant of Schering Plough, Italy.
Weber and Kowcz are employees of Beiersdorf Inc. 100% sponsored by Beiersdorf Inc
P239 TREATMENT, RESOURCES, AND IMPACT OF ATOPIC DERMATITIS-THE TRIAD STUDY Mark Boguniewicz, MD, National Jewish Medical and Research Center, and University of Colorado School of Medicine, Denver, CO, United States, William Abramovits, MD, Baylor University Medical Center and University of Texas Southwestern School of Medicine, Dallas, TX, United States, Diane Whitaker-Worth, MD, University of Connecticut Health Center, Farmington, CT, United States, Amy Paller, MD, Northwestern University Medical School and Children’s Memorial Hospital, Chicago, IL, United States Background. Atopic dermatitis (AD) increases health care utilization, affects patient quality of life, places a burden on caregivers, decreases patient/parent productivity, and adds to health care costs. While other studies have assessed the total burden of AD and its impacts on quality of life, few studies have examined the effect of specific treatment modalities across a variety of AD-related outcomes. Methods. A prospective, multi-center, open-label study was conducted to evaluate the effect of tacrolimus ointment on AD-related outcomes over 6 months. Adult and pediatric patients were eligible for enrollment only if they had moderate to severe disease based on Rajka and Langeland criteria. Data were collected at baseline (prior to treatment with tacrolimus ointment) and each month for 6 months across the following domains: clinical outcome, health care utilization/out-of-pocket costs, productivity/absenteeism, compliance, physical appearance, and quality of life. Results. Five centers around the country enrolled a total of 40 evaluable patients (18 adult; 22 pediatric patients). The mean age was 23.8; 67.5% were female; 52.5% were Caucasian; 72.5% had moderate disease at baseline. BSA and EASI scores for patients treated with tacrolimus decreased significantly between baseline, month 1, and end of treatment. Over time, patients treated with tacrolimus ointment reported fewer physician visits, fewer prescription medications for AD, and lower out-of-pocket expenses (p ⬍ 0.01). Patient quality of life also improved. Conclusions. Patients treated with tacrolimus ointment had improved outcomes as measured by clinical, resource utilization, and quality of life endpoints. Future evaluations of patient management strategies should incorporate more comprehensive assessments of overall patient outcomes to quantify the outcomes of disease and benefits of specific therapeutic regimens.
PHYSICAL COMPATIBILITY OF TACROLIMUS OINTMENT 0.1% WITH OTHER TOPICAL MEDICATIONS Jacob O Levitt, Mount Sinai Medical Center, New York, NY, United States, Masaru Fujiwara, Fujisawa Pharmaceutical Co., Inc., Osaka, Japan, Shuhei Deguchi, Fujisawa Pharmaceutical Co., Inc., Osaka, Japan, Teruyuki Kitagawa, Fujisawa Pharmaceutical Co., Inc., Osaka, Japan Tacrolimus ointment 0.1% is indicated for moderate to severe atopic dermatitis and is currently widely used for a variety of other inflammatory cutaneous conditions. Given its widespread acceptance, tacrolimus ointment is often used in patients who apply other medicines. In this study, the compatibility of tacrolimus ointment with over thirty topical products was evaluated. Combinations included 1:1 weight ratio of tacrolimus ointment 0.1% and: acyclovir 5% ointment, aclometasone dipropionate ointment 0.1%, amcinonide 0.1% ointment, bacitracin/fradiomycin sulfate, betamethasone valerate ointment 0.12%, betamethasone valerate/gentamicin sulfate ointment 0.12%, calcipotriene cream and ointment 0.005%, clobetasol propionate ointment 0.05%, clotrimazole cream 1%, desonide ointment 0.05%, diflucortolone valerate ointment 0.1%, difluprednate ointment 0.05%, fluticasone propionate cream 0.05%, gentamicin sulfate ointment 0.15, hydrocortisone valerate ointment 0.2%, ibuprofen piconol ointment 5%, mometasone furoate cream 0.1%, prednisolone valerate acetate ointment 0.3%, salicylic acid gel 6%, tazarotene cream 0.05% and 0.1%, tazarotene gel 0.05% and 0.1%, triamcinolone acetonide cream 0.1%, terbinafine hydrochloride cream 1%, and vidarabine ointment 3%. Additionally, tacrolimus ointment 0.1% was mixed in a 1:1 weight ratio of several sunscreen products. Combinations were spread in a colorless glass tube and stored at room temperature (30°C) under 500 lux of fluorescent light (room light) for 24 hours. Both visual appearance and tacrolimus concentration remained unchanged (i.e. approximately 100% potency) for all combinations tested. Of special significance is the compatibility of tacrolimus ointment 0.1% with salicylic acid 6%, low-, mid-, and superpotent steroids, and various antibiotic preparations.
Authors have received compensation from Fujisawa Healthcare, Inc. for their work on advisory boards, as lecturers, and through research grants. Research 100% sponsored by Fujisawa Healthcare, Inc.
Masaru Fujiwara, Shuhei Deguchi, and Teruyuki Kitagawa are employees of Fujisawa Pharmaceutical Co., Inc. 100% is Sponsored by Fujisawa Pharmaceutical Co., Inc.
MARCH 2004
P241
J AM ACAD DERMATOL
P63