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The effect of itraconazole on patients with atopic dermatitis of the head and upper trunk
POSTER DISCUSSION SESSION 494— INFECTIONS AND ANTI-INEFFECTIVES
P21 DAPSONE GEL 5% IS AN EFFECTIVE, SAFE, NOVEL TOPICAL TREATMENT OF ACNE VULGARIS David Wilson, MD, The Educational & Research Foundation, Inc., Forest, VA, United States; James Herndon, MD, Stephens and Associates, Carrollton, TX, United States; David Whiting, MD, Dallas Associated Dermatologists, Dallas, TX, United States; Alan Shalita, MD, State University of New York, Brooklyn, NY, United States Objective: To determine the efficacy and safety of 5% dapsone topical gel (DTG) in patients with acne vulgaris. Methods: In this multicenter, double-blind, randomized study, patients at least 12 years of age with facial acne vulgaris applied DTG (n = 330) or vehicle gel (n = 166) twice daily for 12 weeks. Evaluations for safety and efficacy included the Global Acne Assessment Score, acne lesion counts, and adverse event incidence rates. Results: Demographics and baseline disease characteristics were similar between treatment groups; baseline severity was moderate for the majority (72%) of patients with mean total lesion counts of 90 (DTG group) and 86 (vehicle group). Significantly greater responses were observed for the DTG group, compared with the vehicle group for all efficacy end points at week 12/end of treatment. Success (Global Acne Assessment Score of \2 at end of treatment) was significantly greater for the DTG treatment group compared with the vehicle treatment group (26.7% vs 18.7%; P = .042). Treatment with DTG versus vehicle resulted in mean percent reduction of 37.2% versus 26.6% for inflammatory, 27.5% versus 16.8% for noninflammatory, and 32.0% versus 21.9% for total lesion counts, (all P \.005). The majority of treatment-related adverse events were application site reactions, reported by fewer than 2% of patients, mild in severity, and not significantly different between treatment groups. Conclusions: Dapsone gel 5% represents a novel, effective, and safe topical therapy for the treatment of acne vulgaris. Sponsored by Fujisawa Healthcare, Inc. and Atrix Laboratories, Inc.
P23 INDUCERS OF EPITHELIAL ANTIMICROBIAL PEPTIDE EXPRESSION: EXPLORING A NEW POTENTIAL CLASS OF DERMATOLOGIC THERAPEUTICS Michael Zasloff, MD, PhD, Georgetown University School of Medicine, Washington, DC, United States; Otto Mills, PhD, Robert Woods Johnson Medical School, New Brunswick, NJ, United States Antimicrobial peptides are expressed on the epithelial surfaces of all animals, both invertebrates, such as insects, and vertebrates, such as humans1 The principal known peptides in human skin include the defensins (HBD1, HBD2, and HBD3) and the cathelicidin LL-37. These peptides are broad-spectrum effectors active against bacteria, fungi, and certain viruses and are believed to provide both anti-infective defense as well as control over the species and number of organisms that normally reside on the skin. All but HBD1 are inducible, generally after injury and exposure to a microbial challenge. Considerable information has been gathered regarding the pathways involved in induction and it is clear that both certain microbial components as well as certain proinflammatory cytokines can induce the expression of these peptides. In certain disorders, such as atopic dermatitis, recent data have suggested that expression of several antimicrobial peptides are inhibited by cytokines associated with the underlying atopic process, such as interleukins 4 and 13, in part explaining the superinfection accompanying eczema. Several years ago we began a search for substances that could induce epithelial antimicrobial peptide expression, exploring a universe of food substances and both pathogenic and commensal organisms. As a result of this survey we discovered that the essential amino acid, isoleucine was a potent inducer2 In this presentation we will describe several of the other agents discovered to have inducing activity and discuss the possible significance of these findings for the practice of dermatology. References 1. Zasloff M. Nature 2002;415:389. 2. Fehlbaum, et al. Proc Nat Acad Sci 2000;197:12723. Nothing to disclose.
P24 THE EFFECT OF ITRACONAZOLE ON PATIENTS WITH ATOPIC DERMATITIS OF THE HEAD AND UPPER TRUNK Shemer Avner, MD, Nir Nathansohn, MD, Henri Trau, MD, C. Sheba Medical Center, Tel Hashomer, Israel Background: Atopic dermatitis usually affects the folds and upper trunk. Atopic dermatitis of the upper trunk area responds less favorably to topical steroids compared with the folds. Mycologic smears proved high concentrations of Malassezia spp on the upper trunk of atopic dermatitis patients.
P22 HIGH-RESOLUTION IMAGING EVALUATION OF ACNE Theresa Chen, PhD, Neutrogena Skincare Institute, Los Angeles, CA, United States; Georgios Stamatas, PhD, Johnson and Johnson Consumer and Personal Products Worldwide, Skillman, NJ, United States; Huayi Dong, MS, I-Ting Wu, BS, Neutrogena Skincare Institute, Los Angeles, CA, United States Acne is a pleomorphic condition. An acne lesion has its beginning in the clogged pores and follicles long before it becomes visible. The microcomedones, unseen by eyes, have thus been appropriately referred to as ‘‘the invisible time bombs of acne.’’ Noninvasive methods that can detect acne lesions before they become visible and also track the course of resolution should enhance understanding of acne etiology and optimize treatment modality. Several high-resolution imaging methodologies, including spectral imaging, have been developed and used to evaluate acne in its visible and invisible states. Also evaluated were the effects of a spot treatment gel on the dynamics of acne lesion resolution. Although the severity of placebo-treated or untreated lesions worsened from baseline and peaked at 24 to 48 hours, the geltreated lesions showed rapid reduction of erythema, edema, and lesion size within 8 hours after the first application. These results demonstrate the power of the imaging techniques in studying acne and in evaluating acne treatment modality. The authors are employed by the manufacturer of the products, Neutrogena Corporation, or its corporate affiliate, Johnson and Johnson Consumer and Personal Products Worldwide. 100% sponsored by Neutrogena Corporation, a Johnson and Johnson Company
P6
J AM ACAD DERMATOL
Purpose: To test whether itraconazole improves the skin condition of patients with atopic dermatitis around the neck and upper trunk Patients: Thirty adult patients with moderate to severe atopic dermatitis entered the study. All had positive direct smear of Malassezia species on the upper trunk and were instructed to apply only emollients 2 weeks before start of study on affected areas. All patients were treated with bifonazole 1% and flucinonide 0.05% cream in the morning and bifonazole 1% cream in the evening to all affected areas, while taking oral itraconazole 200 mg/d for 2 weeks followed by 4 weeks of the topical regimen only. Skin condition was assessed at weeks 2 and 6. Another 6-week regimen was given to all patients whose skin condition on the head and upper trunk was partially improved with the previous course, up to a total of 3 courses. Results: Twenty-seven patients, aged 11 to 39 years (mean 24 years) completed the study and 3 patients were lost to follow-up. Sixteen patients received 1 pulse (6 weeks) of treatment, 5 patients received 2 pulses, and 6 patients received 3 pulses. At the end of the treatment, itraconazole effect on the head and upper trunk’s skin was excellent in 7 of 27 patients (26%). For all patients responding ‘‘excellent’’ to itraconazole, the skin of the upper trunk and head’s response to topical steroids was poor (topical steroids either worsened the skin’s condition or did not help) (P\.01). No such relationship was noted between the response of the folds’ skin to topical steroids and its response to itraconazole. Patients whose skin of the upper trunk was improved by topical steroids only rarely benefited from the addition of itraconazole. Patients’ age and duration of atopic dermatitis were not related to the response to itraconazole. Conclusion: When the skin of atopic patients in the upper trunk and around the neck does not respond well to topical steroids, itraconazole may induce an excellent response, possibly by reducing the concentration of Malassezia yeasts. Nothing to disclose.
MARCH 2005
P21 DAPSONE GEL 5% IS AN EFFECTIVE, SAFE, NOVEL TOPICAL TREATMENT OF ACNE VULGARIS David Wilson, MD, The Educational & Research Foundation, Inc., Forest, VA, United States; James Herndon, MD, Stephens and Associates, Carrollton, TX, United States; David Whiting, MD, Dallas Associated Dermatologists, Dallas, TX, United States; Alan Shalita, MD, State University of New York, Brooklyn, NY, United States Objective: To determine the efficacy and safety of 5% dapsone topical gel (DTG) in patients with acne vulgaris. Methods: In this multicenter, double-blind, randomized study, patients at least 12 years of age with facial acne vulgaris applied DTG (n = 330) or vehicle gel (n = 166) twice daily for 12 weeks. Evaluations for safety and efficacy included the Global Acne Assessment Score, acne lesion counts, and adverse event incidence rates. Results: Demographics and baseline disease characteristics were similar between treatment groups; baseline severity was moderate for the majority (72%) of patients with mean total lesion counts of 90 (DTG group) and 86 (vehicle group). Significantly greater responses were observed for the DTG group, compared with the vehicle group for all efficacy end points at week 12/end of treatment. Success (Global Acne Assessment Score of \2 at end of treatment) was significantly greater for the DTG treatment group compared with the vehicle treatment group (26.7% vs 18.7%; P = .042). Treatment with DTG versus vehicle resulted in mean percent reduction of 37.2% versus 26.6% for inflammatory, 27.5% versus 16.8% for noninflammatory, and 32.0% versus 21.9% for total lesion counts, (all P \.005). The majority of treatment-related adverse events were application site reactions, reported by fewer than 2% of patients, mild in severity, and not significantly different between treatment groups. Conclusions: Dapsone gel 5% represents a novel, effective, and safe topical therapy for the treatment of acne vulgaris. Sponsored by Fujisawa Healthcare, Inc. and Atrix Laboratories, Inc.
P23 INDUCERS OF EPITHELIAL ANTIMICROBIAL PEPTIDE EXPRESSION: EXPLORING A NEW POTENTIAL CLASS OF DERMATOLOGIC THERAPEUTICS Michael Zasloff, MD, PhD, Georgetown University School of Medicine, Washington, DC, United States; Otto Mills, PhD, Robert Woods Johnson Medical School, New Brunswick, NJ, United States Antimicrobial peptides are expressed on the epithelial surfaces of all animals, both invertebrates, such as insects, and vertebrates, such as humans1 The principal known peptides in human skin include the defensins (HBD1, HBD2, and HBD3) and the cathelicidin LL-37. These peptides are broad-spectrum effectors active against bacteria, fungi, and certain viruses and are believed to provide both anti-infective defense as well as control over the species and number of organisms that normally reside on the skin. All but HBD1 are inducible, generally after injury and exposure to a microbial challenge. Considerable information has been gathered regarding the pathways involved in induction and it is clear that both certain microbial components as well as certain proinflammatory cytokines can induce the expression of these peptides. In certain disorders, such as atopic dermatitis, recent data have suggested that expression of several antimicrobial peptides are inhibited by cytokines associated with the underlying atopic process, such as interleukins 4 and 13, in part explaining the superinfection accompanying eczema. Several years ago we began a search for substances that could induce epithelial antimicrobial peptide expression, exploring a universe of food substances and both pathogenic and commensal organisms. As a result of this survey we discovered that the essential amino acid, isoleucine was a potent inducer2 In this presentation we will describe several of the other agents discovered to have inducing activity and discuss the possible significance of these findings for the practice of dermatology. References 1. Zasloff M. Nature 2002;415:389. 2. Fehlbaum, et al. Proc Nat Acad Sci 2000;197:12723. Nothing to disclose.
P24 THE EFFECT OF ITRACONAZOLE ON PATIENTS WITH ATOPIC DERMATITIS OF THE HEAD AND UPPER TRUNK Shemer Avner, MD, Nir Nathansohn, MD, Henri Trau, MD, C. Sheba Medical Center, Tel Hashomer, Israel Background: Atopic dermatitis usually affects the folds and upper trunk. Atopic dermatitis of the upper trunk area responds less favorably to topical steroids compared with the folds. Mycologic smears proved high concentrations of Malassezia spp on the upper trunk of atopic dermatitis patients.
P22 HIGH-RESOLUTION IMAGING EVALUATION OF ACNE Theresa Chen, PhD, Neutrogena Skincare Institute, Los Angeles, CA, United States; Georgios Stamatas, PhD, Johnson and Johnson Consumer and Personal Products Worldwide, Skillman, NJ, United States; Huayi Dong, MS, I-Ting Wu, BS, Neutrogena Skincare Institute, Los Angeles, CA, United States Acne is a pleomorphic condition. An acne lesion has its beginning in the clogged pores and follicles long before it becomes visible. The microcomedones, unseen by eyes, have thus been appropriately referred to as ‘‘the invisible time bombs of acne.’’ Noninvasive methods that can detect acne lesions before they become visible and also track the course of resolution should enhance understanding of acne etiology and optimize treatment modality. Several high-resolution imaging methodologies, including spectral imaging, have been developed and used to evaluate acne in its visible and invisible states. Also evaluated were the effects of a spot treatment gel on the dynamics of acne lesion resolution. Although the severity of placebo-treated or untreated lesions worsened from baseline and peaked at 24 to 48 hours, the geltreated lesions showed rapid reduction of erythema, edema, and lesion size within 8 hours after the first application. These results demonstrate the power of the imaging techniques in studying acne and in evaluating acne treatment modality. The authors are employed by the manufacturer of the products, Neutrogena Corporation, or its corporate affiliate, Johnson and Johnson Consumer and Personal Products Worldwide. 100% sponsored by Neutrogena Corporation, a Johnson and Johnson Company
P6
J AM ACAD DERMATOL
Purpose: To test whether itraconazole improves the skin condition of patients with atopic dermatitis around the neck and upper trunk Patients: Thirty adult patients with moderate to severe atopic dermatitis entered the study. All had positive direct smear of Malassezia species on the upper trunk and were instructed to apply only emollients 2 weeks before start of study on affected areas. All patients were treated with bifonazole 1% and flucinonide 0.05% cream in the morning and bifonazole 1% cream in the evening to all affected areas, while taking oral itraconazole 200 mg/d for 2 weeks followed by 4 weeks of the topical regimen only. Skin condition was assessed at weeks 2 and 6. Another 6-week regimen was given to all patients whose skin condition on the head and upper trunk was partially improved with the previous course, up to a total of 3 courses. Results: Twenty-seven patients, aged 11 to 39 years (mean 24 years) completed the study and 3 patients were lost to follow-up. Sixteen patients received 1 pulse (6 weeks) of treatment, 5 patients received 2 pulses, and 6 patients received 3 pulses. At the end of the treatment, itraconazole effect on the head and upper trunk’s skin was excellent in 7 of 27 patients (26%). For all patients responding ‘‘excellent’’ to itraconazole, the skin of the upper trunk and head’s response to topical steroids was poor (topical steroids either worsened the skin’s condition or did not help) (P\.01). No such relationship was noted between the response of the folds’ skin to topical steroids and its response to itraconazole. Patients whose skin of the upper trunk was improved by topical steroids only rarely benefited from the addition of itraconazole. Patients’ age and duration of atopic dermatitis were not related to the response to itraconazole. Conclusion: When the skin of atopic patients in the upper trunk and around the neck does not respond well to topical steroids, itraconazole may induce an excellent response, possibly by reducing the concentration of Malassezia yeasts. Nothing to disclose.
MARCH 2005