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Practical pediatric protocol for sequential combination acne therapy
P138
P140
NEUROTICISM, ACNE SEVERITY, AND QUALITY OF LIFE Steven Feldman, MD, PhD, Alan Fleischer Jr, MD, Department of Dermatology, Wake Forest University School of Medicine, Winston-Salem, NC, United States; Derek Rapp, BS, Stephen Rapp, PhD, Department of Psychiatry, Wake Forest University School of Medicine, Winston-Salem, NC, United States
PHARMACOKINETICS OF 5% DAPSONE TOPICAL GEL DEMONSTRATES MINIMAL SYSTEMIC EXPOSURE Diane Thiboutot, MD, Penn State University College of Medicicne, Hershey, PA, United States; Harry Sharata, MD, PhD, Madison Skin & Research, Inc., Madison, WI, United States; Susan Taylor, MD, St. Luke’s Roosevelt Hospital Center, New York, NY, United States; Rebat Halder, MD, Howard University, Washington, DC, United States Objective: To evaluate the pharmacokinetic profile and safety of 5% dapsone topical gel (DTG) in patients with acne vulgaris. Methods: Two separate studies, a single-center, open-label, cross-over design pharmacokinetic (PK) study (n = 18) as well as a 1-year, multicenter, open-label, noncomparative long-term (LT) study (n = 506) were conducted. In both studies, patients applied DTG twice daily to acne-involved areas of the face, back, shoulders, and chest. Plasma dapsone levels were obtained at multiple time points during both studies after topical exposure and in a subset of patients who received a single 100mg dose of oral dapsone in the PK study.
Quality of life (QOL) has become an important outcome in dermatology. Treatments are being evaluated for efficacy and for their impact on QOL. QOL will be influenced by biological, psychological, and social factors in addition to the severity of acne symptoms. Identifying these associated factors is important for understanding the true impact of acne on people. Elucidating the factors associated with acne-related QOL can lead to more effective multimodal treatments. Chronic anxiety is a marker for the personality trait of neuroticism. Neuroticism has been associated with poorer mental health outcomes and QOL and more frequent physical complaints in many patient groups. Little is known about whether neuroticism is associated with acne severity or acne-related QOL. Four hundred eighty persons (16-52 years old) with acne completed a survey of acne and its impact. Individuals describing themselves as at least moderately anxious most of the time were classified as ‘‘high neuroticism’’ (HN) and compared with individuals reporting infrequent anxiety (‘‘low neuroticism’’ [LN]). HN respondents were younger; they reported greater acne severity; poorer global, skin-related, and acne-specific QOL; and more negative mood states (for all, P values \ .01). HN respondents also washed their face more often than LN respondents (P \.004). Results were the same when analyses adjusted comparisons for acne severity and age. Acne severity also was significantly associated with global, dermatology-specific, and acne-specific QOL (for all, P \.01). These associations indicate that neuroticism is an important influence over the way in which acne affects a person in addition to the severity of acne symptoms. Neuroticism levels could be used to identify patients likely to experience poorer adjustment.
Results: In the PK study, systemic exposure after topical application of DTG, calculated by area under the curve (AUC), was 126- to 145-fold lower than for oral dapsone. The median peak plasma dapsone level was 16.44 ng/mL after 14 days’ topical application of DTG and was 1342 ng/mL after the 100-mg oral dapsone dose. In the LT study, plasma levels of dapsone were low and remained low throughout the study; the median plasma dapsone levels ranged between 3.9 and 7.7 ng/mL over 1 year. Conclusions: Following long-term, twice-daily topical application of DTG, there is low systemic exposure without accumulation; additionally, total systemic exposure and peak plasma levels are approximately 100-fold lower than those seen with oral dapsone.
Supported by Johnson & Johnson Supported by Fujisawa Healthcare, Inc. and Atrix Laboratories, Inc.
P141 P139 ONCE-DAILY USE OF A PATENTED PAD FORMULATION OF BENZOYL PEROXIDE IN COMBINATION WITH A TOPICAL RETINOID: AN EVALUATION OF CHEMICAL STABILITY, EFFICACY, AND TOLERABILITY James Del Rosso, DO, University of Nevada School of Medicine, Las Vegas, NV, United States
PRACTICAL PEDIATRIC PROTOCOL FOR SEQUENTIAL COMBINATION ACNE THERAPY James Campbell Jr, MD, MS, Dartmouth Medical School, Dover, NH, United States
The value of combination therapy with benzoyl peroxide and a topical retinoid in the management of acne is well established, effectively reducing both inflammatory and noninflammatory lesions. Most often, benzoyl peroxide is applied in the morning and the retinoid in the evening requiring two medication applications per day. A novel pad formulation of benzoyl peroxide has been shown to provide even and diffuse drug application to facial skin and a high level of patient acceptability and preference, especially among teenagers. This poster evaluates the chemical stability of benzoyl peroxide and topical retinoids when applied concurrently on the pad vehicle. The efficacy and tolerability of concurrent use once daily is also assessed in an open-label trial.
Acne is a common, often self-limiting dermatologic disorder that involves the pilosebaceous units of the skin. It affects persons of all ages, from neonates/infants to adults, although it tends to occur most commonly in the adolescent population. The management of acne has evolved significantly during the past 30 years. A deeper understanding of the pathophysiology of acne has led to the development of novel formulations of topical and systemic therapies for acne. Recognition and differentiation between lesion type, specifically comedonal and inflammatory lesions, has begun to play a more pivotal role in maximizing treatment options, including combination therapy. This poster will review various cases utilizing a sequence of therapy beginning with combination topical retinoid adapalene gel with the oral antibiotic doxycylcine hyclate, and then transitioning to topical clindamycin 1%/benzoyl peroxide 5% gel and topical adapalene gel. Specifically, for the pediatric patient, this sequential combination approach has proven effective and convenient as a once-daily treatment regimen. Patient, physician, and photographic assessments are reported at baseline and at monthly visits up to 3 months.
Medicis, Allergan, Galderma, Stiefel, Dermik 100% sponsored by Medicis
Galderma Laboratories, Warner-Chilcott 100% supported by Galderma
P20
J AM ACAD DERMATOL
MARCH 2005
P140
NEUROTICISM, ACNE SEVERITY, AND QUALITY OF LIFE Steven Feldman, MD, PhD, Alan Fleischer Jr, MD, Department of Dermatology, Wake Forest University School of Medicine, Winston-Salem, NC, United States; Derek Rapp, BS, Stephen Rapp, PhD, Department of Psychiatry, Wake Forest University School of Medicine, Winston-Salem, NC, United States
PHARMACOKINETICS OF 5% DAPSONE TOPICAL GEL DEMONSTRATES MINIMAL SYSTEMIC EXPOSURE Diane Thiboutot, MD, Penn State University College of Medicicne, Hershey, PA, United States; Harry Sharata, MD, PhD, Madison Skin & Research, Inc., Madison, WI, United States; Susan Taylor, MD, St. Luke’s Roosevelt Hospital Center, New York, NY, United States; Rebat Halder, MD, Howard University, Washington, DC, United States Objective: To evaluate the pharmacokinetic profile and safety of 5% dapsone topical gel (DTG) in patients with acne vulgaris. Methods: Two separate studies, a single-center, open-label, cross-over design pharmacokinetic (PK) study (n = 18) as well as a 1-year, multicenter, open-label, noncomparative long-term (LT) study (n = 506) were conducted. In both studies, patients applied DTG twice daily to acne-involved areas of the face, back, shoulders, and chest. Plasma dapsone levels were obtained at multiple time points during both studies after topical exposure and in a subset of patients who received a single 100mg dose of oral dapsone in the PK study.
Quality of life (QOL) has become an important outcome in dermatology. Treatments are being evaluated for efficacy and for their impact on QOL. QOL will be influenced by biological, psychological, and social factors in addition to the severity of acne symptoms. Identifying these associated factors is important for understanding the true impact of acne on people. Elucidating the factors associated with acne-related QOL can lead to more effective multimodal treatments. Chronic anxiety is a marker for the personality trait of neuroticism. Neuroticism has been associated with poorer mental health outcomes and QOL and more frequent physical complaints in many patient groups. Little is known about whether neuroticism is associated with acne severity or acne-related QOL. Four hundred eighty persons (16-52 years old) with acne completed a survey of acne and its impact. Individuals describing themselves as at least moderately anxious most of the time were classified as ‘‘high neuroticism’’ (HN) and compared with individuals reporting infrequent anxiety (‘‘low neuroticism’’ [LN]). HN respondents were younger; they reported greater acne severity; poorer global, skin-related, and acne-specific QOL; and more negative mood states (for all, P values \ .01). HN respondents also washed their face more often than LN respondents (P \.004). Results were the same when analyses adjusted comparisons for acne severity and age. Acne severity also was significantly associated with global, dermatology-specific, and acne-specific QOL (for all, P \.01). These associations indicate that neuroticism is an important influence over the way in which acne affects a person in addition to the severity of acne symptoms. Neuroticism levels could be used to identify patients likely to experience poorer adjustment.
Results: In the PK study, systemic exposure after topical application of DTG, calculated by area under the curve (AUC), was 126- to 145-fold lower than for oral dapsone. The median peak plasma dapsone level was 16.44 ng/mL after 14 days’ topical application of DTG and was 1342 ng/mL after the 100-mg oral dapsone dose. In the LT study, plasma levels of dapsone were low and remained low throughout the study; the median plasma dapsone levels ranged between 3.9 and 7.7 ng/mL over 1 year. Conclusions: Following long-term, twice-daily topical application of DTG, there is low systemic exposure without accumulation; additionally, total systemic exposure and peak plasma levels are approximately 100-fold lower than those seen with oral dapsone.
Supported by Johnson & Johnson Supported by Fujisawa Healthcare, Inc. and Atrix Laboratories, Inc.
P141 P139 ONCE-DAILY USE OF A PATENTED PAD FORMULATION OF BENZOYL PEROXIDE IN COMBINATION WITH A TOPICAL RETINOID: AN EVALUATION OF CHEMICAL STABILITY, EFFICACY, AND TOLERABILITY James Del Rosso, DO, University of Nevada School of Medicine, Las Vegas, NV, United States
PRACTICAL PEDIATRIC PROTOCOL FOR SEQUENTIAL COMBINATION ACNE THERAPY James Campbell Jr, MD, MS, Dartmouth Medical School, Dover, NH, United States
The value of combination therapy with benzoyl peroxide and a topical retinoid in the management of acne is well established, effectively reducing both inflammatory and noninflammatory lesions. Most often, benzoyl peroxide is applied in the morning and the retinoid in the evening requiring two medication applications per day. A novel pad formulation of benzoyl peroxide has been shown to provide even and diffuse drug application to facial skin and a high level of patient acceptability and preference, especially among teenagers. This poster evaluates the chemical stability of benzoyl peroxide and topical retinoids when applied concurrently on the pad vehicle. The efficacy and tolerability of concurrent use once daily is also assessed in an open-label trial.
Acne is a common, often self-limiting dermatologic disorder that involves the pilosebaceous units of the skin. It affects persons of all ages, from neonates/infants to adults, although it tends to occur most commonly in the adolescent population. The management of acne has evolved significantly during the past 30 years. A deeper understanding of the pathophysiology of acne has led to the development of novel formulations of topical and systemic therapies for acne. Recognition and differentiation between lesion type, specifically comedonal and inflammatory lesions, has begun to play a more pivotal role in maximizing treatment options, including combination therapy. This poster will review various cases utilizing a sequence of therapy beginning with combination topical retinoid adapalene gel with the oral antibiotic doxycylcine hyclate, and then transitioning to topical clindamycin 1%/benzoyl peroxide 5% gel and topical adapalene gel. Specifically, for the pediatric patient, this sequential combination approach has proven effective and convenient as a once-daily treatment regimen. Patient, physician, and photographic assessments are reported at baseline and at monthly visits up to 3 months.
Medicis, Allergan, Galderma, Stiefel, Dermik 100% sponsored by Medicis
Galderma Laboratories, Warner-Chilcott 100% supported by Galderma
P20
J AM ACAD DERMATOL
MARCH 2005