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Biomedical subjects

Alan B Fleischer

Publications and source records attributed to Alan B Fleischer.

At least 37 records · Page 2Linked to original sources

Gel vehicles are not inherently more irritating than creams.

BACKGROUND: It has been thought that topical gels are inherently more irritating than topical creams. Nevertheless, the irritancies of topical products are potentially quite variable, and a priori assumptions about relative irritancy of gels versus creams may not be accurate. PURPOSE: To determine whether a metronidazole gel formulation is more or less irritating to the skin compared to metronidazole creams. METHODS: A total of 32 normal, healthy volunteers were tested using irritancy patches with 0.75% metronidazole gel and cream, 1% metronidazole cream, and petrolatum (used as the "negative control"). Blinded observers evaluated the application sites for signs of irritancy. A numerical score was assigned to these irritancy patch sites each day for 21 days, or until significant irritation developed, and cumulative irritancy scores were calculated for the study period. A mixed model of variance analysis was performed. RESULTS: After 21 days of evaluation, analysis of the mean cumulative irritancy scores for each of the agents used showed there to be no statistical difference in irritancy potential between the metronidazole gel and the metronidazole creams. However, the 1% metronidazole cream was significantly more irritating than petrolatum. CONCLUSION: There was no significant difference in the cumulative irritancy potential of cream and gel preparations of metronidazole. The irritancy of topical formulations for treating rosacea should be considered on a case by case basis.

Administration, Cutaneous↗

Limited availability of psoriasis and phototherapy care: an analysis of advertisements.

Because the number of dermatologists remains stable, patients with medical dermatologic conditions such as psoriasis may find it increasingly difficult to access dermatological treatment. Measuring the competition in the marketing of dermatologic care may provide insight into the availability of dermatology services. The purpose of this study was to determine to what extent dermatologists are using the Yellow Pages to advertise to patients with psoriasis. We performed a quantitative and qualitative assessment of dermatologists' Yellow Pages advertisements in small cities and the ten largest metropolitan regions in the country. Per capita, more advertisements were found in smaller markets than larger markets and a higher percentage was descriptive rather than just a name, address and phone number. Cosmetic and surgical advertisements were more common than psoriasis ads in both markets. Cosmetic ads were more prevalent in larger markets. In all regions, psoriasis and psoriasis treatment ads were least common. These findings raise the concern that incentive structures in the United States healthcare system do not adequately support delivery of dermatologic care for psoriasis. Efforts to promote psoriasis care should be encouraged.

Advertising↗

Lack of efficacy of tacrolimus ointment 0.1% for treatment of hemodialysis-related pruritus: a randomized, double-blind, vehicle-controlled study.

Pruritus is a common and disabling symptom for patients undergoing hemodialysis. Many topical and systemic treatments have been used for uremic pruritus, mostly in anecdotal reports. A recent case series demonstrated that topical tacrolimus ointment 0.03% had a significant antipruritic effect for patients with uremia. In an attempt to confirm these findings, we conducted a randomized, double-blind, vehicle-controlled study to assess the efficacy of tacrolimus ointment 0.1% for the treatment of hemodialysis-related pruritus. The results of this study do not demonstrate that tacrolimus ointment 0.1% is more effective than vehicle in relieving uremic pruritus.

Administration, Topical↗

Tacrolimus ointment is more effective than pimecrolimus cream with a similar safety profile in the treatment of atopic dermatitis: results from 3 randomized, comparative studies.

OBJECTIVE: To compare the efficacy and safety of tacrolimus ointment and pimecrolimus cream in adult and pediatric patients with mild to very severe atopic dermatitis (AD). METHODS: One thousand and sixty-five patients were randomized to treatment in 3 multicenter, randomized, investigator-blinded, 6-week studies. RESULTS: Based on the Eczema Area Severity Index (EASI), tacrolimus ointment was more effective than pimecrolimus cream at the end of the study in adults (54.1% vs. 34.9%, respectively; P < .0001), in children with moderate/severe disease (67.2% vs. 56.4%, respectively; P = .04), in the combined analysis (52.8% vs. 39.1%, respectively; P < .0001), and at week 1 in children with mild disease (39.2% vs. 31.2%, respectively; P = .04). Tacrolimus was also more effective than pimecrolimus based on the Investigator Global AD Assessment (IGADA), improvement in percentage of total body surface area affected, and improvement in itch scores (P < or = .05), with a faster onset of action. There was no significant difference in the incidence of adverse events (AEs), including application site reactions in the 2 studies involving 650 children. Adults treated with tacrolimus experienced a greater number of local application site reactions on day 1; both groups reported a similar incidence of application site reactions thereafter. More pimecrolimus-treated patients than tacrolimus-treated patients withdrew from the studies because of a lack of efficacy (P < or = .03) or adverse events (P = .002; pediatric mild). CONCLUSION: Tacrolimus ointment is more effective and has a faster onset of action than pimecrolimus cream in adults and children with AD; their safety profiles are similar.

Adolescent↗

The cutaneous surgery experience of multiple specialties in the Medicare population.

BACKGROUND: There has been tremendous growth in the performance of ambulatory surgical procedures. Traditional forms of peer review, commonplace for hospital-based procedures, are not typically performed in the office-based setting. Hospital credentialing of physicians has been suggested to be a means of assuring patient safety. Credentialing committees may be unaware of the level of experience of typical office-based physicians who perform cutaneous surgery. PURPOSE: To compare the levels of cutaneous surgery experience of dermatologists and other surgical specialists. METHODS: Medicare claims data on number of cutaneous surgery procedures performed by various medical disciplines, including dermatologists, plastic surgeons, general surgeons, and others, were obtained from the 1998-1999 Medicare Current Beneficiary Survey (MCBS) and analyzed. The number of physicians in each specialty was used to normalize the data to a per physician basis. RESULTS: Dermatologists performed half (50%) of the complex repairs and most of the excisions (58%) and intermediate repairs (62%). Dermatologists performed more flaps (40% of all flaps) than any other specialty, while plastic surgeons performed more total grafts (38%) than any other specialty. Dermatologists and plastic surgeons performed similar numbers of full-thickness skin grafts, while plastic surgeons performed more split-thickness skin grafts. CONCLUSION: As dermatologists seek hospital credentials for performing cutaneous surgery procedures, these data should help surgical colleagues understand the typical level of experience of their dermatologist colleagues.

Clinical Competence↗

Tacrolimus ointment is safe and effective in the treatment of atopic dermatitis: results in 8000 patients.

OBJECTIVE: We sought to evaluate the safety and efficacy of tacrolimus ointment in a large cohort of adult and pediatric patients with atopic dermatitis (AD). METHODS: A cohort of 3964 adult and 3959 pediatric patients with AD were enrolled in this open-label noncomparative study. Patients applied tacrolimus 0.03% or 0.1% ointment twice daily to the affected areas. Efficacy and safety assessments included percentage of body surface area affected and incidence of adverse events, respectively. RESULTS: A total of 7923 patients were evaluated; 95.5% had severe or moderate AD at baseline. There was a 52% decrease from baseline in the mean percentage of body surface area affected at month 1 and a 91% decrease at month 18. Two of the most common adverse events, skin burning and pruritus, were generally mild, transient in nature, and decreased in prevalence as AD improved. Severity and frequency of other common adverse events were consistent with expected rates in the general population. CONCLUSION: Tacrolimus ointment monotherapy in almost 8000 pediatric and adult patients led to continuous improvement in AD and revealed no change in the safety profile reported in previous clinical trials.

Adult↗

Infliximab for inpatient psoriasis management--is there a role?

BACKGROUND: While outpatient management is a realistic goal for most psoriasis patients, inpatient hospitalization may be required for severe acute exacerbations. The paradigm of inpatient psoriasis treatment has changed as reflected in an overall decline in admissions as well as the introduction of several new agents for patients with moderate to severe disease. With these changes as well as the changes in inpatient health care delivery, the costs of inpatient psoriasis therapy need to be re-examined. PURPOSE: To determine the mean charges and length of stay associated with inpatient admissions for psoriasis and compare these with the potential charges for infliximab administration in the inpatient setting. METHODS: Inpatient psoriasis admissions were identified from the State of Maryland Health Services Cost Review Commission (HSCRC) non-confidential database from 1994 to 2003. The mean length of stay and total charges associated with psoriasis admissions were determined and adjusted to current values based upon the hospital costs component of the Consumer Price Index (CPI). The potential charges for infliximab administration were then estimated according to a presumed treatment paradigm and based on median Medicare reimbursement rates. RESULTS: The mean length of stay for an inpatient psoriasis patient was 4.9 days, and the mean CPI adjusted total charges from 1994 to 2003 were $6736. In 2003, the mean total charges for a psoriasis admission were $7578. The total estimated charges for a 2-day inpatient hospitalization with infliximab administration were $6256. CONCLUSIONS: Although infliximab therapy is not currently approved for psoriasis therapy it does have efficacy and may be a first-line therapy for inpatient treatment. Additionally, the high cost of infliximab may be offset by a decreased overall length of stay and its use is therefore potentially justified.

Antibodies, Monoclonal↗

The comorbid state of psoriasis patients in a university dermatology practice.

BACKGROUND: Psoriasis treatment is frequently complicated by the various types and severities of disease as well as the large number of therapies available. Another critical consideration in treatment planning is the presence of comorbid diseases. PURPOSE: The purpose of this study was to evaluate the relative prevalence of major comorbid disease states in patients with psoriasis and to identify significant predictors of these concurrent diseases in such patients. METHODS: A retrospective chart review of 753 patients from an academic dermatology practice was performed. The patients were identified by ICD-9 code for psoriasis in billing records of patients seen between 1997 and 2000. Data on comorbidities were compiled from review of electronic chart notes from all physician visits in the university practice. RESULTS: Comorbid diagnoses were listed in 551 out of 753 (73%) charts. As would be expected, hypertension, dyslipidaemia, diabetes and heart disease were the most common comorbidities; renal failure and hepatitis were least likely. Hepatitis was associated with use of systemic therapies (odds ratio = 2.19) and non-white race. When compared with national prevalence estimates, psoriasis patients had increased heart disease, hypertension, diabetes and emphysema; however, these findings must be interpreted with some caution. CONCLUSIONS: Comorbid diseases are common in psoriasis patients and should be taken into account during treatment planning and surveillance; they may pose unique challenges in caring for patients with psoriasis, particularly those requiring systemic therapy.

Academic Medical Centers↗

Trends in prescription of acne medication in the US: shift from antibiotic to non-antibiotic treatment.

AIM: To describe trends in the prescription of medication for acne vulgaris in the USA from 1990 to 2002 with particular reference to the shift from antibiotic to non-antibiotic treatment. METHODS: Retrospective cross-sectional observational study which analysed the data from the 4922 patient visits for acne vulgaris from the 1990-2002 National Ambulatory Medical Care Survey (NAMCS) to assess medications mentioned or prescribed at office visits for acne vulgaris. We specifically analysed visits for benzoyl peroxide or combination benzoyl peroxide products, topical retinoids, clindamycin, erythromycin, tetracycline group antibiotics and isotretinoin. A priori predictions were made for changes in physician behaviour over time, and were tested by regression. Multivariate regression also assessed the impact of demographic variables such as patient age, gender, race and type of physician seen on prescribing behaviour. RESULTS: From 1990 to 2002 there were significant declines (p<0.01) in the likelihood of use of several drug classes that are reliant on antimicrobial mechanisms for acne including the following: benzoyl peroxide, topical clindamycin, oral erythromycin and tetracycline group antibiotics. There were significant increases in likelihood of utilization for agents not reliant on antimicrobial mechanisms including topical retinoids and oral isotretinoin during this period. These changes in utilization were not affected by controlling for demographic factors in multivariate analysis. CONCLUSION: There has been a shift towards non-antibiotic treatment in acne management. Growing awareness of antibiotic-resistant Propionibacterium species may contribute to increased use of topical and systemic retinoid agents.

Acne Vulgaris↗

Clinical diagnosis of actinic keratosis identifies an elderly population at high risk of developing skin cancer.

BACKGROUND: Development of actinic keratoses (AK) involves some of the same processes as nonmelanoma skin cancer and may serve as a marker for overall increased risk of skin cancer. OBJECTIVE: The objective of this study was to examine the risk of developing skin cancer in an elderly population with and without AK. METHODS: This was a retrospective observational study. Data from the 1992-1998 Medicare Current Beneficiary Study were used in the analyses. RESULTS: Multivariate analysis showed that the risk (odds ratio [OR]) of developing nonmelanoma or melanoma was increased more than sixfold (p < or = .0001) in patients with AK. An increased risk of skin cancer was found in whites (OR 4.3; p < or = .01) and increased age by year (OR 1.04; p < or = .01). Women were less likely to develop skin cancer (OR 0.58; p < or = .01). CONCLUSION: Using data from a nationally representive sample of the Medicare population, this study demonstrates that elders with AK are a population at high risk of developing cutaneous cancer.

Aged↗

Increase in procedures performed at dermatology office visits from 1995 to 2001.

BACKGROUND: Over the past few decades, dermatologists have expanded the scope of their practice to include many surgical and cosmetic procedures in response to the development and demand for new procedures. OBJECTIVE: To examine the trend from 1995 in the proportion of dermatology visits associated with procedures to determine if there has been an increase in the number of procedures performed. METHODS: Data from the National Ambulatory Medical Care Survey were used to look at the proportion and types of dermatology visits associated with procedures performed during the years 1995 to 2001. RESULTS: There has been a progressive increase in the number of dermatology visits with procedures, occurring in 29.8% of visits in 1995 and 40.0% of visits in 2001. The top procedures performed are that of excision and destruction, including cryotherapy, electrodesiccation and curettage, and biopsies. CONCLUSION: The number of dermatology visits associated with procedures has increased since 1995. With the numerous new procedures and techniques that have emerged and continue to develop in our field, we expect that dermatologists will continue to be providers of medical, as well as surgical, care for the skin.

Ambulatory Care↗

Tacrolimus ointment: utilization patterns in children under age 2 years.

Atopic dermatitis (AD) is a common eczematous skin condition; as many as 10-17 percent of all children are affected, and 35-60 percent of affected patients manifest symptoms manifest during the first year of life. Treatment principles for AD in young children involve conservative measures such as avoidance of hot water and environmental irritants, combined with liberal use of emollients after bathing. Low potency topical corticosteroids (TCS) are the current standard of therapy for AD in young children, reserving mid- and high-potency TCS for severe disease. However, complications of long-term use of TCS include skin atrophy, stria formation, telangiectasia, hypopigmentation, secondary infections, steroid acne, allergic contact dermatitis, and miliaria. The pediatric population is also at increased risk for systemic absorption because of their high ratio of skin surface to body mass. Systemic absorption may result in hypothalamic-pituitary-adrenal axis suppression and ultimately growth retardation. Although most topical and systemic corticosteroids are not approved by the Food and Drug Administration for use in children less than 2 years of age, conservative treatment often fails in this age group and frequently patients are treated with TCS, antibiotics, and antihistamines.

Administration, Cutaneous↗

Statistical significance and clinical relevance: the importance of power in clinical trials in dermatology.

When evaluating the validity of a study, the reader must consider both the clinical and statistical significance of the findings. A study that claims clinical relevance may lack sufficient statistical significance to make a meaningful statement. Conversely, a study that shows a statistically significant difference in 2 treatment options may lack practicality. The concept of power of a clinical trial refers to the probability of detecting a difference between study groups when a true difference exists. We will discuss statistical power by examining studies too small to identify important differences, studies so large as to identify differences that are not clinically significant, difficult-to-design studies without very large patient populations, and those studies with both adequate power and clinically relevant findings. Dermatologists should not focus on small P values alone to decide whether a treatment is clinically useful; it is essential to consider the magnitude of treatment differences and the power of the study.

Clinical Trials as Topic↗

Analysis of factors associated with prescription of a potentially inappropriate combination dermatological medication among US outpatient physicians.

PURPOSE: Despite concern associated with the necessity of an additional fluorinated, high potency topical corticosteroid, the clotrimazole/betamethasone diproprionate combination remains a frequently prescribed topical agent in the US. This research was performed to better understand the physician and patient characteristics associated with the prescription of this combination medication in outpatient settings. METHODS: Data from the National Ambulatory Medical Care Survey (1990-2000) were used to determine the patient and physician factors associated with a prescription for clotrimazole/betamethasone diproprionate. The most common diagnoses of patients treated with the drug were also determined. RESULTS: Family medicine physicians were more than twice as likely (OR: 2.28, 95%CI: 1.56, 3.33) and internists were more than 3 times as likely (OR: 3.10, 95%CI: 1.99, 4.84) to prescribe clotrimazole/betamethasone diproprionate compared to pediatricians, the reference category. Dermatologists were less likely to prescribe these medications compared to pediatricians (OR: 0.35, 95%CI: 0.23, 0.54). Prescription for potentially inappropriate indications was detected across all specialties. Prescription rates of the combination medication were higher among patients of non-white race (OR: 1.56, CI: 1.08, 2.26). CONCLUSIONS: The increased risk of potentially inappropriate prescription of clotrimazole/betamethasone diproprionate by physicians across all specialties and increased probability of medication receipt in racial minorities is of concern, when safer alternatives such as antifungals or anti-inflammatory medications without the side effects of the combination medication are easily available.

Administration, Topical↗