Where has Goeckerman treatment gone?
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Combined Modality Therapy↗
Biomedical subjects
Steven R Feldman
Publications and source records attributed to Steven R Feldman.
Clobetasol propionate lotion, an efficient and safe alternative to clobetasol propionate emollient cream in subjects with moderate to severe plaque-type psoriasis.
BACKGROUND: Various formulations of clobetasol propionate are currently used to treat psoriasis due to its anti-inflammatory, anti-pruritic, vasoconstrictive and immunomodulating properties. OBJECTIVE: To assess the efficacy, safety and remission profile of clobetasol propionate lotion compared to that of clobetasol propionate emollient cream and lotion vehicle in subjects with moderate to severe plaque-type psoriasis. METHODS: Multicentre, investigator-blind, randomized, active- and vehicle-controlled, parallel-group study. RESULTS: A total of 192 subjects were treated: 82 with clobetasol propionate lotion, 81 with clobetasol propionate cream and 29 with the vehicle. Clobetasol propionate lotion was significantly more effective than vehicle lotion and was comparable in efficacy to the emollient cream after 4 weeks of treatment. Treatment success was higher for subjects in the clobetasol propionate lotion group than in the emollient cream group after 4 weeks of a treatment-free follow-up period. Clobetasol propionate lotion was safe and well tolerated. CONCLUSION: The present study demonstrates that clobetasol propionate lotion is an efficacious, safe and well-tolerated alternative to the currently available emollient cream formulation, while showing a better remission profile after 4 weeks of treatment-free follow-up period.
Administration, Topical↗
Does the teratogenicity of isotretinoin outweigh its benefits?
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Abnormalities, Drug-Induced↗
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↗
Interpretation of dermatopathology specimens is within the standard of care of dermatology practice.
BACKGROUND: Laws have been passed in New York, California, New Jersey, Nevada, Louisiana, and Rhode Island and were recently tabled in South Carolina to prohibit providers from billing for pathology services provided by other physicians. The Ohio proposal included language stating that only board-certified pathologists be able to directly bill for anatomic pathology services. Dermatologists, however, have extensive training in dermatopathology and frequently bill anatomic pathology codes. OBJECTIVE: To determine if interpretation of cutaneous pathology falls within the standard of care of dermatology practice. DESIGN: We used Medicare part A and B claims data from the Medicare Current Beneficiary Survey, 1992 to 2000. We identified surgical pathology claims by Current Procedural Terminology (CPT) code 88305 and those related to skin disease by the associated International Classification of Disease, 9th Revision (ICD-9), code. Weights were applied to obtain nationally representative estimates. The number of physicians in each specialty was obtained from American Medical Association estimates. RESULTS: Pathologists, independent laboratories and group practices, and dermatologists submitted 59%, 26%, and 13% of total claims, respectively. For skin-related diagnoses, pathologists, dermatologists, and independent laboratories and group practices performed 34.5%, 31.2%, and 32.8% of cases, respectively. Assuming that independent laboratory and group practice claims were performed entirely by pathologists, dermatologists and pathologists submitted 1,047 and 1,154 cases/physician, respectively. CONCLUSION: Dermatologists have extensive training in dermatopathology and interpret a large proportion of cutaneous specimens. Interpretation of anatomic pathology, in particular, skin and subcutaneous pathology specimens, falls within the scope of dermatology practice.
Adult↗
Corrective cosmetics are effective for women with facial pigmentary disorders.
Visible facial lesions are a common and burdensome skin problem. This study examines the impact of corrective cosmetics in women with severe facial pigmentary disorders. Enrollment consisted of 73 women with one or more of the following conditions: acne, dermatosis papulosis, hypopigmentation, lentigines, melasma, rosacea, vascular proliferations, or other facial scars. The corrective cosmetic (Dermablend) was applied at the initial visit, at which time instructions and a supply of product were provided. Assessments were conducted at baseline, 2-week, 4-week, and 3-month follow-up visits on 63 patients using the Skindex-16. The corrective cosmetic was well tolerated. There was improvement in Skindex-16 scores after application of the corrective cosmetic, which continued at each follow-up visit and after adjustment for baseline confounders using multiple regression analyses. At 3 months, there was a 30% improvement in Skindex-16 score (P < .001). The corrective cosmetic was well tolerated and represents a valuable option that dermatologists can offer to patients with these conditions.
Adult↗
An open label study of clobetasol propionate 0.05% and betamethasone valerate 0.12% foams in the treatment of mild to moderate acne keloidalis.
Acne keloidalis (AK) is a disease affecting primarily African American men. Topical steroids are a widely accepted treatment of AK; however, no studies have been published investigating their effectiveness. The purpose of this open-label study was to assess the efficacy and tolerability of clobetasol propionate 0.05% and betamethasone valerate 0.12% foams in the treatment of AK in 20 African American patients. These patients were treated for 8 to 12 weeks using a pulsed-dose regimen. We found topical clobetasol propionate foam to be effective in improving AK, and our patients found the foam vehicle to be cosmetically acceptable.
Acne Keloid↗
Adverse event reporting: lessons learned from 4 years of Florida office data.
BACKGROUND: Patient safety regulations and medical error reporting systems have been at the forefront of current health care legislature. In 2000, Florida mandated that all physicians report, to a central collecting agency, all adverse events occurring in an office setting. PURPOSE: To analyze the scope and incidence of adverse events and deaths resulting from office surgical procedures in Florida from 2000 to 2004. METHODS: We reviewed all reported adverse incidents (the death of a patient, serious injury, and subsequent hospital transfer) occurring in an office setting from March 1, 2000, through March 1, 2004, from the Florida Agency for Health Care Administration. We determined physician board certification status, hospital privileges, and office accreditation via telephone follow-up and Internet searches. RESULTS: Of 286 reported office adverse events, 77 occurred in association with an office surgical procedure (19 deaths and 58 hospital transfers). There were seven complications and five deaths associated with the use of intravenous sedation or general anesthesia. There were no adverse events associated with the use of dilute local (tumescent) anesthesia. Liposuction and/or abdominoplasty under general anesthesia or intravenous sedation were the most common surgical procedures associated with a death or complication. Fifty-three percent of offices reporting an adverse incident were accredited by the Joint Commission on Accreditation of Healthcare Organizations, American Association for Accreditation of Ambulatory Surgical Facilities, or American Association for Ambulatory Health Care. Ninety-four percent of the involved physicians were board certified, and 97% had hospital privileges. Forty-two percent of the reported deaths were delayed by several hours to weeks after uneventful discharge or after hospital transfer. CONCLUSIONS: Requiring physician board certification, physician hospital privileges, or office accreditation is not likely to reduce office adverse events. Restrictions on dilute local (tumescent) anesthesia for liposuction would not reduce adverse events and could increase adverse events if patients are shifted to riskier approaches. State and/or national legislation establishing adverse event reporting systems should be supported and should require the reporting of delayed deaths.
Ambulatory Surgical Procedures↗
Biologic therapy for psoriasis: telephone triage.
The past 15 years have been a time of remarkable achievement in the treatment of psoriasis. New topical medications with efficacy and safety have been introduced. At the same time, there has been resurgence in the use of traditional agents such as methotrexate and cyclosporine. An enlightened understanding of psoriasis as an immune-mediated disease has led to the development of unique injectable medications called biologics. All of these developments have occurred in part as we have gained a better understanding of the powerful impact that psoriasis has on patients. The biologics represent a new and exciting class of medications for treating psoriasis. Their novelty is reflected by both excitement and uncertainty. Efficacy rates of the biologics in treating psoriasis are unparalleled and safety data over the short term is promising. However, long-term safety data does not exist. Furthermore, as with any new class of medication, specifically an injectable preparation costing approximately $18,000 to $30,000 annually, concern on the part of patients is expected. Despite any uncertainty, the biologics are drastically altering the arena of psoriasis care. Clinicians have an entirely new class of medications to recommend to patients who have either failed or are not eligible for traditional agents. At the same time, due to the expense of these agents, the relationship between the patient, clinician, and insurer is changing. Certainly the introduction of biologics has created a need for educating clinic staff regarding these therapies. There are barriers to the effective and safe use of the biologics; often, these barriers lie at the level of the patient and depend on his comfort level and understanding of the treatment. This being said, it is the charge of the dermatology community, especially those on the front lines such as nurses, to lead efforts in patient education to ensure the best care for those suffering from psoriasis.
Drug Storage↗
A Simplified Psoriasis Area Severity Index (SPASI) for rating psoriasis severity in clinic patients.
INTRODUCTION: The Psoriasis Area and Severity Index (PASI) is the most widely used tool to assess psoriasis disease severity in clinical trials, although it can be exceedingly cumbersome for use in daily clinical practice. Because clinical trials rely on the PASI for inclusion criteria, having a PASI score on a clinic patient may be useful for determining if the patient has a level of disease severity similar to that of patients treated in clinical trials. PURPOSE: The purpose of this study is to assess a simplified measure of psoriasis disease severity that is more conducive to use in general dermatology practice, the simplified PASI (SPASI). METHODS: We evaluate an area-weighted assessment of lesion severity composed of the sum of the average redness, thickness, and scaliness of all the psoriasis lesions multiplied by an estimate of total body surface area involved. The SPASI is mathematically derived from the PASI. The SPASI and PASI are not identical because of the categorical nature of area estimates used in the PASI. We use existing psoriasis-population data regarding the anatomical distribution of psoriasis lesions to create a simulated patient database. Monte Carlo analysis is then performed to determine the relation between the PASI and SPASI. RESULTS: For a sample population with a mean PASI score of 12.8, the mean SPASI was 14.2. Correlation between the PASI and the SPASI was high (r = 0.90). Bland-Altman analysis showed no consistent bias between the PASI and the SPASI. When attempting to identify simulated patients with a PASI score of 12 (an inclusion criterion for many clinical trials for severe psoriasis), SPASI was 97 percent sensitive and 66 percent specific. DISCUSSION: The SPASI is much less onerous than the PASI, requiring estimation of only four rather than sixteen independent variables. It provides a quick and practical estimate of disease severity similar to the PASI and can be used to communicate that patients have a level of disease severity similar or dissimilar to that of patients studied in clinical trials.
Dermatology↗
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↗
The safety of office-based surgery: review of recent literature from several disciplines.
OBJECTIVE: To review recent literature pertaining to adverse outcomes and mortality associated with office-based surgery. STUDY SELECTION: Representative articles from the general and plastic surgery, medical, health regulatory, and dermatology literature. DATA EXTRACTION: Information regarding which surgical treatments should be performed, which specialties should perform them, what level of anesthesia is appropriate, and who should administer it was assessed, with particular attention to issues of patient safety. CONCLUSIONS: Office-based surgery is safe and cost-effective. We caution against attempts to prohibit or severely restrict this important aspect of medical care.
Ambulatory Surgical Procedures↗
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↗
Combination therapy to treat moderate to severe psoriasis.
In patients with moderate-to-severe psoriasis, remission can be difficult to achieve and sustain. Both acutely acting and long-term maintenance agents are needed. Speed and efficiency of available monotherapies tend to be inversely proportional to safety. Combination, rotational, and sequential approaches are often more effective and safer than single-agent therapy. Combining agents with complementary adverse effect profiles is preferable. Apparent synergistic enhancement is seen with most paired combinations of the four major therapies: acitretin, phototherapy (ultraviolet B/psoralen plus ultraviolet A), cyclosporine, and methotrexate. Of those, only cyclosporine in combination with psoralen plus ultraviolet A is contraindicated because of increased cancer risk. Combinations of each of those major therapies with topical agents (retinoids, steroids, vitamin D derivatives, and others) have been used with varying efficacy and safety. The immunomodulators, hydroxyurea and thioguanine, have also shown some success in combination therapy. The new biologic agents with their novel modes of action and adverse effect profiles may prove to be important adjuncts in combination/rotational/sequential approaches. In some cases, monotherapy (with either systemic agents or phototherapy) adequately controls moderate to severe disease. A regimen using a single agent has the advantages of lower cost and greater adherence by the patient. For any number of reasons, however, including loss of efficacy, adverse effects, or cumulative or acute toxicity-and especially the inability to clear resistant lesions-a single modality will not be adequate. Using two or more therapies is thus the rule rather than the exception for most patients with moderate-to-severe psoriasis, but picking a combination that serves to balance safety and efficacy needs careful consideration, especially since no evidence-based treatment guidelines exist.
Acitretin↗
A 50% reduction in the Psoriasis Area and Severity Index (PASI 50) is a clinically significant endpoint in the assessment of psoriasis.
A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis. Many consider this endpoint to be too stringent as it places potentially useful therapies at risk of failing to demonstrate efficacy. We hypothesized that a 50% reduction in the PASI score (PASI 50) represents a meaningful change in a person's life and thus is a better primary endpoint. To test this hypothesis, we analyzed PASI scores, quality of life (QoL) data, and desired re-treatment scores from a number of clinical trials in addition to studying individual elements that make up the PASI. This analysis shows (1). the PASI score is not linearly reflective of psoriasis severity (eg, a reduction in area of 95% without a change in redness, scaliness, and induration translates to only a 66% reduction in PASI); conversely, a drop in erythema, scale, and induration from an average of 3 to 1 would not lead to a 75% reduction in PASI; (2). treatment with methotrexate, an effective psoriasis therapy, more frequently reaches PASI 50 than PASI 75 as evidenced by a recent open trial in which 63% of patients achieved PASI 50 versus 26% achieving PASI 75; (3). improvement in QoL exists at PASI 50, using the Dermatology Quality of Life Index, as documented in several recently completed large clinical trials; (4). patients achieving PASI 75 frequently defer therapy until they are well below PASI 50; a clinical trial where retreatment was patient initiated showed patients did not re-treat until their PASI dropped to an average of 20% improvement from baseline; and (5). effective, meaningful therapies are consistently differentiated from placebo at PASI 50 as evidenced by histologic and photographic parameters of clinical trials of alefacept, efalizumab, and etanercept. We conclude that PASI 50 equates to a clinically meaningful improvement in psoriasis and represents a discerning primary endpoint.
Humans↗