Baseline patient-reported outcomes from UNITE: an observational, international, multicentre registry to evaluate hidradenitis suppurativa in clinical practice.

BACKGROUND: Hidradenitis suppurativa (HS) is a chronic, inflammatory, skin condition associated with many comorbidities and often has a substantial impact on patients' lives. OBJECTIVES: To evaluate symptom burden and health-related quality of life (HRQoL) at baseline in patients with HS in an observational, real-world, clinical setting using several tools including a validated HS-specific instrument. METHODS: This study evaluated HRQoL data from the international UNITE HS disease registry. Administration of patient-reported outcome (PRO) instruments and collection of data were executed per local regulations. All data were assessed using descriptive statistical methods. RESULTS: PRO data from 529 adults and 65 adolescents were evaluated. Most adults (64.5%) and adolescents (73.8%) were classified as Hurley Stage II with substantial disease burden at baseline. HS had a large effect (mean DLQI = 12.6) and moderate effect (mean CDLQI = 6.9) on the lives of adults and adolescents, respectively. Approximately 58% of adults and 41% of adolescents had anxiety scores beyond the normal range; 30% of adults and 16% of adolescents exhibited symptoms of depression. Based on HSSA and HSIA scores, approximately 30% of adults reported a substantial burden of multiple HS clinical symptoms and more than 45% reported a significant emotional impact of HS that adversely affected their intimate relationships. Only 60% of adults were employed and of those, 64% reported at least some degree of impairment while working because of HS. CONCLUSIONS: Based on PROs collected from patients enrolled in the UNITE registry, a real-world, clinical setting, HS has a significant negative impact on the everyday lives of patients affected by this disease.

An evidence-based review of systemic treatments for itch.

BACKGROUND AND OBJECTIVE: Many treatment modalities are used for itch treatment in daily medical practices without adequate evidence of their efficacy. The purpose of this study was to provide an evidence-based review of the literature as to the clinical benefits of systemic anti-itch treatments. DATABASES AND DATA TREATMENT: We performed a systematic review and, when appropriate, meta-analysis from available placebo-controlled randomized controlled trails (RCTs). A systematic search of the literature was performed using Pub Med, Cochrane Library and EMBASE. The primary outcome was the change in the itch score comparing the intervention group and placebo group. The meta-analysis method was used to calculate the pooled outcome of each treatment modality. RESULTS: Twenty-six eligible RCTs were included. We found evidence for the effectiveness of: naltrexone (in cholestatic itch and atopic eczema), nalfurafine (in uraemic itch), gabapentin (in uraemic itch) and ursodeoxycholic acid (in intrahepatic cholestasis of pregnancy). The results of two RCTs with naltrexone in uremic itch are conflicting. On the other hand, we did not find any benefit from ondansetron (in cholestatic and uraemic itch), ergocalciferol (in uraemic itch), colesevelam (in cholestatic itch) or gabapentin (in cholestatic itch). The possible effectiveness of sertraline, paroxetine, cromolyn sodium, zinc sulphate, omega-3 fatty acid, montelukast, doxepin and rifampin need to be confirmed from future large studies, because the available evidence is insufficient. CONCLUSIONS: The findings from this study suggest the effective therapeutic approaches for itch. The major limitations are that there are small numbers of available RCTs and methodological differences across studies.

Diagnosed skin diseases among migrant farmworkers in North Carolina: prevalence and risk factors.

Skin diseases are common among farmworkers, yet little research documents their prevalence and risk factors. This analysis documents the prevalence of skin diseases among farmworkers in North Carolina, examines variation in the prevalence across the agricultural season, and delineates factors associated with skin disease. Data are from a longitudinal surveillance study with assessments at approximately three-week intervals from May through October 2005. The sample included 304 farmworkers from 45 camps with 1048 data points. Data collection included a structured interview and a standard set often digital photographs. A board-certified dermatologist reviewed the photographs and made specific diagnoses in five categories: inflammatory disease, infection, pigmentary disorder, tumor, and trauma. The prevalences of the five skin disease categories and specific diagnoses are described with counts and frequencies for the entire season and for six time periods. The inflammatory disease and infectious disease categories are modeled with an extension of logistic regression that accounts for repeated measures and clustering of farmworkers within camps. Farmworkers experience high levels of inflammatory skin disease (57.2%) including acne, folliculitis, and contact dermatitis; infectious skin disease (73.8%) including tinea pedis, onychomycosis, and warts; pigmentary disorders (19.1%); and trauma (34.5%). The odds of inflammatory skin disease decreased with age, while those for infectious skin disease increased with age. The odds of inflammatory skin disease increased with pesticide exposure and decreasing housing quality. Skin diseases are highly prevalent among farmworkers. Research is needed to delineate specific factors causing high levels of infection and inflammation in this population.

A topical azithromycin preparation for the treatment of acne vulgaris and rosacea.

BACKGROUND: Erythromycin is a common therapy for acne and rosacea. A newer macrolide, azithromycin, offers superior tissue distribution and cellular concentration and is an effective oral anti-acne agent. Topical formulations such as erythromycin have been a major clinical therapy for acne. To date, no topical solution of azithromycin is available for the treatment of acne. OBJECTIVE: To prepare a stable topical 2% azithromycin formulation that could be used in an acne clinical trial to determine the efficacy of topical azithromycin in treating subjects with acne vulgaris and acne rosacea. METHODS: The study was divided into two phases. In phase I, azithromycin was prepared over a range of ethanol/water concentrations to determine solubility. The stability of a 2% azithromycin in 60% ethanol/water preparation was assessed by high-pressure liquid chromatography. The temperature, light, and pH dependence of the stability was also assessed. In phase II, a single center, randomized, double-blind, treatment-controlled study compared once-nightly application of topical 2% azithromycin versus 2% erythromycin. A total of 20 subjects with moderate inflammatory acne and 20 with rosacea were examined clinically at 0, 2, 4, 8, and 12 weeks for a 12-week period. Efficacy was evaluated with the Physician's Visual Analog Scale evaluation (PVAS), the papulopustule count, and acne severity rating (in subjects with acne). RESULTS: In phase I, azithromycin was soluble in 60% ethanol/water. A 2% azithromycin in 60% ethanol/water solution maintained stability at room temperature for up to 26 weeks but at 37 degrees C there was some decay (16%) at 26 weeks. The stability was greatest at pH 6.8 and was unaffected by ambient light exposure. In phase II, the number of inflammatory lesions decreased in both acne and rosacea subjects treated with 2% erythromycin (7.56, p=0.03 and 4.4, p=0.01, respectively). Azithromycin was not as effective for the treatment of rosacea. Both azithromycin (p=0.01) and erythromycin (p=0.03) treatment significantly reduced the inflammatory lesion count in acne vulgaris. No significant adverse events were identified in the acne group. In patients with rosacea, transient irritation occurred in five patients. CONCLUSIONS: A 2% azithromycin in 60% ethanol/water solution can be prepared and is stable for at least 6 months at room temperature. The methodology and power of the study were adequate to identify improvement in acne vulgaris and rosacea. Though it appears the formulation of topical azithromycin was at least comparable with topical erythromycin, larger studies would be needed to determine whether topical azithromycin has any significant advantage over topical erythromycin.

Anger and acne: implications for quality of life, patient satisfaction and clinical care.

BACKGROUND: Acne is a common skin disorder with a significant psychological and social impact for some people. Little is known about how personality and emotional traits affect acne and its impact on quality of life and treatment. Trait anger (TA), which is related to heart disease and other morbidities, may also affect acne and patients' adjustment to it. OBJECTIVES: To evaluate the relationship between TA and acne severity, skin-related quality of life, satisfaction with treatment, and adherence to treatment. PARTICIPANTS AND METHODS: A sample of 479 individuals with acne completed a survey instrument to assess acne severity, skin care practices, skin-related quality of life, satisfaction with treatment, adherence, TA and demographic variables. Respondents who reported high TA were compared with individuals with low TA on outcome variables. Regression analyses adjusted for covariates and identified the significant predictors of quality of life, satisfaction and adherence. RESULTS: High TA was unrelated to acne severity (P = 0.2) or frequency of face washing (P = 0.9). Anger was significantly related to both global quality of life (P < 0.001) and skin-related quality of life (P = 0.002) as well as to satisfaction with treatment (P = 0.001) and adherence to treatment advice (P = 0.05) in bivariate analyses. Regression analyses revealed that high TA remained a significant predictor of global (P < 0.001) and skin-related quality of life (P = 0.003) and satisfaction with treatment (P = 0.04), but not adherence to treatment advice (P = 0.8) after controlling for covariates. CONCLUSIONS: Anger is associated with the quality of patients' lives and with their satisfaction with treatment. Care of acne patients should include attention to anger and other chronic emotional states, quality of life, as well as to clinical severity. Simple guidelines are suggested for how clinicians might approach this important aspect of care.

Over-the-counter topical antipruritic agents are commonly recommended by office-based physicians: an analysis of US practice patterns.

BACKGROUND: Pruritus is one of the most common complaints among patients who visit physicians. Over-the-counter topical antipruritic medications are widely recommended by physicians and are self-administered by patients for the treatment of pruritus. However, there are few scientific controlled studies evaluating the effect of these drugs on pruritus. OBJECTIVES: To assess the role of physician-recommended over-the-counter medications for the treatment of pruritus. METHODS: Records were analyzed for office-based physician visits in which over-the-counter antipruritic topical medications were recommended in the National Ambulatory Medical Care Survey between the years 1995 and 2000. RESULTS: The largest proportion of over-the-counter antipruritic agent recommendations were during visits to dermatologists, accounting for 41% of all such recommendations. Other physicians that recommended such agents included family physicians and pediatricians, accounting respectively for 26% and 21% of the recommendations. The most commonly recommended over-the-counter medications included hydrocortisone preparations (72%) and diphenhydramine (15%). Over-the-counter medications were more frequently recommended in the pediatric age group. CONCLUSION: This study demonstrates that over-the-counter medications are frequently recommended for the treatment of pruritus.

Treatment of pityriasis versicolor in the United States.

BACKGROUND: Pityriasis versicolor is a common chronic superficial fungal infection of the skin. OBJECTIVE: The purpose of this study is to determine the frequency of visits for pityriasis versicolor and to assess how it is currently being treated. METHODS: Data from the National Ambulatory Medical Care survey were used from the years 1990-1999. RESULTS: There were 2.9 million visits per year in which pityriasis (tinea) versicolor was listed as a diagnosis; this corresponds to a visit rate of 110 visits per 100,000 persons per year. Visit rates varied among racial and ethnic groups, with the highest visit rates for black people and American Indians/Eskimos. A total of 76% of the medications listed at visits for pityriasis versicolor are FDA approved for the condition; however, many treatments that were prescribed were not. CONCLUSIONS: Given that as many as one-quarter of treatments prescribed for this easily treatable condition are inappropriate, continued education of medical practitioners concerning appropriate treatment options is needed.

Pruritus in adult dermatomyositis.

Dermatomyositis has a significant clinical component of pruritus that has not yet been studied. Pruritus can significantly affect the life of patients. The aim of the present work was to study the degree of pruritus experienced by patients. A four-question survey was sent to patients with documented dermatomyositis. The survey used a 100-mm Visual Analogue Scale (VAS) to describe current, worst and daily pruritus, and the effect this has on daily activities. Twenty-six subjects returned completed questionnaires: four had no pruritus; the majority had a significant amount with means above 50 on the VAS. A mean of 44.6 was found for the effect on daily life. Further studies should be performed to examine the prevalence and severity of pruritus in this population and it's effect on their quality of life. Clinicians must be aware of the significant pruritus and provide adequate therapy to improve quality of life.

Prescribing practices for seborrheic dermatitis vary with the physician's specialty: implications for clinical practice.

The prescribing practices of different medical specialties (dermatology, family medicine, pediatrics and other) for seborrheic dermatitis were analyzed using the National Ambulatory Medical Care Survey (NAMCS). The frequency of use of various antifungal and anti-inflammatory medications was found to differ greatly between specialties, with the greatest difference being seen between dermatologists (who frequently prescribe the antifungal ketoconazole) and non-dermatologists (who most frequently prescribe corticosteroids).

Racial differences in the treatment of pigmentation disorders in outpatient settings: analysis of US national practice data.

OBJECTIVE: Pigmentary disorders tend to disproportionately affect individuals with darker skin pigmentation. An understanding of why certain patients or races present more frequently to physicians would help guide attempts for early interventions and education for these patients. METHODS: Data from the National Ambulatory Medical Care Survey (1996-2000) were used to examine associations between the race/ethnicity of the patient and the type of skin-related visit. We examined the impact of non-white (and separately, black) individuals and Hispanic ethnicity on the probability of a pigmentary disorder or non-pigmentary disorder-related outpatient physician visit in weighted multivariate logistic regression models. RESULTS: Non-white patients have a higher probability of a pigmentary disorder-related skin condition visit than white patients (RR: 1.30; 95% CI: 1.29, 1.31). Black patients are more likely than non-black patients to be seen for a pigmentary disorder (RR: 1.04; 95% CI: 1.03, 1.04). Hispanic patients are less likely to be seen for a pigmentary disorder (RR: 0.90; 95% CI: 0.90, 0.91). This is in contrast to non-pigmentary skin disorder-related visits, where non-white, black, as well as Hispanic patients have a lower probability of visits than white individuals. CONCLUSIONS: There is a race-related differential in the treatment of pigmentary skin disorders, with non-white patients having a probability of receiving more care for these conditions in US outpatient settings. This lends support to our hypothesis that darker pigmentation in non-white populations is the driver of a differential in the utilization of pigmentation-related skin visits.

Class I topical corticosteroid use by psoriasis patients in an academic practice.

BACKGROUND: Psoriasis is a chronic skin disorder that can have a profound impact on the quality of life of patients. The treatment of psoriasis is complicated by the availability of numerous topical agents, systemic agents, and phototherapy. Of the topical preparations available, the ultra-high potency, or Class I steroids, have an important role in treating psoriasis. Their use is most appropriate for the treatment of plaques in regions excluding the face, axilla, groin and genitals. OBJECTIVE: The purpose of this study was to examine the prescribing patterns of Class I topical corticosteroids within a large academic dermatology practice for patients with all types of psoriasis. METHODS: A retrospective chart review of 650 patients with psoriasis from an academic dermatology practice was performed. Class I steroid use was defined as those patients who were observed to be currently using clobetasol propionate, halobetasol propionate, diflorasone, or augmented betamethasone dipropionate. RESULTS: A total of 79% of patients were prescribed topical steroids of any class while 46% of patients were prescribed a Class I steroid. In all, 58% of patients who received topical steroid therapy received a Class I agent; 11% of patients prescribed Class I steroids also received systemic therapy for their psoriasis. Conversely, 35% of patients who received systemic therapy were also receiving Class I topical therapy. DISCUSSION: In our department, Class I topical steroids are commonly used in the treatment of psoriasis. The superpotent topicals are often used as an adjunct to systemic therapy and will likely remain a mainstay of psoriasis therapy.

Physicians underutilize topical retinoids in the management of acne vulgaris: analysis of U.S. National Practice Data.

BACKGROUND: Topical retinoids are effective in the treatment of acne, yet no current guidelines existed in the literature until recently recommending their use as an integral part of mild to moderate acne treatment. OBJECTIVE: To assess whether underutilization of topical retinoids occurs in clinical practice. DESIGN: Weighted data on representative office visits with acne vulgaris diagnoses were analyzed using the National Ambulatory Medical Care Survey (NAMCS), from 1990 to 1999. RESULTS: Of the 54.2 million acne vulgaris visits, retinoids were prescribed at 35.3% visits. Dermatologists prescribed significantly more retinoids than non-dermatologists (39.4%' versus 23%). Dermatology visit was a significant predictor of topical retinoid prescription (RR: 2.27,95% CI: 1.63-3.17). Data suggest that prescribing retinoids for acne has been increasing over the past decade, primarily among dermatologists. CONCLUSION: There is a major difference between suggested treatment guidelines for acne and actual practice in the community. There is distinct under-utilization of topical retinoids for treatment of acne vulgaris by dermatologists and non-dermatologists.

Disease severity and associated family impact in childhood atopic dermatitis.

AIM: To examine the association between childhood atopic dermatitis (AD) severity and family impact at baseline and after an intervention by a physician specialist, using validated measures of both severity and family impact. METHODS: Cross sectional self administered survey of parent-caregivers of 49 randomly selected children with AD; 35 parents were available for follow up. Family impact was measured using a modified AD Family Impact Scale completed by the parent-caregiver. The child's disease severity was measured using both the investigator's assessment via the Eczema Area and Severity Index (EASI) and the caregiver's assessment via the recently validated Self Assessment Eczema Area and Severity Index (SA-EASI). RESULTS: The parent-caregiver's assessment of severity of the child was the most significant correlate of the family impact of the child's AD (p = 0.65 at baseline and p = 0.38 at follow up). In multivariate regression models, the parent-caregiver's estimate of severity remained the single strongest predictor of family impact before and after receipt of dermatologist care, as well as the difference in impact between pre and post-dermatologist care. CONCLUSIONS: There is evidence to support the ability of parent-caregivers of children with AD to accurately determine severity of their child's AD; perceived severity is the driver of the family impact of this condition. Treatment of a child by a physician specialist is associated with reductions in both perceived severity, as well as family impact of this condition.

Use of the Self-Administered Eczema Area and Severity Index by parent caregivers: results of a validation study.

BACKGROUND: The Eczema Area and Severity Index (EASI) is used by dermatological investigators world-wide to assess eczema disease severity. EASI measures are, however, time-consuming and require trained personnel, thereby limiting its application to large-scale epidemiological studies. Additionally, the use of self-assessed severity indices in dermatology is restricted to adult subjects and conditions, thereby not addressing the needs of paediatric patients. OBJECTIVES: To develop and validate an instrument for a caregiver's self-assessment of the severity of his/her child's atopic dermatitis (AD), the Self-Administered EASI (SA-EASI). METHODS: Trained investigators performed a modified EASI assessment on the same day as an SA-EASI was obtained from 47 caregivers of children with AD. RESULTS: The SA-EASI was found to be a valid measure of the severity of AD. Total, acute and chronic SA-EASI scores predicted total, acute and chronic modified EASI scores (P < 0.0001). SA-EASI body surface area (BSA) scores predicted EASI BSA scores (P < 0.0001). SA-EASI pruritus scores correlated with the acute, chronic and total EASI scores (P = 0.0001). CONCLUSIONS: The SA-EASI may provide caregivers the means to report the severity of their child's skin disease objectively. The high correlation with the EASI score observed in this sample implies that statistical inferences with the SA-EASI will be valid for large populations. In future studies, this will permit analysis of the relationship of skin disease severity to such measures as quality of life, disability, patient satisfaction and the costs of various therapies. Moreover, this SA-EASI instrument may allow older children, over 12 years old, to assess the severity of their AD.

Dermatologists and allergists have far more experience and use more complex treatment regimens in the treatment of atopic dermatitis than other physicians.

BACKGROUND: Atopic dermatitis (AD) is a prevalent skin condition, especially in the pediatric population. Whereas it has been shown that dermatologists prefer using more intensive therapy for AD than generalists, actual drug utilization has not been quantified. OBJECTIVE: The purpose of this study is to characterize visits for and treatment of AD in the office-based setting. METHODS: National Ambulatory Medical Care Survey data from 1990 to 1997 was analyzed to determine the use of topical corticosteroids (including their relative potencies), oral antibiotics, and oral antihistamines in the treatment of AD. RESULTS: There were an estimated 900,000 outpatient visits per year for AD. If in some visits to generalists the diagnosis for AD was miscoded as contact dermatitis, there may have been as many as 3 million outpatient visits per year for AD. Topical corticosteroids were used in 67% of visits with a mean potency rank of 4.5 (4.3, 4.8 95% CI). Dermatologists saw 48% of all visits for AD (63 yearly visits/physician) and allergists saw 10% of visits (30 yearly visits/physician). Other physicians saw from 0.1 to 2 yearly visits per physician. Dermatologists were the most likely to use topical corticosteroids (81% of visits) and high-potency corticosteroid agents (22% of visits). Dermatologists and allergists were the only physicians to prescribe ultrahigh-potent corticosteroid agents (12% and 9% of visits, respectively) and were more likely than other physicians to use multiple-agent regimens (21% and 27% of visits treated with a corticosteroid agent, respectively). CONCLUSIONS: Dermatologists and allergists have more expertise in the management of AD than other physicians, as suggested by their higher per capita visits and greater use of complex topical corticosteroid regimens.