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ABSTRACT. Objective. This study was designed to compare the safety and efficacy of tacrolimus ointment 0.03% with vehicle ointment for the treatment of mild to moderate atopic dermatitis (AD) in pediatric patients.Methods. A total of 317 patients (2-15 years of age) with mild to moderate AD were randomized to receive tacrolimus ointment or vehicle ointment twice daily in a 6-week, multicenter, double-blind study. Efficacy evaluations, including the Investigators' Global Atopic Dermatitis Assessment, eczema area and severity index, percentage of total body surface area affected, and patient assessment of itch occurred at baseline, day 4, and weeks 2, 4, and 6. Cutaneous adverse events were recorded to evaluate safety.Results. At the end of study, 50.6% (80 of 158) of the patients were treated successfully with tacrolimus ointment based on Investigators' Global Atopic Dermatitis Assessment scores, a significant improvement compared with patients treated with vehicle ointment (25.8% [41 of 159]). The percent improvement from baseline in eczema area and severity index scores was also significantly greater in tacrolimus-treated patients (54.8%) compared with vehicle-treated patients (20.8%). There was also a significant improvement in the percentage of total body surface area affected of tacrolimus-treated patients (50.5% reduction from baseline) compared with vehicletreated patients (16.4%). Patient itch scores were significantly lower in tacrolimus-treated patients (2.1) versus vehicle-treated patients (3.7). Overall, the incidence of cutaneous adverse events reported was similar for both treatment groups. There was no significant difference in the incidence of burning or stinging between treatment groups. Significantly fewer tacrolimus-treated patients prematurely discontinued from the study because of a cutaneous adverse event in the treatment area or experienced increased itching and erythema at the application site.Conclusion A topic dermatitis (AD) is a recurrent inflammatory skin disease, with intense pruritus as its hallmark symptom, and often follows a chronic, relapsing course. 1 It frequently affects children, with symptoms developing in 65% of patients before 1 year of age and in 90% by 5 years of age. 2 Although many children will outgrow the condition by 10 years of age, 60% remain symptomatic as adults. 2 If not outgrown in childhood, the condition progresses to adulthood, with recurrent flares that may be severe and sometimes debilitating. The prevalence of AD in the United States is projected to be between 7% and 17% of school-aged children and has increased greatly over the past 40 years. 3 Several quality-of-life issues have been reported in children with AD, including sleep disturbances, changes in activity, irritability, and self-consciousness. 4-8 AD exacts a marked toll on the children and their families through both direct and indirect financial expenses of medical care. Even more significant are the stressful impacts of sleep deprivation, missed school and work, and the time spent on the dai...

The purpose of this study was to examine the safety and efficacy of fluvoxamine in the treatment of psychogenic (neurotic) skin excoriation. Fourteen subjects with psychogenic excoriation were given fluvoxamine in a 12-week, open-label trial after completion of the Structured Clinical Interview for DSM-IV. All subjects met DSM-IV criteria for at least one comorbid psychiatric disorder, with mood disorder the most common. Most subjects' excoriation had features of an impulse control disorder. Both completers (N = 7) and the entire group had significant improvement on the modified Yale-Brown Obsessive Compulsive Scale but no improvement on the Hamilton Rating Scale for Depression. In the self-report data, the seven completers had significant reduction in behaviors involving the skin (e.g., scratching, picking, gouging, or squeezing) and in global assessment of symptoms. Endpoint analysis of all 14 subjects' self-report data demonstrated significant improvement in the presence of skin sensations, skin appearance and lesions, behaviors involving the skin, control over skin behavior, and global assessment. The results of this preliminary open trial suggest that fluvoxamine may be effective in reducing psychogenic excoriation, and this effect seems to be independent of mood. Controlled studies are needed to confirm these findings.