Tacrolimus Ointment 0.03% Is Safe and Effective for the Treatment of Mild to Moderate Atopic Dermatitis in Pediatric Patients: Results From a Randomized, Double-Blind, Vehicle-Controlled Study

Abstract

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...

Comparison of topical tacrolimus 0.1 % in pectin ointment with clobetasol 0.5% ointment in adults with moderate to severe desquamative gingivitis: A 4-week, randomized, double-blind clinical trial

“…However, the chronic nature of the autoimmune mucocutaneous diseases that are often associated with DG might require long-term (6-12 weeks) use of topical tacrolimus, which could be associated with immunosuppressant toxicity, including malignancy. 7,8,[12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28]35,36 The specific cause (ie, oral lichen planus, pemphigoid) of DG was not determined in the 24 patients in this study.…”

Treatment Following an Evidence-Based Algorithm versus Individualised Symptom-Oriented Treatment for Atopic Eczema

“…At each visit we assessed: current objective disease activity by means of the SCORAD, current global disease severity independently assessed by the physician (investigator global assessment, IGA [33]) and by the patient (patient global assessment, PGA), and the current impact of AE on everyday life using the children [34] or adult [35] version of the dermatology life quality index (DLQI; children: 5–16 years; adults: 17 years or older). Quality of life was not assessed in children aged <5 years.…”

“…The IGA and PGA are static instruments to assess global disease severity on a 6-point Likert scale by the physician (IGA) and patient (PGA), respectively [33]. DLQI and Children’s DLQI are widely used instruments with adequate psychometric properties to measure health-related quality of life in dermatological patients.…”

Assessment of the severity of atopic dermatitis

“…Investigators' Global Atopic Dermatitis Assessment), która określa nasilenie choroby od braku zmian do bardzo ciężkiego i zawiera szczegółowo opisane zasady, jak oceniać poszczególne objawy dla każdej z kategorii nasilenia choroby [23]. Skala ta nie jest powszechnie stosowana i potrzeba dalszych badań nad oceną jej wiarygodności [14].…”