Perceptions of Physicians and Pediatric Patients About Atopic Dermatitis, Its Impact, and Its Treatment

Paller, Amy S.; McAlister, Robert; Doyle, Jon; Jackson, Archi

doi:10.1177/000992280204100505

Cited by 87 publications

(50 citation statements)

References 9 publications

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“…1 Childhood AE has a substantial impact on the quality of life of both children and their families. [2][3][4] Standard treatment options for AE focus on topical medications: emollients, with the addition of topical corticosteroids and topical calcineurin inhibitors, tailored according to the severity of the AE. 5 Although most cases of AE can be successfully treated with topical medications, many parents express inconvenience and/or concern in using these preparations and are keen to identify new ways of managing the symptoms of AE using non-pharmacological approaches.…”

Section: Chapter 1 Introductionmentioning

confidence: 99%

Randomised controlled trial of silk therapeutic garments for the management of atopic eczema in children: the CLOTHES trial

Kim

Bradshaw

Sach

et al. 2017

Health Technol Assess

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Background: Atopic eczema (AE) is a chronic, itchy, inflammatory skin condition that affects the quality of life of children and their families. The role of specialist clothing in the management of AE is poorly understood.Objectives: To assess the effectiveness and cost-effectiveness of silk garments for the management of AE in children with moderate to severe disease.Design: Parallel-group, observer-blind, randomised controlled trial of 6 months’ duration, followed by a 2-month observational period. A nested qualitative study evaluated the beliefs of trial participants, health-care professionals and health-care commissioners about the use of silk garments for AE.Setting: Secondary care and the community in five UK centres.Participants: Children aged 1–15 years with moderate or severe AE.Interventions: Participants were randomised (1 : 1 using online randomisation) to standard care or standard care plus 100% silk garments made from antimicrobially protected knitted sericin-free silk [DermaSilkTM (AlPreTec Srl, San Donà di Piave, Italy) or DreamSkinTM (DreamSkin Health Ltd, Hatfield, UK)]. Three sets of garments were supplied per participant, to be worn for up to 6 months (day and night). At 6 months the standard care group received the garments to use for the remaining 2-month observational period.Main outcome measures: Primary outcome – AE severity using the Eczema Area and Severity Index (EASI) assessed at 2, 4 and 6 months, by nurses blinded to treatment allocation. EASI scores were log-transformed for analysis. Secondary outcomes – patient-reported eczema symptoms (Patient Oriented Eczema Measure); global assessment of severity (Investigator Global Assessment); quality of life of the child (Atopic Dermatitis Quality of Life, Child Health Utility – 9 Dimensions), family (Dermatitis Family Impact Questionnaire) and main carer (EuroQoL-5 Dimensions-3 Levels); use of standard eczema treatments (e.g. emollients, topical corticosteroids); and cost-effectiveness. The acceptability and durability of the clothing, and adherence to wearing the garments, were assessed by parental/carer self-report. Safety outcomes – number of skin infections and hospitalisations for AE.Results: A total of 300 children were randomised (26 November 2013 to 5 May 2015): 42% female, 79% white, mean age 5 years. The primary analysis included 282 out of 300 (94%) children (n = 141 in each group). Garments were worn for at least 50% of the time by 82% of participants. Geometric mean EASI scores at baseline, 2, 4 and 6 months were 8.4, 6.6, 6.0, 5.4 for standard care and 9.2, 6.4, 5.8, 5.4 for silk clothing, respectively. There was no evidence of difference between the groups in EASI score averaged over all follow-up visits adjusted for baseline EASI score, age and centre (ratio of geometric means 0.95, 95% confidence interval 0.85 to 1.07; p = 0.43). This confidence interval is equivalent to a difference of –1.5 to 0.5 in the original EASI scale units. Skin infections occurred in 39 out of 141 (28%) and 36 out of 142 (25%) participants for sta...

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Section: Chapter 1 Introductionmentioning

confidence: 99%

Randomised controlled trial of silk therapeutic garments for the management of atopic eczema in children: the CLOTHES trial

Kim

Bradshaw

Sach

et al. 2017

Health Technol Assess

View full text Add to dashboard Cite

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“…AD also has dramatic effects on patient quality of life, leading to distress, anxiety, sleep disturbance, poor self-esteem and low self-confidence. In fact, 60% of the daily activities of school-age children are adversely affected [6,7,8,9]. …”

Section: Introductionmentioning

confidence: 99%

Immunomodulation and Safety of Topical Calcineurin Inhibitors for the Treatment of Atopic Dermatitis

2005

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Atopic dermatitis (AD) is a chronic or chronically relapsing inflammatory skin condition that primarily affects children. Topical corticosteroids have been the mainstay of treatment since the late 1950s. While providing excellent short-term efficacy, topical corticosteroid usage is limited by potential adverse effects, including impairment of the function and viability of Langerhans cells/dendritic cells. The recently introduced topical calcineurin inhibitors pimecrolimus cream 1% (Elidel^®) and tacrolimus ointment 0.03 and 0.1% (Protopic^®) exhibit a more selective mechanism of action and do not affect Langerhans cells/dendritic cells. For the immune system of young children ‘learning’ to mount a balanced Th1/Th2 response, this selective effect has particular benefits. In clinical experience, topical calcineurin inhibitors have been shown to be a safe and effective alternative to topical corticosteroids in almost 7 million patients (>5 million on pimecrolimus; >1.7 million on tacrolimus). Topical pimecrolimus is primarily used in children with mild and moderate AD, whereas tacrolimus is used preferentially in more severe cases. None of the topical calcineurin inhibitors have been associated with systemic immunosuppression-related malignancies known to occur following long-term sustained systemic immunosuppression with oral immunosuppressants (e.g., tacrolimus, cyclosporine A, and corticosteroids) in transplant patients. Preclinical and clinical data suggest a greater skin selectivity and larger safety margin for topical pimecrolimus.

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“…3 Several quality-of-life issues have been reported in children with AD, including sleep disturbances, changes in activity, irritability, and self-consciousness. [4][5][6][7][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 daily care and treatments for AD.…”

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confidence: 99%

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

Schachner

Lamerson²,

Sheehan³

et al. 2005

Pediatrics

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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...

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Perceptions of Physicians and Pediatric Patients About Atopic Dermatitis, Its Impact, and Its Treatment

Cited by 87 publications

References 9 publications

Randomised controlled trial of silk therapeutic garments for the management of atopic eczema in children: the CLOTHES trial

Randomised controlled trial of silk therapeutic garments for the management of atopic eczema in children: the CLOTHES trial

Immunomodulation and Safety of Topical Calcineurin Inhibitors for the Treatment of Atopic Dermatitis

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

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