Moderate Atopic Dermatitis In Children Research Articles

482 - Efficacy and safety of sequential topical 0.1% mometasone furoate cream and 2% crisaborole in the treatment of mild to moderate atopic dermatitis in children aged over 2 years—a multicentre parallel randomised controlled study in China

Abstract Background Atopic dermatitis (AD) is a chronic, recurrent pruritic, inflammatory skin disease associated with genetic allergies. Crisaborole is a phosphodiesterase 4 (PDE4) inhibitor approved by the US Food and Drug Administration for the treatment of patients over 2 years of age with mild to moderate AD. Previous studies have focused on the efficacy of crisaborole in the treatment of AD, and its influence on AD recurrence is not clear. Objective To explore the efficacy and safety of sequential topical 0.1% mometasone furoate cream (Elosone) and crisaborole in the treatment of mild to moderate AD in children, and to investigate the effect of crisaborole on the recurrence of AD. Methods Results Conclusion Treatment of mild to moderate AD in children over 2 years of age with sequential topical 0.1% mometasone furoate and crisaborole significantly reduced relapses and the amount of mometasone furoate prescribed and was safe and well tolerated by patients.

Medihoney Derma Cream Treatment for Mild to Moderate Atopic Dermatitis in Children: An Open-Label Randomized Pilot Study.

To the Editor: Topical corticosteroids are considered the main treatment for atopic dermatitis (AD), especially during a flare.1 Although topical corticosteroids have enormous benefits in reducing inflammation, they may be accompanied by significant adverse effects. In addition, the worldwide prevalence of topical corticosteroids phobia is extremely high, ranging from 31% to 95.7%,2 and may lead to poor adherence, resulting in persistent disease and rapid escalation to systemic agents.2 To avoid these adverse effects and the excess use of topical corticosteroids, other topical treatment modalities for AD are needed.3 Medihoney Derma Cream (Med-D-Cream) is a topical emollient cream containing 30% Medihoney antibacterial honey, coconut oil, German chamomile flower extract, evening primrose oil, aloe vera, vitamin E, glucose oxidase, and Leptospermum compounds. It has broad antibacterial and antipruritic activity,4 and by preserving skin barrier integrity and moisture, it aids in maintaining skin pH. Med-D-Cream is licensed for skin and wound care in Australia, Europe, and the United States. To offer an alternative corticosteroid-sparing option for treating mild to moderate AD in children, we conducted a trial comparing the safety and efficacy of Med-D-Cream to a common mild potency corticosteroid cream used worldwide for the treatment of AD (hydrocortisone 1% cream). The trial comprised children aged 2 to 18 years diagnosed with mild to moderate AD, with an Investigator Global Assessment (IGA) score of 2 to 3 and body surface area (BSA) of 1% to 10%, including 30 patients, 20 using Med-D-Cream, and 10 as controls using hydrocortisone 1% cream. Patients applied creams for 2 weeks and were then followed up for 2 more weeks to measure responses using IGA, BSA, Eczema Area and Severity Index score, SCORing Atopic Dermatitis, and Visual Analogue Scale pruritus (Fig. 1). The duration of treatment was limited to 2 weeks to avoid prolonged use of a topical steroid. The response rate (IGA score of 0 or 1 with at least 1-grade reduction after 2 weeks of treatment) was 47.4% (9/19) in the intervention group (Med-D-Cream) and 60% (6/10) in the control group (hydrocortisone 1% cream). There was no statistically significant difference between the 2 arms in response rates. No significant changes were found between the 2 groups regarding the secondary outcomes (BSA, Eczema Area and Severity Index score, SCORing Atopic Dermatitis, and Visual Analogue Scale pruritus). In the Med-D-Cream group, 2 of the 20 patients (10%) had adverse events, which resulted in 1 patient's withdrawal. No adverse events were seen in the hydrocortisone group. Our study had some limitations. First, we had a small sample size because it was a pilot study; however, the cohort size did allow us to draw statistical conclusions. Second, the study had relatively short treatment and follow-up periods (4 weeks overall), limiting the ability to observe potential allergic contact dermatitis and properly assess Med-D-Cream's effect on barrier function. Despite these limitations, this is the first randomized study designed to explore Med-D-Cream clinical activity and compare it with a topical corticosteroid in the pediatric population.Figure 1: Flowchart of the study design and population.In conclusion, the study demonstrated that Med-D-Cream, an emollient, is safe and effective in treating pediatric mild to moderate AD. Although it failed to show that Med-D-Cream had superiority over hydrocortisone 1% cream, it showed comparable clinical efficacy. Amir Horev Pediatric Dermatology Service Soroka University Medical Center Beer Sheva, Israel Faculty of Health Sciences Ben-Gurion University of the Negev Beer Sheva, Israel [email protected]Maayan SherSarah Weissmann Faculty of Health Sciences Ben-Gurion University of the Negev Beer Sheva, IsraelLior Golan Faculty of Health Sciences Ben-Gurion University of the Negev Beer Sheva, Israel Clinical Research Unit Soroka University Medical Center Beer Sheva, IsraelAnat Horev Neurology Department Soroka University Medical Center Beer Sheva, Israel

Efficacy and safety of an over-the-counter 1% colloidal oatmeal cream in the management of mild to moderate atopic dermatitis in children: a double-blind, randomized, active-controlled study

Purpose: The purpose of this study is to evaluate the efficacy and safety of an over-the-counter (OTC) 1% colloidal oatmeal cream versus a prescription barrier cream in children with mild-to-moderate atopic dermatitis (AD).Materials and methods: Eligible patients (6 months–18 years) were randomized to OTC or prescription cream. Eczema Area and Severity Index (EASI) scores, Investigator’s Global Atopic Dermatitis Assessment (IGADA) scores, patients’ and/or caregivers’ assessment of itch using 10-cm visual analog scale (VAS) on day 0, weeks 1, 2, and 3 were assessed. The intention to treat (ITT) and per protocol (PP) populations were analyzed.Results: Ninety patients (mean [SD] age, 8.1 [4] years; boys, 45.6%; African American, 54.4%) were randomized (OTC cream, 45; prescription cream, 45). At week 3, EASI scores showed that the OTC cream was non-inferior (non-inferiority margin = 1.5) to the prescription cream (adjusted mean change [95% CI] from baseline: ITT, 0.18 [−0.35, 0.70]; PP, 0.14 [−0.42, 0.70]). IGADA (adjusted mean between group difference, 0.106 [−0.130, 0.341]) and VAS itch (0.103 [−0.831, 1.038]) scores improved in both groups. No safety issues were identified.Conclusion: OTC 1% oatmeal cream was equally effective and safe as the prescription barrier cream for the symptomatic treatment of mild-to-moderate AD in children.Trial registration number: NCT01326910

Prevention of Flares in Children with Atopic Dermatitis with Regular Use of an Emollient Containing Glycerol and Paraffin: A Randomized Controlled Study

Emollients are part of the standard treatment for atopic dermatitis (AD), although there is limited evidence that regular use of emollients as management therapy reduces the frequency of flares and corticosteroid consumption. The objective of this study was to evaluate the benefit of emollient use in the management of mild to moderate AD in children by assessing the ability of two different emollients (particularly V0034CR) to prevent flares and to reduce the use of corticosteroids. In this randomized, open-label study, patients with a current flare were treated with a potent topical corticosteroid. After flare resolution, patients were centrally randomized to V0034CR emollient, reference emollient, or no emollient (1:1:1 ratio) for 12 weeks. New flares were medically assessed before being treated with a moderately potent corticosteroid. A total of 335 children 2 to 6 years of age were randomized. At 12 weeks, the percentage of patients with one or more flares was statistically significantly lower with V0034CR (35.1%) than without emollient (67.6%; p < 0.001). Fewer patients treated with V0034CR required any corticosteroids or immunosuppressants (23.6%) than patients with no emollient (43.3%) at 12 weeks. The difference was significant at all time points (p = 0.002). Patients treated with emollients had a longer time to first flare, fewer flares, higher complete remission rates, less corticosteroid consumption, lower Investigator Global Assessment scores, and lower Scoring Atopic Dermatitis scores than those who were not. V0034CR was well tolerated, with no specific safety concerns. Regular emollient use in children with mild to moderate AD reduces flares and corticosteroid consumption.

Пимекролимус в лечении атопического дерматита у детей. Вопросы безопасности и эффективности. Опыт пятилетнего применения

A growth in the incidence rate for atopic dermatitis (AD) in infants has been observed for this decade. Early formation of AD (at the age of 3-6 months) is observed in 45% of infants, and in 60% of infants - during the first year of life. As many as 65% of children (by the age of 7) and 74% of children (by the age of 16) suffering from AD have a spontaneous remission of the disease. As many as 20-43% of children suffering from AD further develop bronchial asthma, and the incidence rate of allergic rhinitis is twice as high. In spite of the fact that topical corticosteroids (TCS) are prescribed frequently enough, there is a need in the non-hormonal therapy due to poor compliance with the TCS treatment regimen in connection with side effects. Treatment of AD is often complicated by the colonization with Staphylococcus aureus and inefficacy of the external therapy with topical corticosteroids because many patients with AD have a high level of IgE against the superantigen of Staphylococcus. 1% pimecrolimus cream (PIM) and TCS were compared in a long-term large-scale study involving younger children suffering from mild to moderate AD. Materials and methods. The five-year open-label study involved 2,418 children, who were randomized into groups receiving PIM (n = 1205; in case of an aggravation - short-term administration of TCS) or TCS (n = 1213). The main goal of the study was to compare the safety of these two methods of treatment; an auxiliary goal was to confirm the long-term efficacy of PIM. Treatment was considered to be successful if the score based on the IGA scale was 0 (clean skin) or 1 (almost clean). Results. The effect in both groups of the drugs - PIM and TCS - was fast, and the success of treatment was recorded for &gt;50% of patients by Week 3. In both groups, treatment was determined to be successful after 5 years in &gt;85% of patients, and treatment of manifestations of AD on the face was efficient in 95% of all subjects. In the PIM group, the need in steroids was considerably lower than in the TCS group (7 days of administration vs. 178 days in the TCS group). In both groups, there were adverse events similar by their nature and frequency, and no disorders of humoral or cellular immunity were revealed. Conclusions. The long-term administration of PIM in case of mild to moderate AD in children was revealed to be safe and had no effect on the immune system. When PIM was used, the need in corticosteroids was considerably reduced (steroid-preserving effect). These data confirm that PIM is as efficient as TCS and can be used as the first-line therapy for mild to moderate AD in infants and younger children.

Allergic diseases of the skin and drug allergies – 2015. Randomized controlled, double blind trial of topical twice weekly fluticasone propionate maintenance treatment to reduce risk of relapse in mild or moderate atopic dermatitis in children

Allergic diseases of the skin and drug allergies – 2015. Randomized controlled, double blind trial of topical twice weekly fluticasone propionate maintenance treatment to reduce risk of relapse in mild or moderate atopic dermatitis in children Elena Rubio, Inocencia Martinez-Mir, Francisco J Morales-Olivas, Antonio Martorell-Aragones, Vicente Palop Larrea, Alejandro Bernalte Sese, Juan C Cerda Mir, Pedro Polo Martin, Isabel Febrer, Laura Aranda Grau, Inmaculada Llosa Cortes, Maria Jose Tejedor Sanz, Juan C Julia Benito, Teresa Alvarez De Laviada, Maria Victoria Planelles Cantarino, Esther Apolinar Valiente, Mercedes Loriente Tur, Antonio M Abella Bazataqui, Irene Alvarez Gonzalez, Cristina Morales-Carpi, Maria Enrriqueta Burches Greu, Ana B Ferrer Bautista, Raul Felix Toledo, Dolores Marmeneu Laguia, Victoria E Garcia-Martinez, Maria Antonia Beltran Marques, Maria Begona Rodriguez Gracia, Inocencia Martinez-Mir

Steroid-sparing effect of an emollient in the treatment of mild to moderate atopic dermatitis in children

Steroid-sparing effect of an emollient in the treatment of mild to moderate atopic dermatitis in children

Safety and efficacy of pimecrolimus (ASM 981) cream 1% in the treatment of mild and moderate atopic dermatitis in children and adolescents

Background: The ascomycin derivative pimecrolimus (ASM 981) is a cell-selective cytokine inhibitor, specifically developed for the treatment of inflammatory skin diseases. Objective: When applied topically, pimecrolimus cream 1% has shown promise as a treatment for inflammatory skin conditions, including atopic dermatitis (AD) in children and adults, allergic contact dermatitis, and chronic contact irritant hand dermatitis in adults. Methods: In two independent 6-week, randomized, multicenter studies of identical design, the efficacy and safety of pimecrolimus cream 1% in children with predominantly moderate AD were compared with vehicle. Pooled data from a total of 403 patients were used in the analysis. The primary efficacy parameter was the Investigator's Global Assessment (IGA) score. Secondary parameters included Eczema Area and Severity Index (EASI) and severity of pruritus scores. Subjects were also asked to assess their disease control as uncontrolled, limited, good, or complete. Results: Significant therapeutic benefits relative to vehicle were observed in the pimecrolimus-treated group at the first efficacy assessment, 8 days after initial application of the study medication (eg, relief of pruritus). At each subsequent postbaseline visit, pimecrolimus-treated patients showed significant improvement relative to controls in all efficacy measures. The medication was well tolerated. Conclusion: Pimecrolimus cream 1% appears to be a safe and effective alternative to currently used therapies for AD. (J Am Acad Dermatol 2002;46:495-504.)