Total SCORing Atopic Dermatitis Research Articles

Omalizumab for severe atopic dermatitis in 4- to 19-year-olds: the ADAPT RCT

BackgroundEvidence for systemic treatments for severe childhood eczema is limited. Systemic immunosuppressants are unlicensed for use in children and are associated with unwanted side effects.ObjectiveTo examine the role of anti-immunoglobulin E (IgE) [omalizumab (Xolair®, Novartis Pharmaceuticals UK Ltd, Frimley, UK)] in children and young people with severe eczema.DesignA double-blind, placebo-controlled, parallel-arm randomised (1 : 1) trial.SettingA single specialist centre – Guy’s and St Thomas’ NHS Foundation Trust, London.ParticipantsAtopic children and young people (aged 4–19 years) with severe eczema.InterventionsTreatment with omalizumab or placebo for 24 weeks.Main outcome measuresThe primary outcome was eczema severity, measured using the objective SCORing Atopic Dermatitis (SCORAD) at 24 weeks. Secondary outcomes included validated measures of eczema severity, quality of life (QoL) and potent topical steroid use.ResultsSixty-two participants, with a median baseline total IgE level of 8373 kU/l, received treatment with omalizumab (n = 30) or placebo (n = 32). The unadjusted mean objective SCORAD score at week 24 was 43.1 [standard deviation (SD) 12.5] for participants in the omalizumab arm and 49.2 (SD 11.3) for participants in the placebo arm. After adjustment for baseline objective SCORAD score, age and IgE level, the mean difference between arms at 24 weeks was –6.9 [95% confidence interval (CI) –12.2 to –1.5;p = 0.013], in favour of omalizumab. The mean objective SCORAD scores improved by –12.4 and –5.1 in the omalizumab and placebo arms, respectively, by 24 weeks. Secondary outcome measure estimates were also in favour of omalizumab for eczema severity at 24 weeks: the adjusted mean treatment arm difference was –8.3 (95% CI –15.1 to –1.1;p = 0.024) for total combined objective and subjective SCORAD and –6.7 (95% CI –13.2 to –0.1;p = 0.046) for the Eczema Area and Severity Index, with less effect on the Patient-Oriented Eczema Measure (POEM; –1.1, 95% CI –4.6 to 2.4;p = 0.527). Treatment estimate precision was limited by the sample size. The QoL measures favoured omalizumab, with an improvement (reduction) in both (Children’s) Dermatology Life Quality Index [(C)DLQI] score (mean –3.5, 95% CI –6.4 to –0.5;p = 0.022) and Paediatric Allergic Disease Quality of Life Questionnaire score (mean –0.5, 95% CI –0.9 to 0.0;p = 0.050). The mean (C)DLQI score improved by 50%, from 17.0 (SD 5.6) at baseline to 8.5 (SD 5.9) at week 24, for patients treated with omalizumab. Improvements were seen despite lower potent topical steroid use in the omalizumab arm, with 48% more days of use than (109 days in the placebo arm vs. 161 days in the omalizumab arm) and twice the body surface area coverage of (15.5% in the placebo arm vs. 31.3% in the omalizumab arm) the placebo arm. There were fewer treatment failures and new systemic immunosuppression initiations in the omalizumab arm. There was no difference in the numbers of cases of infective eczema and eczema exacerbation. There was one suspected severe adverse reaction in the omalizumab arm. In each arm, six participants reported a total of seven severe adverse events that were unrelated to treatment. Non-serious respiratory and dermatological adverse event rates were higher in the placebo arm (incidence rate ratio 0.69, 95% CI 0.49 to 0.96).ConclusionsOmalizumab, in a highly atopic paediatric population with severe eczema, reduced eczema severity and improved QoL despite a reduction in potent steroid use and highly elevated total IgE levels. Omalizumab, with its favourable side effect profile, warrants further study as a treatment option for this difficult-to-manage population. Further studies are needed to clarify the role of omalizumab. Treatment benefit became more apparent towards 24 weeks and persisted after treatment stopped. The optimal duration of treatment needs to be determined.Trial registrationThis trial is registered as ISRCTN15090567, EudraCT 2010-020841-29 and ClinicalTrials.gov NCT02300701.FundingThis project was funded by the Efficacy and Mechanism Evaluation programme, a Medical Research Council and National Institute for Health and Care Research (NIHR) partnership. This will be published in full inEfficacy and Mechanism Evaluation; Vol. 9, No. 5. See the NIHR Journals Library website for further project information. A grant from the Guy’s and St Thomas’ Charity supported the Atopic Dermatitis Anti-IgE Paediatric Trial (ADAPT). Omalizumab and the placebo were supplied by Novartis Pharmaceuticals UK Ltd.

Effectiveness of antihistamines for itch and sleep disturbance in atopic dermatitis: a retrospective cohort study

Introduction: Atopic dermatitis (AD) is a common and debilitating condition, with pruritus being the hallmark symptom responsible for negative quality of life in AD patients. Oral antihistamines are commonly used to manage itch in AD, but evidence of its efficacy is lacking and debatable. Methods: A retrospective cohort study on patients with AD treated with antihistamines was conducted at the National Skin Centre from January 2015 to December 2018. Severity of disease was measured using the SCORing Atopic Dermatitis (SCORAD) index. Data was analyzed using a mixed-effects linear model to account for repeated measures on the same individual. Results: There were 161 unique patients with 380 treatment outcomes included in our analysis. Patients who were treated with antihistamines had higher baseline itch and sleep disturbance scores compared with those who were not. We found that the use of antihistamines resulted in significant improvement in itch and sleep disturbance scores with respective mean decreases of 0.67 [95% confidence interval (CI): 0.07, 1.27; P=0.03] and 0.87 (95% CI: 0.22, 1.52; P=0.01) compared with patients not treated with antihistamines. Specifically, second-generation antihistamines improved itch and sleep disturbance scores better than first-generation antihistamines, with a decrease of 0.65 (95% CI: −0.59, 1.88) and 0.61 (95% CI: −0.66, 1.88), respectively, although the difference in effect was not significant. Meanwhile, antihistamine use did not significantly improve total SCORAD and objective SCORAD scores. Conclusion: Treatment with second-generation antihistamines, may be an appropriate treatment modality for managing itch and sleep disturbance in patients with AD.

Efficacy of Short Term Topical Malva Sylvestris L. Cream in Pediatric Patients with Atopic Dermatitis: A Randomized Double-Blind Placebo-Controlled Clinical Trial.

Atopic dermatitis (AD) is a chronic inflammatory pruritic dermatologic disease in children. Malva sylvestris L. (M. sylvestris) is a medicinal plant, which is used as a remedy for eczema in traditional Persian medicine. Previous studies have shown the anti-ulcerogenic and anti-inflammatory activity of this plant. We designed a clinical trial to evaluate the efficacy of topical cream of the M. sylvestris extract in the management of children with AD. Fifty-one children with AD were randomly enrolled in two arms of a randomized, double- blind, controlled clinical trial. They were treated by topical cream of the M. sylvestris extract or placebo for a palm-sized surface (single fingertip unit, twice daily) for 4 weeks. The SCORing Atopic Dermatitis (SCORAD) score was set as the primary outcome measure. There was a significant improvement in the severity of participants' dermatitis regarding skin thickening score, redness score, and total SCORAD score of the M. sylvestris group as compared with the placebo group (P= 0.009, P=0.01, and P=0.03; respectively). According to the results of this clinical trial, it could be concluded that the topical use of M. sylvestris extract cream was effective in the reduction of AD symptoms in children. This study is registered by the Iranian Registry of Clinical Trials with the code: IRCT20170107031814N2.

Effect of pine-tar bath on disease severity in moderate-to-severe childhood eczema: an investigator-blinded, crossover, randomized clinical trial

Background Atopic dermatitis (AD) is a chronic inflammatory disease associated with pruritus and sleep loss. Pine-tar has long been used for various chronic skin conditions in which its polycyclic aromatic hydrocarbon (PAH) component is anti-inflammatory and its resin acids antiseptic. The null hypothesis of this trial is that there is no difference in clinical efficacy between a pine-tar product and its vehicle for AD. Methods A 3-month, investigator-blinded, crossover, randomized control trial (RCT) was conducted in which each patient was assigned to bathing with pine-tar bath oil for one month and vehicle bath oil for another, with a washout period of 1-month in-between. Acceptability and efficacy of the bath products were measured. Disease severity scores (scoring atopic dermatitis (SCORAD) and patient-oriented eczema measure (POEM), quality of life questionnaires, noninvasive skin biophysiological measurements, blood IgE levels, and Staphylococcus aureus (SA) colonization status were assessed before and following bathing. Results Significant improvements were found in total SCORAD (p = .030), POEM (p = .004), SA colonization status (p = .002), and log-transformed IgE level (p = .009) among patients who bathed with pine-tar in the overall RCT study using intention-to-treat analysis. For per protocol analysis, significant improvements were found in total SCORAD (p = .024), objective SCORAD (p = .011), extent (p = .014), intensity (p = .032), pruritus (p = .047), POEM (p = .044), SA colonization status (p = .035), and log-transformed IgE level (p = .028). Acceptability to both bath-oils was good, and no product-related serious adverse events were recorded. Conclusions Bathing with pine-tar is an efficacious and recommendable adjuvant practice for AD patients. Disease improvement is associated with reduction of SA and IgE.

Validation of four single-item patient-reported assessments of sleep in adult atopic dermatitis patients

BackgroundThe optimal approaches for monitoring sleep disturbances in adults with atopic dermatitis (AD) is not established. Multiple patient-reported outcome measures for AD and itch have sleep-related items. These items have not been validated previously. ObjectiveAssess the measurement properties of sleep-related items from the Patient-Oriented Eczema Measure (POEM), SCORing AD (SCORAD), 5-dimensions of itch (5D), and ItchyQOL in adults with AD. MethodsWe performed a prospective dermatology practice-based study using questionnaires and evaluation by a dermatologist (n = 115). ResultsThere was modest overlap and weak-moderate concordance of responses to the different assessments. Regarding concurrent validity, POEM-sleep, SCORAD-sleep, 5D-sleep, and ItchyQOL-sleep showed moderate correlations with each other. Regarding convergent validity, all items showed moderate correlation with total POEM, but weak correlations with Eczema Area and Severity Index (EASI), objective and total SCORAD, moderate to strong correlations with mean ItchyQOL and Dermatology Life Quality Index (DLQI), but poor or no significant correlation with Numeric Rating Scale (NRS) for worst or average itch. Regarding discriminant validity, all items showed significant and stepwise increases with increasing self-reported and physician-reported AD severity (Kruskal-Wallis, P < .01 for all). Floor effects were observed for POEM-sleep (n = 53, 46.1%), SCORAD-sleep (n = 28, 24.4%), 5D-sleep (n = 41, 35.7%), and ItchyQOL-sleep (n = 33, 28.7%); no ceiling effects were observed. Change in sleep-related item scores showed moderate strong correlations with change in POEM, 5Ditch, mean ItchyQOL, DLQI, objective and total SCORAD, and EASI, but inconsistent correlations with change of itch severity. ConclusionSleep-related items from POEM, SCORAD, 5D and ItchyQOL showed good validity and responsiveness to monitor sleep disturbances in adult AD patients.

Acupuncture Treatment for Symptom Management in Atopic Dermatitis: A Study Protocol for a Randomized, Participant- and Assessor-Blind, Sham-Controlled Trial.

Atopic dermatitis (AD) is a chronic inflammatory skin disease with persistent itching, which impairs quality of life (QoL). Although various conventional treatments for AD exist, patients with AD often seek complementary and alternative therapies when conventional therapy has failed to relieve their AD symptoms or has had adverse effects. Acupuncture treatment may relieve AD symptoms, but controlled trials are needed to confirm this. Following our pilot study, which found that acupuncture treatment improves AD symptoms in mild-to-moderate AD patients, we will assess the effect of acupuncture treatment for symptom relief of AD using a trial with a complemented protocol. This is a two-arm, randomized, participant- and assessor-blinded, sham-controlled trial. A total of 36 mild-to-moderate AD patients will be randomly assigned in a 1:1 ratio to receive eight sessions twice weekly of either verum acupuncture (VA) or nonpenetrating sham acupuncture (SA) over four weeks. The primary outcome measured will be the change in the total Scoring Atopic Dermatitis (SCORAD) score. Secondary outcomes will be (1) changes in AD symptoms, QoL, dyspepsia symptoms, and electroencephalography (EEG) between baseline and week 4 and (2) changes in AD symptoms and QoL at baseline and at weeks 2, 4, and 8. This study will assess acupuncture treatment for the alleviation of AD symptoms in patients with mild-to-moderate AD. This clinical trial gas been registered in Korean Clinical Trial Registry (registration number: KCT0002796; date of registration: April 13, 2018).

The efficacy of wet wrap therapy in children with atopic dermatitis in a single center

Purpose: Wet wrap therapy is a well-known treatment for severe atopic dermatitis (AD). However, wet wrap therapy with usual ban dage was a troublesome and time-consuming process of application. The aim of this study was to evaluate the efficacy, safety and convenience of wet wrap therapy with new garments in children with moderate-to-severe AD. Methods: We compared 56 AD children treated with wet wrap therapy and 14 AD children treated with only conventional therapy. We retrospectively reviewed the clinical features, change of SCORing Atopic Dermatitis (SCORAD) index, adverse effects and par ent’s reports. Results: The initial mean SCORAD index was 60.3±15.3 points. No significant differences in sex, age, initial SCORAD index, total eo sinophil count, total IgE level, food allergen sensitization, inhalant allergen sensitization or associated allergic diseases were found between the wet wrap and conventional groups. The pharmacological and nonpharmacological interventions except wet wrap therapy were same in the 2 groups. Wet wrap therapy with garments or tubular bandage was easily done one time per day over night in 10.6±3.5 days by parents. Improvement in total SCORAD index, intensity, subjective symptoms and pruritus were signifi cantly higher in the wet wrap group than in the conventional group (36.2 vs. 26.9, 6.0 vs. 4.0, 9.9 vs. 7.4, and 4.8 vs. 3.6 points). No fol liculitis and serious adverse effects were reported. Conclusion: Wet wrap therapy with new garments could be easily done by parents. Wet wrap therapy may be effective and safe in controlling moderate-to-severe AD in children. (Allergy Asthma Respir Dis 2019;7:13-21)

The relationship between severity of disease and vitamin D levels in children with atopic dermatitis.

IntroductionAtopic dermatitis (AD) is a chronic relapsing inflammatory skin disorder. Vitamin D is a liposoluble vitamin synthesized mainly in the skin. Vitamin D has several effects on the skin.AimTo assess the serum level of vitamin D in children with AD and determine its relation to AD severity.Material and methodsSixty patients with AD were enrolled in the study. We evaluated disease severity using the SCORing Atopic Dermatitis (SCORAD) index. The control group consisted of 37 healthy subjects.ResultsThe mean serum concentration of 25(OH)D3 in patients with AD was not statistically different from control subjects (p = 0.065). The vitamin D level was significantly lower in moderate and severe AD compared with mild AD, and this difference was statistically significant (p = 0.001 and p = 0.004). Vitamin D showed a negative correlation with serum total IgE levels (p = 0.007). There was no significant correlation between total IgE levels and SCORAD scores (p = 0.089).ConclusionsThis study suggests that a low serum vitamin D level is inversely associated with severity of AD in children. Vitamin D has not been included in the routine treatment of AD because of the conflicting results of various studies. Thus, there is a need for more detailed and prospective studies.

The patterns and clinical relevance of contact allergen sensitization in a pediatric population with atopic dermatitis.

Data about contact allergen sensitization (CAS) in children with atopic dermatitis (AD) are limited. The purpose of this study was to identify the frequency and patterns of CAS in children with AD by using a ready-to-use patch test system. After receiving the history of CAS in the patients, the severity of AD and IgE-mediated allergen sensitization were determined. Of 134 children with AD, 33.8% (n = 45) had at least 1 positive reaction. The most frequent positive reaction was to nickel sulfate (NS) (37.8%, 17/45), followed by methylchloroisothiazolinone (20.0%, 9/45) and thimerosal (15.6%, 7/45). The total Scoring Atopic Dermatitis (SCORAD) score was significantly higher in the NS-sensitized group (P = 0.036). The patients with NS sensitization had moderate-severe AD more frequently than those without any reaction (P = 0.020). When the SCORAD score was evaluated in detail, extent of eczema, score of sleep loss, and pruritus were significantly higher in the patients with NS sensitization than those without any reaction (P = 0.002, P = 0.001, and P = 0.002, respectively). Our study confirms the necessity of CAS in the management of AD. In particular, NS sensitization should be considered for children with severe AD or larger extent of eczema and trunk involvement.

Inpatient treatment for severe atopic dermatitis in a Traditional Korean Medicine hospital: Introduction and retrospective chart review

Patients with atopic dermatitis increasingly seek complementary and alternative medical treatment. A number of studies have demonstrated the efficacy of herbs and acupuncture in the treatment of atopic dermatitis. Some patients with extensive disease, outpatient treatment failure, acute deterioration or highly impaired everyday functioning require inpatient care. The aim of this study was to introduce and evaluate inpatient treatments for severe atopic dermatitis patients at a Traditional Korean Medicine hospital. We performed a retrospective chart review of inpatients with severe atopic dermatitis between March 2008 and October 2011. Eligibility criteria for inclusion were: (1) a diagnosis of atopic dermatitis according to the criteria established by Hanifin and Rajka and (2) hospitalisation because of severe atopic dermatitis (objective scoring atopic dermatitis (SCORAD) score ≥ 40). The SCORAD score was assessed by trained investigators at admission and discharge. Among 37 inpatients, there were 29 patients who met the criteria. Patients received treatments including acupuncture, herbal medicine and herbal wet wrap dressings. The mean total scoring SCORAD decreased from 60.63 to 37.37 during hospitalisation. Despite the relatively small sample size, these findings were statistically significant. In atopic dermatitis, Traditional Korean Medicine effectively decreased clinical disease severity. This study's weaknesses include the relatively small number of patients, some aspects of the study design, lack of follow-up assessment and lack of second measurement.

A Pilot Study Evaluating the Clinical and Immunomodulatory Effects of an Orally Administered Extract ofDendrobium Huoshanensein Children with Moderate to Severe Recalcitrant Atopic Dermatitis

Atopic dermatitis (AD) is a common inflammatory skin disorder for which few safe and effective systemic treatments are available. To test the clinical and immunomodulatory effects of a crude polysaccharide fraction isolated from Dendrobium huoshanense for the treatment of AD, we conducted a pilot, uncontrolled case series study. Twenty-seven patients aged 4-18 years (mean∓SD, 10.82±4.4) with AD that had not responded to topical therapy were treated with polysaccharide derived from D. huoshanense for 4 weeks and followed-up for another 4 weeks. Progression of AD was determined with the Lund-Browder chart for children, the Investigator's Global Atopic Dermatitis Assessment (IGADA), and the Scoring Atopic Dermatitis (SCORAD) at weeks 0, 2, 4, and 8. Serum levels of cytokines were evaluated. Safety was determined with laboratory and clinical tests. The lesion area, IGADA score, total SCORAD result, and score for sleeplessness decreased significantly from weeks 0 to 4, but did not change significantly between weeks 4 and 8. The scores for subjective symptoms and pruritus decreased significantly from week 0 to week 4 and increased significantly from week 4 to week 8. Serum levels of IL-5, IL-13, IFN-gamma, and TGF-beta1 decreased significantly between weeks 0 and 4 and between weeks 0 and 8. No significant difference in the levels of IL-10 was found. The polysaccharide from D. huoshanense reduced the levels of some cytokines associated with AD and had beneficial effects on symptoms. No serious adverse effects occurred when it was administered orally for 4 weeks.

Assessing itch in children with atopic dermatitis treated with tacrolimus: Objective versus subjective assessment

This study was undertaken to evaluate the clinical efficacy of tacrolimus for itch reduction in children with atopic dermatitis (AD). Seven children (3 boys and 4 girls) with AD were treated with topical tacrolimus for a consecutive 2-wk period after a 1-wk run-in. The clinical severity of AD was assessed with the SCORing Atopic Dermatitis (SCORAD) scale. Sleep disturbance, as reported by patients, and nocturnal scratching documented by a wrist movement monitor (DigiTrac), were evaluated at baseline and throughout treatment. The median (interquartile range) objective SCORAD scores before and after treatment were 27.2 (24.8-36.7) and 23.9 (22.6-36.5), respectively (P=.248). Overall SCORAD scores before and after treatment were 36.1 (32.8-45.7) and 29.4 (24.8-45.4), respectively (P=.05). Scores on the itch and sleep disturbance components of the SCORAD were reduced from 5.0 (5.0-6.5) and 4.0 (3.5-5.0) to 4.0 (2.0-5.0) and 3.0 (0.5-4.5), respectively. Total SCORAD was reduced in 6 patients (range, 8%-36% reduction) and remained similar in 1 patient. No significant change in the area or intensity component of the SCORAD was detected 14 d after treatment began (P=.48 and P=.115, respectively). Scratching activity, as documented by the DigiTrac movement recorder, was reduced from 115.0 g/min (64.8-215.5) to 71.5 g/min (51.0-118.0) (P=.028) after 2 wk of treatment. Daily symptom scores (n=6 pairs) for sleep disturbance reported separately each day by patients and parents correlated strongly with each other (intraclass coefficient, 0.60-0.98). The findings of this study show that tacrolimus is effective in relieving itch in children with AD. Investigators suggest that scratching movements, objectively measured with the use of DigiTrac, provide a reliable indicator of AD severity in children.

Prebiotics and synbiotics: two promising approaches for the treatment of atopic dermatitis in children above 2 years

Appropriate use of prebiotics and optimal combinations of probiotics and prebiotics (synbiotics) could allow significantly better results to be obtained in the treatment of atopic dermatitis (AD). To evaluate the efficiency of synbiotics when compared with prebiotics alone (control group) in the treatment of moderate and severe AD in children aged 2 years and over. Double-blind prospective randomized study performed on children aged at least 2 years presenting AD with a minimum SCORing Atopic Dermatitis (SCORAD) score of 15. A dose of 1.2 x 10(9) colony-forming units Lactobacillus rhamnosus Lcr35 plus prebiotic preparation or an identically appearing prebiotic preparation alone was given three times a day for 3 months. Patients' diet and usual treatment for AD remained unchanged during the study period. Efficiency was evaluated using the SCORAD score. Use of topical drugs was noted. A total of 48 patients were originally enrolled; nine did not complete the study. In synbiotic group, the mean values of the total SCORAD score was 39.1 before treatment vs 20.7 after 3 months of treatment (P < 0.0001). In the prebiotic group, the mean of the total SCORAD score was 39.3 before the treatment vs 24.0 after 3 months (P < 0.0001). After 3 months of treatment, no statistical differences between the two treatment groups with regard to the total SCORAD score were noted (P = 0.535). Neither were there any statistical differences in the total use of ointment between patients receiving prebiotics or synbiotics (P = 0.966) over the study period. Tolerance was excellent in both groups. Both synbiotics and prebiotics used alone seem able to significantly improve the manifestations of AD in children aged 2 years and over.

Brief case series: Montelukast, at doses recommended for asthma treatment, reduces disease severity and increases soluble CD14 in children with atopic dermatitis

Background: The choice of oral therapeutic agents for the treatment of atopic dermatitis (AD) in children is limited. Montelukast, a specific cysteinyl leukotriene (LT) receptor antagonist, may be useful in alleviating AD symptoms. Objective: To evaluate the clinical and immunological effects of montelukast in children with AD. Methods: After a 2‐week run‐in, children with AD were started on oral montelukast 5 mg once‐daily for children <12 years of age and 10 mg for older children. The clinical severity of AD as indicated by the SCORing Atopic Dermatitis (SCORAD) score, and serum soluble CD14 and urinary leukotriene E4 (LTE4) concentrations were evaluated at baseline and the end of a 3‐month treatment period. Results: Four boys and three girls, with a median (range) age of 12 (3–16) years, participated in the study. The total SCORAD was reduced in five patients (by 30–84%) and remained similar in two patients. Their median (range) SCORAD scores before and after treatment were 34.7 (16.5–54.8) and 17.0 (6.9–36.9) (p = 0.046). The intensity component of SCORAD also decreased from 5 (2–10) to 3 (1–7) (p = 0.042). Serum sCD14 levels increased significantly from 5533 (4575–6452) ng/ml to 6259 (5617–8988) ng/ml (p = 0.028), whereas urinary LTE4 levels remained the same (p = 0.735). Conclusions: Montelukast, at doses recommended for asthma treatment, resulted in over 30% reduction in the total SCORAD in some children. Treatment with montelukast may also be associated with deviation of the immune system towards the Th1‐specific pathway.

Effect of probiotic Lactobacillus strains in children with atopic dermatitis

Background: Recent studies suggest that oral bacteriotherapy with probiotics might be useful in the management of atopic dermatitis (AD). Objective: The purpose of this investigation was to evaluate the clinical and anti-inflammatory effect of probiotic supplementation in children with AD. Methods: In a double-blind, placebo-controlled, crossover study, 2 probiotic Lactobacillus strains (lyophilized Lactobacillus rhamnosus 19070-2 and Lactobacillus reuteri DSM 122460) were given in combination for 6 weeks to 1- to 13-year-old children with AD. The patients' evaluations were registered after each intervention (ie, better, unchanged, or worse). The clinical severity of the eczema was evaluated by using the scoring atopic dermatitis (SCORAD) score. As inflammatory markers, eosinophil cationic protein in serum and cytokine production by PBMCs were measured. Results: After active treatment, 56% of the patients experienced improvement of the eczema, whereas only 15% believed their symptoms had improved after placebo (P = .001). The total SCORAD index, however, did not change significantly. The extent of the eczema decreased during active treatment from a mean of 18.2% to 13.7% (P = .02). The treatment response was more pronounced in allergic patients (at least one positive skin prick test response and elevated IgE levels), and in this group the SCORAD score decreased (P = .02 compared with nonallergic patients). During active treatment, serum eosinophil cationic protein levels decreased (P = .03). No significant changes in the production of the cytokines IL-2, IL-4, IL-10, or IFN-γ were found. Conclusions: A combination of L rhamnosus 19070-2 and L reuteri DSM 122460 was beneficial in the management of AD. The effect was more pronounced in patients with a positive skin prick test response and increased IgE levels. (J Allergy Clin Immunol 2003;111:389-95.)