Search Results (69)

Background: Atopic dermatitis (AD) is a chronic, pruritic and relapsing inflammatory skin disorder affecting children’s quality of life (QoL). Despite rising global prevalence, data on its impact on QoL in low-resource settings remain limited. This study aimed to assess the impact of AD and associated factors on the QoL of children and assesses the effect of educational intervention in Ethiopia. Methods: A prospective cohort study was conducted among 461 AD children and their caregivers across four randomly selected hospitals dermatology clinics in Ethiopia from October 2022 to March 2024. Assessments included AD Severity using Scoring Atopic Dermatitis (SCORAD), Infants’ Dermatitis Quality of Life Index (IDLQI) for children aged 0–4, and Children’s Dermatology Life Quality Index (CDLQI) for children aged 5 to 16. Participants received educational guidance from trained nurses during follow-up beyond routine AD treatment. Trained personnel collected clinical and sociodemographic data. AD severity and QoL were reassessed after 6 months. Descriptive, univariate, and linear regression analyses identified factors influencing QoL, with associations reported as odds ratios (95% CI) and significance set at p < 0.05. Results: Of 461 children, 424 (92%) completed follow-up. Most were under five (67%) with a median age of 3 years; 72.2% had AD onset before age two. Most caregivers were female (68.9%). After six months, clinical signs of AD, including dryness, erythema, excoriation, and lichenification, improved notably. Mild AD increased by 33.5%, while moderate and severe cases decreased by 17.5% and 16%, respectively. QoL significantly improved across all domains (p = 0.001). Baseline disease severity (β = 0.11), change in severity (ΔSCORAD) (β = 0.043), number of dependents (β = −0.71), and age at disease onset (β = 0.005) as significant predictors of QoL. Conclusions: AD significantly impairs QoL in Ethiopian children, with greater severity causing more disruption. Routine treatments with educational interventions significantly improve disease severity and QoL. Integrated clinical and psychosocial care approaches for pediatric AD are crucial in resource-limited settings. Full article

Background: Atopic dermatitis (AD) is a chronic inflammatory skin disorder. Revodiol Calming Cream^® (RCC) is a novel dermocosmetic product containing cannabidiol (CBD) and Annona cherimola fruit extract, designed for the management of atopic-prone and sensitive skin. Objective: Clinically assess the efficacy and safety of RCC in the management of atopic-prone and/or sensitive skin. Materials and methods: A prospective study included 20 adults and 22 children with mild-to-moderate atopic-prone skin. RCC was applied daily, for 56 days. Clinical evaluation included the SCORAD index, pruritus and dryness scales; and a Visual Analog Scale (VAS). Biometric assessments (Mexameter^®, Tewameter^®, Visioscan^®, Corneofix^®) were performed. Subjective satisfaction and quality of life (DLQI) were also recorded. Results: RCC was well tolerated, with no significant adverse events. After 56 days, SCORAD scores decreased by 55% in adults and 60% in children. Pruritus and dryness were significantly reduced, and VAS scores indicated a 65% decrease in discomfort. Biometric assessments demonstrated improvements in erythema, skin barrier function, topography, and desquamation. Subjective satisfaction reached 75% in both populations, and DLQI improved by 23%. Conclusions: The synergistic combination of CBD, Annona cherimola extract, and natural humectants offers a safe and effective daily dermocosmetic care for both adults and children. Full article

Background and Objectives: Nationwide registries that provide comprehensive insights into the atopic dermatitis (AD) population and management in routine practice are lacking in Baltic countries. Real-world studies to explore the clinical and economic burden of AD are highly needed. We present findings from the Baltic cohort of the larger observational study ESSENTIAL AD, conducted in Europe, the Middle East, and Africa. Materials and Methods: This cross-sectional, retrospective chart review study enrolled adult AD patients routinely managed with systemic and/or non-systemic therapy in Estonia, Latvia, and Lithuania. Data was collected during one office visit. AD severity was assessed using the Eczema Area and Severity Index (EASI) and SCORing Atopic Dermatitis (SCORAD) and impact on quality of life was assessed using the Dermatology Life Quality Index (DLQI) (primary endpoints). Results: Fifty patients were enrolled, with a mean (standard deviation [SD]) age of 33.6 (11.67) years, and 60% were women. Mean (SD) time since AD diagnosis was 21.8 (14.8) years. An equal proportion of patients received systemic therapy (including combination therapy) or non-systemic therapy (50% each). Mean (SD) EASI, SCORAD, and DLQI total scores were 9.8 (9.76), 38.0 (16.5), and 10.5 (7.1), respectively. No significant difference was observed between patients receiving systemic and non-systemic therapy in terms of EASI (mean [SD] 11.5 [12.2] versus 8.2 [6.3]; p = 0.7636), SCORAD (35.4 [20.8] versus 40.6 [11.5]; p = 0.2563), and DLQI (9.5 [7.6] versus 11.5 [6.5]; p = 0.1962). Hospitalization rate (95% confidence interval) was significantly higher in patients on systemic versus non-systemic therapy (0.4 [0.2–0.8] versus 0.1 [0.0–0.4]; p = 0.0424). Monthly out-of-pocket expenses (USD) were higher in Latvia (mean [SD]: 103.7 [2.64]) versus Estonia (55.6 [1.82]) and Lithuania (53.8 [1.90]). Conclusions: Adult AD patients from the Baltic region still face a considerable disease and economic burden, regardless of treatment received. Improved disease management and better access to guideline-recommended advanced systemic therapies are necessary. Full article

Skin disorders are a major global cause of morbidities, and increasing evidence links several to gut microbiome dysregulation. Because of this the bidirectional gut-skin axis, nutraceuticals have been proposed as therapeutic adjuncts, but their clinical effects across skin conditions remain unclear. To understand how pro/pre/synbiotics can affect health, we conducted a systematic review to investigate disease severity indices, inflammatory and immunological markers, quality of life, and changes in gut microbiota composition. PubMed, Embase, and Web of Science were utilized to identify relevant randomized clinical trials. Selected articles were pre-piloted for in-depth analysis and data extraction. We included 60 randomized controlled trials involving human participants with 5 dermatological conditions, including atopic dermatitis, psoriasis, acne vulgaris, chronic urticaria, and melasma, treated with probiotics, prebiotics, or synbiotics. Risk of bias was generally low across trials, with some having concerns. The SCORAD of the treated group was substantially lower than that of the placebo group in 30 of the 47 trials on atopic dermatitis. Inflammatory markers showed a range of results; some showed significant changes, while others produced contradictory results. Five trials that examined atopic dermatitis and psoriasis independently showed a significant improvement in Quality of Life. The PASI score was considerably lower in psoriasis in three of the five RCTs. Acne vulgaris, melasma, and chronic urticaria were not well documented. Major limitations included heterogeneity in interventions and outcomes, small sample sizes, and inconsistent reporting of microbiome analyses. Nutraceuticals show potential as additional treatments, but further, large scale studies are required. Full article

Introduction: Atopic dermatitis (AD) is driven by complex pathways that mediate inflammation and pruritus. The pathophysiology of AD’s disease involves multiple pathways. Interleukin-13 (IL-13) is considered a major cytokine in Th2-type inflammation, responsible for changing the epidermal barrier and producing chronic inflammation, whereas interleukin-31 (IL-31) is considered a major inducer of pruritus. The exact correlation of each of these cytokines with disease severity in children with AD appears to vary across studies. This study was therefore designed to evaluate whether IL-13 and IL-31 levels contribute complementarily or independently to the overall clinical severity of AD in the Moroccan pediatric population and to analyze the correlation between serum IL-13 and IL-31 levels and investigate their correlation with disease severity in a pediatric cohort. Methods: A total of 52 children with moderate to severe AD were included. The severity of the disease was measured using the SCORing Atopic Dermatitis (SCORAD) index. Serum levels of IL-13 and IL-31 were measured by Enzyme-Linked Immunosorbent Assay (ELISA). Results: The IL-13 serum level showed a considerable positive correlation with the SCORAD score (r_s = 0.7, p < 0.0001). On the other hand, IL-31 levels revealed no correlation with SCORAD (r_s = 0.07, p = 0.62) but were positively correlated with pruritus intensity (r_s = 0.91, p < 0.001). Conclusion: Our results support the presence of different pathophysiological axes in pediatric AD, where IL-13 functions as a reliable biomarker of inflammatory severity. IL-31 acts as a systemic marker of the pruritic pathway. Full article

Background: Disturbed iron metabolism has been described in chronic diseases with pro-inflammatory/immune activation. This study aimed to characterize iron status in patients with atopic dermatitis (AD) and to examine its relationship with disease severity and quality of life. Methods: We prospectively enrolled 86 adult patients with moderate-to-severe AD. Clinical assessments included the Eczema Area and Severity Index (EASI), SCORing Atopic Dermatitis (SCORAD), and the Dermatology Life Quality Index (DLQI). Blood samples were collected for hematologic parameters and iron-related biomarkers, including serum iron, ferritin, transferrin, transferrin saturation (Tsat), soluble transferrin receptor (sTfR), and hepcidin. Associations between iron markers and clinical outcomes were evaluated using beta regression models with variable selection and stability analyses. Results: Abnormalities in circulating iron biomarkers indicating iron deficiency were prevalent in patients with AD: 45% of patients had low Tsat (<20%), 37% low ferritin, and 26% reduced serum iron, despite largely normal hemoglobin. Patients with pro-inflammatory activation (as evidenced by elevated high-sensitivity C-reactive protein (hsCRP) above 5 mg/L) displayed a pattern characterized by lower iron, Tsat and higher sTfR levels. In multivariable analyses, lower serum iron remained associated with worse DLQI scores, while higher transferrin was associated with greater disease severity (EASI, SCORAD). Conclusions: Iron deficiency without anemia was a common feature of moderate-to-severe AD and was associated with higher clinical burden. Dysregulated systemic iron homeostasis was associated with impaired quality of life and increased disease severity. Full article

Background and Objectives: Atopic dermatitis (AD) is a chronic inflammatory skin disorder primarily affecting children, driven by genetic, immunologic, and environmental factors. Emerging evidence links gut microbiota alterations to immune modulation and AD severity. Probiotics, live microorganisms providing health benefits when consumed in adequate amounts, have been proposed as a potential adjunctive therapy. This review evaluates the efficacy of various probiotic treatments in reducing SCORAD indices and symptoms in children with AD, and its effects on immunologic markers such as IgE. Materials and Methods: Through a systematic literature review of multiple electronic databases through 9 October 2024, we identified randomized controlled trials (RCTs) in pediatric patients with an established diagnosis of atopic dermatitis. Our search strategy was as follows: “((atopy) OR (dermatitis) OR (hypersensitivity)) AND pediatric AND probiotic” yielding 25 total studies. Patients were treated with either a probiotic regimen or placebo and assessed for levels of IgE and SCORAD indices. Results: Of 25 studies extracted, 14 RCTs evaluated the effects of probiotics on atopic dermatitis using SCORAD scores. Eleven showed significant reductions in SCORAD indices. Pooled analysis using a random-effects model (Hedges’ g ≈ 0.65, p < 0.05) indicated a moderate to large improvement in AD severity with probiotic therapy. However, heterogeneity in probiotic strains, intervention duration, and limited sample sizes are limitations that warrant further investigation. Secondary analysis of IgE changes showed a non-significant effect (g ≈ 0.15, p = 0.13), possibly due to short study durations (mean 12 weeks). Conclusions: Probiotics demonstrate a moderate to large clinical impact in reducing SCORAD indices among children with atopic dermatitis. These findings highlight their potential as a future adjunctive, non-pharmaceutical therapy for the roughly 9.6 million pediatric patients affected in the United States. Further studies are needed to clarify strain-specific effects and patient factors influencing response. Full article

Atopic dermatitis (AD) is a chronic inflammatory skin condition that affects up to 25% of children and impairs both skin barrier function and quality of life. This study examined the effectiveness of an emulgel containing hyaluronic acid, glycerol, grape seed oil, Calendula officinalis, aloe vera and sh-oligopeptide-1 (a synthetic Epidermal Growth Factor) for treating paediatric AD. In a randomised, self-controlled trial, 57 children (aged 2–14) applied the emulgel twice daily for 10 days to one forearm and left the other forearm as a control. Skin barrier parameters such as transepidermal water loss (TEWL), stratum corneum hydration (SCH), erythema and pH were measured. After applying the emulgel, lesional skin showed reduced erythema (p = 0.007), lower TEWL (p = 0.002) and higher SCH (p < 0.001). Non-lesional skin showed improved SCH (p < 0.001). SCORing Atopic Dermatitis (SCORAD) and Eczema Area and Severity Index (EASI) scores indicated milder disease post-treatment (mild cases: 64.9% to 80.7% SCORAD; 82.5% to 93.0%EASI). The Dermatology Life Quality Index improved by ~3.5 points, and patients reported high satisfaction with no adverse effects. This emulgel is an effective and well-tolerated adjunctive therapy for paediatric AD, enhancing barrier function and clinical outcomes. Full article

Background/Objectives: Recently, epigenetic mechanisms have been recognized as crucial in atopic dermatitis development. The emphasis of this research was on expanding existing knowledge about the epigenetic aspects of atopic dermatitis, as well as identifying new molecules that could serve as disease biomarkers. Methods: The research was conducted as a cross-sectional study examining two groups: the group with atopic dermatitis (50 patients) and the control group (50 healthy adults). The serum levels of total immunoglobulin E (IgE) and eosinophil count (Eos%) were performed in routine laboratory analyses, and the detection of microRNAs from peripheral blood was performed using RT-PCR. Results: Analysis of selected miRNA expressions in patients with atopic dermatitis and controls revealed that only the expression and the relative expression of miRNA-146a were statistically significantly higher in patients with atopic dermatitis than in the control group (p = 0.042 and p = 0.021, respectively). There was a weak positive correlation between miRNA-146a expression and the eosinophilia/IgE level (r = 0.22 and r = 0.25, respectively). MiRNA-21, miRNA-29b, miRNA-143 and miRNA-223 were significantly upregulated in patients with higher SCORAD (p < 0.001, p < 0.001, p < 0.001 and p = 0.015, respectively). ROC curve analysis revealed the specificity of miRNA-146a as 82% and the sensitivity as 62%. The area under the ROC curve (AUC) was 0.7, indicating its diagnostic potential. Conclusions: Our findings imply that miRNA-146a might serve as a biomarker of atopic dermatitis, suggesting its relevance in the development of the disease, while miRNA-21, miRNA-29b, miRNA-143 and miRNA-223 may have an impact on disease progression. Our findings provide a preliminary basis that should precede validation through larger, multicentric studies and use in diagnostics, targeted personalized treatments and monitoring of treatment efficacy in atopic dermatitis. Full article

Inflammatory dermatological diseases represent a significant global health burden, with emerging evidence suggesting that modulation of the gut–skin axis microbial interventions may offer therapeutic benefits. However, current evidence is fragmented, with considerable heterogeneity limiting definitive conclusions. A systematic review and a meta-analysis were conducted following PRISMA guidelines, registered in PROSPERO (CRD42024629809). Seven databases were searched for randomized controlled trials evaluating probiotics, synbiotics, or postbiotics in inflammatory skin conditions. Primary outcomes included disease severity scores (SCORAD for atopic dermatitis, PASI for psoriasis). Statistical analysis employed random-effect models with standardized mean differences (SMDs) and Hedges’ g as effect size measures, using R software. Heterogeneity among studies was assessed using Q statistics and the I² index. Results: In total, 19 studies encompassing 1104 participants met the inclusion criteria. For atopic dermatitis, a meta-analysis of 12 studies (n = 817) demonstrated significant clinical improvement with microbial interventions versus placebo (SMD = −0.72; 95% CI: −1.26 to −0.17; p = 0.015), though substantial heterogeneity in the treatment effects was observed across studies (I² = 85.1%). The psoriasis results were more variable, with five studies (n = 287) showing non-significant pooled effects (SMD = −0.63; 95% CI: −1.74 to 0.48; p = 0.192). Multi-strain formulations and synbiotic combinations appeared to show greater efficacy compared to single-strain preparations. Safety profiles remained consistently favorable across all interventions. Microbial interventions represent a promising adjunctive therapeutic approach for inflammatory dermatological diseases, particularly atopic dermatitis, acting via gut–skin axis mechanisms. The substantial heterogeneity between the included studies emphasizes the need for standardized protocols and personalized medicine approaches integrating microbiome profiling to optimize clinical outcomes. Full article

Atopic dermatitis (AD) is the most common inflammatory skin disease in the pediatric population. In recent years, the role of microRNAs in inflammatory and immunological mechanisms as specific biomarkers of AD has received growing attention. The aim of the present study was a quantitative assessment of serum expression levels of miR-100, miR-224 and miR-155 in children with AD compared with healthy peers, and an analysis of their potential associations with clinical disease phenotype, severity of skin lesions (SCORAD), cytokine profile, immunological parameters and the presence of concomitant allergic diseases. The study included 12 children with AD and 9 healthy children. Selected miRNAs were isolated from serum, followed by reverse transcription using universal primers and quantification by qRT-PCR. Children with AD exhibited significantly higher expression levels of miR-155 compared with controls (p = 0.003). No statistically significant differences were observed for miR-100 and miR-224. miR-100 expression was significantly higher in children with a positive history of inhalant allergy compared with those without such a diagnosis (p = 0.014). A positive correlation was observed between miR-100 levels and the percentage of eosinophils (r = 0.599; p = 0.052) as well as absolute eosinophil count (r = 0.600; p = 0.051). MiR-155 is significantly upregulated in children with AD suggesting it as a candidate biomarker worthy of further investigation in larger cohorts. Although miR-100 did not differentiate the groups, its correlation with eosinophilia and inhalant allergy suggests a role in disease phenotyping. Full article

Background and objectives: Atopic dermatitis (AD) is a chronic inflammatory skin disease that affects not only physical health but also psychological well-being. While the emotional and social burden of AD is well documented, there is still limited research on how AD affects sexual health. The study aimed to evaluate quality of life (QoL), mental health, and risk factors for impaired sexual life, as well as their relationships. Materials and Methods: A total of 201 participants (96 patients with AD and 105 healthy controls) were enrolled in the study. Socio-demographic and clinical data were obtained using a specifically developed questionnaire. In addition, participants completed validated scales, including the DLQI, HADS, FSFI, IIEF-5, and SRSLQ. AD severity was assessed using the SCORAD questionnaire. Results: Our study found that patients with AD had statistically significantly higher mean anxiety (6.8 ± 3.6 vs. 5.0 ± 3.2; p < 0.001), depression (5.2 ± 3.4 vs. 3.9 ± 2.9, p < 0.01), and skin-related sexual dysfunction scores (15.0 ± 4.5 vs. 4.4 ± 4.7, p < 0.001), as well as QoL scores (12.3 ± 6.1 vs. 1.8 ± 3.1, p < 0.001), than healthy controls. Female AD patients reported higher values of depression and anxiety compared to male patients (5.9 ± 3.1 vs. 4.4 ± 3.5, p = 0.03, 7.6 ± 2.9 vs. 6.0 ± 4.1, p = 0.03, respectively) and lower FSFI scores compared to healthy women (24.8 ± 8.0 vs. 31.3 ± 3.0, p < 0.001). Deterioration in sexual health, assessed by the SRSLQ score, was strongly correlated with QoL impairment (R = 0.5, p < 0.001), anxiety (R = 0.51, p < 0.001), and depression (R = 0.5, p < 0.001). Finally, we found that sex life negatively correlates with AD severity (p=0.001), involvement of a genital area (p = 0.005), intensity of pruritus (r = 0.284, p = 0.005), and insomnia (r = 0.366, p < 0.001). Conclusions: AD significantly affects patients’ quality of life, including their sex life. Many factors associated with the disease also contribute to the deterioration of patients’ sexual health. Routine assessment of sexual life in dermatological practice, using validated tools, could facilitate early identification and support for affected patients. Significance: This study highlights the often-overlooked impact of atopic dermatitis on patients’ sexual health. Our findings demonstrate that sexual function is significantly impaired in individuals with atopic dermatitis—particularly among women—and that such dysfunction is closely associated with disease-related symptoms. These results have important implications for improving the quality of care provided to individuals affected by the condition. Full article

Purpose: This study evaluated the effectiveness of a school-based experiential self-management program for children with atopic dermatitis (AD) based on Roy’s adaptation theory. Design and Methods: Data were collected from June to August 2021, with 33 children in the experimental group and 32 in the control group. Participants were 10- to 11-year-old elementary school children who reported having AD symptoms within the past year and were able to complete self-report questionnaires. The program consisted of seven weekly school-based sessions that included disease education, symptom management techniques, skin care practices, nutritional guidance, and self-esteem enhancement activities. Outcomes, including AD severity, disease-related knowledge, adaptive behavior, self-esteem, and quality of life, were measured at baseline, post-intervention, and four weeks post-intervention using Generalized Estimating Equation analysis. Results: The experimental group showed significant improvements in AD severity (SCORAD: 22.80 ± 3.18 to 17.75 ± 2.24), disease-related knowledge (10.64 ± 2.00 to 13.64 ± 1.39), adaptive behavior (3.55 ± 1.70 to 10.58 ± 2.45), self-esteem (26.18 ± 4.76 to 31.55 ± 3.46), and quality of life (90.24 ± 11.07 to 100.27 ± 9.76), while the control group remained unchanged. Improvements were sustained four weeks post-intervention. Conclusions: This program effectively reduced AD severity and enhanced knowledge, adaptive behavior, self-esteem, and quality of life in children with AD. Practice Implications: School-based self-management programs effectively enhance disease knowledge, adaptive behaviors, and quality of life in children with AD. Full article

Background: A shared definition of therapeutic targets in the treatment of atopic dermatitis (AD) allows for the identification of patients who respond rapidly (early responders [ERs]) and optimally (super responders [SRs]) to systemic treatments. A concomitant achievement of EASI75/≤7, PP-NRS ≤ 4, SCORAD-75/≤24, POEM ≤ 7, and DLQI ≤ 5 at 6 months of treatment has been defined as an ideal target for AD. Methods: Patients aged ≥ 12 years treated with dupilumab for moderate-to-severe AD in an Italian center for at least 2 years were analyzed. We defined ERs as those who achieved EASI ≤ 7, PP-NRS ≤ 4, POEM ≤ 7, and DLQI ≤ 5 within 32 weeks, and SRs and long responders (LRs) as those who maintained the target at 1 year and at 2 years, respectively. We subsequently compared baseline characteristics between those who fell within the above definitions and those who did not. Results: Of 171 patients with AD, 76.6% were ERs, 49.1% SRs, and 40.4% LRs. Achievement of combined outcomes was shown by 37.11% of patients at 16 weeks, and increased at the following time points by more than half of patients at 2 years of treatment. Except for a high baseline POEM that appears to be unfavorable for achieving early response (OR 0.93, CI 0.88–0.98, p = 0.006), no baseline characteristics were associated with ERs, SRs, or LRs in this population. Conclusions: According to our definition of responders, we were unable to identify a patient profile at baseline that predicts optimal therapeutic outcomes with dupilumab. Only baseline POEM seems to affect achievement of the selected outcomes. Dupilumab showed a rapid achievement of the outcomes with a stable response after 4 months of treatment, according our definitions. Shared definitions of the different categories of patient responders and a common therapeutic target are necessary for optimal management of AD. Full article

Background/Objectives: Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by recurrent rashes and itching, which seriously affects the quality of life of patients and brings a heavy economic burden to society. The treat-to-target (T2T) strategy was proposed to guide optimal use of systemic therapies in patients with moderate to severe AD, and patients’ adherence is emphasized along with combined evaluation from both health providers and patients. While effective treatments for AD are available, non-adherence of treatment is common in clinical practice due to the patients’ unawareness of self-evaluation and lack of concern about the specific follow-up time points in clinics, which leads to the treatment failure and repeated relapse of AD. Methods: This project consists of three parts. First, an artificial intelligence (AI) model for diagnosis and severity grading of AD based on deep learning will be trained. Second, an AI assistant decision-making system (AIADMS) in the form of an app will be developed. Third, we design a prospective, randomized controlled trial to test the hypothesis that the AIADMS with implementation of the T2T could help control the disease progression and improve the clinical outcomes. Results: A total of 232 participants diagnosed with moderate to severe AD will be included and allocated into the app group or the control group. In the app group, participants will be assisted in using the app during the process of management and follow-up at the scheduled time points, including 2 weeks, 4 weeks, 8 weeks, 12 weeks, 6 months, and 12 months after treatment. In the control group, the diagnosis, treatment, and follow-up of participants will be carried out according to the current routine on a face-to-face basis. The primary outcome is the overall efficiency rate of treating objectives including PP-NRS, EASI, SCORAD, POEM, and DLQI at 12 weeks after treatment, which is calculated as the “Total number of participants with effective treatment of 5 treating objectives/total number of participants *100%”. Spss20.0 software will be used to analyze the data according to the principle of intent to treat. Trial Registration: The protocol was registered at the National Institutes of Health Clinical Trials Registry with the trial registration number NCT06362629 on 11 April 2024. Conclusions: This study aims to improve AD management by integrating advanced technology, patient engagement, and clinician oversight through AIADMS app to achieve treat-to-target (T2T) goals for effective and safe long-term control. Full article