The Role of Confocal Microscopy in Estimating Dupilumab Treatment Response for Moderate/Severe Atopic Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Correlation between baseline RCM features and change in EASI score at week 24
研究概览
简要总结
Atopic dermatitis (AD) is recognized as the most prevalent chronic inflammatory skin disease across all age groups. The introduction of reflectance confocal microscopy (RCM) signifies a substantial leap forward in the non-invasive skin assessment at a cellular level. This advancement holds the potential to diminish the need for skin biopsies in diagnosing and monitoring skin diseases. Given the variability in the efficacy of systemic treatments for AD among patients, RCM emerges as an attractive tool for real-time monitoring of treatment response. This capability enables the treating physician to customize treatment approaches accordingly. There exists a lack of data concerning the subsurface characteristics of the skin explored with RCM before, during, and after dupilumab treatment in patients with moderate to severe AD.
Hypothesis: The characteristics of AD skin at the cellular level evaluated by RCM correlate with treatment response with dupilumab Overall objectives: To evaluate the association between skin characteristics assessed by basal RCM and changes in EASI and vIGA-AD scores at 24 weeks in individuals with mod/sev AD treated with dupilumab.
Methods: Prospective cohort study. Forty patients with mod/sev AD starting dupilumab will be enrolled. Basal and periodic clinimetry, PROs, and evaluation of the affected skin through RCM will be done.
Expected results: To describe RCM phenotypes of responders and not responders to dupilumab Impact: Offering the medical community a non-invasive tool to improve phenotypic characterization for tailoring clinical decisions. The investigators strongly believe this could mark the initial stride towards adopting personalized medicine, ultimately resulting in enhanced therapeutic selection, dosage precision, optimized intervals, increased patient adherence, and reducing need for skin biopsies, particularly in infants.
详细描述
Study Design and Setting
This is a prospective cohort study conducted at Hospital Italiano de Buenos Aires, a high-complexity, non-profit institution with a longstanding commitment to patient care, medical education, and research. The Department of Dermatology spans over 17 clinical sites and is one of the largest in Argentina, with 155,000 annual consultations and a strong focus on immune-mediated skin disorders, including atopic dermatitis (AD). The Division of Immune Skin Diseases includes 12 board-certified dermatologists specialized in managing complex inflammatory skin conditions. Our department actively participates in the Atopic Dermatitis Quality of Care Initiative and collaborates with local and international networks such as the Argentine Society of Dermatology, Pediatric Dermatology Society, and Project ECHO® AD group.
Study Population and Recruitment Strategy
The study will enroll patients from the Buenos Aires Metropolitan Area (population ~14 million), where an estimated 3% of adults and 5% of children are affected by AD, with moderate-to-severe cases representing approximately 0.3%-0.5%. Dermatologists and allergists across all sectors-public, private, and social security-will be invited to refer eligible patients prior to dupilumab treatment initiation. Inclusion will not be restricted by insurance status or care setting, ensuring demographic and socioeconomic diversity.
Study Procedures
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥6 months of age.
- •Diagnosis of AD based on Hanifin and Rajka criteria.
- •Moderate-to-severe AD defined by: EASI >16, BSA >10%, SCORAD >25, or vIGA-AD 3-
- •Starting dupilumab for AD indicated and initiated by the attending physician.
- •Signed informed consent or assent with guardian approval.
- •In those with previous systemic treatment (jaki, oral steroids, methotrexate and phototherapy), a predefined wash-out time of 4 weeks must be guaranteed.
排除标准
- •Inability to comply with study procedures.
- •Refusal to provide informed consent.
研究组 & 干预措施
Control
10 healthy controls, five males and five females
Dupilumab treated patients
Dupilumab treated patients
结局指标
主要结局
Correlation between baseline RCM features and change in EASI score at week 24
时间窗: Baseline and week 24
The correlation between baseline reflectance confocal microscopy (RCM) features (e.g., spongiosis, inflammatory cell infiltrate, disarrayed epidermis, changes in the dermoepidermal junction) and the change in Eczema Area and Severity Index (EASI) from baseline to week 24 will be assessed. Measurement Tool: Eczema Area and Severity Index (EASI) Unit of Measure: Change in EASI score (continuous variable)
Correlation between baseline RCM features and change in vIGA-AD score at week 24
时间窗: Baseline and week 24
The correlation between baseline RCM features and the change in validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) from baseline to week 24 will be assessed. Measurement Tool: Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Unit of Measure: Change in vIGA-AD score (ordinal scale 0-4)
Correlation between baseline RCM features and change in EASI score at week 24
时间窗: Baseline and week 24
The correlation between baseline reflectance confocal microscopy (RCM) features (e.g., spongiosis, inflammatory cell infiltrate, disarrayed epidermis, changes in the dermoepidermal junction) and the change in Eczema Area and Severity Index (EASI) from baseline to week 24 will be assessed. Measurement Tool: Eczema Area and Severity Index (EASI) Unit of Measure: Change in EASI score (continuous variable)
Correlation between baseline RCM features and change in vIGA-AD score at week 24
时间窗: Baseline and week 24
The correlation between baseline RCM features and the change in validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) from baseline to week 24 will be assessed. Measurement Tool: Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Unit of Measure: Change in vIGA-AD score (ordinal scale 0-4)
次要结局
- Correlation between baseline RCM features and change in Patient Global Impression of Severity (PGIS) at week 24(From enrollment to week 24)
- Correlation between baseline RCM features and change in POEM score at week 24(From enrollment to week 24)
- Correlation between baseline RCM features and Patient Global Impression of Change (PGIC) at week 24(Week 24)
- Predictive value of baseline RCM features for achieving EASI-75 at week 24(From enrollment to week 24)
- Predictive value of baseline RCM features for achieving vIGA-AD 0 or 1 at week 24(From enrollment to week 24)
- Predictive value of baseline RCM features for achieving EASI <10 at week 24(From enrollment to week 24)
- Correlation between baseline RCM features and change in SCORAD at week 24(From enrollment to week 24)
- Correlation between baseline RCM features and change in BSA affected at week 24(From enrollment to week 24)
- Correlation between baseline RCM features and change in peak pruritus NRS at week 24(From enrollment to week 24)
- Correlation between baseline RCM features and change in Atopic Dermatitis Control Tool (ADCT) score at week 24(From enrollment to week 24)
- Correlation between baseline RCM features and change in Dermatology Life Quality Index (DLQI) at week 24(From enrollment to week 24)
- Association between clinical phenotype and achievement of EASI-75 at week 24(From enrollment to week 24)
- Association between age of onset and achievement of EASI-75 at week 24(From enrollment to week 24)
- Association between previous treatment failures and achievement of EASI-75 at week 24(From enrollment to week 24)
- Association between family history of atopic disease and achievement of EASI-75 at week 24(From enrollment to week 24)
- Incidence and severity of adverse events during treatment(From enrollment to week 24)
- Rate of patient adherence to treatment(From enrollment to week 24)
- Frequency of treatment modifications (interruptions or switching)(From enrollment to week 24)
- Change in composite RCM score from baseline to week 24(Baseline and week 24)
- Difference in composite RCM score between AD patients and healthy controls(Time Frame: Baseline only)
- Predictive value of baseline RCM features for achieving EASI-75 at week 24(From enrollment to week 24)
- Predictive value of baseline RCM features for achieving vIGA-AD 0 or 1 at week 24(From enrollment to week 24)
- Predictive value of baseline RCM features for achieving EASI <10 at week 24(From enrollment to week 24)
- Correlation between baseline RCM features and change in SCORAD at week 24(From enrollment to week 24)
- Correlation between baseline RCM features and change in BSA affected at week 24(From enrollment to week 24)
- Correlation between baseline RCM features and change in Patient Global Impression of Severity (PGIS) at week 24(From enrollment to week 24)
- Correlation between baseline RCM features and Patient Global Impression of Change (PGIC) at week 24(Week 24)
- Correlation between baseline RCM features and change in peak pruritus NRS at week 24(From enrollment to week 24)
- Correlation between baseline RCM features and change in POEM score at week 24(From enrollment to week 24)
- Correlation between baseline RCM features and change in Atopic Dermatitis Control Tool (ADCT) score at week 24(From enrollment to week 24)
- Correlation between baseline RCM features and change in Dermatology Life Quality Index (DLQI) at week 24(From enrollment to week 24)
- Association between clinical phenotype and achievement of EASI-75 at week 24(From enrollment to week 24)
- Association between age of onset and achievement of EASI-75 at week 24(From enrollment to week 24)
- Association between family history of atopic disease and achievement of EASI-75 at week 24(From enrollment to week 24)
- Association between previous treatment failures and achievement of EASI-75 at week 24(From enrollment to week 24)
- Incidence and severity of adverse events during treatment(From enrollment to week 24)
- Rate of patient adherence to treatment(From enrollment to week 24)
- Frequency of treatment modifications (interruptions or switching)(From enrollment to week 24)
- Change in composite RCM score from baseline to week 24(Baseline and week 24)
- Difference in composite RCM score between AD patients and healthy controls(Time Frame: Baseline only)
研究者
LUIS DANIEL MAZZUOCCOLO
Head of Department of Dermatology
Hospital Italiano de Buenos Aires