NCT07098000Completed
The Role of Confocal Microscopy in Estimating Dupilumab Treatment Response for Moderate/Severe Atopic Dermatitis
Source: ClinicalTrials.gov · Last updated 16 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 40 (actual)
- First submitted
- 3 Jul 2025
- Start date
- 24 Apr 2024
- Primary completion date
- 9 Apr 2026
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT07098000
What you commit to
- Study type: Observational
- Participants enrolled: 40
- From 24 Apr 2024 to the primary completion date, 9 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Inability to comply with study procedures.
- Refusal to provide informed consent.
Who the study is looking for
- ≥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 3-4.
- 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.
Age in the registry: 6 months to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Italiano de Buenos Aires Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.