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NCT07098000

The Role of Confocal Microscopy in Estimating Dupilumab Treatment Response for Moderate/Severe Atopic Dermatitis

Active, enrolled Last updated 1 August 2025
What this trial tests

trial in Atopic Dermatitis in 40 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
24 April 2024
Primary endpoint
12 December 2025
12 April 2026

Quick facts

Lead sponsorHospital Italiano de Buenos Aires
StatusActive, enrolled
Study typeOBSERVATIONAL
Enrollment40
Start date24 April 2024
Primary completion12 December 2025
Estimated completion12 April 2026
Sites1 location across Argentina

Conditions studied

Sponsor

Hospital Italiano de Buenos Aires

Who can join

6 Months and older, any sex, with Atopic Dermatitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Atopic Dermatitis

Currently open trials in the same condition.

Other Hospital Italiano de Buenos Aires trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07098000.

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