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

NCT07098000 | Active Not Recruiting DMC

• 1 other identifier: 6955
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atopic Dermatitis

Keywords

atopic dermatitis; reflectance confocal microscopy; dupilumab

Outcome Measures

Primary Outcomes (2)

• Correlation between baseline RCM features and change in EASI score at 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)

  Baseline and week 24

• Correlation between baseline RCM features and change in vIGA-AD score at 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)

  Baseline and week 24

Secondary Outcomes (20)

• 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

Study Arms (2)

Dupilumab treated patients

Dupilumab treated patients

Control

10 healthy controls, five males and five females

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• ≥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.

You may not qualify if:

• Inability to comply with study procedures.
• Refusal to provide informed consent.

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

Study Sites (1)

Hospital Italiano de Buenos Aires

Buenos Aires, 1199, Argentina

Location

Related Publications (7)

• Yew YW, Dinish US, Choi ECE, Bi R, Ho CJH, Dev K, Li X, Attia ABE, Wong MKW, Balasundaram G, Ntziachristos V, Olivo M, Thng STG. Investigation of morphological, vascular and biochemical changes in the skin of an atopic dermatitis (AD) patient in response to dupilumab using raster scanning optoacoustic mesoscopy (RSOM) and handheld confocal Raman spectroscopy (CRS). J Dermatol Sci. 2019 Sep;95(3):123-125. doi: 10.1016/j.jdermsci.2019.07.003. Epub 2019 Jul 12. No abstract available.

  PMID: 31558224 BACKGROUND

• Csuka EA, Ward SC, Ekelem C, Csuka DA, Ardigo M, Mesinkovska NA. Reflectance Confocal Microscopy, Optical Coherence Tomography, and Multiphoton Microscopy in Inflammatory Skin Disease Diagnosis. Lasers Surg Med. 2021 Aug;53(6):776-797. doi: 10.1002/lsm.23386. Epub 2021 Feb 1.

  PMID: 33527483 BACKGROUND

• Berdyshev E, Goleva E, Bissonnette R, Bronova I, Bronoff AS, Richers BN, Garcia S, Ramirez-Gama M, Taylor P, Praestgaard A, Agueusop I, Jurvilliers P, Boguniewicz M, Levit NA, Rossi AB, Zhang A, Leung DYM. Dupilumab significantly improves skin barrier function in patients with moderate-to-severe atopic dermatitis. Allergy. 2022 Nov;77(11):3388-3397. doi: 10.1111/all.15432. Epub 2022 Jul 21.

  PMID: 35815904 BACKGROUND

• Beck LA, Deleuran M, Bissonnette R, de Bruin-Weller M, Galus R, Nakahara T, Seo SJ, Khokhar FA, Vakil J, Xiao J, Marco AR, Levit NA, O'Malley JT, Shabbir A. Dupilumab Provides Acceptable Safety and Sustained Efficacy for up to 4 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis. Am J Clin Dermatol. 2022 May;23(3):393-408. doi: 10.1007/s40257-022-00685-0. Epub 2022 May 3.

  PMID: 35503163 BACKGROUND

• Beck LA, Cork MJ, Amagai M, De Benedetto A, Kabashima K, Hamilton JD, Rossi AB. Type 2 Inflammation Contributes to Skin Barrier Dysfunction in Atopic Dermatitis. JID Innov. 2022 Apr 26;2(5):100131. doi: 10.1016/j.xjidi.2022.100131. eCollection 2022 Sep.

  PMID: 36059592 BACKGROUND

• Antonietti C, Angles MV, Giachetti A, Diaz MS, Gloser D, Juszkiewicz E, Parrales Villacreses M, Mazzuoccolo L, Parisi C. Atopic dermatitis in children and adolescents seen at a general hospital in the City of Buenos Aires. Arch Argent Pediatr. 2023 Jun 1;121(3):e202202639. doi: 10.5546/aap.2022-02639.eng. Epub 2022 Dec 1. English, Spanish.

  PMID: 36445075 BACKGROUND

• Angles MV, Antonietti CA, Torre AC, Juszkiewicz Franze E, Mazzuoccolo LD, Parisi CAS. Prevalence of atopic dermatitis in adults. An Bras Dermatol. 2022 Jan-Feb;97(1):107-109. doi: 10.1016/j.abd.2020.10.016. Epub 2021 Nov 26. No abstract available.

  PMID: 34839985 BACKGROUND

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Luis D Mazzuoccolo, MD

  Hospital Italiano de Buenos Aires

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Dermatology

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: August 1, 2025
• Study Start: April 24, 2024
• Primary Completion: December 12, 2025
• Study Completion: April 12, 2026
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)