Atopic DermatitisNCT07098000

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

An observational study of Atopic Dermatitis, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 6 months and olderHealthy volunteers can take part
Conditions the study is for: Atopic Dermatitis
How many people: 40 participants
Where: 1 siteArgentina
Study dates: 24 Apr 2024to 9 Apr 2026
How long will I take part?: 3 Months
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 months and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

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.

Who may be able to join

≥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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Argentina1 site

Hospital Italiano de Buenos Aires
Buenos Aires, 1199

Other trials in Argentina

About this study

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.

Read the detailed description

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

Patients will be referred to Hospital Italiano, where the study team will conduct consent and baseline evaluations. Study duration is up to 48 weeks, including four visits: baseline, week 12 and week 24. Systemic treatment will be prescribed independently by the referring physician, allowing the study to observe real-world therapeutic strategies. The coordinating center will manage clinimetric assessments, patient-reported outcomes (PROs), and imaging.

Baseline Assessments:

Demographics and medical history. Clinimetry: vIGA-AD, EASI, BSA, SCORAD, PGIS, PGIC. PROs: PP-NRS, SP-NRS, Sleep-NRS, POEM, ADCT, DLQI. Documentation of prescribed treatment: molecule, route, dose, schedule. RCM imaging of selected lesions (trunk, limbs, face), excluding hyperkeratotic or eroded acral lesions.

RCM Imaging Protocol:

Equipment: Vivascope 1500 and 3000 (Caliber ID). Mosaic acquisition (5x5 mm) at four skin depths: stratum corneum, stratum spinosum, dermoepidermal junction, and superficial dermis.

Stacked images collected from the corneal layer to ~250 μm depth. Facial lesions will be imaged with the handheld Vivascope 3000 when needed. Images stored in a secured, structured database.

Follow-Up Visits (Weeks 12 and 24):

Repeat clinimetry and PRO assessments. Treatment adherence and adverse event monitoring. Repeat RCM imaging on the same anatomical sites.

Predictive and Descriptive Variables:

RCM features: parakeratosis, hyperkeratosis, spongiosis, vesicles, acanthosis, exocytosis, non-edged dermal papillae, DEJ morphology, vascular dilation, dermal infiltration, melanophages.

Clinical: phenotype (e.g., classical, nummular, generalized lichenoid), comorbidities, prior therapies, IgE levels, family history.

Sample Size and Sampling Strategy

This exploratory study does not have a formal sample size estimation. The investigators expect to include 40 consecutive patients on dupilumab therapy, at least ten patients with the main phenotypes:

Classical: Lichenified/exudative flexural dermatitis, almost always associated with head-and-neck eczema and hand eczema
Generalized eczema with a lichenoid pattern: lichenification, excoriations, crusts, and xerosis
Nummular eczema with round, inflamed sores.

Statistical Analysis

Descriptive statistics will include frequencies for categorical variables and medians with interquartile ranges for continuous variables.

Primary analysis: Linear regression using the change (Δ) in EASI and vIGA-AD from baseline to week 24 as outcomes; baseline RCM features as predictors.

Secondary analysis: Logistic regression for binary clinical responses (e.g., achieving EASI-75), reporting odds ratios (ORs) with 95% confidence intervals (CIs).

All analyses will be conducted using STATA v14.1.

Conditions: Atopic Dermatitis
Keywords: atopic dermatitis, reflectance confocal microscopy, dupilumab
Medical subject headings: Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07098000
Study group	Role	What they receive
Dupilumab treated patients		Dupilumab treated patients
Control		10 healthy controls, five males and five females

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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)
Measured: Baseline and week 24

Secondary outcomes (20)

Predictive value of baseline RCM features for achieving EASI-75 at week 24
The association between baseline reflectance confocal microscopy (RCM) features (e.g., spongiosis, inflammatory infiltrate, disarrayed epidermis, changes in the dermoepidermal junction) and achieving at least 75% improvement in Eczema Area and Severity Index (EASI-75) at week 24 will be evaluated.
Measurement Tool: Eczema Area and Severity Index (EASI) Unit of Measure: % of participants achieving EASI-75
Measured: From enrollment to week 24
Predictive value of baseline RCM features for achieving vIGA-AD 0 or 1 at week 24
The association between baseline RCM features and achieving a score of 0 (clear) or 1 (almost clear) in the validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) at week 24 will be evaluated.
Measurement Tool: Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Unit of Measure: % of participants achieving vIGA-AD 0 or 1
Measured: From enrollment to week 24
Predictive value of baseline RCM features for achieving EASI <10 at week 24
The association between baseline RCM features and achieving an EASI score <10 at week 24 will be evaluated.
Measurement Tool: Eczema Area and Severity Index (EASI) Unit of Measure: % of participants with EASI <10
Measured: From enrollment to week 24
Correlation between baseline RCM features and change in SCORAD at week 24
The correlation between baseline reflectance confocal microscopy (RCM) features and change in SCORAD (Scoring Atopic Dermatitis) from baseline to week 24 will be assessed.
Measurement Tool: SCORAD index Unit of Measure: Change in SCORAD score (continuous variable)
Measured: From enrollment to week 24
Correlation between baseline RCM features and change in BSA affected at week 24
The correlation between baseline RCM features and change in Body Surface Area (BSA) affected by atopic dermatitis from baseline to week 24 will be assessed.
Measurement Tool: Clinician-estimated BSA Unit of Measure: Change in % BSA affected
Measured: From enrollment to week 24
Correlation between baseline RCM features and change in Patient Global Impression of Severity (PGIS) at week 24
The correlation between baseline RCM features and change in PGIS scores from baseline to week 24 will be assessed.
Measurement Tool: Patient Global Impression of Severity (PGIS) Unit of Measure: Change in PGIS score (ordinal scale)
Measured: From enrollment to week 24
Correlation between baseline RCM features and Patient Global Impression of Change (PGIC) at week 24
The correlation between baseline RCM features and PGIC score at week 24 will be assessed.
Measurement Tool: Patient Global Impression of Change (PGIC) Unit of Measure: PGIC score at week 24 (ordinal scale)
Measured: Week 24
Correlation between baseline RCM features and change in peak pruritus NRS at week 24
The correlation between baseline RCM features and change in peak pruritus Numeric Rating Scale (NRS) score from baseline to week 24 will be assessed.
Measurement Tool: Peak Pruritus NRS (0-10) Unit of Measure: Change in NRS score (continuous variable)
Measured: From enrollment to week 24
Correlation between baseline RCM features and change in POEM score at week 24
The correlation between baseline RCM features and change in Patient-Oriented Eczema Measure (POEM) from baseline to week 24 will be assessed.
Measurement Tool: POEM questionnaire Unit of Measure: Change in POEM score (continuous variable)
Measured: From enrollment to week 24
Correlation between baseline RCM features and change in Atopic Dermatitis Control Tool (ADCT) score at week 24
The correlation between baseline RCM features and change in ADCT score from baseline to week 24 will be assessed.
Measurement Tool: Atopic Dermatitis Control Tool (ADCT) Unit of Measure: Change in ADCT score (continuous variable)
Measured: From enrollment to week 24
Correlation between baseline RCM features and change in Dermatology Life Quality Index (DLQI) at week 24
The correlation between baseline RCM features and change in DLQI score from baseline to week 24 will be assessed.
Measurement Tool: Dermatology Life Quality Index (DLQI) Unit of Measure: Change in DLQI score (continuous variable)
Measured: From enrollment to week 24
Association between clinical phenotype and achievement of EASI-75 at week 24
The association between baseline clinical phenotype and achieving at least 75% improvement in EASI score (EASI-75) at week 24 will be assessed.
Measurement Tool: Eczema Area and Severity Index (EASI) Unit of Measure: % of participants achieving EASI-75
Measured: From enrollment to week 24
Association between age of onset and achievement of EASI-75 at week 24
The association between age at onset of atopic dermatitis and achieving EASI-75 at week 24 will be evaluated.
Measurement Tool: EASI Unit of Measure: % of participants achieving EASI-75
Measured: From enrollment to week 24
Association between family history of atopic disease and achievement of EASI-75 at week 24
The association between family history of atopic disease and the likelihood of achieving EASI-75 at week 24 will be assessed.
Measurement Tool: EASI Unit of Measure: % of participants achieving EASI-75
Measured: From enrollment to week 24
Association between previous treatment failures and achievement of EASI-75 at week 24
The association between prior failure of topical or systemic treatments and achieving EASI-75 at week 24 will be evaluated.
Measurement Tool: EASI Unit of Measure: % of participants achieving EASI-75
Measured: From enrollment to week 24
Incidence and severity of adverse events during treatment
Adverse events occurring during the 24-week treatment period will be recorded and classified by severity according to the Common Terminology Criteria for Adverse Events (CTCAE).
Measurement Tool: CTCAE v5.0 Unit of Measure: Number of adverse events per CTCAE grade
Measured: From enrollment to week 24
Rate of patient adherence to treatment
Patient adherence will be evaluated as the percentage of prescribed doses (topical and/or systemic) that were effectively administered over the 24-week period.
Measurement Tool: Patient and/or caregiver diary Unit of Measure: % of prescribed doses taken
Measured: From enrollment to week 24
Frequency of treatment modifications (interruptions or switching)
The number and proportion of patients requiring treatment interruption, discontinuation, or change of therapy will be recorded to assess feasibility of the intervention.
Measurement Tool: Study medication records Unit of Measure: % of participants with treatment modifications
Measured: From enrollment to week 24
Change in composite RCM score from baseline to week 24
A composite RCM score (based on presence of spongiosis, inflammatory infiltrate, epidermal disarray, and DEJ abnormalities) will be calculated at baseline and week 24. Mean changes in score will be analyzed across the cohort and by clinical response (EASI-75).
Measurement Tool: Investigator-assessed composite RCM score (0-12) Unit of Measure: Mean change in score (continuous variable)
Measured: Baseline and week 24
Difference in composite RCM score between AD patients and healthy controls
A composite reflectance confocal microscopy (RCM) score will be calculated at baseline for each participant based on the presence and severity of four predefined imaging features: spongiosis, inflammatory cell infiltrate, epidermal disarray, and dermoepidermal junction (DEJ) abnormalities. Mean scores will be compared between patients with atopic dermatitis and age-matched healthy controls to identify structural markers of disease.
Measurement Tool: Investigator-assessed composite RCM score (0-12) Unit of Measure: Mean composite score (continuous variable)
Measured: Time Frame: Baseline only

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Apr 20249 Apr 2026

First posted1 Aug 2025
Study start24 Apr 2024
Primary completion9 Apr 2026
Study completion9 Apr 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Atopic DermatitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 40 participants (actual)
Target duration: 3 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT07098000
Sponsor's protocol ID: 6955
Status last verified: Sep 2026
First submitted: 3 Jul 2025
Last updated: 16 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 31558224
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.
PubMed 33527483
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.
PubMed 35815904
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.
PubMed 35503163
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.
PubMed 36059592
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.
PubMed 36445075
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.
PubMed 34839985

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Role of Confocal Microscopy in Estimating Dupilumab Treatment Response for Moderate/Severe Atopic Dermatitis
ClinicalTrials.gov ID: NCT07098000
Acronym / sponsor ID: 6955
Conditions: Atopic Dermatitis
Keywords: atopic dermatitis, reflectance confocal microscopy, dupilumab
Study type: Observational
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Hospital Italiano de Buenos AiresUniversity, hospital or other
Study start: 24 Apr 2024 (actual)
Primary completion: 9 Apr 2026 (actual)
Study completion: 9 Apr 2026 (actual)
First posted: 1 Aug 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study Design and Setting

Study Population and Recruitment Strategy

Study Procedures

Baseline Assessments:

RCM Imaging Protocol:

Equipment: Vivascope 1500 and 3000 (Caliber ID). Mosaic acquisition (5x5 mm) at four skin depths: stratum corneum, stratum spinosum, dermoepidermal junction, and superficial dermis.

Stacked images collected from the corneal layer to ~250 μm depth. Facial lesions will be imaged with the handheld Vivascope 3000 when needed. Images stored in a secured, structured database.

Follow-Up Visits (Weeks 12 and 24):

Repeat clinimetry and PRO assessments. Treatment adherence and adverse event monitoring. Repeat RCM imaging on the same anatomical sites.

Predictive and Descriptive Variables:

RCM features: parakeratosis, hyperkeratosis, spongiosis, vesicles, acanthosis, exocytosis, non-edged dermal papillae, DEJ morphology, vascular dilation, dermal infiltration, melanophages.

Clinical: phenotype (e.g., classical, nummular, generalized lichenoid), comorbidities, prior therapies, IgE levels, family history.

Sample Size and Sampling Strategy

This exploratory study does not have a formal sample size estimation. The investigators expect to include 40 consecutive patients on dupilumab therapy, at least ten patients with the main phenotypes:

Classical: Lichenified/exudative flexural dermatitis, almost always associated with head-and-neck eczema and hand eczema
Generalized eczema with a lichenoid pattern: lichenification, excoriations, crusts, and xerosis
Nummular eczema with round, inflamed sores.

Statistical Analysis

Descriptive statistics will include frequencies for categorical variables and medians with interquartile ranges for continuous variables.

Primary analysis: Linear regression using the change (Δ) in EASI and vIGA-AD from baseline to week 24 as outcomes; baseline RCM features as predictors.

Secondary analysis: Logistic regression for binary clinical responses (e.g., achieving EASI-75), reporting odds ratios (ORs) with 95% confidence intervals (CIs).

All analyses will be conducted using STATA v14.1.

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 3 Months
Number of arms: 2

Arm	Type	Receives
Dupilumab treated patients	–	–Dupilumab treated patients
Control	–	–10 healthy controls, five males and five females

Who may qualify

Ages: 6 months and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult
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.

Key inclusion criteria (6 listed)

≥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.

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Correlation between baseline RCM features and change in EASI score at week 24
Time frame: 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
Time frame: 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)

20 secondary outcomes

Predictive value of baseline RCM features for achieving EASI-75 at week 24
Time frame: From enrollment to week 24
Predictive value of baseline RCM features for achieving vIGA-AD 0 or 1 at week 24
Time frame: From enrollment to week 24
Predictive value of baseline RCM features for achieving EASI <10 at week 24
Time frame: From enrollment to week 24
Correlation between baseline RCM features and change in SCORAD at week 24
Time frame: From enrollment to week 24
Correlation between baseline RCM features and change in BSA affected at week 24
Time frame: From enrollment to week 24
Correlation between baseline RCM features and change in Patient Global Impression of Severity (PGIS) at week 24
Time frame: From enrollment to week 24
Correlation between baseline RCM features and Patient Global Impression of Change (PGIC) at week 24
Time frame: Week 24
Correlation between baseline RCM features and change in peak pruritus NRS at week 24
Time frame: From enrollment to week 24
Correlation between baseline RCM features and change in POEM score at week 24
Time frame: From enrollment to week 24
Correlation between baseline RCM features and change in Atopic Dermatitis Control Tool (ADCT) score at week 24
Time frame: From enrollment to week 24
Correlation between baseline RCM features and change in Dermatology Life Quality Index (DLQI) at week 24
Time frame: From enrollment to week 24
Association between clinical phenotype and achievement of EASI-75 at week 24
Time frame: From enrollment to week 24
Association between age of onset and achievement of EASI-75 at week 24
Time frame: From enrollment to week 24
Association between family history of atopic disease and achievement of EASI-75 at week 24
Time frame: From enrollment to week 24
Association between previous treatment failures and achievement of EASI-75 at week 24
Time frame: From enrollment to week 24
Incidence and severity of adverse events during treatment
Time frame: From enrollment to week 24
Rate of patient adherence to treatment
Time frame: From enrollment to week 24
Frequency of treatment modifications (interruptions or switching)
Time frame: From enrollment to week 24
Change in composite RCM score from baseline to week 24
Time frame: Baseline and week 24
Difference in composite RCM score between AD patients and healthy controls
Time frame: Time Frame: Baseline only

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
Background: PubMed 31558224Yew 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.
Background: PubMed 33527483Csuka 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.
Background: PubMed 35815904Berdyshev 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.
Background: PubMed 35503163Beck 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.
Background: PubMed 36059592Beck 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.
Background: PubMed 36445075Antonietti 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.
Background: PubMed 34839985Angles 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Luis D Mazzuoccolo, MD principal investigator

Hospital Italiano de Buenos Aires

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Atopic Dermatitis, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation between baseline RCM features and change in EASI score at week 24 (time frame: Baseline and week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07098000, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.