Evaluation by Confocal Reflectance Microscopy of the Skin Structure of Patients With Atopic Dermatitis Treated With Tralokinumab Biotherapy.

NCT07568665 | Recruiting

• 1 other identifier: : 2025-A02067-42
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Atopic dermatitis (AD) is a chronic inflammatory skin disease with pruritus and recurrence of eczematous eruptions. Evaluation of response to treatment are only clinical using Eczema Area Severity Index (EASI), SCOring of Atopic Dermatitis Index (SCORAD) scores, with a risk of intra-observer variations. Tralokinumab is a fully human anti-IL-13 monoclonal antibody that has proven to be effective and well-tolerated for the treatment of patients with moderate-to-severe AD. Reflectance confocal microscopy (RCM) is a noninvasive procedure that allows to evaluate epidermis and papillary dermis at a cellular level. RCM allows skin structural and inflammatory parameters evaluation. The aim of this study is to evaluate by RCM skin modifications of AD patients treated with tralokinumab.

Conditions

Atopic Dermatitis (AD); Atopic Dermatitis (Eczema)

Keywords

atopic dermatis; Reflectance Confocal Microscopy; tralokinumab

Outcome Measures

Primary Outcomes (1)

• Thickness of the atopic skin

  µm, measured by Reflectance Confocal Microscopy (RCM)

  • Before the initiation of treatment. • At Week 16.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with moderate-to-severe Atopic Dermatitis who require systemic treatment with tralokinumab

You may qualify if:

• Patients aged 18 years and older.
• Patients with moderate-to-severe Atopic Dermatitis who require systemic treatment with tralokinumab in the investigator's opinion.
• Patients affiliated with or entitled to a social security scheme.
• Patients capable of giving informed consent.
• Patients who have received informed information about the study and have co-signed an informed consent form for participation in the study, along with the investigator.

You may not qualify if:

• Patients who refuse to participate in the study and legally incapacitated adults
• Patients with an uncontrolled chronic disease that may require corticosteroid courses/treatment.
• Patients with a severe concomitant disease that, in the investigator's opinion, would negatively affect participation in the study.

Sponsors & Collaborators

• Hôpitaux Drôme Nord: lead

Study Sites (1)

Hopitaux Drome NOrd

Romans-sur-Isère, Drôme, 26100, France

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

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 Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: May 6, 2026
• Study Start: November 27, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 01/jun/2026 to 01/nov/2029
• Access Criteria: via Mendeley connection

Locations

FR (1)