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NCT Number: NCT07568665

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

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.

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Key information

Conditions

Atopic Dermatitis (AD) Atopic Dermatitis (Eczema) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Thickness of the atopic skin

    Time frame: • Before the initiation of treatment. • At Week 16.

    µm, measured by Reflectance Confocal Microscopy (RCM)

Sponsors and collaborators

Lead sponsor

Hôpitaux Drôme Nord

Other

Registry information

Acronym: ADUTERCoM

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
May 6, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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