NCT07568665Active, not recruiting
Evaluation by Confocal Reflectance Microscopy of the Skin Structure of Patients With Atopic Dermatitis Treated With Tralokinumab Biotherapy.
Source: ClinicalTrials.gov · Last updated 3 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 15 (estimated)
- First submitted
- 20 Mar 2026
- Start date
- 27 Nov 2025
- Primary completion date
- 1 Feb 2027
- Lead sponsor
- Hôpitaux Drôme Nord
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT07568665
What you commit to
- Study type: Observational
- Planned participants: 15
- From 27 Nov 2025 to the primary completion date, 1 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with a severe concomitant disease that, in the investigator's opinion, would negatively affect participation in the study.
Other illness
- Patients with an uncontrolled chronic disease that may require corticosteroid courses/treatment.
Other
- Patients who refuse to participate in the study and legally incapacitated adults
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopitaux Drome Nord Coordinator of this site? Confirm its status | Romans-Sur-Isere | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.