Actively Recruiting
Evaluation by Confocal Reflectance Microscopy of the Skin Structure of Patients With Atopic Dermatitis Treated With Tralokinumab Biotherapy
Led by Hôpitaux Drôme Nord · Updated on 2026-05-06
15
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying atopic dermatitis (AD), a long-lasting inflammatory skin condition marked by itchiness and recurring eczema. They aim to assess skin changes in patients treated with tralokinumab, an antibody therapy targeting IL-13 that has shown promise for moderate-to-severe AD. Traditional assessments rely on clinical scores like Eczema Area Severity Index (EASI) and SCORAD, which can vary between observers. This study uses reflectance confocal microscopy (RCM), a noninvasive imaging technique that examines the skin at the cellular level to better understand treatment effects. Participants with moderate-to-severe AD who are starting treatment with tralokinumab will be observed. The study will evaluate skin thickness and other structural changes before treatment begins and at 16 weeks after starting therapy using RCM. This observational study does not involve altering patient treatment but monitors skin changes during standard care with tralokinumab. During the study, participants will undergo RCM imaging to assess skin layers and inflammation. Researchers will measure the thickness of affected skin before treatment and at week 16 to track changes. Patients must provide informed consent and be able to participate for the duration of the study. The total study period extends through November 2028, with ongoing observation of skin responses to therapy.
CONDITIONS
Brief Title
Evaluation by Confocal Reflectance Microscopy of the Skin Structure of Patients With Atopic Dermatitis Treated With Tralokinumab Biotherapy.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants are observed to evaluate skin structure before starting treatment and at Week 16.
2 visits (in-person): one before treatment initiation and one at Week 16
Trial Site Locations
Total: 1 location
1
Hopitaux Drome NOrd
Romans-sur-Isère, Drôme, France, 26100
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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