Using confocal reflectance microscopy to monitor skin changes in adults with atopic dermatitis treated with tralokinumab.
Evaluation by Confocal Reflectance Microscopy of the Skin Structure of Patients With Atopic Dermatitis Treated With Tralokinumab Biotherapy.
This project will use a noninvasive skin microscope (reflectance confocal microscopy) to see if adults with moderate-to-severe atopic dermatitis who start tralokinumab show microscopic improvements in their skin.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hôpitaux Drôme Nord Academic / other |
| Drugs / interventions | tralokinumab |
| Locations | 1 site (Romans-sur-Isère, Drôme) |
| Trial ID | NCT07568665 on ClinicalTrials.gov |
What this trial studies
This is a single-center observational imaging project that will take high-resolution reflectance confocal microscopy (RCM) pictures of the epidermis and papillary dermis in adults with moderate-to-severe atopic dermatitis who are starting tralokinumab. Imaging will be done before treatment and at defined follow-up visits to document structural and inflammatory changes at the cellular level. Investigators will compare RCM findings with routine clinical measures such as EASI and SCORAD to explore objective correlates of response. No experimental interventions beyond standard-of-care tralokinumab prescribing are planned.
Who should consider this trial
Good fit: Adults aged 18 or older with moderate-to-severe atopic dermatitis who, in the investigator's judgment, require systemic treatment with tralokinumab and can give informed consent are ideal candidates.
Not a fit: People who are under 18, not starting tralokinumab, have uncontrolled chronic disease or severe comorbidities that affect participation, or cannot attend the single study site are unlikely to benefit from this project.
Why it matters
Potential benefit: If successful, RCM could provide a noninvasive, objective biomarker to track skin-level response to tralokinumab and help guide treatment decisions.
How similar studies have performed: Tralokinumab has demonstrated clinical efficacy in moderate-to-severe atopic dermatitis and RCM has been used to image inflammatory skin disease, but using RCM specifically to monitor tralokinumab response is relatively novel with limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Romans-sur-Isère, Drôme
- Hopitaux Drome NOrd — Romans-sur-Isère, Drôme, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.