Clinical trial Recruiting at 1 site Observational Ages 18 and up

Collection of samples and data for severe drug reactions

Official title: Adverse Cutaneous Drug Reactions Collection of Clinical Data and Biological Samples

Run by Assistance Publique - Hôpitaux de Paris · NCT03659227 · Data updated 2026-11-12

This study is collecting samples and information from patients with severe skin reactions to better understand what causes these reactions and how to improve treatment and prevention.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment500 (estimated)
SponsorAssistance Publique - Hôpitaux de Paris
Academic / other
Locations1 site (Créteil)
StatusRecruiting
StartedSeptember 26, 2018
Main results expectedSeptember 25, 2023
Study endsSeptember 25, 2028
Registry record updatedMay 3, 2022
Trial IDNCT03659227 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults aged 18 and older who have experienced severe cutaneous drug reactions.

Probably not a fit

Patients under legal protection or those not experiencing severe drug reactions may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to gather clinical data and biological samples from patients experiencing severe cutaneous adverse reactions, such as Stevens-Johnson syndrome and Lyell syndrome. Conducted at the dermatology department of Henri Mondor Hospital in France, the study will involve collecting skin biopsies, blood samples, and other biological materials to enhance understanding of the immunological and genetic factors involved in these drug reactions. The collected data will support future research aimed at improving treatment and prevention strategies for affected patients.

Why it matters

Potential benefit: If successful, this study could lead to better understanding and management of severe drug reactions, ultimately improving patient outcomes.

How similar studies have gone: While this approach is focused on observational data collection, similar studies have shown promise in understanding drug reactions, indicating potential for success.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Patient ≥ 18 y-old
* Severe cutaneous drug reaction (AGEP, DRESS, SJS/TEN, generalized bullous fixed drug eruption), drug-induced IgA bullous dermatosis, maculopapular exanthema, erythema multiforme
* Signed consent
* Social security affiliation

Exclusion Criteria:

* Patients law protection

Where it's running

  • Henri Mondor
    Créteil, France
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.