Stevens-Johnson SyndromeNCT03659227
Drug Reactions Sampling (COLLECTIONTOXIDERMIES)
An observational study of Stevens-Johnson Syndrome and Lyell Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Intro: Dermatology department of Henri Mondor Hospital (Creteil, France), is a reference center for toxic bullous diseases and severe cutaneous drug reactions (Stevens-Johnson syndrome (SJS), Lyell syndrome (toxic epidermal necrolysis (TEN)), generalized bullous fixed drug reactions, AGEP, DRESS, drug induced… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stevens-Johnson Syndrome, Lyell Syndrome, Drug Reactions
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 26 Sep 2018to 25 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe cutaneous adverse reactions (DRESS, AGEP, SJS/TEN, generalized bullous fixed drug eruption), drug-induced IgA linear dermatosis, maculo-papular exanthema, erythema multiforme.
Who may be able to join
- 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
Who cannot join
- Patients law protection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Adverse Cutaneous Drug Reactions Collection of Clinical Data and Biological Samples
Intro: Dermatology department of Henri Mondor Hospital (Creteil, France), is a reference center for toxic bullous diseases and severe cutaneous drug reactions (Stevens-Johnson syndrome (SJS), Lyell syndrome (toxic epidermal necrolysis (TEN)), generalized bullous fixed drug reactions, AGEP, DRESS, drug induced immunoglobulin A (IgA) bullous dermatosis, and erythema multiforme). In order to conduct clinical and biological research studies in drug reactions, it is necessary for the investigator's department to implement a collection of clinical data and biological samples.
Hypothesis/Objective: To collect clinical data and cutaneous and biological samples for immunological, biological and genetic studies to improve knowledge about pathophysiology of drug reactions.
Read more
Method: The following samples will be performed in addition to the routine practice samples: one skin punch biopsy (6mm); 43 mL of blood; blister fluid aspiration; oral and nose mucous membrane and skin eSWABs, stool samples.
These samples will be stored in a dedicated biological sampling department ("Platform of biological resources").
Conclusion: The implementation of this collection should allow us to conduct pathophysiological studies about drug reactions.
- Conditions
- Stevens-Johnson Syndrome, Lyell Syndrome, Drug Reactions, AGEP, DRESS, Bullous Dermatosis Caused by Drug Treatment (Disorder)
- Keywords
- Drug reactions, severe cutaneous adverse reactions (SCARs, Stevens-Johnson syndrome, Lyell Syndrome, (generalized bullous) fixed drug reaction, AGEP, DRESS, drug induced IgA bullous dermatosis, maculopapular exanthema, erythema multiforme, sampling, collection
- Medical subject headings
- Stevens-Johnson Syndrome, Drug-Related Side Effects and Adverse Reactions, Drug Eruptions, Erythema Multiforme, Cicatrix
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementation of a clinical data and biological samples collection for cutaneous adverse reactions
Implementation of a clinical data and biological samples collection for cutaneous adverse reactions
Measured: Day 0
Secondary outcomes (1)
To conduct clinical and biological (immunological, histological, microbiological and genetic) studies in cutaneous adverse reactions.
To conduct clinical and biological (immunological, histological, microbiological and genetic) studies in cutaneous adverse reactions.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start26 Sep 2018
- Primary completion25 Sep 2023 (estimated)
- Study completion25 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stevens-Johnson SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saskia Oro, MD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03659227
- Sponsor's protocol ID
- K180201J
- Status last verified
- Apr 2022
- First submitted
- 3 Sep 2018
- Last updated
- 3 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adverse Cutaneous Drug Reactions Collection of Clinical Data and Biological Samples
- ClinicalTrials.gov ID
- NCT03659227
- Acronym / sponsor ID
- K180201J
- Conditions
- Stevens-Johnson Syndrome, Lyell Syndrome, Drug Reactions, AGEP, DRESS, Bullous Dermatosis Caused by Drug Treatment (Disorder)
- Keywords
- Drug reactions, severe cutaneous adverse reactions (SCARs, Stevens-Johnson syndrome, Lyell Syndrome, (generalized bullous) fixed drug reaction, AGEP, DRESS, drug induced IgA bullous dermatosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 26 Sep 2018 (actual)
- Primary completion
- 25 Sep 2023 (estimated)
- Study completion
- 25 Sep 2028 (estimated)
- First posted
- 6 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intro: Dermatology department of Henri Mondor Hospital (Creteil, France), is a reference center for toxic bullous diseases and severe cutaneous drug reactions (Stevens-Johnson syndrome (SJS), Lyell syndrome (toxic epidermal necrolysis (TEN)), generalized bullous fixed drug reactions, AGEP, DRESS, drug induced immunoglobulin A (IgA) bullous dermatosis, and erythema multiforme). In order to conduct clinical and biological research studies in drug reactions, it is necessary for the investigator's department to implement a collection of clinical data and biological samples.
Hypothesis/Objective: To collect clinical data and cutaneous and biological samples for immunological, biological and genetic studies to improve knowledge about pathophysiology of drug reactions.
Method: The following samples will be performed in addition to the routine practice samples: one skin punch biopsy (6mm); 43 mL of blood; blister fluid aspiration; oral and nose mucous membrane and skin eSWABs, stool samples.
These samples will be stored in a dedicated biological sampling department ("Platform of biological resources").
Conclusion: The implementation of this collection should allow us to conduct pathophysiological studies about drug reactions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe cutaneous adverse reactions (DRESS, AGEP, SJS/TEN, generalized bullous fixed drug eruption), drug-induced IgA linear dermatosis, maculo-papular exanthema, erythema multiforme.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patients law protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Implementation of a clinical data and biological samples collection for cutaneous adverse reactions
Time frame: Day 0
Implementation of a clinical data and biological samples collection for cutaneous adverse reactions
1 secondary outcome
To conduct clinical and biological (immunological, histological, microbiological and genetic) studies in cutaneous adverse reactions.
Time frame: Day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Saskia Oro, MD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stevens-Johnson Syndrome and Lyell Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saskia Oro, MD (0149812536 ext. +33, saskia.oro@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implementation of a clinical data and biological samples collection for cutaneous adverse reactions (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2022.