BridgeMD
Severe Erythema Multiforme - CORTICO
EU CTIS ID: 2024-516018-39-00
What this study is testing
To demonstrate that a short course (12 days) of SCS could alleviate pain and improve food intake without rescue therapy, as compared with placebo in the acute established phase of severe EM.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 15 years old and 30 kg ≤ Weight ≤ 150 kg
- Clinical diagnosis of severe EM defined as: o Typical skin lesions if first flare of EM: raised target lesions with 2 or 3 concentric rings located on the extremities or disseminated. In case of recurrent EM, with proven anterior flare (known clinical diagnosis associating typical skin lesions and MM involvement in a previous flare), typical skin lesions are not essential for inclusion, because EM may manifest as isolated mucosal involvement. o Two or more MMs affected (mouth, throat, eyes, ear, nose, genital and/or anal areas), or only the oral MM affected, if severely affected (score* 2 or 3 of Harman criteria) with altered general conditions and significant impact on food intake (solid food impossible). (* Oral score: 1, minor activity (up to three erosions); 2, moderate activity (more than three but less than 10 erosions, or generalized desquamative gingivitis); 3, severe (more than 10 discrete erosions or extensive, confluent erosions, or generalized desquamative gingivitis with discrete erosions at other oral sites)).
- First flare of EM or acute recurrence of previously diagnosed EM
- Disease flare that has lasted for up to 5 days (≤5 days)
- Affiliated with a social security scheme
- Able to provide written informed consent; the consent of both parents will be collected for minors.
You likely can't join if
- EM without involvement of oral cavity compromising normal solid food
- Pregnant or breastfeeding
- Person subject to safeguards of justice, deprived of liberty by judicial or administrative decision
- Person subject to psychiatric care without their consent
- Person admitted to a health or social establishment for purposes other than those of research
- Person unable to express their consent
See the full eligibility criteria
Who can join
- Age ≥ 15 years old and 30 kg ≤ Weight ≤ 150 kg
- Clinical diagnosis of severe EM defined as: o Typical skin lesions if first flare of EM: raised target lesions with 2 or 3 concentric rings located on the extremities or disseminated. In case of recurrent EM, with proven anterior flare (known clinical diagnosis associating typical skin lesions and MM involvement in a previous flare), typical skin lesions are not essential for inclusion, because EM may manifest as isolated mucosal involvement. o Two or more MMs affected (mouth, throat, eyes, ear, nose, genital and/or anal areas), or only the oral MM affected, if severely affected (score* 2 or 3 of Harman criteria) with altered general conditions and significant impact on food intake (solid food impossible). (* Oral score: 1, minor activity (up to three erosions); 2, moderate activity (more than three but less than 10 erosions, or generalized desquamative gingivitis); 3, severe (more than 10 discrete erosions or extensive, confluent erosions, or generalized desquamative gingivitis with discrete erosions at other oral sites)).
- First flare of EM or acute recurrence of previously diagnosed EM
- Disease flare that has lasted for up to 5 days (≤5 days)
- Affiliated with a social security scheme
- Able to provide written informed consent; the consent of both parents will be collected for minors.
What rules you out
- EM without involvement of oral cavity compromising normal solid food
- Pregnant or breastfeeding
- Person subject to safeguards of justice, deprived of liberty by judicial or administrative decision
- Person subject to psychiatric care without their consent
- Person admitted to a health or social establishment for purposes other than those of research
- Person unable to express their consent
- Person under legal protection (guardianship or curatorship)
- Participation in another clinical trial (medicinal products trials) or in the exclusion period at the end of a previous clinical trial concerning medicinal products, if applicable
- (person) on state medical aid
- Patients unable to eat solid food outside of their current pathology (erythema multiforme)
- Other diagnosis potentially involving MMs: Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), pemphigus, herpetic gingivostomatitis
- Systemic Corticosteroids prescribed for another disease on inclusion day (any dose)
- Use of systemic Corticosteroids for > 5 days for any previous flare of EM (>10mg)
- Contraindication to systemic Corticosteroids: o hypersensitivity to systemic Corticosteroids or to an excipient o uncontrolled primary bacterial, viral, fungal or parasitic infections o psychotic states not yet controlled by treatment
- Sepsis (shock, cyanosis, hypothermia, low blood pressure monitored successively twice (systemic blood pressure < 90 mmHg and diastolic blood pressure < 60 mmHg)
- Kidney or liver insufficiency (creatinine level ≥ 150 μmol/L; aspartate aminotransferase or alanine aminotransferase level > 3 times the upper limit of normal)
- Current cancer with the exception of non-metastatic skin carcinoma not requiring immediate medical treatment
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.