Severe Erythema Multiforme - CORTICO

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Feb 12, 2024

Keywords

ClinConnect Summary

The CORTICO trial is studying a condition called severe erythema multiforme (EM), which is a painful skin and mucous membrane disease often triggered by infections like herpes or mycoplasma. This trial aims to find out if using a type of medication called corticosteroids can help improve symptoms more quickly in people experiencing severe EM. Participants will be divided into two groups: one group will receive the corticosteroid prednisone, while the other group will receive a placebo (a pill with no active medication). This trial is essential because there isn't enough solid evidence about using corticosteroids for this condition, and researchers want to provide better guidance for doctors.

To be eligible for the trial, participants must be at least 15 years old, weigh between 30 and 150 kg, and have a clinical diagnosis of severe EM with significant pain or difficulty eating due to mouth sores. They should also be experiencing their first flare-up or a severe recurrence of EM that has lasted less than five days. Participants will need to provide written consent to join the study, and their health will be monitored throughout the trial. This trial is not yet recruiting, so those interested will need to wait for the official start date.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 15 years old and 30 kg ≤ Weight ≤ 150 kg
• * Clinical diagnosis of severe EM defined as:
• • 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 as-sociating 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.
• • 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 criteria22) with altered general conditions and significant impact on food intake (solid food impossible)
• • First flare of EM or acute recurrence of previously diagnosed EM
• • Disease flare that has lasted for up to 5 days (≤5 days)
• • Affiliated to a social security scheme
• • Able to provide written informed consent; consent of both parents will be col-lected for minors
• • 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 gingivi-tis with discrete erosions at other oral sites).
• Exclusion Criteria:
• • EM without involvement of oral cavity compromising normal solid food
• • 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:
• • hypersensitivity to systemic Corticosteroids or to an excipient;
• • uncontrolled primary bacterial, viral, fungal or parasitic infection
• • psychotic states not yet controlled by treatment
• • Sepsis (shock, cyanosis, hypothermia, low blood pressure monitored succes-sively twice (systemic blood pressure \< 90 mmHg and diastolic blood pres-sure \< 60 mmHg)
• • Kidney or liver insufficiency (creatinine level ≥ 150 µmol/L; aspartate ami-notransferase or alanine aminotransferase level \> 3 times the upper limit of normal)
• • Current cancer with the exception of non-metastatic skin carcinoma not re-quiring immediate medical treatment
• • Pregnant or breastfeeding
• • Person subject to safeguards of justice
• • Person 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 interventional study involving human participants or in the exclusion period at the end of a previous study involving human partici-pants, if applicable
• • On state medical aid