Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruitingRare disease

Study on Severe Erythema Multiforme: Comparing Methylprednisolone Acetate and Lidocaine Hydrochloride Monohydrate with Placebo for Hospitalized Patients

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition called severe erythema multiforme, which is a skin disorder that can cause painful skin lesions and affect areas like the mouth, throat, and eyes. The study aims to compare the effects of a short course of systemic corticosteroids (SCS) with a placebo. The treatment being tested includes medications such as methylprednisolone and prednisone, which are types of corticosteroids that help reduce inflammation and pain.

The purpose of the study is to see if a 12-day course of these corticosteroids can help relieve pain and improve the ability to eat without needing additional treatments. Participants in the study will receive either the corticosteroid treatment or a placebo. The study will monitor how quickly participants experience relief from pain, resume eating solid foods, and whether they need any additional treatments. The trial will also observe the healing of skin and mucosal areas, the resolution of fever, and the overall length of hospital stay.

Throughout the study, participants' pain levels will be assessed regularly, and their ability to eat will be evaluated daily. The study will also track any side effects and assess the quality of life of participants using a scale called the Patient Global Impression of Change (PGIC). The trial is expected to run until November 2027, with recruitment starting in November 2024.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, weight, and clinical diagnosis of severe erythema multiforme (EM).

    The condition must be in its acute phase, with symptoms lasting no more than 5 days.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the severity of symptoms, including skin lesions and mucosal involvement.

    Pain levels and the ability to consume food are assessed using standardized scales.

  3. Step 3

    Treatment phase

    Participants are randomly assigned to receive either a short course of systemic corticosteroids (SCS) or a placebo.

    The medication used is prednisone, administered orally in the form of a 20 mg tablet.

    The treatment duration is 12 days, with daily monitoring of symptoms and side effects.

  4. Step 4

    Monitoring and evaluation

    Pain is assessed three times a day during hospitalization and once a day after discharge until the primary endpoint is achieved.

    Daily evaluations include the ability to resume eating solid food and the need for any additional pain relief.

  5. Step 5

    Follow-up

    Follow-up assessments occur at the end of hospitalization, on day 7, day 15, and one month after treatment.

    The quality of life is evaluated using a 7-point scale, and any adverse events are recorded.

  6. Step 6

    Long-term evaluation

    Long-term effects are assessed at 3 months and 6 months post-treatment, focusing on any lasting skin or mucosal changes.

    The overall success of the treatment is determined by the absence of new lesions and the resolution of existing symptoms.

Who can join the trial?

7 criteria

  • Must be **15 years or older** and weigh between **30 kg and 150 kg**.
  • Have a **clinical diagnosis of severe erythema multiforme (EM)**. This means having typical skin lesions, which are raised target-like spots with rings, usually on the arms and legs. If it's a recurring case, these skin lesions might not be necessary if there was a previous diagnosis involving mucous membranes (MM), like the mouth or eyes.
  • Two or more **mucous membranes (MM)** must be affected, such as the mouth, throat, eyes, ears, nose, or genital areas. If only the mouth is affected, it must be severe, making it hard to eat solid food.
  • It should be the **first flare** of EM or a sudden return of a previously diagnosed EM.
  • The disease flare should have lasted for **up to 5 days**.
  • Must be **affiliated with a social security scheme**.
  • Must be able to **provide written informed consent**. For minors, consent from both parents is required.

Who cannot join the trial?

5 criteria

  • Patients who do not have severe erythema multiforme (a skin condition) managed at the hospital.
  • Patients who are not in the acute established phase of severe erythema multiforme.
  • Patients who require rescue therapy for their condition.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Systemic Corticosteroids (SCS) are medications used in this trial to help reduce inflammation and alleviate pain in patients with severe erythema multiforme. They work by suppressing the immune system to decrease the body's inflammatory response, which can help improve symptoms such as pain and difficulty with food intake.

What is already known about the treatment

Systemic Corticosteroids (SCS) – This medication is administered orally or intravenously, depending on the severity of the condition. It is currently being studied in clinical trials for its effectiveness in treating severe erythema multiforme, a skin condition that can cause painful lesions. The main therapeutic indication is to reduce inflammation and alleviate pain associated with this condition. At the molecular level, SCS works by suppressing the immune system's inflammatory response, thereby reducing swelling and discomfort. It is classified as an anti-inflammatory and immunosuppressive agent.

Investigated diseases

Erythema Multiforme – Erythema multiforme is a skin condition characterized by red, target-like spots or patches that appear on the skin. It often occurs in response to infections or medications. The condition can range from mild to severe, with severe cases involving extensive skin lesions and mucous membrane involvement. In its severe form, it may require hospitalization due to significant discomfort and difficulty in eating or drinking. The lesions typically start as red spots and can develop into blisters or ulcers. Over time, the skin lesions may heal, but the process can be slow and uncomfortable.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516018-39-00Protocol codeAPHP200073Estimated enrolment96 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.