Study on Filgrastim for Patients with Severe Bullous Drug Eruptions: Lyell and Stevens-Johnson Syndromes

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What is this study about?

This clinical trial is focused on studying the effects of a medication called filgrastim in treating severe skin reactions known as Stevens-Johnson syndrome and Lyell syndrome. These conditions can cause painful skin rashes and blisters, and in severe cases, can lead to large areas of skin peeling off. The study aims to see if adding filgrastim to the usual treatment can help stop the progression of these skin conditions more effectively than the usual treatment alone.

Participants in the study will be divided into two groups. One group will receive the standard treatment for these skin conditions along with filgrastim, while the other group will receive the standard treatment with a placebo. The study will last for a period of five days, during which the main focus will be on whether the skin condition stops getting worse. The study will also look at other factors, such as how quickly the skin heals, the overall health of participants after 30 days and one year, and any side effects experienced during the study.

The medication filgrastim is given as an injection or infusion, which means it is administered directly into the body through a needle. Another substance used in the study is glucose monohydrate, which is a type of sugar solution often used in medical treatments. The goal of the study is to determine if filgrastim can provide additional benefits in treating these severe skin conditions, potentially improving recovery and quality of life for those affected.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, medical condition, and understanding of the trial’s objectives.

Written consent is required from the patient or guardians, especially for minors or those in life-threatening situations.

2 treatment initiation

The treatment begins on Day 0 (D0).

Patients are divided into two groups: the FILGRASTIM group receives filgrastim in addition to standard treatment, while the CONTROL group receives standard treatment with a placebo.

3 medication administration

Filgrastim is administered as a solution for injection or infusion. The specific dosage and frequency are determined by the medical team.

The treatment aims to halt the progression of skin detachment by Day 5 (D5).

4 monitoring and evaluation

The primary goal is to compare the halt in disease progression between the two groups by Day 5.

Secondary evaluations include the time to stop progression, complete skin healing, and overall survival rates at Day 30 and Day 365.

5 follow-up and observation

Patients are monitored for any adverse events from Day 0 to Day 365.

The study also observes the use of additional treatments, such as corticosteroids, and evaluates the patient’s quality of life and potential long-term effects.

Who Can Join the Study?

Patient must be 6 years of age or older.
Patient must have Stevens-Johnson syndrome (SJS) or Lyell syndrome (also known as Toxic Epidermal Necrolysis, NET). These are serious skin conditions that can be caused by a reaction to medication or an infection.
The condition must have started less than 7 days ago, and there must be a worsening of the skin detachment or rash within the last 48 hours.
Patient and/or their guardians must be able to understand the purpose of the trial and must have given written consent to participate. For minors, parents must give consent, and for patients in life-threatening situations, guardians must give consent.
Patient must be registered with a social security scheme or have a similar type of coverage.
Women who can have children must have a negative pregnancy test before participating.

Who Cannot Join the Study?

Patients with a history of Lyell syndrome cannot participate. This is a severe skin reaction that can cause the skin to peel off.
Patients with a history of Stevens-Johnson syndrome are excluded. This is a serious disorder that affects the skin and mucous membranes, causing painful blisters and sores.
Patients who are not within the specified age range for the study cannot participate. The study includes specific age groups, so those outside these groups are excluded.
Patients who are part of a vulnerable population may not be eligible. This refers to groups of people who might be at a higher risk of harm or exploitation.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Centre Hospitalier Lyon Sud	Pierre Benite	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.09.2024

Trial locations

Investigated drugs:

Filgrastim

Filgrastim is a medication used in this clinical trial to evaluate its effectiveness in treating severe skin reactions known as Lyell and Stevens-Johnson Syndromes. It is being tested to see if it can help stop the progression of these conditions when added to the standard treatment.

Lyell Syndrome – Also known as Toxic Epidermal Necrolysis, this rare condition is characterized by widespread skin detachment and mucous membrane involvement. It often begins with flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters. The top layer of the affected skin then dies and sheds, leading to large areas of raw, exposed skin. This can result in severe fluid loss and increased risk of infection. The condition is often triggered by a reaction to medications. It requires immediate medical attention to manage symptoms and prevent complications.

Stevens-Johnson Syndrome – This is a serious disorder of the skin and mucous membranes, often caused by a reaction to medication or an infection. It typically starts with flu-like symptoms, followed by a painful red or purplish rash that spreads and forms blisters. The top layer of the skin then dies and sheds, similar to a burn. This can lead to complications such as dehydration and infection. The condition primarily affects the skin, eyes, and mucous membranes. It is considered a medical emergency and requires prompt treatment.

Trial ID:

2024-515275-35-00

NCT ID:

NCT04651439

Trial Phase:

Therapeutic use (Phase IV)

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Study on Filgrastim for Patients with Severe Bullous Drug Eruptions: Lyell and Stevens-Johnson Syndromes

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?