Ongoing Clinical Trials for Toxic Epidermal Necrolysis
There are currently 2 clinical trials underway investigating new treatment approaches for toxic epidermal necrolysis, a severe and life-threatening skin reaction. Both trials are taking place in France and focus on improving healing outcomes and stopping disease progression. (Also known as: Lyell Syndrome, TEN, Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis)
Clinical trial locations
- France
Study on Filgrastim for Patients with Severe Bullous Drug Eruptions: Lyell and Stevens-Johnson Syndromes
This trial is investigating whether filgrastim, a medication that stimulates white blood cell production, can help stop the progression of severe skin reactions when added to standard treatment. The study aims to determine if this approach can improve healing and recovery outcomes for patients experiencing these life-threatening conditions.
Who can participate: The trial is open to patients aged 6 years or older who have been diagnosed with Stevens-Johnson syndrome or Lyell syndrome. The condition must have started less than 7 days before enrollment, with worsening skin detachment or rash within the past 48 hours. Participants or their guardians must be able to understand the trial’s purpose and provide written consent. Women of childbearing age must have a negative pregnancy test, and all participants must be registered with a social security scheme.
Who cannot participate: Patients with a previous history of Lyell syndrome or Stevens-Johnson syndrome are excluded from the study. Those outside the specified age range or who belong to vulnerable populations that might be at higher risk of harm are also not eligible to participate.
What the trial involves: Participants are divided into two groups over a five-day treatment period. One group receives filgrastim through injection or infusion along with standard treatment, while the other receives standard treatment with a placebo. The main focus is on whether the medication can halt the progression of skin detachment by day 5. Researchers will also monitor how quickly the skin heals, overall health outcomes at 30 days and one year, and any side effects experienced during the study. Follow-up observations continue for up to one year to evaluate long-term effects and quality of life.
Treatment with Mesenchymal Stromal Cells for Adults with Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS-TEN) Affecting More Than 10% of Body Surface
This innovative trial explores the use of mesenchymal stromal cells derived from donated fat tissue as a potential treatment for severe skin reactions. These specialized cells have natural healing properties and are being tested for their ability to reduce inflammation and promote tissue regeneration in patients with extensive skin damage.
Who can participate: Adults between 18 and 75 years old who have been hospitalized within 10 days of their first symptoms can participate. Patients must have a confirmed diagnosis and be admitted to either a dermatology department or intensive care unit, with at least 10% of their body surface area affected within the first 10 days of symptoms. Participants must be able to provide written informed consent and be enrolled in a social security scheme.
Who cannot participate: The trial excludes individuals under 18 or over 65 years old, pregnant or breastfeeding women, and those with active infections unrelated to the skin condition. Patients with less than 10% body surface area affected, a history of cancer within the past five years, severe liver or kidney disease, uncontrolled diabetes, or severe heart conditions cannot participate. Those who are immunocompromised, have a history of severe allergic reactions, known allergies to study medications, mental health conditions that could interfere with participation, or are currently in other clinical trials are also excluded.
What the trial involves: Participants receive a single dose of mesenchymal stromal cells through intravenous injection, with the amount calculated based on body weight. The primary goal is to achieve at least 90% skin healing within 7 days of treatment. Close monitoring occurs during the first week, with additional assessments on days 5, 10, and 15. Blood samples are collected on day 0, day 10, and at one month, along with a skin sample to analyze healing progress. Recovery of affected areas including the mouth, nose, eyes, and genital regions is carefully tracked. Final assessment occurs at 12 months to evaluate any lasting effects and overall recovery.
Summary
Both ongoing clinical trials for toxic epidermal necrolysis are based in France and represent distinct approaches to treating this severe condition. The first trial investigates filgrastim, a medication that works by stimulating white blood cell production, examining whether it can halt disease progression when added to standard care. The second trial takes an innovative approach using mesenchymal stromal cells, exploring their potential to promote healing through anti-inflammatory and regenerative properties.
What distinguishes these studies is their patient populations and treatment approaches. The filgrastim trial includes both children (from age 6) and adults, while the cell therapy trial focuses exclusively on adults aged 18 to 75. The cell therapy trial also has stricter requirements regarding the extent of body surface involvement and excludes patients with various comorbidities. Both trials emphasize early intervention, requiring enrollment within specific timeframes from symptom onset, reflecting the critical importance of timely treatment in this life-threatening condition.
