Cyclosporine vs Steroids for DRESS Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial compares two treatments—steroids (methylprednisolone and prednisone) and cyclosporine—for drug reaction with eosinophilia and systemic symptoms (DRESS), a condition causing severe skin rashes and other serious issues. The goal is to determine which treatment is more effective and safer for those with DRESS. The study involves adults likely to have DRESS, as determined by a specific score, who do not have active infections like sepsis or hepatitis. Participants will receive either steroids or cyclosporine and may switch treatments if the first one proves ineffective. As an Early Phase 1 trial, this research focuses on understanding how these treatments work in people, offering participants a chance to contribute to groundbreaking medical knowledge.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It focuses on comparing two treatments for DRESS, steroids and cyclosporine, without mentioning changes to other medications.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that both cyclosporine and steroids are safe for treating DRESS syndrome, a severe allergic reaction to medication. Studies have found that cyclosporine works well without causing serious side effects. Specifically, one study reported no negative effects when cyclosporine was used, suggesting it is well-tolerated by patients with DRESS.
Steroids are often the first choice for treating DRESS. Although strong evidence specifically for DRESS is limited, steroids are well-known and widely used for many conditions. They help by reducing inflammation, decreasing swelling and redness in the body.
Both treatments are part of the standard care for DRESS, meaning doctors use them regularly because they are considered safe and effective. This trial aims to determine which one works better, but both have a good safety record based on current information.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for DRESS Syndrome because they offer different approaches compared to the usual steroid-based therapies. Cyclosporine, typically used for its immune-suppressing abilities in transplant patients, is being evaluated here for its potential to rapidly control the overactive immune response seen in DRESS. Unlike standard corticosteroid treatments, which can take longer to taper and manage, cyclosporine might provide a quicker resolution of symptoms by targeting T-cell activation more directly. The corticosteroid regimen, on the other hand, is being explored for its precise tapering strategy, potentially reducing the side effects typically associated with prolonged steroid use. These innovative strategies could lead to faster recovery and fewer complications for patients.
What evidence suggests that this trial's treatments could be effective for DRESS?
This trial will treat participants with either cyclosporine or corticosteroids to determine which is more effective for DRESS syndrome. Previous studies have shown that cyclosporine often leads to improvements in fever and rash within about 4 days. Research also indicates that cyclosporine can be beneficial when long-term steroid use isn't possible. Conversely, steroids are a standard treatment for DRESS, helping to control inflammation and symptoms. Both treatments offer potential benefits, but clear comparisons between them remain necessary. This study aims to identify which treatment works better for DRESS.36789
Are You a Good Fit for This Trial?
Adults with a likely diagnosis of DRESS (a severe skin reaction to drugs) as indicated by a RegiSCAR score over 4 can join this trial. It's not for those who have allergies to steroids or cyclosporine, active hepatitis B/C, sepsis, tuberculosis, or severely reduced kidney function unless they're on dialysis.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either corticosteroids or cyclosporine based on randomization to compare efficacy in treating DRESS
Follow-up
Participants are monitored for safety and effectiveness after treatment, including resolution of symptoms and any adverse effects
Long-term monitoring
Participants are monitored for long-term outcomes such as autoimmune development and viral reactivation
What Are the Treatments Tested in This Trial?
Interventions
- Cyclosporine
- Methylprednisolone and Prednisone
Cyclosporine is already approved in European Union, United States, Canada, Japan for the following indications:
- Prevention of organ rejection in kidney, liver, heart, lung, pancreas, and bone marrow transplants
- Treatment of severe psoriasis
- Treatment of nephrotic syndrome
- Prevention of organ rejection in kidney, liver, and heart transplants
- Treatment of severe rheumatoid arthritis
- Treatment of severe psoriasis
- Prevention of organ rejection in kidney, liver, heart, lung, pancreas, and bone marrow transplants
- Treatment of severe psoriasis
- Treatment of nephrotic syndrome
- Prevention of organ rejection in kidney, liver, and heart transplants
- Treatment of severe rheumatoid arthritis
- Treatment of severe psoriasis
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Southern California
Lead Sponsor