Cyclosporine Vs Steroids in DRESS

Enrolling by invitation · Early Phase 1

Conditions studied: DRESS Syndrome, Drug-Induced Hypersensitivity Syndrome

In brief

Current treatments for patients with drug reaction with eosinophilia and systemic symptoms (DRESS) include supportive care, steroids and cyclosporine. No randomized controlled trial (RCT) exists in comparing these treatments and all available literature comes in the form of case reports and case series. These two treatments are considered standard of care and this trial seeks only to compare outcomes of DRESS between these two therapies. No additional labs, therapies or procedures will be used apart from those that are routinely done for patients with this diagnosis. This will be a pilot study to determine efficacy of the two therapies with particular endpoints in mind so that the investigators can study the safety of these two therapies in patients with DRESS. Data suggests a potential benefit for adults with DRESS using either steroids or cyclosporine but the investigators are seeking a comparison of efficacy of these two therapies. The study population will include adults with a Registry of Severe Cutaneous Adverse Reaction (RegiSCAR) score of greater than 4 (i.e. a likely diagnosis of DRESS). The investigators will exclude patients with sepsis, active Hepatitis B or C, active tuberculosis, a documented allergy to steroids or cyclosporine, and patients with an estimated glomerular filtration rate (eGFR) \< 30 (unless on dialysis in which case the participants will be included).

Key facts

Study ID

NCT04988256

Run by

University of Southern California

People needed

50

Starts

2021-09-27

Expected to finish

2026-06-30

Last updated by the study team

2025-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults with a RegiSCAR score of greater than 4 (i.e a likely diagnosis of DRESS)

You may not qualify if…

• Active sepsis
• Active hepatitis B or C
• Active tuberculosis
• Documented allergy to steroids or cyclosporine
• Estimated glomerular filtration rate (eGFR) < 30 (unless on dialysis, in which case they will be included)

Where it is running

• USC — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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