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ENROLLING BY INVITATION
NCT04988256
EARLY_PHASE1

Cyclosporine Vs Steroids in DRESS

Sponsor: University of Southern California

View on ClinicalTrials.gov

Summary

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).

Official title: A Randomized Controlled Pilot Trial of Cyclosporine Vs Steroids in DRESS

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2021-09-27

Completion Date

2026-06-30

Last Updated

2025-03-30

Healthy Volunteers

No

Interventions

DRUG

Cyclosporine

Patients randomized to cyclosporine will be treated as mentioned under "Arm/Group Description"

DRUG

Methylprednisolone and Prednisone

All patients randomized to steroids will initially be treated with IV methylprednisolone and eventually started on an oral prednisone taper.

Locations (1)

USC

Los Angeles, California, United States