← Back to Search

Immunosuppressant

Cyclosporine vs Steroids for DRESS Syndrome

Phase < 1

Waitlist Available

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0-120 days

Awards & highlights

Study Summary

This trial will compare outcomes of DRESS between two standard therapies, steroids and cyclosporine.

Who is the study for?

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.Check my eligibility

What is being tested?

The study compares two standard treatments for DRESS: Cyclosporine versus Steroids (Methylprednisolone and Prednisone). This pilot RCT aims to determine which treatment is more effective without additional procedures beyond routine care.See study design

What are the potential side effects?

Possible side effects from Cyclosporine include kidney problems and high blood pressure. Steroids may cause weight gain, bone loss, high blood sugar levels among other potential issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0-120 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0-120 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-120 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of patients with complete or near complete resolution of erythema at day 30, on steroid therapy and cyclosporine therapy

Percentage of patients with complete or near complete resolution of erythema at day 7, on steroid therapy and cyclosporine therapy

Percentage of patients with complete or near complete resolution of organ involvement at day 30, on steroid therapy and cyclosporine therapy

Secondary outcome measures

30-day readmission rate

Absolute eosinophil proportion compared to peak value

Mortality

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CorticosteroidsExperimental Treatment1 Intervention

All Patients start with 500 mg IV Methylprednisolone for 3 days 1. If >25% improvement (must be >25% in all involved organs), start the taper regimen 2. If 0-25% improvement (in ≥1 involved internal organ), give 500 mg IV Methylprednisolone for 4 days If no improvement, switch to cyclosporine arm of treatment If 0-25% improvement, give 500 mg IV Methylprednisolone for 3 days i. If labs are down-trending, start the taper regimen ii. If labs are not down-trending, switch to cyclosporine arm of the study c. If >25% improvement, start the taper regimen Taper Regimen set as: 125 mg IV Methylprednisolone x3 days 1.2 mg/kg PO prednisone x1 week 1 mg/kg PO prednisone x1 week 0.8 mg/kg PO prednisone x1 week 0.6 mg/kg PO prednisone x1 week 0.4 mg/kg PO prednisone x1 week 0.2 mg/kg PO prednisone x1 week 0.1 mg/kg PO prednisone x1 week 0.05 mg/kg PO prednisone x1 week

Group II: CyclosporineActive Control1 Intervention

All Patients start with 5 mg/kg/day (3 mg/kg/day if renal impairment) PO divided bid for 7 days (or IV if patient is NPO) If complete resolution, stop cyclosporine and monitor closely for relapse a. If patient relapses, give 5 (3 if renal impairment) mg/kg/day PO divided bid PO for 7 days i. If down-trending, start oral taper regimen ii. If not down-trending, switch to steroid arm If >25% improvement and labs are down-trending, start the oral taper regimen. If 0-25% improvement, give 5 (3 if renal impairment) mg/kg/day PO divided bid for 3 days If down-trending, start oral taper regimen If not down-trending, switch to steroid arm If no improvement or up-trending labs at 7 days, switch to steroid arm Oral Taper Regimen set as 3 mg/kg PO divided bid for 14 days, then 2 mg/kg PO divided bid for 20 days. If renal impairment, oral taper regimen set as 2 mg/kg PO divided bid for 14 days, then 1 mg/kg PO divided bid for 20 days

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor

905 Previous Clinical Trials

1,596,228 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the objectives of this medical research endeavor?

"This 7-day evaluation will focus on the percentage of patients who have a near or complete resolution in their organ involvement after 30 days. Secondary objectives include measuring autoimmunity markers, total number of hospitalization days post dermatology consults and percentage of those with fever reduction below 38 degrees Celsius for 24 hours."

Answered by AI

To what ailments are Methylprednisolone and Prednisone typically prescribed?

"Methylprednisolone and Prednison are well-suited to address issues involving scalp structure. Moreover, they have been shown to be successful in treating transplantation, thyroiditis, as well as bulla."

Answered by AI

Is this experiment accepting new participants?

"At the moment, this medical trial is not enrolling patients. It was first advertised on September 27th 2021 and last updated on May 7th 2022. If you are searching for alternative studies, 1638 trials recruiting individuals with dress syndrome exist along with 469 further experiments currently looking to recruit participants who will receive Methylprednisolone or Prednisone treatment."

Answered by AI

What other investigations have been done on the effectiveness of Methylprednisolone and Prednisone?

"Currently, 469 clinical trials are ongoing to assess the efficacy of Methylprednisolone and Prednisone. 125 of these studies have moved into Phase 3. Although the bulk of research is based in Duarte, California, there are 17831 different locations running related investigations across the globe."

Answered by AI

What is the current number of individuals involved in this experiment?

"This trial is no longer seeking participants; it was initially posted on September 27th 2021, and the most recent update to its status occurred May 7th 2022. For those looking for alternative studies, there are presently 1638 research projects actively enrolling patients with dress syndrome as well as 469 trials that involve Methylprednisolone and Prednisone recruiting individuals into their cohort."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cyclosporine vs Steroids in DRESS

Scott Worswick 2021. "Cyclosporine vs Steroids in DRESS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04988256.

All > Penicillin Allergy > Restasis