Clinical Trial: Comparison Between Corticosteroid and Topical Steroids in the DRESS

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: DRESS - Setting of Corticosteroid Treatment.

Brief Summary:

Drug reaction with eosinophilia and systemic symptoms (DRESS) is a rare and severe multiorgan adverse drug reaction occurring within 2 to 6-8 weeks after a new drug intake. DRESS syndrome is defined by the combination of clinical manifestations, cutaneous, visceral and biological disturbances. Its prognosis is directly linked to severity of visceral involvement, with a mortality evaluated above 10%.

Considering curative treatment, there is no consensus. Until now, no controlled trial has been performed. Systemic steroids are mainly used in first intention, in particular for management of visceral involvements, whatever their severity. From clinical practice, topical steroids are often used and could be helpful in the therapeutic management of DRESS.

We propose to evaluate systemic steroids versus very potent topical steroids in a multicentric randomized controlled trial including defined moderate DRESS, ie the non-inferiority of very potent topical steroids in terms of remission of visceral involvement at Day30 and the superiority of very potent topical steroids in terms of delay to remission of skin involvement.


Detailed Summary:
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: Rate of patients with a complete or almost healing of visceral involvement to D30 +/- 5 days AND complete or almost complete healing of skin involvement. [ Time Frame: Day 30 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Rate of patients with a complete or almost complete healing of cutaneous and visceral involvement at Day 30 ± 5 days [ Time Frame: Day 30 ]
  • Delays of complete or almost complete visceral healing [ Time Frame: Month 12 ]
  • Relapse rates and bounces rates between the end of acute treatment and M12 [ Time Frame: Month 12 ]
  • Patients rate evaluating to severe form (occurrence of a criterion defining the severe form cf. Above) [ Time Frame: Month 12 ]
  • Occurrence rate of moderate DRESS visceral involvement, during the initial treatment (D0 to D30) not existing at inclusion [ Time Frame: Day 30 ]
  • Mortality rate at Month 12 [ Time Frame: Month 12 ]
  • Sequelae rate at Month 12 [ Time Frame: Month 12 ]
  • Systemic steroids adverse reactions rate [ Time Frame: Month 12 ]
  • Topical steroids adverse reactions rate [ Time Frame: Month 12 ]
  • Patch tests evaluation in DRESS [ Time Frame: Month 6 ]
  • Reactivation kinetics of Cytomegalovirus (CMV), Epstein-Barr virus (EBV), Herpes Simplex virus (HSV), Human Herpes virus6 (HHV6) and Human Herpes virus7 (HHV7) [ Time Frame: Day 0, Day 7, Day 14, Day 21, Day 30, Month 3, Month 6, Month 12 ]
  • Predictive value of lymphocyte transformation test in imputability [ Time Frame: Day 0, Day 30, Month 6, Month 12 ]
  • Immunological factors evaluation in the skin [ Time Frame: Day 30 ]
  • Blood inflammatory cytokines and chemokines analysis [ Time Frame: Day 0, Day 30, Month 6 ]
  • Blood cytokines polymorphisms analysis [ Time Frame: Month 12 ]


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: September 17, 2013
Date Started: October 2013
Date Completion: October 2016
Last Updated: July 29, 2015
Last Verified: July 2015