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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
112
Prednisone: Day 0 to day 30: 0.5mg/kg/day Day 30 to day 180: doses decreasing from 15 to 25% every 15 days until Day75 and 10 to 15% every 15 days.
Clobetasol: cream 0.05% Day 0 to day 30: 30 grams per day Day 30 to day 45: 20 grams per day Day 45 to day 60: 20 grams every other day Day 60 to day 120: 20 grams biweekly Day 120 to day 150: 20 grams one a week
Henri Mondor Hospital
Créteil, France
RECRUITINGRate 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
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
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