Drug Rash With Eosinophilia and Systemic Symptoms Clinical Trial
Official title:
DRESS - Setting of Corticosteroid Treatment.
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment