Comparison Between Corticosteroid and Topical Steroids in the DRESS
Status:
Unknown status
Trial end date:
2016-10-01
Target enrollment:
Participant gender:
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.