Escalated Therapy of Scabies With INFECTOSCAB 5% (Permethrin)
Status:
Recruiting
Trial end date:
2023-08-01
Target enrollment:
Participant gender:
Summary
The ETSKABI study is a prospective, open-label, multicenter, initially single-armed and in
case of treatment failure subsequently three-armed randomized clinical trial. Within the
initial treatment phase, the to-date clinical efficacy of the standard therapy regimen
according to the current German "S1-guideline for the diagnosis and treatment of scabies" is
to be examined. The subsequent second phase focusses on three differently escalated treatment
regimens in order to evaluate their potential to cure those patients still suffering from
Scabies after standard therapy.
In total, 183 patients with Scabies who meet all inclusion criteria and do not meet none of
the exclusion criteria are to be enrolled and topically treated with Permethrin 5 % cream (up
to two administrations, i.e. repeated one-time on day 14 in case of persisting Scabies). In
case of treatment failure by the end of phase one, adult patients will be randomized to
either receive an (i) escalated therapy with Permethrin 5 % cream (repeated topical
administration on two consecutive days), (ii) an add-on-combination consisting of escalated
therapy with Permethrin 5 % cream and Ivermectin p.o. or (iii) an escalated therapy with
Permethrin 10 % cream (up to two administrations, i.e. repeated one-time on day 14 in case of
persisting Scabies).
The primary objective of the ETSKABI study is the clinical efficacy of the standard therapy
by the end of phase one (standard therapy according to the S1-guideline). Beside this,
clinical efficacy by the end of phase two (escalation phase) will be evaluated as well as
adverse events in order to investigate over-all clinical safety.