A Phase 3 interventional study of InfectoScab 5 % Creme and Permethrin 10 % Creme in Scabies, sponsored by Infectopharm Arzneimittel GmbH. Status unknown at 8 sites in Germany. Open to participants aged 6 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-08-26.
Sponsored by Infectopharm Arzneimittel GmbH · Phase 3, Interventional, and Treatment
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.
Exclusion Criteria:
Drug: InfectoScab 5 % Creme
Drug: InfectoScab 5 % Creme
Drug: Permethrin 10 % Creme
Drug: InfectoScab 5 % Creme · Drug: Driponin 3 mg Tabletten
InfectoScab 5 % Creme is the already approved standard therapeutic agent, containing the active ingredient permethrin in 5 % concentration. In this study, it is used for topical treatment in the first treatment cycle (standard therapy) as well as in the second treatment cycle (escalation therapy).
Permethrin 10 % Creme also contains permethrin as the active ingredient, but in 10 % concentration. Permethrin 10 % creme is used exclusively for topical treatment in the second therapy cycle (escalation therapy).
Driponin 3 mg Tabletten are approved for the treatment of scabies, containing ivermectin as the active ingredient. Driponin is used as a supplementary, peroral add-on combination treatment in addition to topical permethrin therapy and is used exclusively in the second treatment cycle (escalation therapy).
Efficacy (Yes/No)
Efficacy (Yes/No) after completed standard therapy treatment cycle (InfectoScab 5 % Creme, up to two administrations, if necessary), i.e. treatment success on day 14 (one administration) or on day 28 (one readministration due to persisting Scabies on day 14). Treatment success is defined as: * absence of new scabietic skin lesions, AND * all remaining scabietic lesions are in healing, AND * exclusion of mite infestation in all non-healed efflorescences by reflected light microscopy (dermatoscope), possibly confirmed by microscopic examination of a skin sample, AND * exclusion of the usage of other anti-scabietic drugs
Time frame: day 0 - day 28
Efficacy (treatment success) for VS1 and VS2, as well as for the corresponding follow-up visits FUS1 and FUS2 (separately and cumulatively).
Time frame: day 14 - day 70
Efficacy (therapy success) for VE5, VE101/2 (separately and cumulatively) and VEK as well as for the corresponding follow-up visits FUE5/E10/EK, separately as well as cumulatively according to visit type (regular visit, FU visit)
Time frame: day 28 - day 70
Cumulative efficacy (treatment success) of permethrin-only treatment (i.e. without combined escalation permethrin + ivermectin) by visit type (regular visit, FU visit)
Time frame: day 28 - day 56
Frequency of required repeated standard therapy as well as escalated therapy.
Time frame: day 0 - day 70
Itch (numerical rating scale (NRS) of 0-10) and change in itch vs baseline (scale differences) for all visits, for standard therapy and escalated therapy, and for escalated therapy additionally the change in itch vs start of escalated therapy.
Time frame: day 0 - day 70
Number and type of body regions affected (wrists/hands, arm pouches, armpits, genital region, groin, knee, feet/ankles/lower legs, head, torso, other) for all visits.
Time frame: day 0 - day 70
Proportion of patients (in %) with evidence of mites (incl. nymphs and larvae, reflecting light microscopy (dermatoscope) or light microscopy of skin samples) for all visits, for standard therapy and escalated therapy
Time frame: day 0 - day 70
Proportion of patients with use of antiscabiosa not conforming to study procedures for all visits, for standard therapy and escalated therapy
Time frame: day 0 - day 70
Proportion of patients with new scabies efflorescences for all treatment cycles and control visits
Time frame: day 0 - day 70
Patients with "additionally confirmed" therapy failure (in %)
Proportion of patients with new scabies efflorescences at the end of standard therapy or escalated therapy OR with mite detection by microscopic examination of a skin sample at the aforementioned time points OR use of other antiscabiosa not conforming to the study procedure during the respective therapy cycle.
Time frame: day 0 - day 70
Patients with reinfestation (in %): Proportion of patients with microscopically confirmed new efflorescences at the end of standard therapy or escalated therapy (respective FU-visit) who were assessed as cured at the immediately preceding control visit.
Time frame: day 0 - day 70
Adverse events, serious adverse events, unexpected drug reactions, serious unexpected drug reactions (total frequency, type, severity, causality, with frequencies, with separate presentation of local reactions).
Time frame: day 0 - day 70
Plan to share: No
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Infectopharm Arzneimittel GmbH