Escalated Therapy of Scabies With INFECTOSCAB 5% (Permethrin)

Prospective, Open-label, Multicenter, Initially Single-armed and in Case of Treatment Failure Subsequently Three-armed Randomized Clinical Trial of Phase III/IV Investigating the Escalated Therapy of Scabies With INFECTOSCAB 5% (Permethrin)

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.

Inclusion Criteria:

• Confirmed acute scabies disease: detection of mites and/or mite nymphs and/or mite larvae at scabies-typical predilection sites, detected by reflected light microscopy (dermatoscopy) or light microscopy of skin samples.
• Age between 6 and 85 years
• Written informed consent of the study participant (if of age) or of all guardians (in the case of study participants who are minors < 12 years of age) or of all guardians and the study participant (in the case of study participants who are minors ≥ 12 years of age).

Exclusion Criteria:

• Previous treatment with antiscabiosa in the last 14 days.
• Known intolerance to permethrin, other pyrethroids, chrysanthemum, ivermectin or any of the other ingredients of the study medication.
• Scabies crustosa
• Impetiginisation/eczematisation requiring in-patient treatment
• Body weight > 120 kg
• Pregnancy, lactation
• Immunodeficiency (of any kind, including extensive local therapy (>20% body surface area) with corticosteroids >2 weeks in the last 4 weeks or ≥ 10 mg prednisolone equivalent >7 days in the last 4 weeks- even without signs of scabies crustosa)
• Other serious illnesses which, in the opinion of the investigator, prevent the patient from participating in the study (including risk factors for severe COVID-19 disease in the case of SARS-CoV-2 infection).
• Planned systemic use of corticosteroids
• Planned or previous (last 4 weeks) use of systemic or cutaneous non-steroidal immunosuppressants
• Known or clinically suspected blood-brain barrier disruption (e.g. ABCB-1 (=MDR-1) mutation), and history of neurotoxic effects from ivermectin or other substrates/inhibitors of para-glycoprotein (P-gp)
• Apparent unreliability or unwillingness to cooperate.
• Inability to understand and comply with study instructions
• Known alcohol, medication or drug dependence
• Court/agency-ordered institutionalisation
• Dependence on sponsor or investigator
• Previous participation in a clinical trial within the last 30 days or in the same clinical trial