Escalated Therapy of Scabies With INFECTOSCAB 5% (Permethrin)

NCT ID: NCT04814511

Last Updated: 2021-08-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 183 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-11
• Study Completion Date: 2023-08-31

Brief 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.

Conditions

Scabies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard therapy with InfectoScab 5 % Creme

Group Type: OTHER

InfectoScab 5 % Creme

Intervention Type: DRUG

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).

Escalated therapy with InfectoScab 5 % Creme (arm E5)

Group Type: EXPERIMENTAL

InfectoScab 5 % Creme

Intervention Type: DRUG

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).

Escalated therapy with Permethrin 10 % Creme (arm E10)

Group Type: EXPERIMENTAL

Permethrin 10 % Creme

Intervention Type: DRUG

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).

Escalated therapy with InfectoScab 5 % Creme in combination with Driponin 3 mg Tabletten (arm EK)

Group Type: EXPERIMENTAL

InfectoScab 5 % Creme

Intervention Type: DRUG

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).

Driponin 3 mg Tabletten

Intervention Type: DRUG

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).

Interventions

InfectoScab 5 % Creme

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).

Intervention Type: DRUG

Permethrin 10 % Creme

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).

Intervention Type: DRUG

Driponin 3 mg Tabletten

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).

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Winicker Norimed GmbH

INDUSTRY

Sponsor Role: collaborator

Infectopharm Arzneimittel GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cord Sunderkötter, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinik und Poliklinik für Dermatologie und Venerologie

Locations

Uniklinik RWTH Aachen

Aachen, , Germany

Site Status: RECRUITING

Universitätsklinikum Augsburg

Augsburg, , Germany

Site Status: RECRUITING

Klinikum Darmstadt

Darmstadt, , Germany

Site Status: RECRUITING

Städtisches Klinikum Dresden

Dresden, , Germany

Site Status: NOT_YET_RECRUITING

Universitätsklinik und Poliklinik für Dermatologie und Venerologie

Halle, , Germany

Site Status: RECRUITING

Klinikum der Stadt Ludwigshafen

Ludwigshafen, , Germany

Site Status: RECRUITING

Universitätsmedizin Rostock

Rostock, , Germany

Site Status: RECRUITING

Universitätsklinikum Würzburg

Würzburg, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Andreas Linke, Dr.

Role: CONTACT

studien@infectopharm.com

Other Identifiers

2019-003234-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ETSKABI

Identifier Type: -

Identifier Source: org_study_id