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Escalated Therapy of Scabies With INFECTOSCAB 5% (Permethrin) (ETSKABI)

Primary Purpose

Scabies

Status

Unknown status

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

InfectoScab 5 % Creme

Permethrin 10 % Creme

Driponin 3 mg Tabletten

About this trial

This is an interventional treatment trial for Scabies

Eligibility Criteria

6 Years - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Uniklinik RWTH AachenRecruiting
Universitätsklinikum AugsburgRecruiting
Klinikum DarmstadtRecruiting
Städtisches Klinikum Dresden
Universitätsklinik und Poliklinik für Dermatologie und VenerologieRecruiting
Klinikum der Stadt LudwigshafenRecruiting
Universitätsmedizin RostockRecruiting
Universitätsklinikum WürzburgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Experimental

Arm Label

Standard therapy with InfectoScab 5 % Creme

Escalated therapy with InfectoScab 5 % Creme (arm E5)

Escalated therapy with Permethrin 10 % Creme (arm E10)

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

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Efficacy (treatment success) for VS1 and VS2, as well as for the corresponding follow-up visits FUS1 and FUS2 (separately and cumulatively).

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)

Cumulative efficacy (treatment success) of permethrin-only treatment (i.e. without combined escalation permethrin + ivermectin) by visit type (regular visit, FU visit)

Frequency of required repeated standard therapy as well as escalated therapy.

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.

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.

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

Proportion of patients with use of antiscabiosa not conforming to study procedures for all visits, for standard therapy and escalated therapy

Proportion of patients with new scabies efflorescences for all treatment cycles and control visits

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.

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.

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).

Full Information

NCT ID

NCT04814511

First Posted

March 22, 2021

Last Updated

August 25, 2021

Sponsor

Infectopharm Arzneimittel GmbH

Collaborators

Winicker Norimed GmbH

1. Study Identification

Unique Protocol Identification Number

NCT04814511

Brief Title

Escalated Therapy of Scabies With INFECTOSCAB 5% (Permethrin)

Acronym

ETSKABI

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

June 11, 2021 (Actual)

Primary Completion Date

December 2022 (Anticipated)

Study Completion Date

August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Infectopharm Arzneimittel GmbH

Collaborators

Winicker Norimed GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Scabies

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

183 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard therapy with InfectoScab 5 % Creme

Arm Type

Other

Arm Title

Escalated therapy with InfectoScab 5 % Creme (arm E5)

Arm Type

Experimental

Arm Title

Escalated therapy with Permethrin 10 % Creme (arm E10)

Arm Type

Experimental

Arm Title

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

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

InfectoScab 5 % Creme

Intervention Description

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

Intervention Name(s)

Permethrin 10 % Creme

Intervention Description

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

Intervention Name(s)

Driponin 3 mg Tabletten

Intervention Description

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).

Primary Outcome Measure Information:

Title

Efficacy (Yes/No)

Description

Time Frame

day 0 - day 28

Secondary Outcome Measure Information:

Title

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

Title

Time Frame

day 28 - day 70

Title

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

Title

Frequency of required repeated standard therapy as well as escalated therapy.

Time Frame

day 0 - day 70

Title

Time Frame

day 0 - day 70

Title

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

Title

Time Frame

day 0 - day 70

Title

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

Title

Proportion of patients with new scabies efflorescences for all treatment cycles and control visits

Time Frame

day 0 - day 70

Title

Patients with "additionally confirmed" therapy failure (in %)

Description

Time Frame

day 0 - day 70

Title

Time Frame

day 0 - day 70

Title

Time Frame

day 0 - day 70

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Andreas Linke, Dr.

studien@infectopharm.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cord Sunderkötter, Prof. Dr.

Organizational Affiliation

Universitätsklinik und Poliklinik für Dermatologie und Venerologie

Official's Role

Principal Investigator

Facility Information:

Facility Name

Uniklinik RWTH Aachen

City

Aachen

ZIP/Postal Code

52074

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mark Neis, PD Dr.

First Name & Middle Initial & Last Name & Degree

Amir Yazdi, Prof. Dr.

Facility Name

Universitätsklinikum Augsburg

City

Augsburg

ZIP/Postal Code

86179

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Julia Welzel, Prof. Dr.

First Name & Middle Initial & Last Name & Degree

Kai-Uwe Krämer, Dr.

Facility Name

Klinikum Darmstadt

City

Darmstadt

ZIP/Postal Code

64297

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maurizio Podda, Dr.

First Name & Middle Initial & Last Name & Degree

Maximilian Kovacs, Dr.

Facility Name

Städtisches Klinikum Dresden

City

Dresden

ZIP/Postal Code

01067

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Uwe Wollina, Prof. Dr.

First Name & Middle Initial & Last Name & Degree

André Koch, Dr.

Facility Name

Universitätsklinik und Poliklinik für Dermatologie und Venerologie

City

Halle (Saale)

ZIP/Postal Code

06120

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cord Sunderkötter, Prof. Dr.

First Name & Middle Initial & Last Name & Degree

Johannes Wohlrab, Prof. Dr.

Facility Name

Klinikum der Stadt Ludwigshafen

City

Ludwigshafen

ZIP/Postal Code

67063

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christoph Löser, Dr.

First Name & Middle Initial & Last Name & Degree

Edgar Dippel, Prof. Dr.

Facility Name

Universitätsmedizin Rostock

City

Rostock

ZIP/Postal Code

18057

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rüdiger Panzer, Dr.

First Name & Middle Initial & Last Name & Degree

Susanne Krebs, Dr.

Facility Name

Universitätsklinikum Würzburg

City

Würzburg

ZIP/Postal Code

97080

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Johanna Stoevesandt, Dr.

First Name & Middle Initial & Last Name & Degree

Andreas Kerstan, Dr.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Escalated Therapy of Scabies With INFECTOSCAB 5% (Permethrin)

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