Escalated Therapy of Scabies With INFECTOSCAB 5% (Permethrin)

NCT04814511 | Unknown Phase 3

• 2 other identifiers: ETSKABI2019-003234-16
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 8

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

Outcome Measures

Primary Outcomes (1)

• 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

  day 0 - day 28

Secondary Outcomes (12)

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

  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)

  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)

  day 28 - day 56

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

  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.

  day 0 - day 70

Study Arms (4)

Standard therapy with InfectoScab 5 % Creme

OTHER

Drug: InfectoScab 5 % Creme

Escalated therapy with InfectoScab 5 % Creme (arm E5)

EXPERIMENTAL

Drug: InfectoScab 5 % Creme

Escalated therapy with Permethrin 10 % Creme (arm E10)

EXPERIMENTAL

Drug: Permethrin 10 % Creme

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

EXPERIMENTAL

Drug: InfectoScab 5 % Creme; Drug: Driponin 3 mg Tabletten

Interventions

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

Permethrin 10 % Creme 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 Permethrin 10 % Creme (arm E10)

Driponin 3 mg Tabletten 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).

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

Eligibility Criteria

• Age: 6 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Infectopharm Arzneimittel GmbH: lead
• Winicker Norimed GmbH: collaborator

Study Sites (8)

Uniklinik RWTH Aachen

Aachen, 52074, Germany

RECRUITING

Universitätsklinikum Augsburg

Augsburg, 86179, Germany

RECRUITING

Klinikum Darmstadt

Darmstadt, 64297, Germany

RECRUITING

Städtisches Klinikum Dresden

Dresden, 01067, Germany

NOT YET RECRUITING

Universitätsklinik und Poliklinik für Dermatologie und Venerologie

Halle, 06120, Germany

RECRUITING

Klinikum der Stadt Ludwigshafen

Ludwigshafen, 67063, Germany

RECRUITING

Universitätsmedizin Rostock

Rostock, 18057, Germany

RECRUITING

Universitätsklinikum Würzburg

Würzburg, 97080, Germany

RECRUITING

MeSH Terms

Conditions

Scabies

Interventions

Permethrin

Condition Hierarchy (Ancestors)

Mite Infestations; Ectoparasitic Infestations; Skin Diseases, Parasitic; Parasitic Diseases; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phenyl Ethers; Ethers; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pyrethrins; Cyclopentane Monoterpenes; Monoterpenes; Terpenes

Study Officials

• Cord Sunderkötter, Prof. Dr.

  Universitätsklinik und Poliklinik für Dermatologie und Venerologie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas Linke, Dr.

CONTACT

studien@infectopharm.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 24, 2021
• Study Start: June 11, 2021
• Primary Completion: December 1, 2022
• Study Completion: August 1, 2023
• Last Updated: August 26, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (8)