Escalated Therapy of Scabies With INFECTOSCAB 5% (Permethrin)

Last updated: August 25, 2021
Sponsor: Infectopharm Arzneimittel GmbH
Overall Status: Active - Recruiting

Phase

3

Condition

Sexually Transmitted Diseases (Stds)

Rash

Treatment

N/A

Clinical Study ID

NCT04814511
ETSKABI
2019-003234-16
  • Ages 6-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Confirmed acute scabies disease: detection of mites and/or mite nymphs and/or mitelarvae 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 (inthe case of study participants who are minors < 12 years of age) or of all guardiansand the study participant (in the case of study participants who are minors ≥ 12 yearsof age).

Exclusion

Exclusion Criteria:

  • Previous treatment with antiscabiosa in the last 14 days.
  • Known intolerance to permethrin, other pyrethroids, chrysanthemum, ivermectin or anyof 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 surfacearea) with corticosteroids >2 weeks in the last 4 weeks or ≥ 10 mg prednisoloneequivalent >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 patientfrom participating in the study (including risk factors for severe COVID-19 disease inthe case of SARS-CoV-2 infection).
  • Planned systemic use of corticosteroids
  • Planned or previous (last 4 weeks) use of systemic or cutaneous non-steroidalimmunosuppressants
  • Known or clinically suspected blood-brain barrier disruption (e.g. ABCB-1 (=MDR-1)mutation), and history of neurotoxic effects from ivermectin or othersubstrates/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 sameclinical trial

Study Design

Total Participants: 183
Study Start date:
June 11, 2021
Estimated Completion Date:
August 31, 2023

Connect with a study center

  • Uniklinik RWTH Aachen

    Aachen, 52074
    Germany

    Active - Recruiting

  • Universitätsklinikum Augsburg

    Augsburg, 86179
    Germany

    Active - Recruiting

  • Klinikum Darmstadt

    Darmstadt, 64297
    Germany

    Active - Recruiting

  • Städtisches Klinikum Dresden

    Dresden, 01067
    Germany

    Site Not Available

  • Universitätsklinik und Poliklinik für Dermatologie und Venerologie

    Halle (Saale), 06120
    Germany

    Active - Recruiting

  • Klinikum der Stadt Ludwigshafen

    Ludwigshafen, 67063
    Germany

    Active - Recruiting

  • Universitätsmedizin Rostock

    Rostock, 18057
    Germany

    Active - Recruiting

  • Universitätsklinikum Würzburg

    Würzburg, 97080
    Germany

    Active - Recruiting

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