Status:
UNKNOWN
Escalated Therapy of Scabies With INFECTOSCAB 5% (Permethrin)
Lead Sponsor:
Infectopharm Arzneimittel GmbH
Collaborating Sponsors:
Winicker Norimed GmbH
Conditions:
Scabies
Eligibility:
All Genders
6-85 years
Phase:
PHASE3
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 ph...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
183 Patients enrolled
Trial Details
Trial ID
NCT04814511
Start Date
June 11 2021
End Date
August 1 2023
Last Update
August 26 2021
Active Locations (8)
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1
Uniklinik RWTH Aachen
Aachen, Germany, 52074
2
Universitätsklinikum Augsburg
Augsburg, Germany, 86179
3
Klinikum Darmstadt
Darmstadt, Germany, 64297
4
Städtisches Klinikum Dresden
Dresden, Germany, 01067