SKABUP
Studieninformationen
Studien-Code
UME-ID-12252
Studien-Akronym
SKABUP
Studientitel
Multizentrische, prospektive, randomisierte, doppelblinde Phase III-Studie zum Vergleich der Wirksamkeit und Sicherheit der Therapie der Skabies mit zwei unterschiedlich konzentrierten Permethrin-Cremes
Kurzbeschreibung
Therapy for Scabies With Two Differently Concentrated Permethrin Creams (SKABUP)
NCT-Nummer: NCT06380452
Aktueller Studienstatus: Aktiv, rekrutierend
Studie aktiv in den Jahren: 2025,2026
Beteiligte
Institut
Dermatologie
Prüfarzt (AMG) / Studienleitung (BO)
Dr. med. Frederik Krefting
+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de
Hufelandstr. 55
45147 Essen
Studiendesign
randomisiert, doppelt verblindet, multizentrisch
Einschlusskriterien
• Confirmed acute scabies disease: Detection of mites and/or mite nymphs and/or mite larvae, by reflected light microscopy or light microscopy of skin samples, at scabies-typical predilection sites
• Age between 2 years and 85 years
• Written informed consent of the study participant (if of legal age) or all legal guardians (for underage study participants < 12 years) or all legal guardians and the study participant (for underage study participants ? 12 years)
• Practicable application of the trial medication by trained specialist staff at the trial site
Ausschlusskriterien
• Pre-treatment with antiscabiosa in the last 14 days
• Combined antiscabial treatment (i.e. simultaneous/simultaneous topical and systemic scabies treatment with medication) in the last 3 months
• Known intolerance to permethrin, other pyrethroids, chrysanthemums or any of the other ingredients of the study medication
• Scabies crustosa
• Impetiginization/eczematization requiring inpatient treatment
• Body weight > 120 kg
• Pregnancy, breastfeeding
• Clinically relevant immunodeficiency (of any kind, including extensive local therapy (>20% body surface) 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
• Planned systemic use of corticosteroids
• Planned or previous (last 4 weeks) use of systemic or cutaneous non-steroidal immunosuppressants
• Apparent unreliability or unwillingness to cooperate
• Inability to understand and comply with study instructions
• Known alcohol, medication or drug dependence
• Placement in a facility where people live together for long periods of time, are cared for or receive medical care, and where close skin-to-skin contact is common, or placement in an institution ordered by a court/authority
• 5 or more close contacts (persons with close, extensive skin-to-skin contact with the scabies patient for more than 5-10 minutes)
• Close contact person who refuses scabies treatment or for whom treatment is not possible
• Dependence on sponsor or investigator
• Previous participation in a clinical trial in the last 30 days or in the same clinical trial
Studienteilnehmende Mindestalter
85 Jahr(e)
Studienteilnehmende Höchstalter
85 Jahr(e)
Geschlecht
Divers/Männlich/Weiblich
Indikation
Skabies
Medizinischer Befund
Scabies