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