Phase III Multicenter, Prospective, Randomized, Double-blind Study Comparing the Efficacy and Safety of Therapy for Scabies With Two Differently Concentrated Permethrin Creams.

SKABUP

The multi-center, prospective, randomized, double-blind phase III clinical trial will primarily investigate the efficacy and safety of treatment of scabies with Permethrin Cream 5% (approved drug InfectoScab 5% Cream) in direct comparison with Permethrin Cream 10%. The trial participants will be randomly assigned and blinded to either Permethrin Cream 5% or Permethrin Cream 10%.

2024-05-01

2027-07-01

2028-12-01

Not yet recruiting

Early phase I

220

Inclusion Criteria: * 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 Exclusion Criteria: * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The SKABUP study is a prospective, randomized, double-blind, 2-arm superiority study in a group sequential design with recruitment stop and interim analysis after 172 patients. If there is no evidence of superiority in the interim analysis, the study will be continued unchanged up to the planned number of 220 patients and will be terminated and analyzed regularly.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'double-blind', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 220, 'type': 'ESTIMATED'}}

2024-04-23