Therapy for Scabies With Two Differently Concentrated Permethrin Creams (NCT06380452) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Therapy for Scabies With Two Differently Concentrated Permethrin Creams
220 participantsStarted 2024-05
Plain-language summary
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%.
Who can participate
Age range2 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 o…