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 range
2 Years – 85 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.