Therapy for Scabies With Two Differently Concentrated Permethrin Creams
ConditionScabies
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-85
SponsorInfectopharm Arzneimittel GmbH
About this trial
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%.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- 5% Permethrin Creme
- 10% Permethrin Creme
Treatment groups
220 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Infectopharm Arzneimittel GmbH
Lead sponsor
Winicker Norimed GmbH
Collaborator
Source ClinicalTrials.gov