Investigation to assess the efficacy of benzyl benzoate emulsion versus permethrin creme for scabies treatment
Phase 1
- Conditions
- ScabiesTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2022-000660-22-AT
- Lead Sponsor
- andeskrankenhaus Salzburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- diagnosis of scabies (dermatoscopically confirmed)
- age =6 years
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
Exclusion Criteria
-Scabies crustosa
- use of topical Permethrin (e.g. Infectoscab 5% Creme®) or Benzyl Benzoate emulsion or oral ivermectin within the last 3 weeks
exception: childres 6-18 years and or adults with high mite density (>5 mites) can be included 2 weeks after pre-treatment.
- allergy or intolerance agains top. benzyl benzoate emulsion or permethrin cream
- mental disfunction
- pregnancy/breast-feeding
- alcohol abuse
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: topical Benzyl Benzoate ist superior to topical permethrin in treating scabies;Secondary Objective: n.a.;Primary end point(s): cure rate of topical benzyl benzoate versus topical permethrin in treating scabies;Timepoint(s) of evaluation of this end point: week 3 (to 5)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): safety and tolerability of of topical benzyl benzoate versus topical permethrin in treating scabies;Timepoint(s) of evaluation of this end point: week 3 (to 5);