Investigation to assess the efficacy of benzyl benzoate 10/25% emulsion versus oral ivermectin for scabies treatment

Phase 1

• Conditions: Scabies; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2020-003255-15-AT
• Lead Sponsor: andeskrankenhaus Salzburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-27
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

- diagnosis of scabies (dermatoscopically confirmed)
- age = 2 months

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 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

-Scabies crutosa
-pre-treatment with topical Benzyl Benzoate
- use of topical Permethrin (e.g. Infectoscab 5% Creme®) within the last 2 weeks (child <6 years) or 3 weeks (age = 6years)
- sufficient use of oral ivermectin within the last 3 months
- allergy or intolerance agains top. benzyl benzoate Emulsion
- mental disfunction
- pregnancy/breast-feeding
- alcohol abuse

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified