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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-003255-15-AT

Enrollment

200

Registered

2020-10-27

Start date

2020-12-17

Completion date

Unknown

Last updated

2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scabies

Interventions

Trade Name: Scabioral 3mg Tablette Product Name: Scabioral Product Code: 138560 Pharmaceutical Form: Tablet INN or Proposed INN: Ivermectin CAS Number: 70288-86-7 Other descriptive name: IVERMECTIN C

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: topical Benzyl Benzoate ist coequal to oral ivermectin in treating scabies;Secondary Objective: topical Benzyl Benzoate istinferior to oral ivermectin in treating scabies;Primary end point(s): cure rate of topical benzyl benzoate versus oral ivermectin in treating scabies;Timepoint(s) of evaluation of this end point: week 3 (to 5); (2-4 weeks after end of Treatment)	—

Secondary

Measure	Time frame
Secondary end point(s): safety and tolerability of of topical benzyl benzoate versus oral ivermectin in treating scabies;Timepoint(s) of evaluation of this end point: week 3 (to 5); (2-4 weeks after end of Treatment)	—

Countries

Austria

Contacts

Public ContactUniversitätsklinik für Dermatologie

Landeskrankenhaus Salzburg

d.meyersburg@gmx.de00435725558673

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 27, 2026