Comparison of the Efficacy and Safety of Ivermectin to Permethrin

Phase 2

Completed

• Conditions: Scabies

• Registration Number: NCT00262418
• Lead Sponsor: University Ghent

Brief Summary

Comparison of the efficacy and safety of a single administration of ivermectin to a single administration of permethrin for the treatment of scabies

Detailed Description

Administration of ivermectin or permethrin on day0 Clinical examination and pictures on day0, day14 and day28 Blood sample on day0 VAS for pruritus, DLQI and SF-36 on day0, day14 and day28

Study Timeline

• Study Start: 2004-07
• Study Completion: 2005-05
• Study First Submitted: 2005-12-04
• Study First Submitted QC: 2005-12-04
• Study First Posted: 2005-12-06
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-19
• Last Update Posted: 2007-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

At least one of the following inclusion criteria:

• Scabies tunnels
• Positive microscopic examination (acarids, faeces or ova)

At least two of the three following inclusion criteria:

• Non-specific injuries with a typical distribution pattern
• Serious itching which increases during the night
• Family or contacts with similar complaints

Exclusion Criteria

• Treatment for scabies < 4 weeks ago
• Treatment with corticoids < 1 week ago
• Pregnancy
• Breast-feeding
• HIV
• Serious immunodepressive patients
• Sensitivity or allergy to one of the components of the study medication
• Damage of the central nerve system

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Clinical healing of the skin injuries	on day28

Secondary Outcome Measures

Name	Time	Method
Decrease of itching	on day28
Amelioration of the life quality	on day28
Number and gravity of adverse events

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium