Comparison of the Efficacy and Safety of Ivermectin to Permethrin

Scabies Clinical Trial

Official title:

A Randomised, Double Blind, Double Dummy Study to Compare the Efficacy and Safety of a Single Administration of Ivermectin to a Single Administration of Permethrin for the Treatment of Scabies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00262418
• Other study ID #: 2004/212
• Status: Completed
• Phase: Phase 2
• First received: December 4, 2005
• Last updated: December 19, 2007
• Start date: July 2004
• Est. completion date: May 2005

Study information

• Verified date: December 2007
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Scabies

Intervention

Drug:
• Administration of ivermectin or permethrin

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical healing of the skin injuries		on day28
Secondary	Decrease of itching		on day28
Secondary	Amelioration of the life quality		on day28
Secondary	Number and gravity of adverse events

External Links

•   Website of the University Hospital Ghent