Comparison of the Efficacy and Safety of Ivermectin to Permethrin

This study has been completed.

Sponsor:

Information provided by:

University Ghent

ClinicalTrials.gov Identifier:

NCT00262418

First received: December 4, 2005

Last updated: December 19, 2007

Last verified: December 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

December 4, 2005

Last Updated Date

December 19, 2007

Start Date ^ICMJE

July 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Clinical healing of the skin injuries [ Time Frame: on day28 ]

Original Primary Outcome Measures ^ICMJE

Clinical healing of the skin injuries on day28

Change History

Complete list of historical versions of study NCT00262418 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Decrease of itching [ Time Frame: on day28 ]
Amelioration of the life quality [ Time Frame: on day28 ]
Number and gravity of adverse events

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Comparison of the Efficacy and Safety of Ivermectin to Permethrin

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Scabies

Intervention ^ICMJE

Drug: Administration of ivermectin or permethrin

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

160

Completion Date

May 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

5 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium

Administrative Information

NCT Number ^ICMJE

NCT00262418

Other Study ID Numbers ^ICMJE

2004/212

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

University Ghent

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jean-Marie Naeyaert, MD, PhD

University Hospital, Ghent

Information Provided By

University Ghent

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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