Comparison of the Efficacy and Safety of Ivermectin to Permethrin

This study has been completed.

First Received: December 4, 2005 Last Updated: December 19, 2007 History of Changes

Sponsored by:	University Ghent
Information provided by:	University Ghent
ClinicalTrials.gov Identifier:	NCT00262418

Purpose

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

Condition	Intervention	Phase
Scabies	Drug: Administration of ivermectin or permethrin	Phase II

MedlinePlus related topics: Scabies

Drug Information available for: Permethrin Ivermectin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by University Ghent:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	160
Study Start Date:	July 2004
Study Completion Date:	May 2005

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

Eligibility

Ages Eligible for Study:	5 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00262418

Locations

Belgium
University Hospital Ghent
Ghent, Belgium, 9000

Sponsors and Collaborators

University Ghent

Investigators

Principal Investigator:

Jean-Marie Naeyaert, MD, PhD

University Hospital, Ghent

More Information

Additional Information:

Website of the University Hospital Ghent This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	2004/212
Study First Received:	December 4, 2005
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00262418 History of Changes
Health Authority:	Belgium: Institutional Review Board

Study placed in the following topic categories:

Skin Diseases, Infectious
Skin Diseases
Ivermectin

Scabies
Permethrin
Parasitic Diseases

Additional relevant MeSH terms:

Ectoparasitic Infestations
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Skin Diseases, Parasitic
Skin Diseases
Scabies
Permethrin
Enzyme Inhibitors

Mite Infestations
Pharmacologic Actions
Skin Diseases, Infectious
Antiparasitic Agents
Ivermectin
Therapeutic Uses
Parasitic Diseases

ClinicalTrials.gov processed this record on May 07, 2009