Comparison of the Efficacy and Safety of Ivermectin to Permethrin - Full Text View

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Scabies

Drug Information available for: Permethrin Ivermectin

U.S. FDA Resources

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

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

Additional relevant MeSH terms:

Scabies
Mite Infestations
Ectoparasitic Infestations
Skin Diseases, Parasitic
Parasitic Diseases
Skin Diseases, Infectious
Skin Diseases
Ivermectin

Permethrin
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012