- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00262418
Comparison of the Efficacy and Safety of Ivermectin to Permethrin
December 19, 2007 updated by: University Ghent
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
Comparison of the efficacy and safety of a single administration of ivermectin to a single administration of permethrin for the treatment of scabies
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
160
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ghent, Belgium, 9000
- University Hospital Ghent
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical healing of the skin injuries
Time Frame: on day28
|
on day28
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Decrease of itching
Time Frame: on day28
|
on day28
|
Amelioration of the life quality
Time Frame: on day28
|
on day28
|
Number and gravity of adverse events
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jean-Marie Naeyaert, MD, PhD, University Hospital, Ghent
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2004
Study Completion (Actual)
May 1, 2005
Study Registration Dates
First Submitted
December 4, 2005
First Submitted That Met QC Criteria
December 4, 2005
First Posted (Estimate)
December 6, 2005
Study Record Updates
Last Update Posted (Estimate)
December 28, 2007
Last Update Submitted That Met QC Criteria
December 19, 2007
Last Verified
December 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2004/212
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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