Back to resultsComparison of the Efficacy and Safety of Ivermectin to Permethrin
Primary Purpose
Scabies
Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Administration of ivermectin or permethrin
Sponsored by
About this trial
This is an interventional treatment trial for Scabies
Eligibility 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
Sites / Locations
- University Hospital Ghent
Outcomes
Primary Outcome Measures
Clinical healing of the skin injuries
Secondary Outcome Measures
Decrease of itching
Amelioration of the life quality
Number and gravity of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00262418
Brief Title
Comparison of the Efficacy and Safety of Ivermectin to Permethrin
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Ghent
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scabies
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Administration of ivermectin or permethrin
Primary Outcome Measure Information:
Title
Clinical healing of the skin injuries
Time Frame
on day28
Secondary Outcome Measure Information:
Title
Decrease of itching
Time Frame
on day28
Title
Amelioration of the life quality
Time Frame
on day28
Title
Number and gravity of adverse events
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Marie Naeyaert, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
Website of the University Hospital Ghent
Learn more about this trial
Comparison of the Efficacy and Safety of Ivermectin to Permethrin
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