Comparison of the Efficacy and Safety of Ivermectin to Permethrin
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
1 other identifier
interventional
160
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2004
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 4, 2005
CompletedFirst Posted
Study publicly available on registry
December 6, 2005
CompletedDecember 28, 2007
December 1, 2007
December 4, 2005
December 19, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical healing of the skin injuries
on day28
Secondary Outcomes (3)
Decrease of itching
on day28
Amelioration of the life quality
on day28
Number and gravity of adverse events
Interventions
Eligibility Criteria
You may qualify if:
- Scabies tunnels
- Positive microscopic examination (acarids, faeces or ova)
- Non-specific injuries with a typical distribution pattern
- Serious itching which increases during the night
- Family or contacts with similar complaints
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Ghentlead
Study Sites (1)
University Hospital Ghent
Ghent, 9000, Belgium
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Marie Naeyaert, MD, PhD
University Hospital, Ghent
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 4, 2005
First Posted
December 6, 2005
Study Start
July 1, 2004
Study Completion
May 1, 2005
Last Updated
December 28, 2007
Record last verified: 2007-12