Comparison of the Efficacy and Safety of Ivermectin to Permethrin
Information source: University Ghent
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Scabies
Intervention: Administration of ivermectin or permethrin (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University Ghent Official(s) and/or principal investigator(s):
Jean-Marie Naeyaert, MD, PhD, Principal Investigator, Affiliation: University Hospital, Ghent
Summary
Comparison of the efficacy and safety of a single administration of ivermectin to a single
administration of permethrin for the treatment of scabies
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Clinical healing of the skin injuries
Secondary outcome: Decrease of itchingAmelioration of the life quality Number and gravity of adverse events
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
Minimum age: 5 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
University Hospital Ghent, Ghent 9000, Belgium
Additional Information
Website of the University Hospital Ghent
Starting date: July 2004
Last updated: December 19, 2007
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