Comparison of the Efficacy and Safety of Ivermectin to Permethrin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2005-05-31

Brief Summary

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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

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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

Conditions

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Scabies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Administration of ivermectin or permethrin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

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

Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Jean-Marie Naeyaert, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2004/212

Identifier Type: -

Identifier Source: org_study_id