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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00262418

Enrollment

160

Registered

2005-12-06

Start date

2004-07-31

Completion date

2005-05-31

Last updated

2007-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scabies

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

Interventions

DRUGAdministration of ivermectin or permethrin

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

5 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Clinical healing of the skin injuries	on day28

Secondary

Measure	Time frame
Decrease of itching	on day28
Amelioration of the life quality	on day28
Number and gravity of adverse events	—

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026