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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00262418
Other study ID # 2004/212
Secondary ID
Status Completed
Phase Phase 2
First received December 4, 2005
Last updated December 19, 2007
Start date July 2004
Est. completion date May 2005

Study information

Verified date December 2007
Source University Ghent
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Comparison of the efficacy and safety of a single administration of ivermectin to a single administration of permethrin for the treatment of scabies


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


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date May 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 5 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Administration of ivermectin or permethrin


Locations

Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (1)

Lead Sponsor Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical healing of the skin injuries on day28
Secondary Decrease of itching on day28
Secondary Amelioration of the life quality on day28
Secondary Number and gravity of adverse events
See also
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Completed NCT02485717 - Phase 3 Trial to Assess the Safety and Efficacy of Natroba for the Treatment of Scabies Phase 3
Completed NCT02485704 - Phase 3 Trial to Assess the Safety and Efficacy of Natroba for the Treatment of Scabies Phase 3
Recruiting NCT05310734 - PK and Safety Study of Natroba Topical Suspension 0.9% in Subjects 1 Month to 3 Years 11 Months of Age With Scabies Phase 4
Recruiting NCT04931680 - Risk Factors for Treatment Failure of Scabies in Autochthonous Populations of French Guiana (GUYAGALE)
Completed NCT06396507 - Sulfur vs. Different Regimes of Permethrin for Scabies Phase 3
Completed NCT05862701 - Comparison of Topical 5% Permethrin and Topical 10% Sulfur in the Treatment of Scabies Phase 1
Not yet recruiting NCT05500326 - Ivermectin Therapy for Scabies Infection in Children Younger Than 5 Years of Age (ITCHY Study) Phase 2