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Comparing the Effectiveness of Individual vs. Household Treatment for Scabies in Lambaréné, Gabon

NCT ID: NCT04205669

Last Updated: 2020-11-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-04

Study Completion Date

2019-02-21

Brief Summary

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It is unclear whether individual treatment of scabies is similarly effective compared to household treatment. This study therefore compares these two treatment strategies with topical benzyl benzoate for treating scabies in Lambaréné and surroundings in Gabon.

Subjects presenting with uncomplicated scabies are randomized into either the Individual Treatment group, where only the affected subjects receive treatment, or the Household Treatment group, where all family members are treated in parallel to the affected subjects regardless of signs and symptoms. The primary endpoint is clinical cure after 28 days; the secondary endpoint is the proportion of affected household members per household after 28 days.

Detailed Description

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Conditions

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Scabies Households

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Individual Treatment

Group Type ACTIVE_COMPARATOR

Benzyl Benzoate 25% Topical Application Lotion

Intervention Type DRUG

Applied to skin for the treatment of scabies

Household Treatment

Group Type ACTIVE_COMPARATOR

Benzyl Benzoate 25% Topical Application Lotion

Intervention Type DRUG

Applied to skin for the treatment of scabies

Interventions

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Benzyl Benzoate 25% Topical Application Lotion

Applied to skin for the treatment of scabies

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* diagnosed with active, uncomplicated scabies
* no known hypersensitivity or allergy against benzyl benzoate

Exclusion Criteria

* hypersensitivity or allergy against benzyl benzoate
* severe superinfection of scabies lesions
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bernhard Nocht Institute for Tropical Medicine

OTHER_GOV

Sponsor Role collaborator

University Hospital Tuebingen

OTHER

Sponsor Role collaborator

Medical University of Vienna

OTHER

Sponsor Role collaborator

Centre de Recherche Médicale de Lambaréné

OTHER

Sponsor Role lead

Responsible Party

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Julian Matthewman

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Centre de Recherches Médicales de Lambaréné

Lambaréné, , Gabon

Site Status

Countries

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Gabon

References

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Matthewman J, Manego RZ, Dimessa Mbadinga LB, Sinkovec H, Volker K, Akinosho M, Haedrich C, Tardif d'Hamonville J, Lell B, Adegnika AA, Ramharter M, Mombo-Ngoma G. A randomized controlled trial comparing the effectiveness of individual versus household treatment for Scabies in Lambarene, Gabon. PLoS Negl Trop Dis. 2020 Jun 26;14(6):e0008423. doi: 10.1371/journal.pntd.0008423. eCollection 2020 Jun.

Reference Type DERIVED
PMID: 32589632 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Study Documents

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Document Type: Individual Participant Data Set

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Other Identifiers

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GrattiGratta31082018

Identifier Type: -

Identifier Source: org_study_id