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

October 21, 2020 updated by: Julian Matthewman, Centre de Recherche Médicale de Lambaréné

A Randomized Controlled Trial Comparing the Effectiveness of Individual vs. Household Treatment for Scabies in Lambaréné, Gabon

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Gabon
      • Lambaréné, Gabon, BP 242
        • Centre de Recherches Medicales de Lambarene

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Individual Treatment
Drug: Benzyl Benzoate 25% Topical Application Lotion
Applied to skin for the treatment of scabies
Active Comparator: Household Treatment
Drug: Benzyl Benzoate 25% Topical Application Lotion
Applied to skin for the treatment of scabies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Clinical Cure
Time Frame: after 28 days from baseline
clinical improvement in skin lesions with no new lesions occurring since treatment application as assessed by skin examination
after 28 days from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Affected Household Members Per Household
Time Frame: after 28 days from baseline
proportion of scabies cases per household after 4 weeks
after 28 days from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre de Recherche Médicale de Lambaréné

Collaborators

Medical University of Vienna
University Hospital Tuebingen
Bernhard Nocht Institute for Tropical Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2018

Primary Completion (Actual)

February 21, 2019

Study Completion (Actual)

February 21, 2019

Study Registration Dates

First Submitted

December 18, 2019

First Submitted That Met QC Criteria

December 18, 2019

First Posted (Actual)

December 19, 2019

Study Record Updates

Last Update Posted (Actual)

November 13, 2020

Last Update Submitted That Met QC Criteria

October 21, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GrattiGratta31082018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

IPD with identifying data removed uploaded to public repository under https://www.kaggle.com/julianmatthewman/grattigratta-data

Study Data/Documents

  1. Individual Participant Data Set

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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