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

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ClinicalTrials.gov Identifier: NCT04205669
Recruitment Status : Completed
First Posted : December 19, 2019
Results First Posted : November 13, 2020
Last Update Posted : November 13, 2020
Sponsor:
Collaborators:
Bernhard Nocht Institute for Tropical Medicine
University Hospital Tuebingen
Medical University of Vienna
Information provided by (Responsible Party):
Julian Matthewman, Centre de Recherche Médicale de Lambaréné

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Scabies Households Drug: Benzyl Benzoate 25% Topical Application Lotion Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing the Effectiveness of Individual vs. Household Treatment for Scabies in Lambaréné, Gabon
Actual Study Start Date : October 4, 2018
Actual Primary Completion Date : February 21, 2019
Actual Study Completion Date : February 21, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scabies

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Proportion of Affected Household Members Per Household [ Time Frame: after 28 days from baseline ]
    proportion of scabies cases per household after 4 weeks


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04205669


Locations
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Gabon
Centre de Recherches Médicales de Lambaréné
Lambaréné, Gabon, BP 242
Sponsors and Collaborators
Centre de Recherche Médicale de Lambaréné
Bernhard Nocht Institute for Tropical Medicine
University Hospital Tuebingen
Medical University of Vienna
  Study Documents (Full-Text)

Documents provided by Julian Matthewman, Centre de Recherche Médicale de Lambaréné:
Study Protocol and Statistical Analysis Plan  [PDF] August 31, 2018

More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Julian Matthewman, Principal Investigator, Centre de Recherche Médicale de Lambaréné
ClinicalTrials.gov Identifier: NCT04205669    
Other Study ID Numbers: GrattiGratta31082018
First Posted: December 19, 2019    Key Record Dates
Results First Posted: November 13, 2020
Last Update Posted: November 13, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD with identifying data removed uploaded to public repository under https://www.kaggle.com/julianmatthewman/grattigratta-data
URL: https://www.kaggle.com/julianmatthewman/grattigratta-data

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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
Additional relevant MeSH terms:
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Scabies
Mite Infestations
Ectoparasitic Infestations
Skin Diseases, Parasitic
 Parasitic Diseases
Skin Diseases, Infectious
Skin Diseases