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Completed

NCT Number: NCT04205669

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.

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Key information

Conditions

Scabies Ectoparasitic Infestations Households Infections Mite Infestations Parasitic Diseases Skin Diseases Skin Diseases, Infectious Skin Diseases, Parasitic Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre de Recherches Médicales de Lambaréné

Lambaréné, BP 242, Gabon

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Benzyl Benzoate 25% Topical Application Lotion

Drug

Applied to skin for the treatment of scabies

Primary outcomes

  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 outcomes

  1. Proportion of Affected Household Members Per Household

    Time frame: after 28 days from baseline

    proportion of scabies cases per household after 4 weeks

Sponsors and collaborators

Lead sponsor

Centre de Recherche Médicale de Lambaréné

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 19, 2019
Registry last updated
Nov 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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