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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04205669
Other study ID # GrattiGratta31082018
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 4, 2018
Est. completion date February 21, 2019

Study information

Verified date October 2020
Source Centre de Recherche Médicale de Lambaréné
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 104
Est. completion date February 21, 2019
Est. primary completion date February 21, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Benzyl Benzoate 25% Topical Application Lotion
Applied to skin for the treatment of scabies

Locations

Country Name City State
Gabon Centre de Recherches Médicales de Lambaréné Lambaréné

Sponsors (4)

Lead Sponsor Collaborator
Centre de Recherche Médicale de Lambaréné Bernhard Nocht Institute for Tropical Medicine, Medical University of Vienna, University Hospital Tuebingen

Country where clinical trial is conducted

Gabon, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Clinical Cure clinical improvement in skin lesions with no new lesions occurring since treatment application as assessed by skin examination after 28 days from baseline
Secondary Proportion of Affected Household Members Per Household proportion of scabies cases per household after 4 weeks after 28 days from baseline
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