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

Scabies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04205669
• Other study ID #: GrattiGratta31082018
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Households
• Scabies

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