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

Phase 4

Completed

• Conditions: Scabies; Households
• Interventions: Drug: Benzyl Benzoate 25% Topical Application Lotion

• Registration Number: NCT04205669
• Lead Sponsor: Centre de Recherche Médicale de Lambaréné

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-04
• Primary Completion: 2019-02-21
• Study Completion: 2019-02-21
• Study First Submitted: 2019-12-18
• Study First Submitted QC: 2019-12-18
• Study First Posted: 2019-12-19
• Results First Submitted: 2020-07-08
• Status Verified: 2020-10
• Results First Submitted QC: 2020-10-21
• Last Update Submitted: 2020-10-21
• Results First Posted: 2020-11-13
• Last Update Posted: 2020-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individual Treatment	Benzyl Benzoate 25% Topical Application Lotion	-
Household Treatment	Benzyl Benzoate 25% Topical Application Lotion	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Clinical Cure	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

Name	Time	Method
Proportion of Affected Household Members Per Household	after 28 days from baseline	proportion of scabies cases per household after 4 weeks

Trial Locations

Locations (1)

Centre de Recherches Médicales de Lambaréné; 🇬🇦 Lambaréné, Gabon