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

Centre de Recherche Médicale de Lambaréné

Status and phase: Completed; Phase 4

Conditions: Households; Scabies

Treatments: Drug: Benzyl Benzoate 25% Topical Application Lotion

Study type: Interventional

Funder types: Other

Identifiers

NCT04205669

GrattiGratta31082018

Details and patient eligibility

About

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.

Enrollment: 104 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 2 patient groups

Individual Treatment

Active Comparator group

Treatment:

Drug: Benzyl Benzoate 25% Topical Application Lotion

Household Treatment

Active Comparator group

Treatment:

Drug: Benzyl Benzoate 25% Topical Application Lotion