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

Primary Purpose

Scabies, Households

Status

Completed

Phase

Phase 4

Locations

Gabon

Study Type

Interventional

Intervention

Benzyl Benzoate 25% Topical Application Lotion

About this trial

This is an interventional treatment trial for Scabies

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Centre de Recherches Médicales de Lambaréné

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Individual Treatment

Household Treatment

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Clinical Cure

clinical improvement in skin lesions with no new lesions occurring since treatment application as assessed by skin examination

Secondary Outcome Measures

Proportion of Affected Household Members Per Household

proportion of scabies cases per household after 4 weeks

Full Information

NCT ID

NCT04205669

First Posted

December 18, 2019

Last Updated

October 21, 2020

Sponsor

Centre de Recherche Médicale de Lambaréné

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04205669

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

October 4, 2018 (Actual)

Primary Completion Date

February 21, 2019 (Actual)

Study Completion Date

February 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Centre de Recherche Médicale de Lambaréné

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Scabies, Households

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

104 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Individual Treatment

Arm Type

Active Comparator

Arm Title

Household Treatment

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Benzyl Benzoate 25% Topical Application Lotion

Intervention Description

Applied to skin for the treatment of scabies

Primary Outcome Measure Information:

Title

Number of Participants With Clinical Cure

Description

clinical improvement in skin lesions with no new lesions occurring since treatment application as assessed by skin examination

Time Frame

after 28 days from baseline

Secondary Outcome Measure Information:

Title

Proportion of Affected Household Members Per Household

Description

proportion of scabies cases per household after 4 weeks

Time Frame

after 28 days from baseline

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Centre de Recherches Médicales de Lambaréné

City

Lambaréné

ZIP/Postal Code

BP 242

Country

Gabon

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

IPD with identifying data removed uploaded to public repository under https://www.kaggle.com/julianmatthewman/grattigratta-data

IPD Sharing URL

https://www.kaggle.com/julianmatthewman/grattigratta-data

Citations:

PubMed Identifier

32589632

Citation

Matthewman J, Manego RZ, Dimessa Mbadinga LB, Sinkovec H, Volker K, Akinosho M, Haedrich C, Tardif d'Hamonville J, Lell B, Adegnika AA, Ramharter M, Mombo-Ngoma G. A randomized controlled trial comparing the effectiveness of individual versus household treatment for Scabies in Lambarene, Gabon. PLoS Negl Trop Dis. 2020 Jun 26;14(6):e0008423. doi: 10.1371/journal.pntd.0008423. eCollection 2020 Jun.

Results Reference

derived

Available IPD and Supporting Information:

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.kaggle.com/julianmatthewman/grattigratta-data

Learn more about this trial

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

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