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

NCT04205669 | Completed Phase 4 Results

• 1 other identifier: GrattiGratta31082018
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Scabies; Households

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Proportion of Affected Household Members Per Household

  after 28 days from baseline

Study Arms (2)

Individual Treatment

ACTIVE COMPARATOR

Drug: Benzyl Benzoate 25% Topical Application Lotion

Household Treatment

ACTIVE COMPARATOR

Drug: Benzyl Benzoate 25% Topical Application Lotion

Interventions

Benzyl Benzoate 25% Topical Application Lotion DRUG

Applied to skin for the treatment of scabies

Household Treatment; Individual Treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed with active, uncomplicated scabies
• no known hypersensitivity or allergy against benzyl benzoate

You may not qualify if:

• hypersensitivity or allergy against benzyl benzoate
• severe superinfection of scabies lesions

Sponsors & Collaborators

• Centre de Recherche Médicale de Lambaréné: lead
• Bernhard Nocht Institute for Tropical Medicine: collaborator
• University Hospital Tuebingen: collaborator
• Medical University of Vienna: collaborator

Study Sites (1)

Centre de Recherches Médicales de Lambaréné

Lambaréné, BP 242, Gabon

Location

Related Publications (1)

• 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.

  PMID: 32589632 DERIVED

MeSH Terms

Conditions

Scabies

Interventions

benzyl benzoate

Condition Hierarchy (Ancestors)

Mite Infestations; Ectoparasitic Infestations; Skin Diseases, Parasitic; Parasitic Diseases; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Julian Matthewman
• Organization: CERMEL

julianmatthewman@gmail.com

00241 07-98-91-91

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: December 19, 2019
• Study Start: October 4, 2018
• Primary Completion: February 21, 2019
• Study Completion: February 21, 2019
• Last Updated: November 13, 2020
• Results First Posted: November 13, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share

Locations

GA (1)