Impact of Community Scabies Treatment on Head Lice Prevalence in the Solomon Islands

NCT ID: NCT03236168

Last Updated: 2019-06-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2018-02-28

Brief Summary

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This is a pilot study evaluating if treatment for scabies also treats headlice in the same community

Detailed Description

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Background:

Scabies and head lice are both ubiquitous ectoparasitic infections that have been identified as common public health problems in the Pacific Island Country Territories. Mass drug administration using ivermectin is increasingly recognised as an effective strategy for scabies treatment and control, however, its possible impact on prevalence of head lice has not been evaluated. Given that oral ivermectin is an effective treatment option for pediculosis capitis, we hypothesise that community treatment with ivermectin for scabies would also provide benefit by reducing prevalence of head lice infestation in the community. We aim to test this hypothesis with a small-scale pilot study in the Solomon Islands.

Methodology:

The study would be carried out at the Atoifi Adventist Hospital campus, on the North-Eastern coast of the island of Malaita. The campus houses an estimated 180 individuals and all residents would be invited to participate in the study and be offered treatment.

At baseline all individuals would undergo a standardized examination to collect data on the presence of scabies, impetigo and head lice. Following examination individuals would be weighed and given directly observed standard treatment for scabies.

Treatment for scabies consists of one oral dose of ivermectin (200 micrograms per kilogram) at day 1 and at day 8.

Individuals with contra-indications (pregnancy, breast feeding, weight under 15kg) would be offered the alternative of 5% permethrin cream and malathion shampoo.

Individuals would be re-examined at 48hours (to assess immediate killing of head lice) and again at 2 weeks. Final follow-up will be at 3 months to establish: 1) whether changes in head lice prevalence have been sustained 2) what the impact of treatment on scabies and impetigo with ivermectin is in this specific community.

Conditions

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Scabies Head Lice

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention Arm

This study consists of a single treatment arm. Patients will receive Ivermectin or where contraindicated (Pregnancy, Breastfeeding, Weight \<15kg) Permethrin Cream and Malathion shampoo

Group Type OTHER

Ivermectin

Intervention Type DRUG

A single weight based dose of ivermectin

Permethrin 5%

Intervention Type DRUG

Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated

Malathion Shampoo 0.5%

Intervention Type DRUG

Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated

Interventions

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Ivermectin

A single weight based dose of ivermectin

Intervention Type DRUG

Permethrin 5%

Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated

Intervention Type DRUG

Malathion Shampoo 0.5%

Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All participants living in the community will be offered treatment

Exclusion Criteria

* Patients with a contradindication to study medication
* Patients unable to provide consent
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Atoifi Adventist Hospital

Atoifi, Malaita Province, Solomon Islands

Site Status

Countries

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Solomon Islands

References

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Coscione S, Esau T, Kekeubata E, Diau J, Asugeni R, MacLaren D, Steer AC, Kositz C, Marks M. Impact of ivermectin administered for scabies treatment on the prevalence of head lice in Atoifi, Solomon Islands. PLoS Negl Trop Dis. 2018 Sep 25;12(9):e0006825. doi: 10.1371/journal.pntd.0006825. eCollection 2018 Sep.

Reference Type DERIVED
PMID: 30252856 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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14257

Identifier Type: -

Identifier Source: org_study_id

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