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Completed

NCT Number: NCT03236168

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

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

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Key information

Conditions

Scabies Ectoparasitic Infestations Head Lice Infections Mite Infestations Parasitic Diseases Skin Diseases Skin Diseases, Infectious Skin Diseases, Parasitic Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Atoifi Adventist Hospital

Atoifi, Malaita Province, Solomon Islands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ivermectin

Drug

A single weight based dose of ivermectin

Permethrin 5%

Drug

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

Malathion Shampoo 0.5%

Drug

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

Primary outcomes

  1. Number of Participants With Headlice

    Time frame: 2 Weeks after treatment

    Assessed in the study population by physical examination of hair

Secondary outcomes

  1. Number of Participants With Headlice

    Time frame: 48hrs after treatment

    Assessed in the study population by physical examination of hair

  2. Number of Participants With Headlice

    Time frame: 3 Months after treatment

    Assessed in the study population by physical examination of hair

Sponsors and collaborators

Lead sponsor

London School of Hygiene and Tropical Medicine

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Aug 1, 2017
Registry last updated
Jun 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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