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

Scabies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03236168
• Other study ID #: 14257
• Status: Completed
• Phase: Phase 3
• Start date: August 1, 2017
• Est. completion date: February 28, 2018

Study information

• Verified date: November 2018
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: February 28, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Head Lice
• Lice Infestations
• Scabies

Intervention

Drug:
• Ivermectin
A single weight based dose of ivermectin
• Permethrin 5%
Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated
• Malathion Shampoo 0.5%
Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated

Locations

Country	Name	City	State
Solomon Islands	Atoifi Adventist Hospital	Atoifi	Malaita

Sponsors (1)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine

Country where clinical trial is conducted

Solomon Islands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Headlice	Assessed in the study population by physical examination of hair	2 Weeks after treatment
Secondary	Number of Participants With Headlice	Assessed in the study population by physical examination of hair	48hrs after treatment
Secondary	Number of Participants With Headlice	Assessed in the study population by physical examination of hair	3 Months after treatment