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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03236168
Other study ID # 14257
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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