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

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ClinicalTrials.gov Identifier: NCT03236168
Recruitment Status : Completed
First Posted : August 1, 2017
Results First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

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

Condition or disease Intervention/treatment Phase
Scabies Head Lice Drug: Ivermectin Drug: Permethrin 5% Drug: Malathion Shampoo 0.5% Phase 3

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Community Scabies Treatment on Head Lice Prevalence in the Solomon Islands
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scabies

Arm Intervention/treatment
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
Drug: Ivermectin
A single weight based dose of ivermectin

Drug: Permethrin 5%
Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated

Drug: Malathion Shampoo 0.5%
Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated




Primary Outcome Measures :
  1. Number of Participants With Headlice [ Time Frame: 2 Weeks after treatment ]
    Assessed in the study population by physical examination of hair


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03236168


Locations
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Solomon Islands
Atoifi Adventist Hospital
Atoifi, Malaita, Solomon Islands
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
  Study Documents (Full-Text)

Documents provided by London School of Hygiene and Tropical Medicine:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT03236168     History of Changes
Other Study ID Numbers: 14257
First Posted: August 1, 2017    Key Record Dates
Results First Posted: June 14, 2019
Last Update Posted: June 14, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Anonymised data may be made available alongside any future publications

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Permethrin
Lice Infestations
Scabies
Ectoparasitic Infestations
Skin Diseases, Parasitic
Parasitic Diseases
Skin Diseases, Infectious
Skin Diseases
Mite Infestations
Ivermectin
Malathion
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinesterase Inhibitors
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs