Impact of Community Scabies Treatment on Head Lice Prevalence in the Solomon Islands
Primary Purpose
Scabies, Head Lice
Status
Completed
Phase
Phase 3
Locations
Solomon Islands
Study Type
Interventional
Intervention
Ivermectin
Permethrin 5%
Malathion Shampoo 0.5%
Sponsored by
About this trial
This is an interventional treatment trial for Scabies
Eligibility 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
Sites / Locations
- Atoifi Adventist Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Intervention Arm
Arm Description
This study consists of a single treatment arm. Patients will receive Ivermectin or where contraindicated (Pregnancy, Breastfeeding, Weight <15kg) Permethrin Cream and Malathion shampoo
Outcomes
Primary Outcome Measures
Number of Participants With Headlice
Assessed in the study population by physical examination of hair
Secondary Outcome Measures
Number of Participants With Headlice
Assessed in the study population by physical examination of hair
Number of Participants With Headlice
Assessed in the study population by physical examination of hair
Full Information
NCT ID
NCT03236168
First Posted
July 26, 2017
Last Updated
March 13, 2019
Sponsor
London School of Hygiene and Tropical Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03236168
Brief Title
Impact of Community Scabies Treatment on Head Lice Prevalence in the Solomon Islands
Official Title
Impact of Community Scabies Treatment on Head Lice Prevalence in the Solomon Islands
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
February 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
London School of Hygiene and Tropical Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a pilot study evaluating if treatment for scabies also treats headlice in the same community
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scabies, Head Lice
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
118 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Arm
Arm Type
Other
Arm Description
This study consists of a single treatment arm. Patients will receive Ivermectin or where contraindicated (Pregnancy, Breastfeeding, Weight <15kg) Permethrin Cream and Malathion shampoo
Intervention Type
Drug
Intervention Name(s)
Ivermectin
Intervention Description
A single weight based dose of ivermectin
Intervention Type
Drug
Intervention Name(s)
Permethrin 5%
Intervention Description
Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated
Intervention Type
Drug
Intervention Name(s)
Malathion Shampoo 0.5%
Intervention Description
Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated
Primary Outcome Measure Information:
Title
Number of Participants With Headlice
Description
Assessed in the study population by physical examination of hair
Time Frame
2 Weeks after treatment
Secondary Outcome Measure Information:
Title
Number of Participants With Headlice
Description
Assessed in the study population by physical examination of hair
Time Frame
48hrs after treatment
Title
Number of Participants With Headlice
Description
Assessed in the study population by physical examination of hair
Time Frame
3 Months after treatment
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Atoifi Adventist Hospital
City
Atoifi
State/Province
Malaita
Country
Solomon Islands
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Anonymised data may be made available alongside any future publications
Citations:
PubMed Identifier
30252856
Citation
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.
Results Reference
derived
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Impact of Community Scabies Treatment on Head Lice Prevalence in the Solomon Islands
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