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
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Tracking Information | |||||
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First Submitted Date ICMJE | July 26, 2017 | ||||
First Posted Date ICMJE | August 1, 2017 | ||||
Results First Submitted Date ICMJE | November 8, 2018 | ||||
Results First Posted Date ICMJE | June 14, 2019 | ||||
Last Update Posted Date | June 14, 2019 | ||||
Actual Study Start Date ICMJE | August 1, 2017 | ||||
Actual Primary Completion Date | December 31, 2017 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Number of Participants With Headlice [ Time Frame: 2 Weeks after treatment ] Assessed in the study population by physical examination of hair
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Impact of Community Scabies Treatment on Head Lice Prevalence in the Solomon Islands | ||||
Official Title ICMJE | Impact of Community Scabies Treatment on Head Lice Prevalence in the Solomon Islands | ||||
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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | 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
Interventions:
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Publications * | 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. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
118 | ||||
Original Estimated Enrollment ICMJE |
180 | ||||
Actual Study Completion Date ICMJE | February 28, 2018 | ||||
Actual Primary Completion Date | December 31, 2017 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | Child, Adult, Older Adult | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Solomon Islands | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03236168 | ||||
Other Study ID Numbers ICMJE | 14257 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | London School of Hygiene and Tropical Medicine | ||||
Study Sponsor ICMJE | London School of Hygiene and Tropical Medicine | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | London School of Hygiene and Tropical Medicine | ||||
Verification Date | November 2018 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |