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This is a pilot study evaluating if treatment for scabies also treats headlice in the same community
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Other | This study consists of a single treatment arm. Patients will receive Ivermectin or where contraindicated (Pregnancy, Breastfeeding, Weight <15kg) Permethrin Cream and Malathion shampoo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivermectin | Drug | A single weight based dose of ivermectin |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Headlice | Assessed in the study population by physical examination of hair | 2 Weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Headlice | Assessed in the study population by physical examination of hair | 48hrs after treatment |
| Number of Participants With Headlice | Assessed in the study population by physical examination of hair |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atoifi Adventist Hospital | Atoifi | Malaita Province | Solomon Islands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30252856 | Derived | 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. |
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Anonymised data may be made available alongside any future publications
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Headlice | Assessed in the study population by physical examination of hair | Posted | Count of Participants | Participants | 2 Weeks after treatment |
|
|
2 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Michael Marks | London School of Hygiene and Tropical Medicine | 02079272566 | michael.marks@lshtm.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 16, 2017 | Mar 11, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012532 | Scabies |
| ID | Term |
|---|---|
| D008924 | Mite Infestations |
| D004478 | Ectoparasitic Infestations |
| D012876 | Skin Diseases, Parasitic |
| D010272 | Parasitic Diseases |
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| ID | Term |
|---|---|
| D007559 | Ivermectin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Permethrin 5% |
| Drug |
Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated |
|
| Malathion Shampoo 0.5% | Drug | Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated |
|
| 3 Months after treatment |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Headline Prevalence | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Number of Participants With Headlice | Assessed in the study population by physical examination of hair | Not Posted | 48hrs after treatment | Participants |
| Secondary | Number of Participants With Headlice | Assessed in the study population by physical examination of hair | Not Posted | 3 Months after treatment | Participants |
| 0 |
| 118 |
| 0 |
| 118 |
| 0 |
| 118 |
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| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |