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

• 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: London School of Hygiene and Tropical Medicine
• Information provided by (Responsible Party): London School of Hygiene and Tropical Medicine

Tracking Information

• First Submitted Date: July 26, 2017
• First Posted Date: August 1, 2017
• Results First Submitted Date: November 8, 2018
• Results First Posted Date: June 14, 2019
• Last Update Posted Date: June 14, 2019
• Actual Study Start Date: August 1, 2017
• Actual Primary Completion Date: December 31, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 27, 2017)

Number of Participants With Headlice [ Time Frame: 2 Weeks after treatment ]

Assessed in the study population by physical examination of hair

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT03236168 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: July 27, 2017)

• Number of Participants With Headlice [ Time Frame: 48hrs after treatment ]
  Assessed in the study population by physical examination of hair
• Number of Participants With Headlice [ Time Frame: 3 Months after treatment ]
  Assessed in the study population by physical examination of hair

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Scabies
• Head Lice

Intervention

• 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

Study Arms

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:

• Drug: Ivermectin
• Drug: Permethrin 5%
• Drug: Malathion Shampoo 0.5%

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 13, 2019): 118
• Original Estimated Enrollment (submitted: July 27, 2017): 180
• Actual Study Completion Date: February 28, 2018
• Actual Primary Completion Date: December 31, 2017 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Solomon Islands

Administrative Information

• NCT Number: NCT03236168
• Other Study ID Numbers: 14257
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: Undecided
• Plan Description: Anonymised data may be made available alongside any future publications

• Responsible Party: London School of Hygiene and Tropical Medicine
• Study Sponsor: London School of Hygiene and Tropical Medicine
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: London School of Hygiene and Tropical Medicine
• Verification Date: November 2018