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Trial record 2 of 4 for:    Solomon | Solomon Islands

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

Tracking Information
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
 (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  ICMJE Same as current
Change History Complete list of historical versions of study NCT03236168 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (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  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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Scabies
  • Head Lice
Intervention  ICMJE
  • 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  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:
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 13, 2019)
118
Original Estimated Enrollment  ICMJE
 (submitted: July 27, 2017)
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:

  • 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  ICMJE
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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  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