NCT03236168

Brief Summary

This is a pilot study evaluating if treatment for scabies also treats headlice in the same community

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2017

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 1, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

June 14, 2019

Completed
Last Updated

June 14, 2019

Status Verified

November 1, 2018

Enrollment Period

5 months

First QC Date

July 26, 2017

Results QC Date

November 8, 2018

Last Update Submit

March 13, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Headlice

    Assessed in the study population by physical examination of hair

    2 Weeks after treatment

Secondary Outcomes (2)

  • Number of Participants With Headlice

    48hrs after treatment

  • Number of Participants With Headlice

    3 Months after treatment

Study Arms (1)

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

Drug: IvermectinDrug: Permethrin 5%Drug: Malathion Shampoo 0.5%

Interventions

A single weight based dose of ivermectin

Intervention Arm

Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated

Intervention Arm

Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated

Intervention Arm

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All participants living in the community will be offered treatment

You may not qualify if:

  • Patients with a contradindication to study medication
  • Patients unable to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atoifi Adventist Hospital

Atoifi, Malaita Province, Solomon Islands

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Scabies

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Mite InfestationsEctoparasitic InfestationsSkin Diseases, ParasiticParasitic DiseasesInfectionsSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic Chemicals

Results Point of Contact

Title
Dr Michael Marks
Organization
London School of Hygiene and Tropical Medicine

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2017

First Posted

August 1, 2017

Study Start

August 1, 2017

Primary Completion

December 31, 2017

Study Completion

February 28, 2018

Last Updated

June 14, 2019

Results First Posted

June 14, 2019

Record last verified: 2018-11

Locations