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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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Scabies
Head Lice
Interventions Drug: Ivermectin
Drug: Permethrin 5%
Drug: Malathion Shampoo 0.5%
Enrollment 118
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intervention Arm
Hide Arm/Group Description

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

Period Title: Overall Study
Started 118
Completed 107
Not Completed 11
Arm/Group Title Intervention Arm
Hide Arm/Group Description

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

Overall Number of Baseline Participants 118
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 118 participants
<= 10 years
32
  27.1%
11-20 years
31
  26.3%
>= 21 years
55
  46.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 118 participants
Female
61
  51.7%
Male
57
  48.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 118 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
118
 100.0%
Black or African American
0
   0.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Solomon Islands Number Analyzed 118 participants
118
Headline Prevalence  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 118 participants
30
  25.4%
1.Primary Outcome
Title Number of Participants With Headlice
Hide Description Assessed in the study population by physical examination of hair
Time Frame 2 Weeks after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Arm
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 117
Measure Type: Count of Participants
Unit of Measure: Participants
3
   2.6%
2.Secondary Outcome
Title Number of Participants With Headlice
Hide Description Assessed in the study population by physical examination of hair
Time Frame 48hrs after treatment
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Number of Participants With Headlice
Hide Description Assessed in the study population by physical examination of hair
Time Frame 3 Months after treatment
Outcome Measure Data Not Reported
Time Frame 2 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention Arm
Hide Arm/Group Description

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

All-Cause Mortality
Intervention Arm
Affected / at Risk (%)
Total   0/118 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Intervention Arm
Affected / at Risk (%)
Total   0/118 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention Arm
Affected / at Risk (%)
Total   0/118 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Michael Marks
Organization: London School of Hygiene and Tropical Medicine
Phone: 02079272566
EMail: michael.marks@lshtm.ac.uk
Layout table for additonal information
Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT03236168     History of Changes
Other Study ID Numbers: 14257
First Submitted: July 26, 2017
First Posted: August 1, 2017
Results First Submitted: November 8, 2018
Results First Posted: June 14, 2019
Last Update Posted: June 14, 2019