Trial Outcomes & Findings for Impact of Community Scabies Treatment on Head Lice Prevalence in the Solomon Islands (NCT NCT03236168)
NCT ID: NCT03236168
Last Updated: 2019-06-14
Results Overview
Assessed in the study population by physical examination of hair
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
118 participants
Primary outcome timeframe
2 Weeks after treatment
Results posted on
2019-06-14
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
118
|
|
Overall Study
COMPLETED
|
107
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Community Scabies Treatment on Head Lice Prevalence in the Solomon Islands
Baseline characteristics by cohort
| Measure |
Intervention Arm
n=118 Participants
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
|
|---|---|
|
Age, Customized
<= 10 years
|
32 Participants
n=5 Participants
|
|
Age, Customized
11-20 years
|
31 Participants
n=5 Participants
|
|
Age, Customized
>= 21 years
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
118 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Solomon Islands
|
118 participants
n=5 Participants
|
|
Headline Prevalence
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 Weeks after treatmentAssessed in the study population by physical examination of hair
Outcome measures
| Measure |
Intervention Arm
n=117 Participants
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
|
|---|---|
|
Number of Participants With Headlice
|
3 Participants
|
SECONDARY outcome
Timeframe: 48hrs after treatmentAssessed in the study population by physical examination of hair
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 Months after treatmentAssessed in the study population by physical examination of hair
Outcome measures
Outcome data not reported
Adverse Events
Intervention Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Michael Marks
London School of Hygiene and Tropical Medicine
Phone: 02079272566
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place