Head Lice, Scabies
Conditions
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.
Interventions
DRUGIvermectin
A single weight based dose of ivermectin
DRUGPermethrin 5%
Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated
DRUGMalathion Shampoo 0.5%
Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated
Sponsors
London School of Hygiene and Tropical Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Headlice | 2 Weeks after treatment | Assessed in the study population by physical examination of hair |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Headlice | 48hrs after treatment | Assessed in the study population by physical examination of hair |
Countries
Solomon Islands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 118 |
| Total | 118 |
Baseline characteristics
| Characteristic | Intervention Arm |
|---|---|
| Age, Customized <= 10 years | 32 Participants |
| Age, Customized 11-20 years | 31 Participants |
| Age, Customized >= 21 years | 55 Participants |
| Headline Prevalence | 30 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 118 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Solomon Islands | 118 participants |
| Sex: Female, Male Female | 61 Participants |
| Sex: Female, Male Male | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 118 |
| other Total, other adverse events | 0 / 118 |
| serious Total, serious adverse events | 0 / 118 |
Outcome results
Primary
Number of Participants With Headlice
Assessed in the study population by physical examination of hair
Time frame: 2 Weeks after treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Number of Participants With Headlice | 3 Participants |
Secondary
Number of Participants With Headlice
Assessed in the study population by physical examination of hair
Time frame: 48hrs after treatment
Secondary
Number of Participants With Headlice
Assessed in the study population by physical examination of hair
Time frame: 3 Months after treatment