A Phase 3 interventional study of Ivermectin and Permethrin 5% in Scabies and Head Lice, sponsored by London School of Hygiene and Tropical Medicine. Completed at 1 site in Solomon Islands. Per ClinicalTrials.gov, last updated 2019-06-14.
Sponsored by London School of Hygiene and Tropical Medicine · Phase 3, Interventional, and Treatment
This is a pilot study evaluating if treatment for scabies also treats headlice in the same community
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.
Exclusion Criteria:
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: Ivermectin · Drug: Permethrin 5% · Drug: Malathion Shampoo 0.5%
A single weight based dose of ivermectin
Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated
Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated
Number of Participants With Headlice
Assessed in the study population by physical examination of hair
Time frame: 2 Weeks after treatment
Number of Participants With Headlice
Assessed in the study population by physical examination of hair
Time frame: 48hrs after treatment
Number of Participants With Headlice
Assessed in the study population by physical examination of hair
Time frame: 3 Months after treatment
| Milestone | Intervention Arm |
|---|---|
| Started | 118 |
| Completed | 107 |
| Not completed | 11 |
Assessed in the study population by physical examination of hair
| Participants | Intervention Arm |
|---|---|
| Number of Participants With Headlice | 3 |
Assessed in the study population by physical examination of hair
Results for this outcome have not been posted.
Assessed in the study population by physical examination of hair
Results for this outcome have not been posted.
Collected over 2 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Arm | 0/118 (0%) | 0/118 (0%) | 0/118 (0%) |
| Age, Customized(Participants) | Intervention Arm |
|---|---|
| <= 10 years | 32 |
| 11-20 years | 31 |
| >= 21 years | 55 |
| Sex: Female, Male(Participants) | Intervention Arm |
|---|---|
| Female | 61 |
| Male | 57 |
| Race (NIH/OMB)(Participants) | Intervention Arm |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 118 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Intervention Arm |
|---|---|
| Solomon Islands | 118 |
| Headline Prevalence(Participants) | Intervention Arm |
|---|---|
| Count of participants | 30 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided — Anonymised data may be made available alongside any future publications
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
London School of Hygiene and Tropical Medicine