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
Among 10 studies testing ivermectin in Scabies — 1 open to participants now, 2 under way, none of them phase 3. Ivermectin · Scabies.
Among the 10 studies testing ivermectin in Scabies, this one is the 7th largest by enrollment, is the only one that started in 2017, is one of 3 in phase 3, and was the 4th registered.
51 studies on the registry are indexed under Scabies; 10 are open to participants now.
This study's enrollment of 118 is below the median of 183 across 41 interventional studies indexed under Scabies.
Browse Scabies studies →1 of the 10 studies testing ivermectin in Scabies is open now, in 1 country. Each count lists the studies.
Ivermectin: first FDA approval 1996 (STROMECTOL). What it is approved for, and how studies give it, is on its page →
Of the 4 Scabies studies recruiting now, 3 (75%) set no upper age limit and 1 (25%) stop at 75 or younger; 3 take children under 18; 3 take healthy volunteers.
This study: all sexes · healthy volunteers too.
The full table on the hub →10 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 1 started in 2017.
Median enrollment 180 across the 10 interventional studies. Of the 7 that completed or were terminated, 2 (29%) have results posted.
None of the 10 has an industry lead sponsor. The 8 most frequent:
London School of Hygiene and Tropical Medicine is the lead sponsor of 298 studies on the registry; 15 are open to participants now.
London School of Hygiene and Tropical Medicine has 4 studies filed under Scabies — fewer than ten, so there is no comparison to draw.
1 of the studies testing ivermectin in Scabies that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05500326Murdoch Childrens Research InstituteIvermectin Therapy for Scabies Infection in Children Younger Than 5 Years of Age (ITCHY Study) | 2026-12 |
Among the 10 studies testing ivermectin in Scabies, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 |
PDFs hosted by the registry, ClinicalTrials.gov.
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.
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Studies of the drugs tested here: Ivermectin · Permethrin
London School of Hygiene and Tropical Medicine →