Scabies Clinical Trial
Official title:
Ivermectin Therapy for Scabies Infection in Children Younger Than 5 Years of Age (ITCHY Study)
This is an open label prospective pharmacokinetic single arm study in Laos PDR. This study will be embedded within a cluster-randomized controlled trial of interventions to address childhood undernutrition (SUANHOAM Trial, ACTRN12620000520932) and involves a collaboration with the Murdoch Children's Research Institute, Burnet institute and Lao Tropical and Public Health Institute. ITCHY Study: The primary objective is to determine in young children aged 2 to <5 years and weighing 10 to <15 kg if an ivermectin dose of 3 mg achieves comparable drug exposures to the recommended dose in older children. It aims to provide reliable evidence for a safe and effective dose of ivermectin in young children who are especially vulnerable to scabies infections and the associated secondary complications. ITCHY2 Study: An embedded phase 2 multicentre, open label prospective pharmacokinetic study in Laos PDR of ITCHY Study. The primary objective is to determine the plasma ivermectin drug exposure in children aged 3 months to 2 years and weighing ≥2 kg receiving an age specific ivermectin dose.
ITCHY study: 100 children aged 2 to <5years and weighing 10 to <15 kg with clinically diagnosed scabies infection in the participating sites in Laos PDR will be approached for recruitment into the study if eligible (see eligibility criteria) and allocated into one of four blood sampling groups with 25 participants in each group. The 3mg dose of ivermectin will be administered orally and blood samples will be collected at two different time points accordingly to blood sampling groups allocation after the first 3mg dose of ivermectin. Clinical responses will be assessed on day 14. A second dose of ivermectin to complete the treatment will only be administered if the first dose has been tolerated by the participants. The 3mg ivermectin drug exposure, safety and effectiveness will be measured. ITCHY2 Study: 120 children aged 3 months to 2 years and weighing ≥2 kg with clinically diagnosed scabies infection in the participating sites in Laos PDR will be approached for recruitment into the study if eligible (see eligibility criteria) and allocated into one of four blood sampling groups with 30 participants in each group. An age specific dose of ivermectin will be administered orally and blood samples will be collected at two different time points accordingly to blood sampling groups allocation after the first dose of ivermectin. Age specific ivermectin dose: - 0.75mg of ivermectin will be given to participants aged 3 to 7 months - 1.5mg of ivermectin will be given to participants aged 8 to 12 months - 3mg of ivermectin will be given to participants aged 13 to 24 months Clinical responses of the participants will be assessed on day 14. A second age specific dose of ivermectin to complete the treatment will only be administered if the first dose has been tolerated by the participants. The ivermectin plasma drug exposure, safety and effectiveness will be measured. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02572986 -
A Study to Evaluate the Therapeutic Equivalence of Generic Permethrin Cream 5% to Elimite® in the Treatment of Scabies
|
Phase 3 | |
| Completed |
NCT00884728 -
Evaluation of a Regional Healthy Skin Program in Remote Aboriginal Communities of Australia's Northern Territory
|
N/A | |
| Completed |
NCT05025696 -
Efficacy and Side Effects of Blacksoap® as Adjuvant Therapy of Scabies
|
N/A | |
| Completed |
NCT04205669 -
Comparing the Effectiveness of Individual vs. Household Treatment for Scabies in Lambaréné, Gabon
|
Phase 4 | |
| Completed |
NCT02254564 -
PCR (Polymerase Chain Reaction) Assay for Diagnosis of Sarcoptes Scabiei
|
||
| Completed |
NCT03676140 -
Safety of Co-administration of IDA and Azithromycin for NTDs ( ComboNTDs )
|
Phase 3 | |
| Recruiting |
NCT05875441 -
Efficacy and Safety Study of Moxidectin in Adults With Scabies
|
Phase 2 | |
| Completed |
NCT02978508 -
Bio-equivalence Study Comparing Permethrin Cream, 5% With Elimite in Patients With Active Scabies.
|
Phase 3 | |
| Recruiting |
NCT04332068 -
Ivermectin Safety in Small Children
|
Phase 2 | |
| Recruiting |
NCT04844905 -
Adjunctive Ivermectin Mass Drug Administration for Malaria Control
|
Phase 3 | |
| Not yet recruiting |
NCT06380452 -
Therapy for Scabies With Two Differently Concentrated Permethrin Creams
|
Phase 3 | |
| Completed |
NCT00604084 -
Veron Scabies Education and Eradication Program
|
N/A | |
| Completed |
NCT02485717 -
Phase 3 Trial to Assess the Safety and Efficacy of Natroba for the Treatment of Scabies
|
Phase 3 | |
| Completed |
NCT02485704 -
Phase 3 Trial to Assess the Safety and Efficacy of Natroba for the Treatment of Scabies
|
Phase 3 | |
| Recruiting |
NCT05310734 -
PK and Safety Study of Natroba Topical Suspension 0.9% in Subjects 1 Month to 3 Years 11 Months of Age With Scabies
|
Phase 4 | |
| Recruiting |
NCT04931680 -
Risk Factors for Treatment Failure of Scabies in Autochthonous Populations of French Guiana (GUYAGALE)
|
||
| Completed |
NCT05862701 -
Comparison of Topical 5% Permethrin and Topical 10% Sulfur in the Treatment of Scabies
|
Phase 1 | |
| Recruiting |
NCT04814511 -
Escalated Therapy of Scabies With INFECTOSCAB 5% (Permethrin)
|
Phase 3 | |
| Completed |
NCT05362513 -
Comparative Study Between Topical Permethrin 5% and Oral Ivermectin for the Treatment of Scabies
|
Phase 1 | |
| Completed |
NCT03178942 -
Multiple-Site Study to Evaluate the Therapeutic Equivalence of Permethrin Cream, 5% in the Treatment of Scabies
|
Phase 3 |