drugset / Trial / NCT02841215

Efficacy Study Between Two Different Dosages of an Antiparasitic in Patients With Crusted Scabies

NCT02841215

Phase 3 Completed 133 enrolled Assistance Publique - Hôpitaux de Paris
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Severe forms of scabies (crusted scabies and profuse scabies) require a specific treatment. Ivermectin is a recommended treatment in common forms of scabies and represents a promising treatment in crusted scabies in case reports. However, response to ivermectin remains variable among studies, and there is no consensus on the schemes to adopt (dosages and administrations). Ivermectin at 400 µg/kg has already been used, without showing toxicity (in head lice treatment in particular). Investigators propose to demonstrate that 400µg/kg ivermectin dosage will show better efficacy than a 200µg/kg in patients with severe forms of scabies (crusted and profuse).

Timeline

Start
2017-10-11
Primary completion
2022-01-12
Completion
2022-01-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ivermectin Small molecule 200 ug/kg Oral
Comparator Ivermectin Small molecule 400 ug/kg Oral

Indications