NCT02407782

Oral Ivermectin Versus Topical Permethrin to Treat Scabies in Children and Adults

Oral Ivermectin Versus Topical Permethrin to Treat Scabies in Children and Adults: a Cluster Multicenter Randomized Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,092 (actual)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Scabies remains a frequent condition that affects adults and children. The aim of this study is to compare the efficacy and safety of two drug treatments against scabies in children and their close contacts. One group will apply topical permethrin 5% and the other group will receive oral ivermectin. Both groups will be treated twice, once at inclusion and the second time 10 days later. Both treatment regimens have been used widely and are safe to use.

Detailed description

Scabies is a common condition, even in European countries, and the annual incidence seems to have increased over the past several years. Children and infants represent one-third of patients with scabies. Diagnostic features comprise pruritus, skin burrows and the delta jet wing dermoscopic sign. In many countries, topical permethrin is the first line therapy. Moreover, oral treatment with ivermectin represents an interesting alternative therapy, usually used as one dose of 200μg/kg, and more and more frequently recommended as two doses (one on day 1 and one between day 8 and day 15) without strong evidence. Management of scabies requires giving a treatment not only to the patient but also to the patient's close contacts. The objective of our study is to compare efficacy and safety of topical permethrin applied twice at day 1 and day 10 versus oral ivermectin given twice at day 1 and day 10 to treat scabies in children and their close contacts. Children (2 to15 years) with scabies and their close contacts - or first circle- will be randomized 1:1 to receive permethrin or ivermectin. A clinical follow-up will be performed 28 days (V2) and 56 days (V3) after the inclusion, including a dermatological examination and to collect safety data.

Conditions

• Scabies

Interventions

Type	Name	Description
DRUG	Ivermectin	oral ivermectin, 200μg/kg given at baseline and at day 10.
DRUG	Permethrin	topical permethrin 5% cream applied at baseline and at day 10.

Timeline

• Start date: 2016-01-19
• Primary completion: 2021-12-16
• Completion: 2022-01-18
• First posted: 2015-04-03
• Last updated: 2024-06-17

Locations

29 sites across 2 countries: France, Guadeloupe