NCT02841215

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

A Randomized Controlled Double-blind Trial Assessing the Efficacy of a 400µg/kg Ivermectin /5% Permethrin / Emollient Cream Regimen in Patients With Crusted Scabies as Compared to a 200µg/kg Ivermectin /5% Permethrin /Emollient Cream Regimen

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Gale
• Severe Forms of Scabies
• Oral Parasitic Drug
• Ivermectin

Interventions

Type	Name	Description
DRUG	Ivermectin 200 µg/kg	Oral ivermectin 200 µg/kg three times (D0, D7 and D14) + topical treatment (permethrin 5% cream) on skin, hair and genital organs (D0 and D7) + emollient cream (Dexeryl® or other) daily on skin (D0 to D28)
DRUG	Ivermectin 400 µg/kg	Oral ivermectin 400 µg/kg three times (D0, D7 and D14) + topical treatment (permethrin 5% cream) on skin, hair and genital organs (D0 and D7) + emollient cream (Dexeryl® or other)daily on skin (D0 to D28)

Timeline

• Start date: 2017-10-11
• Primary completion: 2022-01-12
• Completion: 2022-01-12
• First posted: 2016-07-22
• Last updated: 2023-09-22

Locations

1 site across 1 country: France