Clinical Trial: Efficacy Study Between Two Different Dosages of an Antiparasitic in Patients With Crusted Scabies
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: A Randomized Controlled Double-blind Trial Assessing the Efficacy of a 400 ug/kg Ivermectin Regime in Patients With Crusted Scabies as Compared to a 200 ug/kg
Brief 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).
Detailed Summary:
Sponsor: Assistance Publique - Hôpitaux de Paris
Current Primary Outcome:
- Rate of a successful treatment defined by : -Two negative parasitologic or two dermoscopic exams [ Time Frame: Days 21+/-2 days ]Parasitologic or dermoscopic exams will be perform at days 18 +/-2days and at days 21+/-2 days
- Rate of a successful treatment defined by : - A clinical response : disappearance of clinical active lesions [ Time Frame: Days 28+/- 2 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Rate of adverse effects [ Time Frame: Days 18 +/-2 days, Days 21+/-2 days and Days 28+/-2 days ]
Original Secondary Outcome: Same as current
Information By: Assistance Publique - Hôpitaux de Paris
Dates:
Date Received: June 30, 2016
Date Started: March 2017
Date Completion: March 2019
Last Updated: December 7, 2016
Last Verified: December 2016
