Oral Ivermectin Versus Topical Permethrin to Treat Scabies in Children

Oral Ivermectin Versus Topical Permethrin to Treat Scabies in
Children
Status: Recruiting
Study Phase: Phase 3
Start Date: January 2016 | Completion Date: September 2017
Condition(s): Scabies
Full Title of Study
Oral Ivermectin Versus Topical Permethrin to Treat Scabies in Children: a Cluster
Multicenter Randomized Trial
Overview
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.
Study Details
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study,
Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary
Purpose: Treatment
Investigator Details
Lead Sponsor: University Hospital, Bordeaux
Study Chair: Bruneau Giraudeau, Doctor Centre d'investigation clinique Inserm 1415 CHRU de Tours
Trial Location Details
Facility: CHU de Bordeaux Hôpital Pellegrin Bordeaux, France
Sub-Investigator: Christine Léauté-Labrèze, Dr
Sub-Investigator: Valérie Fontès-Plantade, Dr
Facility: CHG de Chalon sur Saône Chalon sur Saône, France
Sub-Investigator: Jean Friedel, Doctor
Sub-Investigator: Camille Leleu, Doctor
Sub-Investigator: Julie Journet, Doctor
Facility: CHU de Dijon Dijon, France
Sub-Investigator: Bertille Bonniaud, Doctor
Sub-Investigator: Blandine Bel, Doctor
Sub-Investigator: Géraldine Jeudy, Doctor
Facility: CHU de Rennes Rennes, France
Sub-Investigator: Catherine Droitcourt, Doctor
Sub-Investigator: Henri Adamski, Doctor
Sub-Investigator: Monica Dinulescu, Doctor
Facility: CHRU de Tours Tours, France
Sub-Investigator: Marie Berton, Doctor
Sub-Investigator: Jean-Paul Claudel, Doctor
Sub-Investigator: Carole Dannepond, Doctor
Sub-Investigator: Gabriela Georgescou, Doctor
Sub-Investigator: Louise Lagier, Doctor
Sub-Investigator: Emmanuelle Le Bire, Doctor
Sub-Investigator: Gérard Lorette, Doctor
Facility: CH d'Argenteuil Argenteuil, France
Sub-Investigator: Maud Amy de la Bretèque, Doctor
Sub-Investigator: Michèle Sigal, Doctor
Sub-Investigator: Carole Sin, Doctor
Sub-Investigator: Paul Bilan, Doctor
Facility: CHU de Créteil - Hôpital Henry Mondor Créteil, France
Sub-Investigator: Giao Do Pham, Doctor
Sub-Investigator: Amandine Servy, Doctor
Sub-Investigator: Saskia Oro, Doctor
Facility: AP-HP - Hôpital Robert Debré Paris, France
Sub-Investigator: Ulrich Meinzer, Doctor
Facility: CHU de Montpellier Montpellier, France
Sub-Investigator: Charlotte Pernet, Doctor
Facility: CHU de la Réunion Saint-Pierre, France
Sub-Investigator: Aude Fischer, Doctor
Sub-Investigator: Julie Guinaud, Doctor
Facility: CHU d'Angers Angers, France
Sub-Investigator: Martine Avenel-Audran, Doctor
Sub-Investigator: Yannick Le Corre, Doctor
Sub-Investigator: Marie-Elodie Sarre, Doctor
Facility: CH du Mans Le Mans, France
Sub-Investigator: Corina Bara, Doctor
Sub-Investigator: Hervé Maillard, Doctor
Sub-Investigator: Marie Lecouflet, Doctor
Facility: CHU de Nantes Nantes, France
Sub-Investigator: Hélène Aubert-Wastiaux, Doctor
Sub-Investigator: Claire Bernier, Doctor
Facility: CHI de Fréjus Fréjus, France
Sub-Investigator: Pascal Del Giudice, Doctor
Facility: CHU de Nice Nice, France
Sub-Investigator: Pascal Delaunay, Doctor
Facility: CHU de Lyon Bron, France
Sub-Investigator: Mona Amini-Adle, Doctor
Sub-Investigator: Stéphane Dalle, Doctor
Sub-Investigator: Nicolas Poulahon, Doctor
Interventions
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.
Information Source
ID Number: CHUBX 2011/16
NCT Identifier: NCT02407782
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
Full Source of Clinical Trial Data: https://clinicaltrials.gov/show/NCT02407782
ClinicalTrials.gov processed this data on September 29, 2016
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately
by this site. Please see the full source link above for retrieving further details from the government database.