DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Oral Ivermectin Versus Topical Permethrin to Treat Scabies in Children

Information source: University Hospital, Bordeaux
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Scabies

Intervention: Ivermectin (Drug); Permethrin (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: University Hospital, Bordeaux

Official(s) and/or principal investigator(s):
Bruneau Giraudeau, Doctor, Study Chair, Affiliation: Centre d'investigation clinique Inserm 1415 CHRU de Tours

Overall contact:
Franck BORALEVI, Professor, Phone: 05 56 79 59 41, Email: franck.boralevi@chu-bordeaux.fr


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Assessment of skin lesions and healing at day 28

Secondary outcome:

Assessment of skin lesions and healing at day 56

Assessment of skin lesions and healing at day 28 and 56 in children

Number of unaffected members in clusters treated by permethrin versus ivermectin at D0, D28 and D56.

Evaluation of delta wing jet sign(s) and mite egs

Incidence of serious adverse events

adherence of patients

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.


Minimum age: N/A. Maximum age: 16 Years. Gender(s): Both.


Inclusion Criteria:

- Age less than 16 years

- Weight more than 15 kg

- Documented diagnosis of scabies, defined by positive dermoscopic examination.

Exclusion Criteria:

- Previous scabies therapy during the past 4 weeks

- Known allergy to ivermectin or permethrin

- Widespread eczematization or impetiginization

- Liver or renal failure

Locations and Contacts

Franck BORALEVI, Professor, Phone: 05 56 79 59 41, Email: franck.boralevi@chu-bordeaux.fr

CHU de Bordeaux Hôpital Pellegrin, Bordeaux, Aquitaine 33000, France; Not yet recruiting
Franck BORALEVI, Professor, Phone: 05 56 79 59 41, Email: franck.boralevi@chu-bordeaux.fr
Fabienne NACKA, PhD, Phone: 05 57 82 01 08, Email: fabienne.nacka@chu-bordeaux.fr
Christine Léauté-Labrèze, Dr, Sub-Investigator
Valérie Fontès-Plantade, Dr, Sub-Investigator

CHG de Chalon sur Saône, Chalon sur Saône, Bourgogne 71321, France; Not yet recruiting
Elisa Groujon, Doctor, Phone: 03 85 91 00 53, Email: Elisa.Goujon@ch-chalon71.fr
Jean Friedel, Doctor, Sub-Investigator
Camille Leleu, Doctor, Sub-Investigator
Julie Journet, Doctor, Sub-Investigator

CHU de Dijon, Dijon, Bourgogne 21079, France; Not yet recruiting
Pierre Vabres, Professor, Phone: 03 80 29 33 36, Email: pierre.vabres@chu-dijon.fr
Bertille Bonniaud, Doctor, Sub-Investigator
Blandine Bel, Doctor, Sub-Investigator
Géraldine Jeudy, Doctor, Sub-Investigator

CHU de Rennes, Rennes, Bretagne 35000, France; Not yet recruiting
Alain Dupuy, Professor, Phone: 02 99 28 43 68, Email: alain.dupuy@chu-rennes.fr
Catherine Droitcourt, Doctor, Sub-Investigator
Henri Adamski, Doctor, Sub-Investigator
Monica Dinulescu, Doctor, Sub-Investigator

CHRU de Tours, Tours, Centre-Val de Loire 37044, France; Not yet recruiting
Annabel Maruani, Professor, Phone: 02 47 47 46 25, Email: annabel.maruani@univ-tours.fr
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, Sub-Investigator

CH d'Argenteuil, Argenteuil, Ile de France 95107, France; Not yet recruiting
Emmanuel Mahé, Doctor, Phone: 01 34 23 28 99, Email: emmanuel.mahe@apr.aphp.fr
Maud Amy de la Bretèque, Doctor, Sub-Investigator
Michèle Sigal, Doctor, Sub-Investigator
Carole Sin, Doctor, Sub-Investigator
Paul Bilan, Doctor, Sub-Investigator

CHU de Créteil - Hôpital Henry Mondor, Créteil, Ile de France 94010, France; Not yet recruiting
Olivier Chosidow, Professor, Phone: 01 49 81 25 01, Email: olivier.chosidow@hmn.aphp.fr
Giao Do Pham, Doctor, Sub-Investigator
Amandine Servy, Doctor, Sub-Investigator
Saskia Oro, Doctor, Sub-Investigator

AP-HP - Hôpital Robert Debré, Paris, Ile de France 75935, France; Not yet recruiting
Emmanuelle Bourrat, Doctor, Phone: 01 40 09 41 39, Email: emmanuelle.bourrat@rdb.aphp.fr
Ulrich Meinzer, Doctor, Sub-Investigator

CHU de Montpellier, Montpellier, Languedoc-Roussillon 34295, France; Not yet recruiting
Didier Bessis, Doctor, Phone: 04 67 33 69 59, Email: d-bessis@chu-montpellier.fr
Charlotte Pernet, Doctor, Sub-Investigator

CHU de la Réunion, Saint-Pierre, Martinique 97448, France; Not yet recruiting
Juliette Miquel, Doctor, Phone: 0262359000, Email: miquel.juliette@wanadoo.fr
Aude Fischer, Doctor, Sub-Investigator
Julie Guinaud, Doctor, Sub-Investigator

CHU d'Angers, Angers, Pays de La Loire 49933, France; Not yet recruiting
Ludovic Martin, Professor, Phone: 06 65 81 12 95, Email: LuMartin@chu-angers.fr
Martine Avenel-Audran, Doctor, Sub-Investigator
Yannick Le Corre, Doctor, Sub-Investigator
Marie-Elodie Sarre, Doctor, Sub-Investigator

CH du Mans, Le Mans, Pays de la Loire 72037, France; Not yet recruiting
Nathalie Beneton, Doctor, Phone: 02 43 43 43 58, Email: nbeneton@ch-lemans.fr
Corina Bara, Doctor, Sub-Investigator
Hervé Maillard, Doctor, Sub-Investigator
Marie Lecouflet, Doctor, Sub-Investigator

CHU de Nantes, Nantes, Pays de la Loire 44093, France; Not yet recruiting
Sébastien Barbarot, Doctor, Phone: 02 40 08 40 86, Email: sebastien.barbarot@chu-nantes.fr
Hélène Aubert-Wastiaux, Doctor, Sub-Investigator
Claire Bernier, Doctor, Sub-Investigator

CHI de Fréjus, Fréjus, Provence-Alpes-Côte d'Azur 83600, France; Not yet recruiting
Thomas Hubiche, Doctor, Phone: 04 94 40 25 46, Email: hubiche-t@chi-frejus-saint-raphael.fr
Pascal Del Giudice, Doctor, Sub-Investigator

CHU de Nice, Nice, Provence-Alpes-Côte-d'Azur 06202, France; Not yet recruiting
Christine Chiaverini, Doctor, Phone: 04 92 03 92 11, Email: chiaverini.c@chu-nice.fr
Pascal Delaunay, Doctor, Sub-Investigator

CHU de Lyon, Bron, Rhône-Alpes 69677, France; Not yet recruiting
Alice Phan, Doctor, Phone: 04 27 85 61 26, Email: alice.phan@chu-lyon.fr
Mona Amini-Adle, Doctor, Sub-Investigator
Stéphane Dalle, Doctor, Sub-Investigator
Nicolas Poulahon, Doctor, Sub-Investigator

Additional Information

Starting date: September 2015
Last updated: March 30, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017