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
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.
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 56Assessment 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.
Eligibility
Minimum age: N/A.
Maximum age: 16 Years.
Gender(s): Both.
Criteria:
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
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