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Oral Ivermectin Versus Topical Permethrin to Treat Scabies in Children (SCRATCH)

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ClinicalTrials.gov Identifier: NCT02407782
Recruitment Status : Unknown
Verified June 2016 by University Hospital, Bordeaux.
Recruitment status was:  Recruiting
First Posted : April 3, 2015
Last Update Posted : June 6, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief 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.


Condition or disease Intervention/treatment Phase
Scabies Drug: Ivermectin Drug: Permethrin Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 502 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Oral Ivermectin Versus Topical Permethrin to Treat Scabies in Children: a Cluster Multicenter Randomized Trial
Study Start Date : January 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scabies

Arm Intervention/treatment
Experimental: Ivermectin Drug: Ivermectin
oral ivermectin, 200μg/kg given at baseline and at day 10.

Experimental: Permethrin Drug: Permethrin
topical permethrin 5% cream applied at baseline and at day 10.




Primary Outcome Measures :
  1. Assessment of skin lesions and healing at day 28 [ Time Frame: Day 28 ]
    Healing of skin lesions and disappearance of pruritus at day 28 of the treatment in the cluster composed by the child and its close contacts


Secondary Outcome Measures :
  1. Assessment of skin lesions and healing at day 56 [ Time Frame: day 56 ]
    Healing of skin lesions and disappearance of pruritus at day 56 of the treatment in the cluster composed by the child and its close contacts.

  2. Assessment of skin lesions and healing at day 28 and 56 in children [ Time Frame: Day 28 and Day 56 ]
    Healing of skin lesions and disappearance of pruritus at day 28 and day 56 of the treatment in children

  3. Number of unaffected members in clusters treated by permethrin versus ivermectin at D0, D28 and D56. [ Time Frame: day 0, day 28 and d56 ]
  4. Evaluation of delta wing jet sign(s) and mite egs [ Time Frame: Day 56 ]
  5. Incidence of serious adverse events [ Time Frame: Day 56 ]
    Safety in both groups

  6. adherence of patients [ Time Frame: Day 56 ]
    Preference and adherence of patients in both groups



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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02407782


Contacts
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Contact: Franck BORALEVI, Professor 05 56 79 59 41 franck.boralevi@chu-bordeaux.fr
Contact: Fabienne NACKA, PhD 05 57 82 01 08 fabienne.nacka@chu-bordeaux.fr

Locations
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France
CHU de Bordeaux Hôpital Pellegrin Recruiting
Bordeaux, Aquitaine, France, 33000
Contact: Franck BORALEVI, Professor    05 56 79 59 41    franck.boralevi@chu-bordeaux.fr   
Contact: Fabienne NACKA, PhD    05 57 82 01 08    fabienne.nacka@chu-bordeaux.fr   
Sub-Investigator: Christine Léauté-Labrèze, Dr         
Sub-Investigator: Valérie Fontès-Plantade, Dr         
CHG de Chalon sur Saône Recruiting
Chalon sur Saône, Bourgogne, France, 71321
Contact: Elisa Groujon, Doctor    03 85 91 00 53    Elisa.Goujon@ch-chalon71.fr   
Sub-Investigator: Jean Friedel, Doctor         
Sub-Investigator: Camille Leleu, Doctor         
Sub-Investigator: Julie Journet, Doctor         
CHU de Dijon Recruiting
Dijon, Bourgogne, France, 21079
Contact: Pierre Vabres, Professor    03 80 29 33 36    pierre.vabres@chu-dijon.fr   
Sub-Investigator: Bertille Bonniaud, Doctor         
Sub-Investigator: Blandine Bel, Doctor         
Sub-Investigator: Géraldine Jeudy, Doctor         
CHU de Rennes Recruiting
Rennes, Bretagne, France, 35000
Contact: Alain Dupuy, Professor    02 99 28 43 68    alain.dupuy@chu-rennes.fr   
Sub-Investigator: Catherine Droitcourt, Doctor         
Sub-Investigator: Henri Adamski, Doctor         
Sub-Investigator: Monica Dinulescu, Doctor         
CHRU de Tours Recruiting
Tours, Centre-Val de Loire, France, 37044
Contact: Annabel Maruani, Professor    02 47 47 46 25    annabel.maruani@univ-tours.fr   
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         
CH d'Argenteuil Recruiting
Argenteuil, Ile de France, France, 95107
Contact: Emmanuel Mahé, Doctor    01 34 23 28 99    emmanuel.mahe@apr.aphp.fr   
Sub-Investigator: Maud Amy de la Bretèque, Doctor         
Sub-Investigator: Michèle Sigal, Doctor         
Sub-Investigator: Carole Sin, Doctor         
Sub-Investigator: Paul Bilan, Doctor         
CHU de Créteil - Hôpital Henry Mondor Recruiting
Créteil, Ile de France, France, 94010
Contact: Olivier Chosidow, Professor    01 49 81 25 01    olivier.chosidow@hmn.aphp.fr   
Sub-Investigator: Giao Do Pham, Doctor         
Sub-Investigator: Amandine Servy, Doctor         
Sub-Investigator: Saskia Oro, Doctor         
AP-HP - Hôpital Robert Debré Recruiting
Paris, Ile de France, France, 75935
Contact: Emmanuelle Bourrat, Doctor    01 40 09 41 39    emmanuelle.bourrat@rdb.aphp.fr   
Sub-Investigator: Ulrich Meinzer, Doctor         
CHU de Montpellier Recruiting
Montpellier, Languedoc-Roussillon, France, 34295
Contact: Didier Bessis, Doctor    04 67 33 69 59    d-bessis@chu-montpellier.fr   
Sub-Investigator: Charlotte Pernet, Doctor         
CHU de la Réunion Recruiting
Saint-Pierre, Martinique, France, 97448
Contact: Juliette Miquel, Doctor    0262359000    miquel.juliette@wanadoo.fr   
Sub-Investigator: Aude Fischer, Doctor         
Sub-Investigator: Julie Guinaud, Doctor         
CHU d'Angers Recruiting
Angers, Pays de La Loire, France, 49933
Contact: Ludovic Martin, Professor    06 65 81 12 95    LuMartin@chu-angers.fr   
Sub-Investigator: Martine Avenel-Audran, Doctor         
Sub-Investigator: Yannick Le Corre, Doctor         
Sub-Investigator: Marie-Elodie Sarre, Doctor         
CH du Mans Recruiting
Le Mans, Pays de la Loire, France, 72037
Contact: Nathalie Beneton, Doctor    02 43 43 43 58    nbeneton@ch-lemans.fr   
Sub-Investigator: Corina Bara, Doctor         
Sub-Investigator: Hervé Maillard, Doctor         
Sub-Investigator: Marie Lecouflet, Doctor         
CHU de Nantes Recruiting
Nantes, Pays de la Loire, France, 44093
Contact: Sébastien Barbarot, Doctor    02 40 08 40 86    sebastien.barbarot@chu-nantes.fr   
Sub-Investigator: Hélène Aubert-Wastiaux, Doctor         
Sub-Investigator: Claire Bernier, Doctor         
CHI de Fréjus Recruiting
Fréjus, Provence-Alpes-Côte d'Azur, France, 83600
Contact: Thomas Hubiche, Doctor    04 94 40 25 46    hubiche-t@chi-frejus-saint-raphael.fr   
Sub-Investigator: Pascal Del Giudice, Doctor         
CHU de Nice Recruiting
Nice, Provence-Alpes-Côte-d'Azur, France, 06202
Contact: Christine Chiaverini, Doctor    04 92 03 92 11    chiaverini.c@chu-nice.fr   
Sub-Investigator: Pascal Delaunay, Doctor         
CHU de Lyon Recruiting
Bron, Rhône-Alpes, France, 69677
Contact: Alice Phan, Doctor    04 27 85 61 26    alice.phan@chu-lyon.fr   
Sub-Investigator: Mona Amini-Adle, Doctor         
Sub-Investigator: Stéphane Dalle, Doctor         
Sub-Investigator: Nicolas Poulahon, Doctor         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Study Chair: Bruneau Giraudeau, Doctor Centre d'investigation clinique Inserm 1415 CHRU de Tours

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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT02407782     History of Changes
Other Study ID Numbers: CHUBX 2011/16
First Posted: April 3, 2015    Key Record Dates
Last Update Posted: June 6, 2016
Last Verified: June 2016

Keywords provided by University Hospital, Bordeaux:
Scabies
children
cluster
permethrin
Ivermectin

Additional relevant MeSH terms:
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Scabies
Mite Infestations
Ectoparasitic Infestations
Skin Diseases, Parasitic
Parasitic Diseases
Skin Diseases, Infectious
Skin Diseases
Ivermectin
Permethrin
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action