Oral Ivermectin Versus Topical Permethrin to Treat Scabies in Children and Adults
NCT ID: NCT02407782
Last Updated: 2024-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1092 participants
INTERVENTIONAL
2016-01-19
2022-01-18
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Ivermectin
Ivermectin
oral ivermectin, 200μg/kg given at baseline and at day 10.
Permethrin
Permethrin
topical permethrin 5% cream applied at baseline and at day 10.
Interventions
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Ivermectin
oral ivermectin, 200μg/kg given at baseline and at day 10.
Permethrin
topical permethrin 5% cream applied at baseline and at day 10.
Eligibility Criteria
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Inclusion Criteria
* For children, weight more than 15 kg
* Documented diagnosis of scabies, defined by positive dermoscopic examination.
Exclusion Criteria
* Known allergy to ivermectin or permethrin
* Widespread eczematization or impetiginization
* Liver or renal failure
ALL
No
Sponsors
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University Hospital, Bordeaux
OTHER
Responsible Party
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Principal Investigators
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Bruneau Giraudeau, Doctor
Role: STUDY_CHAIR
Centre d'investigation clinique Inserm 1415 CHRU de Tours
Locations
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CHU de Bordeaux Hôpital Pellegrin
Bordeaux, Aquitaine, France
CHU de Lyon
Bron, Auvergne-Rhône-Alpes, France
CHG de Chalon sur Saône
Chalon-sur-Saône, Bourgogne-Franche-Comté, France
CHU de Dijon
Dijon, Bourgogne-Franche-Comté, France
CHU de Rennes
Rennes, Brittany Region, France
CHRU de Tours
Tours, Centre-Val de Loire, France
CHU de Montpellier
Montpellier, Languedoc-Roussillon, France
CHU de la Réunion
Saint-Pierre, Martinique, France
CHU d'Angers
Angers, Pays de la Loire Region, France
CH du Mans
Le Mans, Pays de la Loire Region, France
CHU de Nantes
Nantes, Pays de la Loire Region, France
CHI de Fréjus
Fréjus, Provence-Alpes-Côte d'Azur Region, France
CHU de Nice
Nice, Provence-Alpes-Côte d'Azur Region, France
APHP- Bobigny - Avicenne
Bobigny, , France
CHU de Bordeaux - Saint André
Bordeaux, , France
CHU de Brest
Brest, , France
CHD Vendée
La Roche-sur-Yon, , France
CH Le Havre
Le Havre, , France
CHRU de Lille
Lille, , France
AP-HM
Marseille, , France
APHP Hôpital Cochin
Paris, , France
CH de Périgueux
Périgueux, , France
CHU de Reims
Reims, , France
CHU de Rouen
Rouen, , France
CHU de Saint-Etienne
Saint-Etienne, , France
CH d'Argenteuil
Argenteuil, Île-de-France Region, France
CHU de Créteil - Hôpital Henry Mondor
Créteil, Île-de-France Region, France
AP-HP - Hôpital Robert Debré
Paris, Île-de-France Region, France
CHU de Pointe à Pitre
Pointe-à-Pitre, , Guadeloupe
Countries
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Other Identifiers
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CHUBX 2011/16
Identifier Type: -
Identifier Source: org_study_id
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