Oral Ivermectin Versus Topical Permethrin to Treat Scabies in Children and Adults
SCRATCH
1 other identifier
interventional
1,092
2 countries
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2016
Longer than P75 for phase_3
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2015
CompletedFirst Posted
Study publicly available on registry
April 3, 2015
CompletedStudy Start
First participant enrolled
January 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 16, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 18, 2022
CompletedJune 17, 2024
June 1, 2016
5.9 years
March 24, 2015
June 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of skin lesions and healing at 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
Day 28
Secondary Outcomes (6)
Assessment of skin lesions and healing at day 56
day 56
Assessment of skin lesions and healing at day 28 and 56 in children
Day 28 and Day 56
Number of unaffected members in clusters treated by permethrin versus ivermectin at D0, D28 and D56.
day 0, day 28 and d56
Evaluation of delta wing jet sign(s) and mite egs
Day 56
Incidence of serious adverse events
Day 56
- +1 more secondary outcomes
Study Arms (2)
Ivermectin
EXPERIMENTALPermethrin
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- children or adult
- For children, weight more than 15 kg
- Documented diagnosis of scabies, defined by positive dermoscopic examination.
You may not qualify if:
- Previous scabies therapy during the past 4 weeks
- Known allergy to ivermectin or permethrin
- Widespread eczematization or impetiginization
- Liver or renal failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
CHU de Bordeaux Hôpital Pellegrin
Bordeaux, Aquitaine, 33000, France
CHU de Lyon
Bron, Auvergne-Rhône-Alpes, 69677, France
CHG de Chalon sur Saône
Chalon-sur-Saône, Bourgogne-Franche-Comté, 71321, France
CHU de Dijon
Dijon, Bourgogne-Franche-Comté, 21079, France
CHU de Rennes
Rennes, Brittany Region, 35000, France
CHRU de Tours
Tours, Centre-Val de Loire, 37044, France
CHU de Montpellier
Montpellier, Languedoc-Roussillon, 34295, France
CHU de la Réunion
Saint-Pierre, Martinique, 97448, France
CHU d'Angers
Angers, Pays de la Loire Region, 49933, France
CH du Mans
Le Mans, Pays de la Loire Region, 72037, France
CHU de Nantes
Nantes, Pays de la Loire Region, 44093, France
CHI de Fréjus
Fréjus, Provence-Alpes-Côte d'Azur Region, 83600, France
CHU de Nice
Nice, Provence-Alpes-Côte d'Azur Region, 06202, 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, 95107, France
CHU de Créteil - Hôpital Henry Mondor
Créteil, Île-de-France Region, 94010, France
AP-HP - Hôpital Robert Debré
Paris, Île-de-France Region, 75935, France
CHU de Pointe à Pitre
Pointe-à-Pitre, Guadeloupe
Related Publications (1)
Boralevi F, Simon G, Bernigaud C, Brun J, Goujon E, Perrot JL, Phan A, Herisse AL, Maruani A, Vanhaecke C, Couty E, Abasq-Thomas C, Fournet M, Mallet S, Brenaut E, Hubiche T, Balguerie X, Caux F, Beneton N, Dutkiewicz AS, Adamski H, Aubert H, Bourrat E, Couzan C, Eyraud A, Janela-Lapert R, Marti A, Miquel J, Richard M, Barbarot S, Bonniaud B, Chabbert C, Delion F, Dinulescu M, Duong TA, Etienne M, Hirsch G, Isnard C, Huet F, Le Bidre E, Leducq S, Legrand A, Monestier S, Morice-Picard F, Seneschal J, Capelli A, Lacoste C, Labreze C, Miraglia G, Do-Pham G, Giraudeau B, Chosidow O. Oral ivermectin versus 5% permethrin cream to treat children and adults with classic scabies: multicentre, assessor blinded, cluster randomised clinical trial. BMJ. 2026 Jan 6;392:e086277. doi: 10.1136/bmj-2025-086277.
PMID: 41494769DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Bruneau Giraudeau, Doctor
Centre d'investigation clinique Inserm 1415 CHRU de Tours
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2015
First Posted
April 3, 2015
Study Start
January 19, 2016
Primary Completion
December 16, 2021
Study Completion
January 18, 2022
Last Updated
June 17, 2024
Record last verified: 2016-06