Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ivermectin | Experimental |
| |
| Permethrin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivermectin | Drug | oral ivermectin, 200μg/kg given at baseline and at day 10. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of skin lesions and healing at 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. | day 56 |
| Assessment of skin lesions and healing at day 28 and 56 in children |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bruneau Giraudeau, Doctor | Centre d'investigation clinique Inserm 1415 CHRU de Tours | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux Hôpital Pellegrin | Bordeaux | Aquitaine | 33000 | France | ||
| CHU de Lyon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41494769 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Permethrin |
| Drug |
topical permethrin 5% cream applied at baseline and at day 10. |
|
Healing of skin lesions and disappearance of pruritus at day 28 and day 56 of the treatment 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 | Safety in both groups | Day 56 |
| adherence of patients | Preference and adherence of patients in both groups | Day 56 |
| 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 |
| ID | Term |
|---|---|
| D012532 | Scabies |
| ID | Term |
|---|---|
| D008924 | Mite Infestations |
| D004478 | Ectoparasitic Infestations |
| D012876 | Skin Diseases, Parasitic |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007559 | Ivermectin |
| D026023 | Permethrin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011722 | Pyrethrins |
| D000081004 | Cyclopentane Monoterpenes |
| D039821 | Monoterpenes |
| D013729 | Terpenes |
Not provided
Not provided