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Severe forms of scabies (crusted scabies and profuse scabies) require a specific treatment. Ivermectin is a recommended treatment in common forms of scabies and represents a promising treatment in crusted scabies in case reports. However, response to ivermectin remains variable among studies, and there is no consensus on the schemes to adopt (dosages and administrations). Ivermectin at 400 µg/kg has already been used, without showing toxicity (in head lice treatment in particular). Investigators propose to demonstrate that 400µg/kg ivermectin dosage will show better efficacy than a 200µg/kg in patients with severe forms of scabies (crusted and profuse).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral ivermectin 400 µg/kg | Experimental | Oral ivermectin 400 µg/kg + topical treatment (permethrin 5% cream) + emollient cream (Dexeryl® or other) |
|
| Oral ivermectin 200 µg/kg | Active Comparator | Oral ivermectin 200 µg/kg + topical treatment (permethrin 5% cream) + emollient cream (Dexeryl® or other) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivermectin 200 µg/kg | Drug | Oral ivermectin 200 µg/kg three times (D0, D7 and D14) + topical treatment (permethrin 5% cream) on skin, hair and genital organs (D0 and D7) + emollient cream (Dexeryl® or other) daily on skin (D0 to D28) |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of a successful treatment defined by : -Two negative parasitologic and/or two dermoscopic exams | Parasitologic and/or dermoscopic exams will be perform at days 18 +/-2days and at days 21+/-2 days | Days 21+/-2 days |
| Rate of a successful treatment defined by : - A clinical response : disappearance of clinical active lesions | Days 28+/- 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of adverse effects | Days 18 +/-2 days, Days 21+/-2 days and Days 28+/-2 days |
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Inclusion Criteria:
Patients ≥ 18 years old, diagnosed with severe forms of scabies
clinical criteria : cutaneous lesions of scabies
paraclinical criteria:
Effective contraception for women in age of pregnancy Written consent from patient or his/her legal representant, trustworthy person or family member Affiliated to a social security scheme
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giao DO-PHAM, MD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henri Mondor Hospital | Créteil | 94010 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42090793 | Derived | Bernigaud C, Do-Pham G, Guichard E, Beylot-Barry M, Goujon E, Isnard C, Beneton N, Samimi M, Tedbirt B, Adamski H, Azib S, Mahe E, Michel C, Perrot JL, Acquitter M, Bursztejn AC, Chaby G, Caux F, Passeron T, Vanhaecke C, Mahe A, Leccia MT, Barbarot S, Lenormand C, Aubin F, Foulet F, Gregoire L, Giraudeau B, Chosidow O. Combined Oral Ivermectin and 5% Permethrin Cream to Treat Severe Scabies. N Engl J Med. 2026 May 7;394(18):1814-1823. doi: 10.1056/NEJMoa2411721. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D005693 | Galactosemias |
| ID | Term |
|---|---|
| D020739 | Brain Diseases, Metabolic, Inborn |
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D007559 | Ivermectin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Ivermectin 400 µg/kg | Drug | Oral ivermectin 400 µg/kg three times (D0, D7 and D14) + topical treatment (permethrin 5% cream) on skin, hair and genital organs (D0 and D7) + emollient cream (Dexeryl® or other)daily on skin (D0 to D28) |
|
| Related Info | View source |
| D009422 | Nervous System Diseases |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D002239 | Carbohydrate Metabolism, Inborn Errors |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |