A Randomized Controlled Double-blind Trial Assessing the Efficacy of a 400µg/kg Ivermectin /5% Permethrin / Emollient Cream Regimen in Patients With Crusted Scabies as Compared to a 200µg/kg Ivermectin /5% Permethrin /Emollient Cream Regimen
| Registry | NCT02841215, acronym GALECRUSTED |
|---|---|
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
| Enrollment | 133 (Actual) |
| Sponsor | Assistance Publique - Hôpitaux de Paris (Other) |
| Conditions | Gale, Severe Forms of Scabies, Oral Parasitic Drug, Ivermectin |
| Interventions | Ivermectin 200 µg/kg, Ivermectin 400 µg/kg (Drug) |
| Dates | start 2017-10-11, primary completion 2022-01-12, completion 2022-01-12, first posted 2016-07-22, last updated 2023-09-22 |
| Locations | 1 site in France |
Related Papers Related Patents Related Grants Related Experts
All trials for Gale All trials for Severe Forms of Scabies All trials of Ivermectin 200 µg/kg All trials of Ivermectin 400 µg/kg
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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Oral ivermectin 400 µg/kg | Experimental | Drug: Ivermectin 400 µg/kg | Oral ivermectin 400 µg/kg + topical treatment (permethrin 5% cream) + emollient cream (Dexeryl® or other) |
| Oral ivermectin 200 µg/kg | Active comparator | Drug: Ivermectin 200 µg/kg | Oral ivermectin 200 µg/kg + topical treatment (permethrin 5% cream) + emollient cream (Dexeryl® or other) |
Sex: All, ages: 18 Years to any
Inclusion Criteria: Patients ≥ 18 years old, diagnosed with severe forms of scabies 1. clinical criteria : cutaneous lesions of scabies * crusted scabies: at least two sites of hyperkeratosis will define crusted scabies and/or * profuse scabies : spreading lesions with erythematous scaly eruption of the neck, face or trunk without hyperkeratosis 2. paraclinical criteria: * Positive parasitological test * and/or dermoscopic exam with signs of scabies 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: * Pregnant and/or breastfeeding women * Intolerance to ivermectin or topical treatment (permethrin 5% cream) or emollient cream * Use of anti parasitic drug (ivermectin or albendazole) within the past 7 days * Abnormal liver test results: ALT and/or AST >3N within the past 7 days (within 6 months if no hepatic history) * Participation in other biomedical drug research * Patient deprived of freedom * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
| Facility | City | Country | Status |
|---|---|---|---|
| Henri Mondor Hospital | Créteil | France |