Efficacy Study Between Two Different Dosages of an Antiparasitic in Patients With Crusted Scabies

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Gale, Severe Forms of Scabies, Oral Parasitic Drug, Ivermectin

Intervention / Treatment
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* Drug: Ivermectin 200 µg/kg
* Drug: Ivermectin 400 µg/kg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥ 18 years old, diagnosed with severe forms of scabies 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral ivermectin 400 µg/kg<br>Oral ivermectin 400 µg/kg + topical treatment (permethrin 5% cream) + emollient cream (Dexeryl® or other) | Drug: Ivermectin 400 µg/kg<br>* 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)<br>|
| Active Comparator: Oral ivermectin 200 µg/kg<br>Oral ivermectin 200 µg/kg + topical treatment (permethrin 5% cream) + emollient cream (Dexeryl® or other) | Drug: Ivermectin 200 µg/kg<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adverse effects |  | Days 18 +/-2 days, Days 21+/-2 days and Days 28+/-2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gale, Severe forms of scabies, Oral parasitic drug, Ivermectin