Oral Ivermectin Versus Topical Permethrin to Treat Scabies in Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Oral Ivermectin Versus Topical Permethrin to Treat Scabies in Children: a Cluster Multicenter Randomized Trial

Conditions
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Scabies

Intervention / Treatment
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* Drug: Ivermectin
* Drug: Permethrin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age less than 16 years Weight more than 15 kg Documented diagnosis of scabies, defined by positive dermoscopic examination. Exclusion Criteria: Previous scabies therapy during the past 4 weeks Known allergy to ivermectin or permethrin Widespread eczematization or impetiginization Liver or renal failure

Ages Eligible for Study
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Maximum Age: 16 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ivermectin<br> | Drug: Ivermectin<br>* oral ivermectin, 200μg/kg given at baseline and at day 10.<br>|
| Experimental: Permethrin<br> | Drug: Permethrin<br>* topical permethrin 5% cream applied at baseline and at day 10.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Scabies, children, cluster, permethrin, Ivermectin