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Completed

NCT Number: NCT02407782

Oral Ivermectin Versus Topical Permethrin to Treat Scabies in Children and Adults

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU de Bordeaux Hôpital Pellegrin, Bordeaux, Aquitaine, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • children or adult
  • For children, 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

Treatment and study plan

Ivermectin

Drug

oral ivermectin, 200μg/kg given at baseline and at day 10.

Permethrin

Drug

topical permethrin 5% cream applied at baseline and at day 10.

Primary outcomes

  1. Assessment of skin lesions and healing at day 28

    Time frame: 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

Secondary outcomes

  1. Assessment of skin lesions and healing at day 56

    Time frame: 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.

  2. Assessment of skin lesions and healing at day 28 and 56 in children

    Time frame: Day 28 and Day 56

    Healing of skin lesions and disappearance of pruritus at day 28 and day 56 of the treatment in children

  3. Number of unaffected members in clusters treated by permethrin versus ivermectin at D0, D28 and D56.

    Time frame: day 0, day 28 and d56

  4. Evaluation of delta wing jet sign(s) and mite egs

    Time frame: Day 56

  5. Incidence of serious adverse events

    Time frame: Day 56

    Safety in both groups

  6. adherence of patients

    Time frame: Day 56

    Preference and adherence of patients in both groups

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: SCRATCH

Important dates

Study start
2016
Primary completion
2021
Study completion
2022
First posted
Apr 3, 2015
Registry last updated
Jun 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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