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

June 14, 2024 updated by: University Hospital, Bordeaux

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1092

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Bobigny, France
        • APHP- Bobigny - Avicenne
      • Bordeaux, France
        • CHU de Bordeaux - Saint André
      • Brest, France
        • CHU de Brest
      • La Roche-sur-Yon, France
        • CHD Vendée
      • Le Havre, France
        • CH Le Havre
      • Lille, France
        • CHRU de Lille
      • Marseille, France
        • AP-HM
      • Paris, France
        • APHP Hôpital Cochin
      • Périgueux, France
        • CH de Périgueux
      • Reims, France
        • CHU de Reims
      • Rouen, France
        • CHU de Rouen
      • Saint-Etienne, France
        • CHU de Saint-Etienne
    • Aquitaine
      • Bordeaux, Aquitaine, France, 33000
        • CHU de Bordeaux Hôpital Pellegrin
    • Bourgogne
      • Chalon sur Saône, Bourgogne, France, 71321
        • CHG de Chalon sur Saône
      • Dijon, Bourgogne, France, 21079
        • CHU de Dijon
    • Bretagne
      • Rennes, Bretagne, France, 35000
        • CHU de Rennes
    • Centre-Val De Loire
      • Tours, Centre-Val De Loire, France, 37044
        • CHRU DE TOURS
    • ILE DE France
      • Argenteuil, ILE DE France, France, 95107
        • CH D'argenteuil
      • Créteil, ILE DE France, France, 94010
        • CHU de Créteil - Hôpital Henry Mondor
    • Ile De France
      • Paris, Ile De France, France, 75935
        • AP-HP - Hopital Robert Debré
    • Languedoc-Roussillon
      • Montpellier, Languedoc-Roussillon, France, 34295
        • CHU de Montpellier
    • Martinique
      • Saint-Pierre, Martinique, France, 97448
        • CHU de la Réunion
    • PAYS DE LA Loire
      • Angers, PAYS DE LA Loire, France, 49933
        • CHU d'Angers
    • Pays De La Loire
      • Le Mans, Pays De La Loire, France, 72037
        • CH du Mans
      • Nantes, Pays De La Loire, France, 44093
        • CHU de Nantes
    • Provence-Alpes-Côte d'Azur
      • Fréjus, Provence-Alpes-Côte d'Azur, France, 83600
        • CHI de Fréjus
    • Provence-Alpes-Côte-d'Azur
      • Nice, Provence-Alpes-Côte-d'Azur, France, 06202
        • CHU de Nice
    • Rhône-Alpes
      • Bron, Rhône-Alpes, France, 69677
        • CHU de Lyon
  • Guadeloupe
      • Pointe à Pitre, Guadeloupe
        • CHU de Pointe à Pitre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 16 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ivermectin
Drug: Ivermectin
oral ivermectin, 200μg/kg given at baseline and at day 10.
Experimental: Permethrin
Drug: Permethrin
topical permethrin 5% cream applied at baseline and at day 10.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Day 28

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
day 56
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
Day 28 and Day 56
Number of unaffected members in clusters treated by permethrin versus ivermectin at D0, D28 and D56.
Time Frame: day 0, day 28 and d56
day 0, day 28 and d56
Evaluation of delta wing jet sign(s) and mite egs
Time Frame: Day 56
Day 56
Incidence of serious adverse events
Time Frame: Day 56
Safety in both groups
Day 56
adherence of patients
Time Frame: Day 56
Preference and adherence of patients in both groups
Day 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Bordeaux

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Bruneau Giraudeau, Doctor, Centre d'investigation clinique Inserm 1415 CHRU de Tours

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 19, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 16, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 18, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHUBX 2011/16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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