{
  "abstract": "Abstract Objective To investigate whether oral ivermectin or topical 5% permethrin can clinically cure scabies in index cases and in members of their households.Design Multicentre, assessor blinded, cluster randomised clinical trial.Setting 28 French hospitals, 19 January 2016 to 16 December 2021.Participants Index cases; adults and children weighing >15 kg with scabies, confirmed by dermoscopy.Interventions Index cases were randomly assigned to the ivermectin group or permethrin group (1:1 ratio). Each member of the cluster, defined as the household of each index case, received the same treatment as the index case, except for children weighing <15 kg who were prescribed topical 5% permethrin. All participants received oral ivermectin 200 µg/kg or 5% permethrin cream on day 0 and day 10. Permethrin cream was applied to the whole body, from head to toe.Main outcome measures The primary outcome was clinical cure of the cluster on day 28 (ie, disappearance of clinical signs and symptoms of scabies for all cluster members). Secondary outcomes were index case and individual level analyses and safety. Dermatologists were used as assessors and were masked to the treatment.Results 507 participants in 142 households (clusters) were treated with ivermectin and 568 participants in 147 households received permethrin. Cluster level cure rates were 71.8% versus 88.5% (–16.7 percentage point difference, 95% confidence interval (CI) –26.3 to –7.1) for ivermectin versus permethrin. Secondary outcome percentage point differences also showed the inferiority of ivermectin compared with 5% permethrin for index cases (76.6% v 91.5%; percentage point difference –14.9, 95% CI –23.6 to –6.2) and participants (85.3% v 94.2%; –9.2 percentage point difference, –14.9 to –3.5). Intraclass correlation coefficients were higher for permethrin than ivermectin for all clusters (0.68, 95% CI 0.61 to 0.75 v 0.46, 0.37 to 0.56) and for cluster size >1 (0.67, 0.60 to 0.74 v 0.47, 0.37 to 0.56). Cutaneous adverse events were found in 11.9% and 15.6% of participants treated with ivermectin and permethrin, respectively.Conclusions The results of this cluster randomised trial of classic scabies, confirmed by dermoscopy, did not show the non-inferiority of oral ivermectin compared with 5% permethrin cream, given on days 0 and 10, in achieving clinical cure of scabies on day 28 in index cases and their household members. Conversely, the trial showed the statistical superiority of 5% permethrin cream.Trial registration NCT02407782.",
  "authors": [
    {
      "affiliations": [
        "Department of Paediatric Dermatology, Hôpital des Enfants, Groupe Hospitalier Pellegrin, Bordeaux, France",
        "Groupe de Recherche de la Société Française de Dermatologie Pédiatrique, Paris, France"
      ],
      "name": "Franck Boralevi"
    },
    {
      "affiliations": [
        "Department of Paediatric Dermatology, Hôpital des Enfants, Groupe Hospitalier Pellegrin, Bordeaux, France"
      ],
      "name": "Guillaume Simon"
    },
    {
      "affiliations": [
        "Department of Dermatology, Hôpital Henri-Mondor, AP-HP, Créteil, France",
        "Groupe Infectiologie Dermatologique et Infections Sexuellement Transmissibles (GrIDIST) of the French Society of Dermatology, Paris, France"
      ],
      "name": "Charlotte Bernigaud"
    },
    {
      "affiliations": [
        "Department of Paediatrics, Fondation Lenval, Hôpital pour Enfants and Department of Dermatology, CHU de Nice, Nice, France"
      ],
      "name": "Jennifer Brun"
    },
    {
      "affiliations": [
        "Department of Dermatology, Centre Hospitalier William-Morey, Chalon-sur-Saône, France",
        "Groupe de Recherche de la Société Française de Dermatologie Pédiatrique, Paris, France"
      ],
      "name": "Elisa Goujon"
    },
    {
      "affiliations": [
        "Department of Dermato-Allergo-Oncology, CHU Nord Saint-Étienne, Saint-Priest-en-Jarez, France"
      ],
      "name": "Jean-Luc Perrot"
    },
    {
      "affiliations": [
        "Department of Paediatrics, Hospices Civils de Lyon-HCL, Lyon, France",
        "Groupe de Recherche de la Société Française de Dermatologie Pédiatrique, Paris, France"
      ],
      "name": "Alice Phan"
    },
    {
      "affiliations": [
        "Department of Paediatrics, Fondation Lenval, Hôpital pour Enfants and Department of Dermatology, CHU de Nice, Nice, France"
      ],
      "name": "Anne-Laure Hérissé"
    },
    {
      "affiliations": [
        "Department of Dermatology and Department of Paediatric Dermatology, CHRU Hôpitaux de Tours, Tours, France",
        "INSERM CIC 1415, CHRU de Tours, Tours, France",
        "Université de Tours, Université de Nantes, INSERM, SPHERE U1246, Tours, France",
        "Groupe de Recherche de la Société Française de Dermatologie Pédiatrique, Paris, France",
        "Centre of Evidence of the French Society of Dermatology, Paris, France"
      ],
      "name": "Annabel Maruani"
    },
    {
      "affiliations": [
        "Department of Dermatology, Hôpital Robert-Debré, CHU de Reims, Reims, France",
        "Groupe Infectiologie Dermatologique et Infections Sexuellement Transmissibles (GrIDIST) of the French Society of Dermatology, Paris, France"
      ],
      "name": "Clélia Vanhaecke"
    },
    {
      "affiliations": [
        "Department of Dermato-Allergo-Oncology, CHU Nord Saint-Étienne, Saint-Priest-en-Jarez, France"
      ],
      "name": "Emmanuelle Couty"
    },
    {
      "affiliations": [
        "Department of Dermatology, CHU Morvan, Brest, France",
        "Groupe de Recherche de la Société Française de Dermatologie Pédiatrique, Paris, France"
      ],
      "name": "Claire Abasq-Thomas"
    },
    {
      "affiliations": [
        "Department of Paediatric Dermatology, Hôpital des Enfants, Groupe Hospitalier Pellegrin, Bordeaux, France"
      ],
      "name": "Marine Fournet"
    },
    {
      "affiliations": [
        "Department of Dermatology and Cutaneous Oncology, Hôpitaux Universitaires de Marseille Timone, AP-HM, Marseille, France",
        "Groupe de Recherche de la Société Française de Dermatologie Pédiatrique, Paris, France"
      ],
      "name": "Stéphanie Mallet"
    },
    {
      "affiliations": [
        "Department of Dermatology, CHU Morvan, Brest, France"
      ],
      "name": "Emilie Brenaut"
    },
    {
      "affiliations": [
        "Department of Dermatology and Infectious Diseases, CHI Fréjus/Saint-Raphaël, Fréjus, France",
        "Groupe de Recherche de la Société Française de Dermatologie Pédiatrique, Paris, France",
        "Groupe Infectiologie Dermatologique et Infections Sexuellement Transmissibles (GrIDIST) of the French Society of Dermatology, Paris, France"
      ],
      "name": "Thomas Hubiche"
    },
    {
      "affiliations": [
        "Department of Dermatology, Hôpital Charles-Nicolle, CHU de Rouen, Rouen, France",
        "Groupe de Recherche de la Société Française de Dermatologie Pédiatrique, Paris, France"
      ],
      "name": "Xavier Balguerie"
    },
    {
      "affiliations": [
        "Department of Dermatology, Hôpital Avicenne, AP-HP, Bobigny, France"
      ],
      "name": "Frédéric Caux"
    },
    {
      "affiliations": [
        "Department of Dermatology, CHR Le Mans, Le Mans, France"
      ],
      "name": "Nathalie Beneton"
    },
    {
      "affiliations": [
        "Department of Paediatric Dermatology, Hôpital des Enfants, Groupe Hospitalier Pellegrin, Bordeaux, France"
      ],
      "name": "Anne-Sophie Dutkiewicz"
    },
    {
      "affiliations": [
        "Department of Dermatology, Hôpital Pontchaillou, CHU de Rennes, Rennes, France",
        "Groupe de Recherche de la Société Française de Dermatologie Pédiatrique, Paris, France"
      ],
      "name": "Henri Adamski"
    },
    {
      "affiliations": [
        "Department of Dermatology, Hôtel-Dieu, CHU de Nantes, Nantes, France"
      ],
      "name": "Hélène Aubert"
    },
    {
      "affiliations": [
        "Department of Dermatology, Hôpital Saint-Louis and Department of Paediatrics, Hôpital Robert-Debré, AP-HP, Paris, France",
        "Groupe de Recherche de la Société Française de Dermatologie Pédiatrique, Paris, France"
      ],
      "name": "Emmanuelle Bourrat"
    },
    {
      "affiliations": [
        "Department of Dermato-Allergo-Oncology, CHU Nord Saint-Étienne, Saint-Priest-en-Jarez, France"
      ],
      "name": "Caroline Couzan"
    },
    {
      "affiliations": [
        "Department of Dermatology, Centre Hospitalier de Périgueux, Périgueux, France"
      ],
      "name": "Alexia Eyraud"
    },
    {
      "affiliations": [
        "Department of Dermatology, Hôpital Charles-Nicolle, CHU de Rouen, Rouen, France"
      ],
      "name": "Raphaël Janela-Lapert"
    },
    {
      "affiliations": [
        "Department of Dermatology, Centre Hospitalier de Périgueux, Périgueux, France"
      ],
      "name": "Aurélie Marti"
    },
    {
      "affiliations": [
        "Unit of Paediatric Dermatology, CHU de La Réunion, Saint-Pierre, Réunion, France",
        "Groupe de Recherche de la Société Française de Dermatologie Pédiatrique, Paris, France"
      ],
      "name": "Juliette Miquel"
    },
    {
      "affiliations": [
        "Department of Paediatric Dermatology, Hôpital des Enfants, Groupe Hospitalier Pellegrin, Bordeaux, France"
      ],
      "name": "Muriel Richard"
    },
    {
      "affiliations": [
        "Department of Dermatology, Hôtel-Dieu, CHU de Nantes, Nantes, France",
        "Groupe de Recherche de la Société Française de Dermatologie Pédiatrique, Paris, France",
        "Centre of Evidence of the French Society of Dermatology, Paris, France"
      ],
      "name": "Sébastien Barbarot"
    },
    {
      "affiliations": [
        "Department of Dermatology, CHU de Dijon, Dijon, France",
        "Groupe de Recherche de la Société Française de Dermatologie Pédiatrique, Paris, France"
      ],
      "name": "Bertille Bonniaud"
    },
    {
      "affiliations": [
        "Department of Dermatology, Centre Hospitalier de Périgueux, Périgueux, France"
      ],
      "name": "Cécile Chabbert"
    },
    {
      "affiliations": [
        "Department of Paediatrics, CHU de la Guadeloupe, Les Abymes, Guadeloupe, France"
      ],
      "name": "Frédérique Delion"
    },
    {
      "affiliations": [
        "Department of Dermatology, Hôpital Pontchaillou, CHU de Rennes, Rennes, France"
      ],
      "name": "Monica Dinulescu"
    },
    {
      "affiliations": [
        "Department of Dermatology, Hôpital Henri-Mondor, AP-HP, Créteil, France"
      ],
      "name": "Tu-Anh Duong"
    },
    {
      "affiliations": [
        "Department of Dermatology, CHU Morvan, Brest, France"
      ],
      "name": "Maxime Etienne"
    },
    {
      "affiliations": [
        "Department of Dermatology, Hôpital Henri-Mondor, AP-HP, Créteil, France"
      ],
      "name": "Gaëlle Hirsch"
    },
    {
      "affiliations": [
        "Department of Dermatology, Hôpital Cochin-Port-Royal, AP-HP, Paris, France"
      ],
      "name": "Camille Isnard"
    },
    {
      "affiliations": [
        "Department of Dermatology, CHU Morvan, Brest, France"
      ],
      "name": "Flavien Huet"
    },
    {
      "affiliations": [
        "Department of Dermatology and Department of Paediatric Dermatology, CHRU Hôpitaux de Tours, Tours, France"
      ],
      "name": "Emmanuelle Le Bidre"
    },
    {
      "affiliations": [
        "Department of Dermatology and Department of Paediatric Dermatology, CHRU Hôpitaux de Tours, Tours, France",
        "INSERM CIC 1415, CHRU de Tours, Tours, France",
        "Université de Tours, Université de Nantes, INSERM, SPHERE U1246, Tours, France",
        "Groupe de Recherche de la Société Française de Dermatologie Pédiatrique, Paris, France",
        "Centre of Evidence of the French Society of Dermatology, Paris, France"
      ],
      "name": "Sophie Leducq"
    },
    {
      "affiliations": [
        "Department of Paediatric Dermatology, Hôpital des Enfants, Groupe Hospitalier Pellegrin, Bordeaux, France"
      ],
      "name": "Adeline Legrand"
    },
    {
      "affiliations": [
        "Department of Dermatology and Cutaneous Oncology, Hôpitaux Universitaires de Marseille Timone, AP-HM, Marseille, France"
      ],
      "name": "Sandrine Monestier"
    },
    {
      "affiliations": [
        "Department of Paediatric Dermatology, Hôpital des Enfants, Groupe Hospitalier Pellegrin, Bordeaux, France",
        "Department of Dermatology, Hôpital Saint-André, Bordeaux, France",
        "Groupe de Recherche de la Société Française de Dermatologie Pédiatrique, Paris, France"
      ],
      "name": "Fanny Morice-Picard"
    },
    {
      "affiliations": [
        "Department of Dermatology, Hôpital Saint-André, Bordeaux, France"
      ],
      "name": "Julien Seneschal"
    },
    {
      "affiliations": [
        "Department of Clinical Research and Innovation, CHU de Bordeaux, Bordeaux, France"
      ],
      "name": "Aurore Capelli"
    },
    {
      "affiliations": [
        "Department of Clinical Research and Innovation, CHU de Bordeaux, Bordeaux, France"
      ],
      "name": "Caroline Lacoste"
    },
    {
      "affiliations": [
        "Department of Paediatric Dermatology, Hôpital des Enfants, Groupe Hospitalier Pellegrin, Bordeaux, France",
        "Groupe de Recherche de la Société Française de Dermatologie Pédiatrique, Paris, France"
      ],
      "name": "Christine Labrèze"
    },
    {
      "affiliations": [
        "INSERM CIC 1415, CHRU de Tours, Tours, France",
        "Université de Tours, Université de Nantes, INSERM, SPHERE U1246, Tours, France"
      ],
      "name": "Giulio Miraglia"
    },
    {
      "affiliations": [
        "Department of Internal Medicine, Centre Hospitalier intercommunal de Créteil, Créteil, France"
      ],
      "name": "Giao Do-Pham"
    },
    {
      "affiliations": [
        "INSERM CIC 1415, CHRU de Tours, Tours, France",
        "Université de Tours, Université de Nantes, INSERM, SPHERE U1246, Tours, France"
      ],
      "name": "Bruno Giraudeau"
    },
    {
      "affiliations": [
        "Department of Dermatology, Hôpital Henri-Mondor, AP-HP, Créteil, France",
        "Groupe Infectiologie Dermatologique et Infections Sexuellement Transmissibles (GrIDIST) of the French Society of Dermatology, Paris, France",
        "Centre of Evidence of the French Society of Dermatology, Paris, France"
      ],
      "name": "Olivier Chosidow"
    }
  ],
  "title": "Oral ivermectin versus 5% permethrin cream to treat children and adults with classic scabies: multicentre, assessor blinded, cluster randomised clinical trial",
  "uid": "712acd12-276a-5919-a76a-4beb24062690"
}