Oral ivermectin versus 5% permethrin cream to treat children and adults with classic scabies: multicentre, assessor blinded, cluster randomised clinical trial.
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Boralevi Franck, Simon Guillaume, Bernigaud Charlotte, Brun Jennifer, Goujon Elisa, Perrot Jean-Luc, Phan Alice, Hérissé Anne-Laure, Maruani Annabel, Vanhaecke Clélia, Couty Emmanuelle, Abasq-Thomas Claire, Fournet Marine, Mallet Stéphanie, Brenaut Emilie, Hubiche Thomas, Balguerie Xavier, Caux Frédéric, Beneton Nathalie, Dutkiewicz Anne-Sophie, Adamski Henri, Aubert Hélène, Bourrat Emmanuelle, Couzan Caroline, Eyraud Alexia, Janela-Lapert Raphaël, Marti Aurélie, Miquel Juliette, Richard Muriel, Barbarot Sébastien, Bonniaud Bertille, Chabbert Cécile, Delion Frédérique, Dinulescu Monica, Duong Tu-Anh, Etienne Maxime, Hirsch Gaëlle, Isnard Camille, Huet Flavien, Le Bidre Emmanuelle, Leducq Sophie, Legrand Adeline, Monestier Sandrine, Morice-Picard Fanny, Seneschal Julien, Capelli Aurore, Lacoste Caroline, Labrèze Christine, Miraglia Giulio, Do-Pham Giao, Giraudeau Bruno, Chosidow Olivier
Аннотация
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.