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

Phase 3

Completed

• Conditions: Scabies
• Interventions: Drug: Ivermectin; Drug: Permethrin

• Registration Number: NCT02407782
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

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

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 Timeline

• Study First Submitted: 2015-03-24
• Study First Submitted QC: 2015-03-30
• Study First Posted: 2015-04-03
• Study Start: 2016-01-19
• Status Verified: 2016-06
• Primary Completion: 2021-12-16
• Study Completion: 2022-01-18
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1092

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ivermectin	Ivermectin	-
Permethrin	Permethrin	-

Primary Outcome Measures

Name	Time	Method
Assessment of skin lesions and healing at day 28	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 Outcome Measures

Name	Time	Method
Number of unaffected members in clusters treated by permethrin versus ivermectin at D0, D28 and D56.	day 0, day 28 and d56
Assessment of skin lesions and healing at day 56	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.
Evaluation of delta wing jet sign(s) and mite egs	Day 56
Assessment of skin lesions and healing at day 28 and 56 in children	Day 28 and Day 56	Healing of skin lesions and disappearance of pruritus at day 28 and day 56 of the treatment in children
adherence of patients	Day 56	Preference and adherence of patients in both groups
Incidence of serious adverse events	Day 56	Safety in both groups

Trial Locations

Locations (29)

CHU de Dijon; 🇫🇷 Dijon, Bourgogne, France

CHG de Chalon sur Saône; 🇫🇷 Chalon sur Saône, Bourgogne, France

CHU de Rennes; 🇫🇷 Rennes, Bretagne, France

CHU de Bordeaux Hôpital Pellegrin; 🇫🇷 Bordeaux, Aquitaine, France

AP-HP - Hôpital Robert Debré; 🇫🇷 Paris, Ile De France, France

CHU d'Angers; 🇫🇷 Angers, PAYS DE LA Loire, France

AP-HM; 🇫🇷 Marseille, France

CHI de Fréjus; 🇫🇷 Fréjus, Provence-Alpes-Côte d'Azur, France

CHU de Brest; 🇫🇷 Brest, France

APHP Hôpital Cochin; 🇫🇷 Paris, France

CH d'Argenteuil; 🇫🇷 Argenteuil, ILE DE France, France

CH du Mans; 🇫🇷 Le Mans, Pays De La Loire, France

CHU de Nantes; 🇫🇷 Nantes, Pays De La Loire, France

CHU de Nice; 🇫🇷 Nice, Provence-Alpes-Côte-d'Azur, France

APHP- Bobigny - Avicenne; 🇫🇷 Bobigny, France

CHU de Bordeaux - Saint André; 🇫🇷 Bordeaux, France

CHD Vendée; 🇫🇷 La Roche-sur-Yon, France

CHRU de Lille; 🇫🇷 Lille, France

CH Le Havre; 🇫🇷 Le Havre, France

CH de Périgueux; 🇫🇷 Périgueux, France

CHU de Rouen; 🇫🇷 Rouen, France

CHU de Créteil - Hôpital Henry Mondor; 🇫🇷 Créteil, ILE DE France, France

CHU de Montpellier; 🇫🇷 Montpellier, Languedoc-Roussillon, France

CHU de Lyon; 🇫🇷 Bron, Rhône-Alpes, France

CHU de Saint-Etienne; 🇫🇷 Saint-Etienne, France

CHU de Reims; 🇫🇷 Reims, France

CHU de la Réunion; 🇫🇷 Saint-Pierre, Martinique, France

CHRU de Tours; 🇫🇷 Tours, Centre-Val De Loire, France

CHU de Pointe à Pitre; 🇬🇵 Pointe à Pitre, Guadeloupe