Clinical trial NCT02407782: Oral Ivermectin Versus Topical Permethrin to Treat Scabies in Children and Adults
Official title: Oral Ivermectin Versus Topical Permethrin to Treat Scabies in Children and Adults: a Cluster Multicenter Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Scabies
Keywords: Scabies
children
cluster
permethrin
Ivermectin
adults
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2015-04-03
Enrollment: 1092
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of skin lesions and healing at day 28
timeFrame: Day 28
Secondary outcomes:
measure: Assessment of skin lesions and healing at day 56
timeFrame: day 56
measure: Assessment of skin lesions and healing at day 28 and 56 in children
timeFrame: Day 28 and Day 56
measure: Number of unaffected members in clusters treated by permethrin versus ivermectin at D0, D28 and D56.
timeFrame: day 0, day 28 and d56
measure: Evaluation of delta wing jet sign(s) and mite egs
timeFrame: Day 56
measure: Incidence of serious adverse events
timeFrame: Day 56
measure: adherence of patients
timeFrame: Day 56
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux Hôpital Pellegrin
state: Aquitaine
city: Chalon sur Saône
country: France
facility: CHG de Chalon sur Saône
state: Bourgogne
city: Dijon
country: France
facility: CHU de Dijon
state: Bourgogne
city: Rennes
country: France
facility: CHU de Rennes
state: Bretagne
city: Tours
country: France
facility: CHRU de Tours
state: Centre-Val De Loire
city: Argenteuil
country: France
facility: CH d'Argenteuil
state: ILE DE France
city: Créteil
country: France
facility: CHU de Créteil - Hôpital Henry Mondor
state: ILE DE France
city: Paris
country: France
facility: AP-HP - Hôpital Robert Debré
state: Ile De France
city: Montpellier
country: France
facility: CHU de Montpellier
state: Languedoc-Roussillon
city: Saint-Pierre
country: France
facility: CHU de la Réunion
state: Martinique
city: Angers
country: France
facility: CHU d'Angers
state: PAYS DE LA Loire
city: Le Mans
country: France
facility: CH du Mans
state: Pays De La Loire
city: Nantes
country: France
facility: CHU de Nantes
state: Pays De La Loire
city: Fréjus
country: France
facility: CHI de Fréjus
state: Provence-Alpes-Côte d'Azur
city: Nice
country: France
facility: CHU de Nice
state: Provence-Alpes-Côte-d'Azur
city: Bron
country: France
facility: CHU de Lyon
state: Rhône-Alpes
city: Bobigny
country: France
facility: APHP- Bobigny - Avicenne
city: Bordeaux
country: France
facility: CHU de Bordeaux - Saint André
city: Brest
country: France
facility: CHU de Brest
city: La Roche-sur-Yon
country: France
facility: CHD Vendée
city: Le Havre
country: France
facility: CH Le Havre
city: Lille
country: France
facility: CHRU de Lille
city: Marseille
country: France
facility: AP-HM
city: Paris
country: France
facility: APHP Hôpital Cochin
city: Périgueux
country: France
facility: CH de Périgueux
city: Reims
country: France
facility: CHU de Reims
city: Rouen
country: France
facility: CHU de Rouen
city: Saint-Etienne
country: France
facility: CHU de Saint-Etienne
city: Pointe à Pitre
country: Guadeloupe
facility: CHU de Pointe à Pitre
Study officials:
affiliation: Centre d'investigation clinique Inserm 1415 CHRU de Tours
name: Bruneau Giraudeau, Doctor
role: STUDY_CHAIR
References: