Oral Ivermectin Versus Topical Permethrin to Treat Scabies in Children

Scabies Clinical Trial

— SCRATCH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02407782
• Other study ID #: CHUBX 2011/16
• Status: Recruiting
• Phase: Phase 3
• First received: March 24, 2015
• Last updated: June 3, 2016
• Start date: January 2016
• Est. completion date: September 2017

Study information

• Verified date: June 2016
• Source: University Hospital, Bordeaux
• Contact: Franck BORALEVI, Professor
• Phone: 05 56 79 59 41
• Email: franck.boralevi[@]chu-bordeaux.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 502
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 16 Years

Eligibility

Inclusion Criteria:

• Age less than 16 years

• 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Scabies

Intervention

Drug:
• Ivermectin
oral ivermectin, 200µg/kg given at baseline and at day 10.
• Permethrin
topical permethrin 5% cream applied at baseline and at day 10.

Locations

Country	Name	City	State
France	CHU d'Angers	Angers	Pays de La Loire
France	CH d'Argenteuil	Argenteuil	Ile de France
France	CHU de Bordeaux Hôpital Pellegrin	Bordeaux	Aquitaine
France	CHU de Lyon	Bron	Rhône-Alpes
France	CHG de Chalon sur Saône	Chalon sur Saône	Bourgogne
France	CHU de Créteil - Hôpital Henry Mondor	Créteil	Ile de France
France	CHU de Dijon	Dijon	Bourgogne
France	CHI de Fréjus	Fréjus	Provence-Alpes-Côte d'Azur
France	CH du Mans	Le Mans	Pays de la Loire
France	CHU de Montpellier	Montpellier	Languedoc-Roussillon
France	CHU de Nantes	Nantes	Pays de la Loire
France	CHU de Nice	Nice	Provence-Alpes-Côte-d'Azur
France	AP-HP - Hôpital Robert Debré	Paris	Ile de France
France	CHU de Rennes	Rennes	Bretagne
France	CHU de la Réunion	Saint-Pierre	Martinique
France	CHRU de Tours	Tours	Centre-Val de Loire

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of skin lesions and healing at 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	No
Secondary	Assessment of skin lesions and healing at 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	No
Secondary	Assessment of skin lesions and healing at day 28 and 56 in children	Healing of skin lesions and disappearance of pruritus at day 28 and day 56 of the treatment in children	Day 28 and Day 56	No
Secondary	Number of unaffected members in clusters treated by permethrin versus ivermectin at D0, D28 and D56.		day 0, day 28 and d56	No
Secondary	Evaluation of delta wing jet sign(s) and mite egs		Day 56	No
Secondary	Incidence of serious adverse events	Safety in both groups	Day 56	Yes
Secondary	adherence of patients	Preference and adherence of patients in both groups	Day 56	No