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

University Hospital of Bordeaux

Status and phase: Completed; Phase 3

Conditions: Scabies

Treatments: Drug: Ivermectin; Drug: Permethrin

Study type: Interventional

Funder types: Other

Identifiers

NCT02407782

CHUBX 2011/16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,092 patients

Sex: All

Ages: Under 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

1,092 participants in 2 patient groups

Ivermectin

Experimental group

Treatment:

Drug: Ivermectin

Permethrin

Experimental group

Treatment:

Drug: Permethrin