Scabies Clinical Trial
Official title:
Oral Ivermectin Versus Topical Permethrin to Treat Scabies in Children: a Cluster Multicenter Randomized Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02572986 -
A Study to Evaluate the Therapeutic Equivalence of Generic Permethrin Cream 5% to Elimite® in the Treatment of Scabies
|
Phase 3 | |
| Completed |
NCT00884728 -
Evaluation of a Regional Healthy Skin Program in Remote Aboriginal Communities of Australia's Northern Territory
|
N/A | |
| Completed |
NCT05025696 -
Efficacy and Side Effects of Blacksoap® as Adjuvant Therapy of Scabies
|
N/A | |
| Completed |
NCT04205669 -
Comparing the Effectiveness of Individual vs. Household Treatment for Scabies in Lambaréné, Gabon
|
Phase 4 | |
| Completed |
NCT02254564 -
PCR (Polymerase Chain Reaction) Assay for Diagnosis of Sarcoptes Scabiei
|
||
| Completed |
NCT03676140 -
Safety of Co-administration of IDA and Azithromycin for NTDs ( ComboNTDs )
|
Phase 3 | |
| Recruiting |
NCT05875441 -
Efficacy and Safety Study of Moxidectin in Adults With Scabies
|
Phase 2 | |
| Completed |
NCT02978508 -
Bio-equivalence Study Comparing Permethrin Cream, 5% With Elimite in Patients With Active Scabies.
|
Phase 3 | |
| Recruiting |
NCT04332068 -
Ivermectin Safety in Small Children
|
Phase 2 | |
| Recruiting |
NCT04844905 -
Adjunctive Ivermectin Mass Drug Administration for Malaria Control
|
Phase 3 | |
| Not yet recruiting |
NCT06380452 -
Therapy for Scabies With Two Differently Concentrated Permethrin Creams
|
Phase 3 | |
| Completed |
NCT00604084 -
Veron Scabies Education and Eradication Program
|
N/A | |
| Completed |
NCT02485717 -
Phase 3 Trial to Assess the Safety and Efficacy of Natroba for the Treatment of Scabies
|
Phase 3 | |
| Completed |
NCT02485704 -
Phase 3 Trial to Assess the Safety and Efficacy of Natroba for the Treatment of Scabies
|
Phase 3 | |
| Recruiting |
NCT05310734 -
PK and Safety Study of Natroba Topical Suspension 0.9% in Subjects 1 Month to 3 Years 11 Months of Age With Scabies
|
Phase 4 | |
| Recruiting |
NCT04931680 -
Risk Factors for Treatment Failure of Scabies in Autochthonous Populations of French Guiana (GUYAGALE)
|
||
| Completed |
NCT05862701 -
Comparison of Topical 5% Permethrin and Topical 10% Sulfur in the Treatment of Scabies
|
Phase 1 | |
| Active, not recruiting |
NCT05500326 -
Ivermectin Therapy for Scabies Infection in Children Younger Than 5 Years of Age (ITCHY Study)
|
Phase 2 | |
| Recruiting |
NCT04814511 -
Escalated Therapy of Scabies With INFECTOSCAB 5% (Permethrin)
|
Phase 3 | |
| Completed |
NCT05362513 -
Comparative Study Between Topical Permethrin 5% and Oral Ivermectin for the Treatment of Scabies
|
Phase 1 |