A Phase 3 interventional study of Ivermectin and Permethrin in Scabies, sponsored by University Hospital, Bordeaux. Completed at 29 sites in 2 countries. Per ClinicalTrials.gov, last updated 2024-06-17.
Sponsored by University Hospital, Bordeaux · Phase 3, Interventional, and Treatment
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.
51 studies on the registry are indexed under Scabies; 10 are open to participants now.
This study's enrollment of 1,092 is above the median of 183 across 41 interventional studies indexed under Scabies.
Browse Scabies studies →University Hospital, Bordeaux is the lead sponsor of 806 studies on the registry; 197 are open to participants now.
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Exclusion Criteria:
Drug: Ivermectin
Drug: Permethrin
oral ivermectin, 200μg/kg given at baseline and at day 10.
topical permethrin 5% cream applied at baseline and at day 10.
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
Time frame: Day 28
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.
Time frame: day 56
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
Time frame: Day 28 and Day 56
Number of unaffected members in clusters treated by permethrin versus ivermectin at D0, D28 and D56.
Time frame: day 0, day 28 and d56
Evaluation of delta wing jet sign(s) and mite egs
Time frame: Day 56
Incidence of serious adverse events
Safety in both groups
Time frame: Day 56
adherence of patients
Preference and adherence of patients in both groups
Time frame: Day 56
Ran from Jan 2016 to primary completion in Dec 2021, 70 months.
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This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Ivermectin · Permethrin
University Hospital, Bordeaux →