Comparing effectiveness of topical permethrin, oral ivermectin, and their combination for treating patients with confirmed scabies infection
- Participants:Adults
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Permethrin (CIS:trans 25:75) is a pyrethroid, a class of medicines that acts against a broad range of pests including lice, ticks, fleas, mites and other arthropods.[2] It is a topical scabicidal agent, meaning it is applied to the skin to kill the mite that causes scabies.[2] The substance is a mixture of cis and trans isomers of a pyrethroid compound, with the cis:trans ratio approximately 25:75.[2] Its molecular formula is C21H20Cl2O3 and its molecular weight is 391.29.[2] Permethrin is already authorised as a medicine in Italy, where it is supplied by GIULIANI SPA under the product name SCABIACID 5% crema.[1] It is classified under the ATC code P03AC04, which places it among ectoparasiticides, including scabicides.[1]
Permethrin acts on the nerve cell membrane of the mite. It disrupts the sodium channel current, which is the mechanism by which the polarisation of the nerve cell membrane is regulated.[2] This disruption leads to delayed repolarisation and paralysis of the pest.[2] After application to the skin, permethrin is rapidly metabolised by ester hydrolysis into inactive metabolites, which are excreted primarily in the urine.[2]
Permethrin is given as a cream for cutaneous use, meaning it is applied to the skin.[1] The authorised product in the trial is SCABIACID 5% crema, supplied in a 30 g tube.[1] Each gram of the cream contains 50 mg (5%) of permethrin as the active ingredient.[2] The product is for topical use only.[2]
One Phase 3 clinical trial is authorised in the EU, registered under the number 2024-520348-40-00.[1] The trial is a superiority study that compares the clinical cure rate of standard treatments for scabies: topical permethrin 5% cream alone, oral ivermectin alone, and the combination of topical permethrin and oral ivermectin.[1] It plans to enrol 120 participants with clinical and light microscopy confirmed scabies.[1] The primary outcome is the percentage of subjects with a complete cure rate, defined as Score 0, at Visit 1, which takes place one week after treatment.[1] The trial is currently in the authorised status, meaning it has received regulatory approval to proceed.[1]
The provided sources do not contain a detailed side effect profile for permethrin cream. The DailyMed label describes the pharmacology and composition of the product but does not list adverse reactions in the excerpt provided.[2] The Leeds Formulary notes that there is evidence of resistance to permethrin in the UK, with a randomised controlled trial reporting a cure rate of only 19% with permethrin 1% cream rinse for head lice.[4] This resistance concern relates to effectiveness rather than side effects, and no specific adverse event data are available from the provided sources.
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