A randomised, controlled, assessor-blind, clinical trial to compare Liceko ® with NIX/Lyclear 1% permethrin crème rinse in the treatment of head lice.

INTERVENTION: Trade Name: Lyclear creme rinse Product Name: Lyclear creme rinse Pharmaceutical Form: Cream INN or Proposed INN: permethrin CAS Number: 52645531 Other descriptive name: 3Phenoxybenzyl (1RS)cis, trans3( 2,2dichlorovinyl) 2,2dimethylcyclopropanecarboxylate Concentration unit: % (W/W) percent weight/weight Concentration type: equal Concentration number: 1‐ CONDITION: Head louse infestation (pediculosis capitis) ; MedDRA version: 13.1 Level: LLT Classification code 10034214 Term: Pediculus capitis (head louse) System Organ Class: 10021881 ‐ Infections and infestations PRIMARY OUTCOME: Main Objective: To confirm the efficacy of Liceko using two applications of 20 minutes duration applied 7 days apart. Primary end point(s): The primary outcome measure for each of the treatments is cure (or exceptionally cure followed by reinfestation from a contact, as defined by algorithm), indicated by no evidence of active head louse infestation following the second application of treatment. Secondary Objective: To compare efficacy of Liceko with that of Lyclear creme rinse for elimination of infestation with head lice. INCLUSION CRITERIA: 1. Children and adults aged 6 months and over with no upper age limit. 2. People who upon examination, are confirmed to have live head lice. 3. People who give written informed consent, or if the participant is under 16 years of age whose parent/guardian gives written informed consent to participate in the study. 4. People who will be available for home visits by MEC study team members over the 14 days following first treatment. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range