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
Conditions
Interventions
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, trans
Sponsors
Panin S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. People with a known sensitivity to any of the ingredients in Liceko spray or Lyclear 1% permethin creme rinse. 2. People with a bacterial infection of the scalp (e.g. impetigo) or who have an active long term scalp condition (e.g. psoriasis of the scalp). 3. People who have been treated with other head lice products within the previous two weeks. 4. People who have bleached hair, or hair that has been permanently waved within the previous four weeks 5. People who have been treated with the antibiotics CoTrimoxazole or Trimethoprim within the previous four weeks, or who are currently taking such a course. 6. Pregnant or nursing mothers. 7. People who have participated in another clinical study within 1 month before entry to this study. 8. People who have already participated in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm the efficacy of Liceko using two applications of 20 minutes duration applied 7 days apart.;Secondary Objective: To compare efficacy of Liceko with that of Lyclear creme rinse for elimination of infestation with head lice.;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. | — |
Countries
United Kingdom
Outcome results
None listed