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: 52645-53-1
Other descriptive name: 3-Phenoxybenzyl (1RS)-cis,tr
Sponsors
Thornton & Ross Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children and adults aged 6 months and over of both sexes 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 follow up visits by 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 Hedrin Once liquid gel 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 been treated with the antibiotics CoTrimoxazole or Trimethoprim within the previous four weeks, or who are currently taking such a course. 5. Pregnant or nursing mothers. 6. People who have participated in another clinical study within 1 month before entry to this study. 7. People who have already participated in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm the efficacy of Hedrin Once liquid gel using a single application of 15 minutes duration;Secondary Objective: To compare efficacy of Hedrin Once liquid gel 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 treatment (in the case of Lyclear creme rinse following the second application of treatment) | — |
Countries
United Kingdom
Outcome results
None listed