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

• Conditions: Head louse infestation (pediculosis capitis); MedDRA version: 13.1Level: LLTClassification code 10034214Term: Pediculus capitis (head louse)System Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2011-001892-38-GB
• Lead Sponsor: Panin S.r.l.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-19
• Last Update Posted: 24 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 44

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.