A phase III, randomised, controlled, assessor-blind, parallel group clinical trial to confirm the safety and efficacy of an experimental pediculicide rinse and Lyclear Creme Rinse in the treatment of head lice.
- Conditions
- Head lice infestation
- Registration Number
- EUCTR2005-004084-37-GB
- Lead Sponsor
- SSL International plc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 250
1. Patients aged 6 months and over.
2. Patients who upon examination, are confirmed to have live head lice.
3. Patients who give written informed consent, or if the patient is below 16 years of age whose parent/guardian gives written informed consent to participate in the study.
4. Patients who will be available for home visits from MEC study team members over the next 14 days.
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
1. Patients with a known sensitivity to any of the ingredients in Lyclear Crème Rinse or to pyrethrins or pyrethroids.
2. Patients who have been treated with other head lice products within the last two weeks. This includes pharmaceutical products, medical devices and herbal remedies. Fine-toothed combing with an ordinary conditioner is acceptable.
3. Patients who have bleached hair, or hair that has been colour treated or permanently waved within the last four weeks. Wash in/wash out colours are acceptable.
4. Patients who have been treated with the antibiotics Co-Trimoxazole, Septrin or Trimethoprim within the last four weeks, or who are currently taking such a course of treatment.
5. Pregnant or nursing mothers.
6. Patients who have participated in another clinical study within 1 month before entry to this study.
7. Patients 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 safety of Product X during clinical use and to confirm the efficacy of Product X and Lyclear to kill head lice and cure an infestation.;Secondary Objective: To monitor the ease of application and overall patient acceptability of both products. ;Primary end point(s): The primary endpoint is the frequency of adverse events possibly or probably due to treatment, with the frequency estimated using the intention-to-treat population. Secondary endpoints will be the frequency of specific types of adverse events, the frequency of success (cure or reinfestation), the frequency of ovicidal failure, and the numbers of lice seen at the different assessment times. Other endpoints will include ease of use and patient acceptance.
- Secondary Outcome Measures
Name Time Method