A phase II randomised, controlled, assessor-blind, parallel group clinical trial to demonstrate the proof of concept of an experimental pediculicide rinse and Lyclear Creme Rinse in the treatment of head lice - Study of two treatments in the eradication of head lice (25/02/2004)
- Conditions
- Head lice infestation
- Registration Number
- EUCTR2004-002022-22-GB
- Lead Sponsor
- SSL International plc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Patients aged four 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 under 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 IRD 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 Product X or Lyclear (e.g. pyrethroids or chrysanthemums).
2. Patients with a secondary bacterial infection of the scalp (e.g. impetigo) or who have a long term scalp condition (e.g. psoriasis of the scalp).
3. Patients who have been treated with other head lice products within the last two weeks.
4. 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).
5. 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.
6. Pregnant or nursing mothers.
7. Patients who have participated in another clinical study within 1 month before entry to this study.
8. 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 compare the efficacy of Product X against Lyclear in the eradication of head lice ;Secondary Objective: To assess the safety, ease of application and patient acceptability of Product X;Primary end point(s): The primary endpoint is the frequency of cure, with the difference between the two groups tested using the intention-to-treat population. Secondary endpoints will be the frequency of ovicidal failure and of reinfestation and the numbers of lice seen at the different assessment times. Other endpoints will be the safety of the product, the ease of use and patient acceptance.
- Secondary Outcome Measures
Name Time Method