EUCTR2004-002022-22-GB
Active, not recruiting
Not Applicable
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)
SSL International plc0 sitesFebruary 23, 2005
ConditionsHead lice infestation
DrugsLyclear Creme Rinse
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Head lice infestation
- Sponsor
- SSL International plc
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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