ISRCTN14615267
Completed
未知
A randomised, double-blind, cross-over, placebo controlled clinical trial to demonstrate the effectiveness of a product designed to protect against establishment of a head louse infestation.
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Oystershell NV
- Enrollment
- 70
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Potential participants attending school with no upper age limit, although they must be the youngest qualifying member of the household
- •2\. Potential participants who upon examination, are confirmed to be at risk of infestation with head lice
- •3\. Potential participants 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\. Potential participants who will be available for home visits by MEC study team members over the 13 weeks of the study
Exclusion Criteria
- •1\. Potential participants with a known sensitivity to sesame, sesame oil, any of the ingredients in Elimax shampoo, Elimax lotion or the placebo shampoo preparations
- •2\. Potential participants 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\. Pregnant or nursing mothers
- •4\. Potential participants who have participated in another clinical study within 1 month before entry to this study
- •5\. Potential participants who have already participated in this clinical study
Outcomes
Primary Outcomes
Not specified
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