ISRCTN95412572
Completed
Phase 4
A proof of concept clinical investigation to evaluate the activity of Hedrin® 4% lotion in the treatment of head lice using a 1-hour application time
Thornton & Ross Ltd (UK)0 sites40 target enrollmentDecember 1, 2008
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Head louse infestation
- Sponsor
- Thornton & Ross Ltd (UK)
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Both males and females, aged 6 months and over with no upper age limit
- •2\. Participants who upon examination, are confirmed to have live head lice
- •3\. 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\. Participants who will be available for follow\-up visits by study team members over the 14 days following first treatment
Exclusion Criteria
- •1\. Participants with a known sensitivity to any of the ingredients in Hedrin® 4% lotion
- •2\. Participants with a secondary bacterial infection of the scalp (e.g. impetigo) or who have an active long\-term scalp condition (e.g. psoriasis of the scalp)
- •3\. Participants who have been treated with other head lice products within the previous two weeks
- •4\. Participants who have bleached hair, or hair that has been permanently waved within the previous four weeks
- •5\. Participants who have been treated with the antibiotics co\-trimoxazole or trimethoprim within the previous four weeks, or who are currently taking such a course
- •6\. Pregnant or nursing mothers
- •7\. Participants who have participated in another clinical study within 1 month before entry to this study
- •8\. Participants who have already participated in this clinical study
Outcomes
Primary Outcomes
Not specified
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