EUCTR2006-004136-73-GB
Active, not recruiting
Phase 1
A randomised, controlled, assessor-blind, clinical trial to demonstrate superiority of Hedrin 4% dimeticone lotion compared with Derbac-M 0.5% malathion aqueous liquid in the treatment of head lice - Is Hedrin 4% more effective than Derbac-M for the treatment of head lice?
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Thornton & Ross Limited
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Participants 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 home visits by MEC study team members over the 14 days following first treatment.
- •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\. Participants with a known sensitivity to any of the ingredients in Hedrin 4% lotion or Derbac\-M liquid.
- •2\. 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\. 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 colour treated or permanently waved within the previous four weeks (wash in/wash out colours are acceptable).
- •5\. Participants who have been treated with the antibiotics Co\-Trimoxazole, Septrin 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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