EUCTR2011-000257-23-GB
Active, not recruiting
Not Applicable
A randomised, controlled, assessor-blind, clinical trial to demonstrate superiority of Hedrin® Once liquid gel compared with Lyclear 1% permethrin crème rinse in the treatment of head lice - Hedrin Once versus Lyclear against head lice
ConditionsHead louse infestation (pediculosis capitis)MedDRA version: 13.1Level: LLTClassification code 10034214Term: Pediculus capitis (head louse)System Organ Class: 10021881 - Infections and infestations
DrugsLyclear creme rinse
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Head louse infestation (pediculosis capitis)
- Sponsor
- Thornton & Ross Ltd
- Enrollment
- 84
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Children and adults aged 6 months and over of both sexes with no upper age limit.
- •2\. People who upon examination, are confirmed to have live head lice.
- •3\. People 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\. People who will be available for follow up visits by 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\. People with a known sensitivity to any of the ingredients in Hedrin Once liquid gel or Lyclear 1% permethin creme rinse.
- •2\. People with a bacterial infection of the scalp (e.g. impetigo) or who have an active long term scalp condition (e.g. psoriasis of the scalp).
- •3\. People who have been treated with other head lice products within the previous two weeks.
- •4\. People who have been treated with the antibiotics CoTrimoxazole or Trimethoprim within the previous four weeks, or who are currently taking such a course.
- •5\. Pregnant or nursing mothers.
- •6\. People who have participated in another clinical study within 1 month before entry to this study.
- •7\. People who have already participated in this clinical study.
Outcomes
Primary Outcomes
Not specified
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