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Clinical Trials/ISRCTN10431107
ISRCTN10431107
Completed
Phase 3

A randomised, controlled, assessor-blind, clinical trial to compare Hedrin® 4% dimeticone lotion with Hedrin® 4% lotion Dev 42 in the treatment of head lice

Thornton & Ross Ltd (UK)0 sites72 target enrollmentMarch 19, 2009

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Head louse infestation
Sponsor
Thornton & Ross Ltd (UK)
Enrollment
72
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

2009 results in https://www.ncbi.nlm.nih.gov/pubmed/19951427 (added 30/03/2020)

Registry
who.int
Start Date
March 19, 2009
End Date
May 31, 2008
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Thornton & Ross Ltd (UK)

Eligibility Criteria

Inclusion Criteria

  • 1\. Both males and females, aged 4 years 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 or Hedrin® 4% lotion Dev 42
  • 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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