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Clinical Trials/ISRCTN66611560
ISRCTN66611560
Completed
Not Applicable

A phase IIa clinical trial to demonstrate proof of concept of an experimental pediculicide lotion for the treatment of head lice

EctoPharma Limited (UK)0 sites20 target enrollmentJuly 20, 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Head lice infestation
Sponsor
EctoPharma Limited (UK)
Enrollment
20
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 20, 2006
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
EctoPharma Limited (UK)

Eligibility Criteria

Inclusion Criteria

  • 1\. Patients aged four and over
  • 2\. Patients who upon examination, are confirmed to have live head lice
  • 3\. Patients who give their written informed consent, or if the patient is less than 16 years of age, whose parent/guardian gives written informed consent to participate in the study
  • 4\. Patients who will be available for home visits from Medical Entomology Centre (MEC) study team members over the 15 days of the study

Exclusion Criteria

  • 1\. Patients with a known sensitivity to any of the ingredients in the product
  • 2\. Patients 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\. Patients known to suffer from asthma
  • 4\. Patients who have been treated with other head lice products within the last two weeks. There must be a 14\-day gap since treatment for head lice was last used before the patient can be accepted on to this trial.
  • 5\. Patients who have bleached hair, or hair that has been colour treated or permanently waved within the last four weeks (wash in/wash out colours are acceptable)
  • 6\. Patients who have been treated with the antibiotics co\-trimoxazole, septrin or trimethoprim within the last four weeks, or who are currently taking such a course
  • 7\. Pregnant or nursing mothers
  • 8\. Patients who have participated in another clinical study within one month before entry to this study
  • 9\. Patients who have already participated in this clinical study

Outcomes

Primary Outcomes

Not specified

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