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

EctoPharma Limited0 sites20 target enrollmentApril 3, 2006

Overview

No summary available.

Registry

who.int

Start Date

April 3, 2006

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

EctoPharma Limited

•Patients aged four and over.
•Patients who upon examination, are confirmed to have live head lice.
•Patients who have given 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.
•Patients who will be available for home visits from MEC study team members over the fifteen days of the study.
•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

•Patients with a known sensitivity to any of the ingredients in the product.
•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).
•Patients known to suffer from asthma.
•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.
•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).
•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.
•Pregnant or nursing mothers.
•Patients who have participated in another clinical study within 1 month before entry to this study.
•Patients who have already participated in this clinical study.