Cocamide DEA vs Permethrin for Head Lice

Study Overview
=================
Brief Summary
-----------------
To assess the efficacy and safety of 10% Cocamide DEA and Lyclear creme rinse (permethrin1%) in the eradication of head lice. To assess the ability of each product to kill all viable ova and to assess patient acceptability of the product in use.

Detailed Description
-----------------
A formulation of cocamide diethanolamine (DEA) surfactant was previously reported as showing efficacy to eliminate head louse infestation. This study has been designed to test those data using a new formulation of 10% cocamide DEA in an aqueous basis in comparison with the standard of care product 1% permethrin creme rinse. It is believed that surfactants like cocamide DEA are capable of eliminating lice resistant to conventional insecticides. A planned total of 120 patients who, following examination, are found to suffer from active head lice infestation will be recruited to the trial. The patient will be treated with the appropriate product according to the randomization code from a pre-prepared listing in balanced blocks of 12. 10% Cocamide DEA is applied directly to dry hair and is washed off with shampoo after 60 minutes. Permethrin 1% creme rinse is applied to shampooed and towel dried hair and left in situ for 10 minutes, then rinsed off with clean water. Treatments will be applied by experienced investigators throughout the study. Assessments will be made by other investigators unaware of the treatment regimen used. After treatment (day 0), follow up assessments will be performed on days 4, 7,10 then again at day 14 after which they will leave the study. Any adverse events or side effects from the treatments will be monitored during the study.

Official Title
-----------------
A Randomised, Controlled, Assessor-blind, Parallel Group Clinical Trial to Assess the Efficacy, Safety and Acceptability of a Surfactant Based Lotion and a Permethrin Creme Rinse in the Treatment of Head Lice

Conditions
-----------------
Pediculosis Capitis, Head Louse Infestation

Intervention / Treatment
-----------------
* Drug: Cocamide diethanolamine
* Drug: Permethrin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients over the age of 4 who are found to have a head lice infection. Patients who give written informed consent or, if the patient is under 16 years of age, whose guardian gives written informed consent to participate in the study. Available for the duration of study i.e. 15 days. Exclusion Criteria: Patients with a known sensitivity to pyrethroid, organophosphate, and/or carbamate insecticides, sensitivity to chrysanthemums and/or known sensitivity to paraben preservatives. Patients who have been treated with other head lice products within the last 4 weeks. Patients who have undergone a course of antibiotic treatment within the last 4 weeks. Patients who have any persistent skin disorder of the scalp (i.e. eczema, chronic dermatitis, psoriasis). Patients with asthma Patients whose hair has been bleached, colour treated or permed within the last 4 weeks. Pregnant or nursing mothers. Patients who have participated in another clinical trial within 1 month prior to entry to this study. Patients who have already participated in this clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 10% Cocamide diethanolamine<br>10% Cocamide DEA aqueous lotion is applied directly to dry hair on a single occasion and is washed off with shampoo after 60 minutes. | Drug: Cocamide diethanolamine<br>* Topical lotion<br>* Other names: Lauramine diethanolamine;|
| Active Comparator: 1% permethrin creme rinse<br>1% permethrin creme rinse is applied to shampooed and towel dried hair on a single occasion and left in situ for 10 minutes, then rinsed off with clean water. | Drug: Permethrin<br>* Topical creme rinse<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elimination of infestation | No evidence of active head lice infestation 14 days after enrolment. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of participants with treatment related adverse events as a measure of safety | No treatment related adverse events following treatment | 14 days |