A Phase 3 interventional study of Cocamide diethanolamine and Permethrin in Pediculosis Capitis and Head Louse Infestation, sponsored by Medical Entomology Centre. Terminated at 1 site in United Kingdom. Open to participants aged 4 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-07-16.
Sponsored by Medical Entomology Centre · Phase 3, Interventional, and Treatment
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.
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.
58 studies on the registry are indexed under Lice Infestations; 4 are open to participants now.
This study's enrollment of 44 is below the median of 118 across 56 interventional studies indexed under Lice Infestations.
Browse Lice Infestations studies →Medical Entomology Centre is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
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
Topical lotion
Also known as: Lauramine diethanolamine
Topical creme rinse
Elimination of infestation
No evidence of active head lice infestation 14 days after enrolment.
Time frame: 14 days
The number of participants with treatment related adverse events as a measure of safety
No treatment related adverse events following treatment
Time frame: 14 days
This study is terminated, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Medical Entomology Centre