Pediculosis Clinical Trial
Official title:
A Randomised, Parallel Group Clinical Trial to Assess the Efficacy, Safety and Acceptability of a Surfactant Based Lotion in the Treatment of Head Louse Infection.
To assess the efficacy and safety of 10% Cocamide DEA using two treatment regimens in the eradication of head lice. To assess the ability of each treatment regimen to kill all viable ova and to assess patient acceptability of the product in use
A previous study found that a formulation of 10% cocamide diethanolamine (DEA) aqueous
lotion showed some efficacy to eliminate head louse infestation but that the treatment
regimen was inadequate to kill all lice or louse eggs. This study has been designed to
compare two different application regimens that have been shown effective in vitro.
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 10%
cocamide DEA lotion using the appropriate treatment regimen according to the randomization
code from a pre-prepared listing in balanced blocks of 12.
Group 1: 10% cocamide DEA is applied directly to dry hair, the excess water evaporated off
using a hair dryer and is then left for 8 hour/overnight before washing off with clean
water.
Group 2: 10% cocamide DEA is applied directly to dry hair, the excess water evaporated off
using a hair dryer and is then left for 2 hours before washing off with clean water. A
follow up treatment is given after 7 days.
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, 8,11 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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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