Clinical trials update 2016

A review of head lice clinical trials news in 2016.

Recruiting

• A study on the effectiveness of the “No More” anti-lice medical device to kill lice and lice eggs by Pharmayeda is recruiting. The study expects to test up to 80 participants aged 3 to 18 years. The estimated completion date is December 2016.

Completed studies

• A study on the effectiveness of Spinosad Crème Rinse by ParaPRO LLC has been marked as completed. This was a pilot dose ranging study to evaluate the safety and efficacy of different strengths of Spinosad Creme versus a vehicle control.
• A safety study on the sensitizing potential of Abametapir lotion by Hatchtech Pty has been marked as completed. This was a randomised controlled trial using a patch-test design to investigate sensitising potential of the product.
• A Phase 3 trial on the efficacy and safety of Abametapir lotion by Hatchtech Pty has also been marked as completed. It was aimed at evaluating the efficacy of at-home administration of a single application of abametapir lotion 0.74% w/w for the treatment of head lice. The study was looking for the proportion of index subjects who are lice-free at all follow-up visits through to the Day 14 visit.
• A third study by Hatchtech Pty, this time looking at ovicidal efficacy of 0.74% Abametapir lotion, has also been marked as complete. This was a randomised controlled trial examining the proportion of hatched eggs pre- and post-treatment versus placebo.
• A bioequivalence study on 5% Benzyl Alcohol lotion by Akorn Inc has been marked as completed. This was a randomised controlled Phase 3 trial looking at lice elimination versus placebo.