NEX in head lice infestation. Version 1.0
Research type
Research Study
Full title
A randomised, active-controlled, observer-blind, non-inferiority study to investigate the efficacy, safety and tolerability of a local treatment with dimeticone-based pediculicides in head lice infestation.
IRAS ID
126506
Contact name
Ronald Behrens
Contact email
Sponsor organisation
G. Pohl-Boskamp GmbH & Co. KG
Eudract number
2013-004860-78
Research summary
This study is a randomised active-controlled, observer-blind, parallel-group trial in subjects with head lice infestation. The aim of the study is to describe and compare the efficacy of a local treatment with NEX (active: dimethicone) in subjects with head lice infestations in terms of non-inferiority to the control after two applications.
The target population will be 194 healthy human volunteers of mixed sex aged 2 to 11 years. The test product is NEX (Investigational Medical Device, IMD) which contains: dimeticone, isododecane, medium chain triglycerides, jojoba wax and boabo oil. It will be applied on Day 0 and Day 7 and left for 30 minutes after each application. The control product is Hedrin® 4% Lotion (Investigational Medicinal Product, IMP), which contains dimeticone and cyclometicone 5. It will be applied on Day 0 and Day 7 and left for 8 hours after each application.
Each participant will be enrolled into the study for ten days from recruitment during Visit 1 on Day 0 until the final follow-up during Visit 4 on Day 10. Participants will be visited at home by trial staff.From initial contact within schools to the last participant exits the trial is expected to last six months.
The outcome measure will be the number of live head lice found on each subject assessed on visits 2, 3 and 4. Any live lice found on subjects will be sent to LSHTM for assessment of developmental stages. The primary endpoint is the rate of treatment success, defined as absence of any viable head lice on Day 10: Evaluation for non-inferiority of NEX to the comparator, with a non-inferiority margin of 10% based on the Per Protocol (PP) Set.REC name
London - Dulwich Research Ethics Committee
REC reference
14/LO/0151
Date of REC Opinion
9 May 2014
REC opinion
Further Information Favourable Opinion