Vamousse Lice Defence Shampoo Version 1 26th June 2020
Research type
Research Study
Full title
Prevention of infestation with Pediculus humanus capitis in the family group using a pediculicidal shampoo: A prospective, randomised controlled study.
IRAS ID
286424
Contact name
Ian Burgess
Contact email
Sponsor organisation
Alliance Pharmaceuticals Ltd
Duration of Study in the UK
0 years, 10 months, 31 days
Research summary
Despite the introduction of physically acting treatments for head louse infestation that are not affected by resistance, infestation with the human head louse (Pediculus capitis) is still of widespread concern, partly because most families act individually and there are no coordinated efforts to eliminate infestation in most communities and partly because not all products are fully effective to eliminate infestation. It has long been known that infestations of head lice occur most frequently in young children, but that the wider family can be a source of spreading the infestation and of re-infestation. Detection combing is a skilled procedure and may not be effective in the hands of the general public and over-use of neurotoxic insecticidal lice treatments has led to the evolution of resistant strains of head lice. The active ingredients in Vamousse Shampoo have been demonstrated in vitro to dissolve the waxy cuticle of the louse, which then dies from dehydration. As the shampoo is less effective at killing lice eggs, the shampoo needs to be used for approximately two weeks, in order that all nymphs, hatching from viable eggs, can be exposed to the shampoo.
The rationale behind this study is that treatment with a cosmetically acceptable, daily-use lice-killing shampoo can help to prevent the spread of an infestation among close family members, prevent re-infestation of the index case and therefore reduce the impact of the infestation. To this end, the study will evaluate the superiority of Vamousse Lice Defence Shampoo used daily for 14 days in preventing the spread of infestation in the family group, compared with a control shampoo with no active ingredients.Lay Summary of Results
In a randomised, controlled, double-blinded clinical field trial, a total of 83 participants in total of whom 25 were Primary Index Cases and 9 were Secondary Index Cases with confirmed head lice infestation, and apparently satisfying defined inclusion and exclusion criteria. Index cases were initially treated using Vamousse Treatment Mousse to eliminate their existing infestations, after which they and as many consenting household members who were at risk of infestation commenced daily use of one of the investigational shampoos (either Vamousse Lice Defence Shampoo or a Control shampoo). Treatment was to be applied for at least 3 minutes but no more than 5 minutes on each occasion. Index cases received a follow up at Day 3 to confirm elimination of infestation but if lice persisted a second treatment with Vamousse Treatment Mousse was given. Similarly, a further follow up was made at Day 6 and a third treatment if required. All participants were assessed for the presence of lice at the end of the study at Day 14.
The aims of the study were to evaluate efficacy, measured as the proportion of individuals in each household with active head lice infestation at Day 14 and the safety and acceptability of the new formulation.
There were 18 reported adverse events in 11 individuals that were related to treatment in some way. These were mostly stinging or itchy reactions to treatment and one in which some of the fluid ran or dripped into an eye between application and washing off.
All participants satisfied the inclusion and exclusion criteria and all except one completed the study although some appointments were missed. They came from 25 households, 77.1% were female, and 33 were aged over 15.
The analysis and report were prepared and written before code break. The treatment allocation code was subsequently broken to reveal that: shampoo treatment “A” was Vamousse Lice Defence Shampoo and shampoo treatment “B” was the Control Shampoo.
Of the 24 participants found to have lice at Day 14, 14/34 from 9 households were allocated the shampoo randomised under group “A” (Vamousse Lice Defence Shampoo) and the other 10/25 from 7 households allocated the shampoo under group “B” (Control Shampoo), meaning no lice were found on 8 participants from 3 households allocated “A” and 16 participants from 6 households on “B”. There were numerous issues with treatment compliance in terms of number of applications of shampoo used and the length of time the shampoo was applied consequently, there was a considerable discrepancy between the intention to treat population and the per-protocol population. Based on the participant outcomes data in terms of numbers of cases of infestations relative to the numbers of households there was no detectable difference between the two treatments, with a slight trend in favour of the Control Shampoo, treatment “B”.
Has the registry been updated to include summary results?: No
If yes - please enter the URL to summary results:
If no – why not?: This is currently in progress and should be completed before the end of March 2024.
Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Pending
If yes, describe or provide URLs to disseminated materials:
If pending, date when dissemination is expected:
If no, explain why you didn't follow it:
Have participants been informed of the results of the study?: Yes
If yes, describe and/or provide URLs to materials shared and how they were shared: The outcomes of the study stating that no difference was detectable in the effects of the test and control shampoos were communicated to each household by letter.
If pending, date when feedback is expected:
If no, explain why they haven't:
Have you enabled sharing of study data with others?: No
If yes, describe or provide URLs to how it has been shared:
If no, explain why sharing hasn't been enabled: This was a study of an experimental formulation. There are currently no direct means for sharing the data obtained from this study, although data can be made available on request, but there are no relevant interest groups or communities. Sharing with participants has been carried out on an individual basis.
Have you enabled sharing of tissue samples and associated data with others?: No
If yes, describe or provide a URL:
If no, explain why: There are no tissue samples as none were taken.REC name
London - Stanmore Research Ethics Committee
REC reference
20/LO/1022
Date of REC Opinion
21 Sep 2020
REC opinion
Further Information Favourable Opinion