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Downloadable PDF - Hedrin

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Product Information <strong>Hedrin</strong> 4% Lotion<br />

Presentation: cutaneous solution containing 4% dimeticone w/w.<br />

Indications: for the eradication of headlice infestations Dosage and<br />

administration: Adults and children over 6 months: Apply su cient lotion<br />

to cover dry hair from the base to the tip to ensure that no part of the scalp<br />

is left uncovered. Work into the hair spreading the liquid evenly from roots<br />

to tips. Allow hair to dry naturally. <strong>Hedrin</strong> should be left on hair for a<br />

minimum of 8 hours or overnight. Wash out with normal shampoo, rinsing<br />

thoroughly with water. Repeat the treatment after seven days.<br />

Contraindications: Hypersensitivity to any of the ingredients. Precautions<br />

and Warnings: Discontinue at the appearance of a skin rash or any<br />

other signs of local or general hypersensitivity. For external use only. If<br />

accidentally introduced into the eyes, with water. Side E ects: Minor<br />

adverse events include an itchy or scalp and dripping/irritation around<br />

the eyes. Product Licence Holder: Thornton & Ross Ltd, HD7 5QH<br />

Product Licence No: PL00240/0137 Date of preparation: May 2008<br />

References:<br />

1. Burkhart CG, Burkhart CN. Asphyxiation of lice with topical agents not a reality…yet, J Am<br />

Acad Dermatol. 2006: 54: 721-2<br />

2. Webb JE. Spiracle structure as a guide to the phylogenetic relationships of the Anoplura<br />

(biting and sucking lice), with notes on the a nities of the mammalian hosts. Proc.<br />

Zool Soc.1946 116: 49-119<br />

3. Van Reeth, Wilson, Cosmetics & Toiletries Magazine, July 1994<br />

4. Burgess IF, Brown CM, Lee PN, Treatment of head louse infestation with<br />

4% dimeticone lotion: randomised controlled equivalence trial BMJ<br />

2005; 330:1423 (18 June)<br />

5. Burgess IF, Lee PN, Matlock G, Randomised, controlled, assessor<br />

blind trial comparing 4% dimeticone lotion with 0.5% malathion<br />

liquid for head louse infestation, PLoS ONE. 2007; 2(11):e1127<br />

6. Burgess IF, Water - is it the “Achilles heel” of sucking lice? 3rd<br />

International Congress On Phthiraptera, Buenos Aires,<br />

Argentina, 16 - 20 October, 2006<br />

Acknowledgements:<br />

With thanks to<br />

Mr Trevor Fairhead and Mr Jon Rickard<br />

Sector of Biological and Soft Systems<br />

Department of Physics<br />

University of Cambridge<br />

Cavendish Laboratory<br />

Cambridge<br />

United Kingdom<br />

Licence Holder & Manufacturer:<br />

Thornton & Ross Ltd.<br />

Linthwaite, HD7 5QH, UK<br />

Distributor:<br />

Nice-Pak Products Pty Ltd.<br />

2-4 Sullivan Street, Moorabbin 3189 Victoria Australia<br />

Nice-Pak Products (NZ) Pty Ltd.<br />

PO Box 2296, Auckland 1 New Zealand<br />

For further information and ordering<br />

07 3345 5598<br />

Ian Burgess - Director, Medical Entomology Centre<br />

“ <strong>Hedrin</strong> ® 4%<br />

Dimeticone lotion is<br />

a patented new<br />

generation of head<br />

louse treatment based<br />

on silicone oils.<br />

Its has been<br />

proven<br />

both in vitro and in<br />

clinical trials” 4,5<br />

®<br />

®<br />

The mode of action of <strong>Hedrin</strong> 4%<br />

Dimeticone Lotion in killing head lice<br />

This paper describes<br />

how <strong>Hedrin</strong> ® ’s multiacting<br />

optimised<br />

formulation actually<br />

kills the lice.<br />

www.hedrin.com.au


Background and purpose<br />

A new generation<br />

of products based<br />

on silicone oils has<br />

been developed<br />

human head lice<br />

market.<br />

Many of these<br />

relatively new<br />

products have not<br />

Untreated head louse<br />

been through the<br />

rigours of a regulatory process and have not had<br />

This has led to a number of simplistic and<br />

inaccurate claims being made.<br />

The purpose of this paper is to use evidence-based<br />

data to describe how <strong>Hedrin</strong> ® 4% dimeticone<br />

lotion kills head lice.<br />

Death by asphyxiation? ...UNLIKELY!<br />

A simplistic view is that physical blockage of spiracles and<br />

tracheae eventually kill lice by oxygen starvation.<br />

The theory of lice asphyxiation was reviewed by Burkhart 1<br />

who discussed the practical issues and the implausibility of it<br />

as a realistic mechanism of louse death, based on the<br />

anatomy of louse spiracles and the defence systems in place<br />

to protect the louse.<br />

Lice can survive oxygen deprivation for many hours and<br />

silicone oils are permeable to gases including oxygen, making<br />

asphyxiation a highly unlikely cause of death in the head<br />

louse.<br />

This is the experimental paper of its kind to prove that<br />

<strong>Hedrin</strong> ® 4% dimeticone lotion penetrates louse spiracles<br />

beyond the<br />

atrium and<br />

into the<br />

tracheae.<br />

Thoracic<br />

spiracle<br />

Experimental method<br />

<strong>Hedrin</strong> ® 4% dimeticone lotion is normally applied to the hair<br />

and left overnight. To have a physical e ect on lice the lotion<br />

must penetrate and/or block the spiracles.<br />

Live adult head lice were collected from healthy volunteers.<br />

They were treated by coating in <strong>Hedrin</strong> ® 4% dimeticone lotion<br />

and left overnight at room temperature.<br />

Treated and untreated lice were then viewed by scanning<br />

electron microscopy and the chemical elements found in the<br />

spiracles were determined by cutting the surrounding tissues<br />

away using a focused ion beam and X-ray microanalysis to<br />

the chemical element silicon, which is present in<br />

dimeticone but not in lice.<br />

Silicone plug inside spiracle<br />

Shown below is a typical X-ray spectrum indicating the presence of silicon on the<br />

surface of a treated louse (as seen at spectrum points 1- 3 above)<br />

Experimental results<br />

X-ray analysis showed silicon present over the whole surface<br />

of treated lice but absent on untreated lice - it formed a plug<br />

or a thin coating on the inside of the spiracles of treated lice.<br />

Ion beam cutting in the scanning electron microscope created<br />

a cross section of an abdominal spiracle. X-ray spectral analysis<br />

of the sectioned area highlighted the distribution of silicon<br />

from the dimeticone.<br />

Colour-enhanced cross section of abdominal<br />

spiracle showing distribution of silicon<br />

The re (left) shows<br />

the anatomical<br />

structure of a spiracle,<br />

as drawn by Webb 2 ,<br />

superimposed on the<br />

cross section of the<br />

spiracle. The white<br />

dots indicate the<br />

distribution of silicon<br />

in the spiracle atrium<br />

and into the outer<br />

section of trachea.<br />

Disruption of water management in lice by<br />

<strong>Hedrin</strong>® 4% dimeticone, causing death<br />

Human head lice have a unique strategy of water<br />

management. They do not produce urine, but eliminate excess<br />

water by respiratory transpiration via the trachea and<br />

spiracles. 6 Blockage of the spiracles was shown to prevent or<br />

reduce water excretion, often leading to death by gut rupture.<br />

When head lice were immersed in <strong>Hedrin</strong> ® 4% dimeticone<br />

lotion, locomotion ceased within 30 seconds with no further<br />

movements of appendages, although slight gut movements<br />

could be seen in some lice.<br />

When lice were treated using<br />

<strong>Hedrin</strong> ® 4% dimeticone<br />

lotion after taking a blood<br />

meal they initially lost weight<br />

at a similar rate to untreated<br />

lice but, from about 30<br />

minutes after treatment, the<br />

rate of water excretion was<br />

reduced, so that after 4 hours<br />

the treated group had lost<br />

only 15% of the weight of<br />

the blood meal compared<br />

with 45% in the untreated<br />

group. This indicates a<br />

blockage of the louse<br />

transpiration process.<br />

Fed louse treated with <strong>Hedrin</strong> ® 4%<br />

dimeticone lotion with large blood<br />

gut<br />

Treated louse after several hours,<br />

demonstrating gut rupture as evidenced<br />

by the visible of blood into the<br />

thoracic cavity<br />

Some insects experienced gut rupture several hours after<br />

treatment believed to be due to a reverse osmotic e ect. 6<br />

It should be noted that gut rupture has only been observed in<br />

fed lice with a blood gut. This is highly visible and an<br />

extreme mechanism of death. However unfed lice also die as<br />

a result of immobility, which is in e ect death from starvation.<br />

<strong>Hedrin</strong>® 4% dimeticone – the optimal choice<br />

for water management disruption<br />

The water vapour barrier e cacy of silicones is a complex<br />

relationship between the structure, molecular weight, and<br />

thickness of the silicone oil m 3 - the higher the molecular<br />

weight, the better its barrier properties.<br />

<strong>Hedrin</strong> ® 4% dimeticone lotion contains<br />

the very high molecular weight<br />

dimeticone (100 000 CSt), providing<br />

the best barrier function.<br />

<strong>Hedrin</strong> ® 4% dimeticone lotion is an<br />

optimised blend of silicones to<br />

meet all parameters required of<br />

a commercial product.<br />

Conclusions<br />

The experiments support the published work4,5 that<br />

demonstrated the clinical performance of <strong>Hedrin</strong> ® 4%<br />

dimeticone lotion.<br />

Results indicate that blockage of the spiracles and<br />

trachea by <strong>Hedrin</strong> ® 4% dimeticone lotion induces head<br />

lice to enter a similar immobility state to that<br />

caused by immersion in water.<br />

The crucial observation is that lice<br />

treated with <strong>Hedrin</strong> ® 4% dimeticone<br />

lotion always enter a moribund<br />

state and we have never observed<br />

them to recover.<br />

The exact mechanism of death has been debated and<br />

simplistically attributed to asphyxiation, but observations<br />

in this paper Burkhart’s view 1 that this is unlikely<br />

to be the case.<br />

We conclude that, although asphyxiation cannot be<br />

ruled out as one mechanism by which <strong>Hedrin</strong> ® 4%<br />

dimeticone lotion could kill head lice, the major cause is<br />

undoubtedly the prolonged immobility associated<br />

with osmotic disruption and gut rupture or starvation.

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