Research Report TM/08/02 June 2008

Assessing the effectiveness of ‘Hands First’ Barrier Cream Phase 1: Laboratory study Y Christopher, KS Galea

Research Report TM/08/02 June 2008

Assessing the effectiveness of ‘Hands First’ Barrier Cream: Phase I laboratory study Y Christopher, KS Galea A laboratory-based study was undertaken to determine the effectiveness of ‘Hands First, invisible gloves dry feel barrier cream’ in preventing the skin of the hands from becoming contaminated with an aqueous solution during a simulated exposure scenario, and to compare the product’s effectiveness with other barrier cream products (BC) readily available on the market and one emollient hand cream. The level of skin protection afforded by five creams was tested using a panel of 5 volunteers. A fluorescent tracer was used as the test substance. The difference in skin protection between the five products was evaluated. Our findings suggest that Hands First Barrier Cream was the most protective of the four barrier cream products tested in this study, covering between 9-11% more of the participant’s hands than the three other BCs tested. However, the control emollient cream seemed to perform better than the barrier creams tested. Given the small difference in protective ratings between the Hands First Cream and the other BCs and the small sample size of this study there is some degree of uncertainty and the results should be interpreted with care. A much larger laboratory study will be needed to establish if the differences observed are statistically significant. Based on a subjective assessment of the creams by the participants, the control emollient cream was most frequently rated the negative quality of being ‘wet/sticky’, while the two creams with the least protective effect were most strongly rated on positive qualities ‘easily absorbed’ and ‘pleasant/comfortable’. Hands First Barrier Cream was strongly positively rated for having a ‘pleasant/comfortable’ feel on the skin and was not rated strongly for any of the negative properties. Physical qualities of BCs such as ease of absorption and wetness and stickiness have been listed among the important qualities of BCs as having an effect on user compliance and safety issues with respect to interference of grip. An overall assessment of BCs needs to take these factors into consideration together with the hydrating or protective effect of the cream. Although the small sample size puts limitations on the confidence with which these products can be rated against each other, the results suggest that overall Hands First Barrier Cream scored better than the other barrier cream products tested when one considers both protectiveness and desirable properties to users.

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Copyright © 2008 Institute of Occupational Medicine. No part of this publication may be reproduced, stored or transmitted in any form or by any means without written permission from the IOM

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CONTENTS 1

INTRODUCTION

1

2

AIMS

3

3

METHODS

5

3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9

Introduction Experimental set-up Selection of products for testing Participants Test arrangements Observations and data recording Assessment of participants’ hand condition Participants’ assessment of products tested Data analysis

5 5 6 7 7 9 9 9 10

4

RESULTS

13

4.1 4.2 4.3 4.4 4.5 4.6

Participant details Product tests Assessment of skin condition of participants’ skin Subjective assessment of skin products tested Protective ratings of the barrier creams Relative performance of hands first barrier cream

13 13 14 14 16 19

5

CONCLUSION AND DISCUSSION

21

6

GLOSSARY

23

7

ACKNOWLEDGEMENTS

25

8

REFERENCES

27

APPENDIX I – LABORATORY STUDY RECORD SHEETS

29

APPENDIX II – DETAILED RESULTS OF PARTICIPANTS’ ASSESSMENT OF PRODUCTS

33

APPENDIX III – FIGURES SHOWING PRE- AND POST- TEST FLUORESCENCE OF THE DIFFERENT AREAS OF THE HANDS OF THE 5 PARTICIPANTS

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1 INTRODUCTION Occupational skin disease may be defined as any disorder of the skin which is caused by or made worse by work or any workplace activity (HSE, 2008). The 2006/07 Self-reported Workrelated Illness survey estimated that there were 29,000 people in the UK with "skin problems" which they believed to be work-related (Turner et al, 2008). High-risk jobs include hairdressing, catering, motor vehicle repair, printing (HSE, 2008), with the occupations with the highest estimated incidence rates in 2004-2006 being "floral arrangers and florists", "hairdressers and barbers"; "rubber process operatives"; "glass and ceramics process operatives" and "beauticians. Agents commonly linked as causes of skin disease include soaps and cleaners, rubber chemicals and materials and wet work (HSE, 2008) Barrier cream products are designed to prevent or reduce the penetration and absorption of irritants (and allergens) into the skin, preventing skin lesions and/or other toxic effects from dermal exposure (Zhai and Maiback, 2002). Barrier creams can also be referred to using a variety of terms including ‘skin protective creams’, ‘protective creams’, ‘pre-work creams’ to name but a few (Zhai and Maiback, 2002; Parkinson, 2000). They tend to be recommended for low-grade irritants such as water, detergents, and organic solvents, cutting oils in order to inhibit or at least reduce the development of cumulative insult dermatitis (Frosch et al, 1992). Such products are typically applied to the hands prior to commencing work activities where the individual may be exposed to potential irritants or wet-work activities. Teichmann et al (2006) reports that barrier creams may act in three different levels on the epidermis, these being an immediate effect by adding a lipid mixture to the skin surface (occlusion); an intermediate effect by adding a lipid mixture to the intercellular spaces and a delayed effect by providing lipids to the epidermal cells which could restore the natural barrier function of the skin. The efficacy of barrier creams had been widely investigated by both in-vitro and in-vivo studies as reported by Zhai and Maibach (2002) and scientific ‘human’ based studies have cast some doubt on the effectiveness of barrier cream products. For example, one workplace based study aimed at comparing the effect of a barrier cream and an afterwork emollient on occupational metalworking fluid dermatitis, no significant differences were found between those workers who used the barrier creams and those who did not use any creams (Gok and Gan, 1994). The UK Health and Safety Executive (HSE) emphasises that caution should be taken when using barrier creams as they ‘they do not make a full barrier to the skin’ (i.e. HSE, 2006) The HSE in an earlier publication also state that such creams ‘.. cannot be relied upon for primary protection of the skin as there is no information on the rate of penetration of chemicals through creams. Also, people habitually miss areas of their exposed skin when applying creams and so complete skin cover cannot be guaranteed.., pre-work creams should not be regarded as PPE.” (HSE, 2001). Barrier cream products are frequently used in a wide variety of working environments and persons using water, soaps and detergents may benefit from frequent application of barrier creams. However to achieve optimal protective effects the products used must be selected with due consideration of the specific exposure conditions, with users being instructed how to apply the product correctly (Zhai and Maibach, 2002). Personal Brands Ltd, contracted the Institute of Occupational Medicine (IOM) to investigate the effectiveness of their barrier cream product called ‘Hands First, invisible gloves dry feel barrier cream*’ in preventing the hands from becoming contaminated compared to other barrier cream products available on the marketplace. This product is designed to be used in a variety of industries including hairdressers, food services, horticulture and the automotive industry. *‘Hands First, invisible gloves dry feel barrier cream’ is a registered trademark of Personal Brands Ltd.

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2 AIMS The primary aim of the laboratory based evaluation was to establish the effectiveness of ‘Hands First, invisible gloves dry feel barrier cream’ in preventing the skin of the hands from becoming contaminated during a simulated handling task, and to compare the products’ effectiveness with other barrier cream products readily available on the market. Secondary research questions included assessing the user acceptability of the barrier cream products tested. We achieved these aims by addressing the following principal objectives: • •

Testing the extent of skin coverage of five barrier creams using a panel of 5 volunteers using a methodology previously described by Parkinson (2000) and Parkinson and Cherrie (2001). The five products to be tested were agreed by Personal Brands. Evaluating the differences, if any, in skin protection between the five products.

This report describes the methodology employed to achieve these objectives, the results of the laboratory based study as well as a discussion of the main study findings.

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3 METHODS 3.1

INTRODUCTION

Methodology previously described by Parkinson (2000) and Parkinson and Cherrie (2001) was used to assess the effectiveness of the barrier creams in protecting the hands from potential water-based contaminants. This method is based on the assumption that to protect the skin a barrier cream must prevent the contaminant from coming into contact and binding with the proteins of the stratum corneum. The method used a fluorescent tracer as a marker of exposure. Barrier cream was firstly applied to the skin. The skin was then sprayed with a liquid containing a fluorescent tracer. After a period of exposure the hands were washed using soap and water. The washing process removes the barrier cream and whatever proportion of tracer that has not come into contact with the skin and bound with the proteins in the stratum corneum. It is assumed that the tracer will be removed along with the barrier cream in areas where the skin was protected. The proportion of the skin area that is unprotected i.e. showing fluorescence is such that the change in fluorescence is inversely proportional to the efficacy of the product in protecting the skin. Subjects had their hands photographed under ultraviolet (UV) light following application of the barrier cream and then at the end of the test period after washing their hands. The protected area was used as our marker of effectiveness. 3.2

EXPERIMENTAL SET-UP

A small light-tight box: 395mm length, 340mm width, 255mm height and 5mm thickness was used (Figure 1). One hole was cut into the side of the box which was large enough for participants to pass one hand into the box. Participants placed their hand on a foam platform that was located on the base of the box. The hole through which the hand was passed was surrounded by a rubber shield to prevent extraneous light from entering. A second hole was made in the lid of the box for a digital camera, which was also lined with foam to prevent light from entering the box whilst ensuring the camera was securely in position. The foam platform which participants placed their hands on ensured that the photographic area remained constant for all experiments. It was determined that this set-up allowed a photographic area of 286 cm2 as described in section 3.7.1.

Figure 1: Example of test box used in laboratory study

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Four battery-powered UV lamps each fitted with a 4-Watt black-light UV tube (F/6INCH/T5/G5/4W/BL), were attached to the underside of the box lid with Velcro attachments. Each lamp was powered by four 1.2V AA batteries. The lamps, which gave an UV light emission of peak wavelengths (350 – 360 nm), were positioned to give the best possible illumination of the participants hands with each lamp located approximately 7.5 cm from the central viewing hole. The fluorescent tracer used in the study was ‘Fluorescent Brightener 28 (free acid) (CAS Number 4404-43-7) supplied by Sigma-Aldrich, Gillingham Dorset. This product is also known as ‘Calcofluor White M2R’ or ‘Tinopal LPW’. The optimal wavelengths for excitation of this product are between 365nm and 400nm. The fluorescent tracer was dissolved in water to give a concentration of 0.0025 w/v %. The fluorescence of this solution decays over time so a fresh solution was prepared on each day of experiments and discarded at the end of the day. The solution bottle was also wrapped in aluminum foil to protect it from UV light. A Sony DSC-U30 digital camera was used to take photographs of the dorsal (back) and palmar (front) regions of both hands of the participants during the study and the digital images were stored electronically on a Memory Stick. The digital camera was set to capture the image sizes of 2.0M pixels (1632 x 1224 pixels) and the flashbulb of the camera was covered with black tape. At the end of each series of tests the images were downloaded to a computer and the area of fluorescence analysed using the Corel Photo-Paint part of the Corel Draw Graphics Suite 12. The graphics analysis package allowed the user to convert the fluorescence in the digital image to a number of white pixels on screen. The use of this program for photographic image analysis is described in further detail in Section 3.9 under Data analysis. 3.3

SELECTION OF PRODUCTS FOR TESTING

‘Hands first barrier cream’ was tested alongside three barrier creams and one emollient cream. This allowed a preliminary comparison with products already available in the skin protection market place. The emollient cream acted as a control against which all the products could be compared. As agreed with Personal Products Ltd, the following products were tested during the laboratory evaluation. (The information provided in the following sections is that provided on the products packaging): 3.3.1

Hands first barrier cream

This product is reported to “create a protective shield’, locking-in moisture whilst remaining completely dry” and is designed to be used in a variety of industries and workplaces including hairdressers, food services, horticulture and the automotive industry. 3.3.2

DEB Protect hand cream

Deb Protect is a multi- purpose barrier cream, which according to the manufacturer will provide protection against both water-based and non-water based contaminants such as oils, grease, detergents, solvents, dry powders and adhesives. The product contains added Paraffinium Liquidum which helps the skin to repel aqueous based substances.

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3.3.3

Savlon barrier cream

Savlon Barrier Cream is reported to give protection against irritants likely to cause dermatitis, giving protection against both wet and dry work involving, for example, water, detergents, paints, oils and grease. 3.3.4

Skinsure salon

This product is a ‘waterproof, antibacterial professional protective moisturizing cream’, which is marketed as being formulated especially for dry skin conditions such as eczema and dermatitis. It is claimed that the product is ideal for hairdressers who already suffer from these complaints as the cream ‘forms a barrier which locks in moisture giving damaged skin the opportunity to begin healing’. The barrier cream is claimed to last for three hours and is waterproof so hands can be washed and it remains active. 3.3.5

E45

This product is an emollient hand cream, suitable as a treatment ‘for dry skin conditions’ and is not marketed as a barrier cream. It is a non-perfumed and non greasy emollient (an agent that softens and soothes the skin) and has been clinically proven to treat and soothe a wide range of dry skin conditions. The performance of the barrier creams relative to this product was determined.

3.4

PARTICIPANTS

Five volunteers from IOM staff were asked to volunteer to participate in the study. 3.5

TEST ARRANGEMENTS

3.5.1

Product preparation and experimental schedule

The identity of the five test products was not made known to the study participants, or to the researcher administering the products during the tests. The products were decanted into a plastic jars by a scientist not involved in the tests, with each being randomly assigned codes known only to this individual (these being A, B, C, D and E). All volunteers were asked to participate in five tests: one product per test. Table 1 shows the schedule for the course of experiments (Table 1). Table 1: Product allocation for each participant test

Test One Two Three Four Five

P01 Product A Product B Product E Product D Product C

P02 Product B Product D Product C Product A Product E

Study participant P03 Product C Product A Product B Product E Product D

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P04 Product D Product E Product A Product C Product B

P05 Product E Product C Product D Product B Product A

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3.5.2

Product Trials

The UV lights in the digital imaging dark box were switched on for 10 minutes prior to each test trial to allow them to reach their standard operating temperature. The sequence of events for experiments started with the participants washing and drying their hands (Table 2). After 5 minutes skin moisture readings were then taken at ten points on the front of the hand: the tip of each of the five digits of the hand and five points on the palm using a corneometer (DermaLab, Cortex Technology). The average of the values for these ten points was recorded as the moisture measurement for the palmar surface of the hand. Similarly for the back of the hand, readings from ten points were used for an estimate of the average moisture level of the dorsal surface of the hand. Trans-epidermal water loss (TEWL) measurements were taken by placing the instrument’s probe for 5 seconds in the middle of the palm and the dorsal surface of the hand for an estimate of TEWL of the palmar and dorsal surfaces of the hand, respectively. The final TEWL reading recorded for each anatomical area was the average of 5 readings taken over the time the probe was in contact with the skin surface. The participant was then requested to read the manufacturer’s instructions for applying the cream and apply the cream accordingly. (The product was unidentifiable from the instructions provided). Following application, the participants were asked to assess the product based on five statements asked by the researcher (Section 3.8). The participant then placed his or her hand in the photographic black box and four images of the hand coated with barrier cream – right palmar area, right dorsal area, left palmar area, left dorsal area - were taken. Each hand was then sprayed ten times with the fluorescent tracer solution resulting in complete and even coverage of the hands, similar to that achieved during an immersion scenario. The participant’s hands were then allowed to dry naturally for a period of 20 minutes. The participant then washed his or her hands with soap and water for one minute before drying his or her hands using disposable paper towels. Finally four images (right palmar area, right dorsal area, left palmar area, left dorsal area) were taken again of the hands. Table 2 Sequence of steps performed during barrier cream tests Action sequence

Sample

Volunteer washes and dries hands (hand wash 1)

-

TEWL and moisture readings of hands obtained

-

Volunteer reads instructions and applies barrier cream

-

Images of hands obtained

RP1; RB1; LP1; LB1*

Rest 5 minutes

-

Hands sprayed with fluorescent tracer (5 sprays each side)

-

Natural hand drying (15 – 20 minutes)

-

Volunteer washes and dries hands (hand wash 2)

-

Fluorescent images of the hands obtained

RP2; RB2; LP2; LB2

Notes: *RP – right palmar area; RB – right dorsal area; LP – left palmar area; LB – left dorsal area

The amount of barrier cream applied by each participant was determined by recording the weight of the container and test product before and after each application. As fluorescent tracer can have a residual effect on the skin, a time period of at least 3-4 days was left between subsequent tests to allow the skin to be naturally shed and replenished. Periodic checks of participants were done on days between the experiments to ensure that sufficient desquamation resulting in removal of fluorescence from the stratum corneum,

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occurred before the next set of experiments. These checks involved looking at the palmar surface in the photographic black box, photographing the hand and analyzing the hand with the Corel Draw software. 3.6

OBSERVATIONS AND DATA RECORDING

A standard form was developed to record key information in a controlled systematic manner during the laboratory tests (Appendix I). This included information on: • • • •

3.7

Participant information – e.g. age, gender, work undertaken prior to test and normal use of hand creams/ barrier creams Skin condition – e.g. skin ‘type’, skin hydration and TEWL measurements Test information – date and time of test, product tested, photograph file numbers Product information – participants’ assessment of the product e.g. ease of application, whether the product felt greasy, subjective assessment of skin quality following test. ASSESSMENT OF PARTICIPANTS’ HAND CONDITION

Hand condition was assessed using two different methods. In the first method a subjective visual assessment of the participant’s skin condition prior to participating in each of the tests was carried by the researcher conducting the experiments. This involved a brief inspection of the surface area of the hands and recording five markers of hand condition: (i) Redness and swelling of hand/fingers (ii) Cracking of skin on hands/fingers (iii) Blisters on hands/fingers (iv) Flaking or scaling of skin on hands/finger and (v) Itching of fingers/hands with cracks or splits. The second method was a quantitative method in which measures of TEWL and the skin hydration state were taken. TEWL is the rate at which water vapour is lost from the body across the skin and is based on the measurement of the vapour pressure gradient between two points close to the skin. TEWL units are expressed as grams of water loss per body surface area in one hour (g/m2/hr). TEWL measurements may be useful for identifying skin damage as rates of TEWL increase in proportion to the level of damage. Measurements of Skin Hydration are based on the water binding capacity of the stratum corneum. The principle of measurement is based on determining the electrical capacitance (dielectricity) of skin. Skin hydration units are arbitrary units. Both TEWL and moisture content measures were taken using the DermaLab® (Cortex Technology, as described in section 3.5.2. This device was also equipped to take humidity and temperature measurements and these were also recorded during each test. 3.8

PARTICIPANTS’ ASSESSMENT OF PRODUCTS TESTED

Each participant was asked to assess the ease of application and influences on skin quality following application of the creams. Their level of agreement on a five-point Likert scale for five statements was recorded. The choices were ‘strongly agree’, ‘agree’, ‘neutral’, ‘disagree’ and ‘strongly disagree’ to the statements: Statement 1: The cream I used today was easily absorbed. Statement 2: The cream I used today left my hands feeling wet/sticky Statement 3: The cream I used today felt pleasant/ comfortable on my skin Statement 4: The cream I used today irritated my skin Statement 5: The cream I used today improved the condition of my skin.

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3.9

DATA ANALYSIS

3.9.1

Image analysis

Photographic images were analysed using the Corel Photo Paint element of the Corel Draw Graphics Suite 12 software package (Corel Draw Corporation, 2005). A facility of the Corel Photo Paint software is a histogram relating the brightness of different sections of an image with values ranging from 0 (black) to 255 (white). When converted to greyscale the level of brightness in the white regions is 255. The number of pixels occupied by an area of certain brightness can be determined from the histogram window. Making use of this information it was possible to determine the number of pixels occupied by any white area of an image. The photographic area within the black box in view of the camera when placed into position was determined by placing a white sheet of paper on the foam platform inside the box and marking off the photographic area within the camera’s view. It was determined that the total photographic area was equivalent to 286 cm2. The camera was set to take image sizes of 1,997,568 (i.e.1632 x 12224) pixels. The relationship between the photographic surface area and pixels for the experimental set-up used was calculated to be 1.4 x 10-4 cm2/pixel. Each hand image was imported into Corel Photo Paint and the colour mode set to an 8-bit greyscale. In the Corel software there is an option to set a threshold value which allows users to specify a brightness value as a threshold. The threshold is a value in the image that represents the border between black and white, so that all values in the image that are lighter than the threshold appear as white, and all values darker appear as black. Thus, pixels with a brightness value higher or lower than the threshold will display in white with a brightness value of 255 or black with a brightness value of 0, depending on the threshold option specified. In this study a threshold value of 5 was chosen for all images analysed. The number of pixels corresponding to the white (i.e. fluorescent) regions was recorded for each image. 3.9.2

Exposure Calculations

The measure of the efficiency of the respective creams in protecting the skin was based on the ability of the cream to act as a barrier between the fluorescent solution sprayed onto the creamprotected skin and the stratum corneum. Following application of the fluorescent solution to the cream-covered skin and subsequent hand-washing, any fluorescence detected that is in excess of that detected when the skin is covered with barrier cream alone (see Table 2), is indicative of the fluorescent solution breaking through the protective barrier cream layer. Consequently, the protectiveness of the creams was related to the change in fluorescence as indicated by the change in the number of pixels corresponding to the white regions on the hand images. The following equations were used to determine the change in fluorescence of dermal surfaces. The equation used for calculating product usage or hand coverage is also given. Pre- and Post- Hand Fluorescence is calculated as:

⎞ ⎟⎟ × 100 ⎝ Total photographic area ( pixels) ⎠ ⎛

preHand fluorescence (%) = ⎜⎜

preHandF ( pixels)

⎞ ⎟⎟ × 100 ⎝ Total photographic area ( pixels) ⎠ ⎛

postHand fluorescence (%) = ⎜⎜

postHandF ( pixels)

10

(1)

(2)

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preDermal area of fluorescence (cm 2 ) = pre − Hand Fluorescence x Dermal area (cm 2 )

(3)

postDermal area of fluorescence (cm 2 ) = post − Hand Flourescence x Dermal area (cm 2 )

(4)

where, preHandF = Area of fluorescence of hand when covered with barrier cream (pixels) postHandF = Area of fluorescence of hand after spraying and second hand washing (pixels) preDermal area of fluorescence = Area of fluorescence of hand when covered with barrier cream (cm2) postDermal area of fluorescence = Area of fluorescence of hand after spraying and second hand washing (cm2) and, Dermal Area male hands (cm2) = 210 cm2 ( 1) Dermal Area female hands (cm2) = 186.5 cm2

(1)

The final index of protection is calculated as the average of two estimates of protection. The first estimate of protection, Protection factor 1 (PF1), assumes a best-case scenario. In this calculation, the fluorescent areas of the cream-covered skin prior to application of the fluorescent test solution are assumed to confer 100 percent protection. The second estimate of protection. Protection factor 2 (PF2), assumes a worst-case scenario, where areas showing fluorescence prior to fluorescent solution application, experienced breakthrough of the Barrier Cream. These protection factors are expressed as percentage of skin protection afforded. The relevant calculations are as follows.

⎛ ⎞ Area protected (cm 2 ) ⎟ x100 PF1 = ⎜⎜ 2 2 ⎟ ⎝ Dermal area (cm ) − preDermal Area of fluorescence (cm ) ⎠

(5)

⎛ Area protected (cm 2 ) ⎞ ⎟⎟ x100 PF2 = ⎜⎜ 2 Dermal area ( cm ) ⎠ ⎝

(6)

⎛ PF + PF2 ⎞ PF = ⎜ 1 ⎟ 2 ⎝ ⎠

(7)

where, PF1 (%) = protection factor 1: percentage of the hand protected by the barrier cream, assuming there was no breakthrough of the barrier cream by the fluorescent (1)

Values based on the US EPA Exposure Factors Handbook 1997. In this handbook, Total dermal surface for male hands = 840 cm2 and for female hands = 746 cm2. The values used in equations 3 and 4 are for the surface of half of one hand.

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test solution in the areas that showed fluorescence prior to application of the test solution. PF2 (%) = protection factor 2: percentage of the hand protected by the barrier cream, assuming there was breakthrough of the barrier cream by the fluorescent test solution in the areas that showed fluorescence prior to application of the test solution. PF (%) = Overall Protection Factor: estimate of the percentage of the hand protected by the barrier cream.

The hand coverage of the cream could influence the protectiveness of the cream. Equation (8) shows the calculations for the dermal surface load of the cream.

Hand Cream Load ( mg / cm 2 ) =

Mass of cream used (mg ) Surface area of both hands (cm 2 )

(8)

where, Surface area for male hands = 840 cm2 Surface area for female hands = 746 cm2

3.9.3

Data Analysis

Data were analysed using the statistical package SPSS 15 for Windows and Microsoft Excel. The researcher performing the data analysis remained blind to the identity of the barrier creams.

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4 RESULTS 4.1

PARTICIPANT DETAILS

It was not possible to adhere to the experiment schedule shown in Table 1 due to a combination of participant availability and residual fluorescence on participants’ hands from previous test days. Consequently, the study involved nine days of laboratory tests during which one female and four male volunteers participated. The details of the participants’ characteristics are provided in Table 3. The skin condition of the hand based on the researcher’s visual inspection of the dermal surface is also detailed. The skin condition of participants did not change over the duration of the experiments. One exception to this was noted in participant P05 where a mild abrasion on the surface of his palm was noted on one of the test days. There were two participants, P02 and P03, whose hands showed some degree of cracking. For the other three participants none of the symptoms examined of interest were observed. Table 3: Study participant details PartID

Gender

Age

P01

male

50

P02

male

52

P03

male

22

P04

female

-

P05

male

24

Skin colour

white, tans easily white, does not tan easily white, does not tan easily white, tans easily white, tans easily

Initial skin condition of the hand redness & swelling X

cracking

blisters

X

X

itching with cracks/splits

X

flaking & scaling X

9

X

X

X

X

9

X

X

X

X

X

X

X

X

X

X

X

X

X

X

9 - symptom observed X – symptom not observed Participants ranged in age from 22 to 52 years of age. Most of the participants were generally engaged in deskwork or dry laboratory work just prior to participating in these tests. One participant, P04 had used a hand lotion on two occasions at least one hour prior to taking part in the test. However, all participants washed their hands just prior to test so this should have had minimal influence. 4.2

PRODUCT TESTS

The name of the five products tested remained unknown to the researcher throughout the laboratory trials and the data analysis. To assist with interpreting the results it can be revealed that ‘Hands first barrier cream’ is product C and E45, the control emollient cream is product A. Four of the five volunteers participated in all five product tests. However due to lack of availability, one volunteer was only able to participate in three product tests (Table 4). This resulted in a total of 23 product tests being completed, with the complete test runs being achieved with products A, B and C and four out of the five tests being completed for products D and E.

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Table 4: Completed product tests Product

Study participant P02 P03 9 9 9 9 9 9 9 × 9 ×

P01 9 9 9 9 9

A B C D E

9 - test completed;

4.3

P04 9 9 9 9 9

P05 9 9 9 9 9

Completed tests 5 5 5 4 4

× - test not completed

ASSESSMENT OF SKIN CONDITION OF PARTICIPANTS’ SKIN

Table 5 shows the results for the quantitative measurements of skin condition for the five participants over the course of the study. Generally, average TEWL and skin hydration measurements did not differ significantly among participants and the values for the two participants whose hands had shown symptoms of physical damage, P02 and P03, were not reflected in the TEWL or skin hydration measurements. Table 5 Skin condition of participants’ hands using quantitative measurements Part ID

TEWL (g/m2/hr)

N

Skin hydration (AU)

AM (SD)

AM (SD)

RP 8.6 (1.2)

RB 11.2 (11.3)

LP 7.8 (3.3)

LB 10.9 (11.7)

RP 33 (24)

RB 22 (6)

LP 23 (14)

LB 22 (5)

P01

4

P02

4

10.35 (4.4)

10.05 (3.8)

15.05 (7)

9.3 (7.2)

30 (15)

38 (39)

17 (12)

17 (11)

P03

3

14.07 (9.7)

11.93 (13.1)

6.77 (1.6)

9.43 (4.3)

33 (13)

32 (14)

31 (14)

19 (8)

P04

5 5

12 (7.3) 13.36 (9.7)

8.8 (3.9) 12.94 (4.5)

14.2 (9.2)

P05

13.3 (5.7) 10.24 (4.8)

17 (7) 191 (151)

31 (5) 36 (17)

23 (5) 364 (179)

22 (10) 42 (7)

9.66 (4.4)

Note: AU - Arbitrary units; AM – Arithmetic mean; SD – Standard deviation; RP – Right palmar region; RB – Right dorsal region; LP – Left palmar region; LB – Left dorsal region

Given the apparent similarity of the skin condition of the participants based on the subjective and quantitative assessments we have not considered this influence in further analyses. 4.4

SUBJECTIVE ASSESSMENT OF SKIN PRODUCTS TESTED

The detailed results of the participants’ assessment of the skin products are given in Appendix II. Each product should have been rated 5 times (once by each participant). However, due to missing data, products D and E were rated 4 times. Table 6 gives the results of the first three statements and Table 7 gives the results for the latter two statements. In Tables 6 and 7 the choices of ‘strongly agree’ and ‘agree’ were collapsed into one category called ‘Yes’ and

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‘strongly disagree’ and ‘disagree’ were collapsed into one category of ‘No’. This was to provide a more useful assessment of the results since the numbers were small. Statements 1 and 3 were statements about a positive quality of the cream while statement 2 would have been considered a negative quality. Products D and E scored the highest with respect to these positive statements with all 4 participants who tested product E rating it as both ‘easily absorbed’ and ‘pleasant/comfortable’ and all 4 participants who tested product D rating it as ‘easily absorbed’ and 3 out of 4 rating it as ‘pleasant/comfortable’. For the remaining 3 products, E45 (product A), product B and Hands First Barrier Cream (product C), there was an almost equal split between ‘yes’ and ‘no’ for it being ‘easily absorbed’. However most participants found the creams felt pleasant/comfortable. With respect to statement 2, cream A was most highly rated as leaving participants’ hands ‘wet and sticky’ with 4 our of 5 participants indicating this. Most participants (4 out of 5) found that Hands First Barrier Cream did not leave the hands feeling wet/sticky. Table 6 Results of the rating of the creams for statements 1 to 3 Product

The cream I used today … …was easily absorbed

A B C D E

…left my hands feeling wet/sticky

…felt pleasant/ comfortable

Yes

neutral

No

Yes

neutral

No

Yes

neutral

No

2 3 2 4 4

0 0 0 0 0

3 2 3 0 0

4 3 1 2 0

0 0 0 0 1

1 2 4 2 3

3 4 4 3 4

1 0 0 0 0

1 1 1 1 0

Note: Product A – E45; Product C – ‘Hands first barrier cream’ With respect to Statements 4 and 5 where participants were asked whether the cream ‘irritated’ (statement 4) or improved (statement 5), their skin, most participants disagreed that the cream irritated their skin. Statement 5 resulted in the highest number of neutral answers (52%) out of all the statements put to the participants. These participants found it difficult to assess whether or not a cream improved their skin in such a short space of time. All other answers for this question were positive with participants agreeing that the product improved their skin. However, no product stood out with respect to this property. Table 7 Results of the rating of the creams for statements 4 and 5 Product

The cream I used today … …irritated my skin

A B C D E

…improved the condition of my skin

Yes

neutral

No

Yes

neutral

No

0 0 0 0 0

0 1 1 0 0

5 4 4 4 4

2 3 3 2 1

3 2 2 2 3

0 0 0 0 0

Note: Product A – E45; Product C – ‘Hands first barrier cream’

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4.5

PROTECTIVE RATINGS OF THE BARRIER CREAMS

In total 183 images were taken and analysed during the course of the study. Ninety-one of these were images of participants hands covered with product, prior to applying the fluorescent solution and ninety-two were images of the hands after application of the fluorescent solution. One pre-image was not recorded properly so that image was discarded, resulting in 91 complete data image sets. Participants had been asked to apply the respective creams after reading the manufacturer’s instructions. The average dermal coverage of the creams was 3.3 mg/cm2 (N=23; SD = 1.2 mg/cm2). The average pre- and post- fluorescence of the different areas of the hands are given in Table 8. In general, the average fluorescence on the palmar areas of the hands was higher than on the dorsal regions of the hand with initial fluorescence of the right and left palms ranging from 0.26 to 24.41 % (SD 5.39) and 0.22 to 25.31 % (SD 5.15), respectively. For the dorsal regions of the right and left hands the initial fluorescence ranged from 0.15 to 5.72% (SD 1.57) and 0.12 to 5.76% (SD 1.59), respectively. Table 8 Average overall initial and post-fluorescence by body-part Bodypart

right palm right back hand left palm left back hand

N

23 23 23 22

PRE- fluorescence (%) AM Range 5.9 0.3 - 24.4 1.6 0. 2 - 5.7 4.6 0.2 - 25.3 1.4 0.1 - 5.8

SD 5.4 1.6 5.2 1.4

POST- fluorescence (%) AM Range SD 39.2 3.9 - 53.6 11.6 29.8 0.6 - 47.2 13.6 37.0 5.5 - 52.1 12.4 27.8 0.6 - 48.5 14.3

Note: AM – Arithmetic mean; SD – Standard deviation Initial fluorescence was generally below 10% of the skin area, although this was exceeded in 4 out of the 91 pre-images. All were on the palms, three from the same participant (P01) during tests with products A and C and the one was with participant 4 during tests with product D (Appendix III: Figure A4.1). Similar to the initial fluorescence values, the average post-fluorescence on the palmar regions of the hands was higher than on the dorsal regions of the hand. The post fluorescence of the right and left palms ranged from 3.9 to 53.6 (SD 11.6) and 5.5 - 52.1 % (SD 12.4), respectively. For the dorsal areas of the right and left hands the post fluorescence ranged from 0.6 - 47.2% (SD 13.6) and 0.6 - 48.5% (SD 14.3), respectively (Table 8). Product A appears to have maintained the highest number of recorded post-fluorescence values under 10% (9 out of 20), with the majority of the post-fluorescence values remaining below 30% (16 out of 20). This is followed by Product C with just 2 out of 20 post-fluorescence values under 10% but with 7 out of 20 post-fluorescence images under 30% (Appendix III: Figure A4.2). However, the overall protectiveness of the creams is better illustrated in Table 9 and Figures 2 and 3. (Appendix III: Figure A4.3 shows these results by individual hand region). The pre- and post- Hand Fluorescence values have been used in equations (1) to (7) to calculate the protection factor for each cream. This protection factor (PF) gives an estimate of the protection afforded by the respective creams and is expressed in terms of percentage of the dermal area protected by the cream. Table 9 gives the results of the protection conferred by each cream on the four different regions of the hand. The average of these is taken as the overall protection factor of the cream. Table 9 also gives the dermal concentration of the cream applied in mass per square metre of skin (hand cream load).

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Changes in protection ranged from 60.7% to 82.9%. i.e. protected areas ranged from 509 cm2 to 696 cm2 for the male hand. Based on the Protection Factors (PF), Product A, the emollient cream E45 was the most protective with a PF value of 82.9%. This was followed by Hands First Barrier Cream with a PF value of 69.8%. The PF values of the other three products, Products B, D and E, did not differ considerably from each other with values ranging from 60.7% to 62.2%. The consistency of protection varied among products with the most variable results being obtained for Product D with a standard deviation (SD)of PF of 23%. This was followed by Product E with a SD of 18.7. The most consistent was for Product B with a SD of 8.6% while that of Hands First was 11.4%. Table 9 Protection of the test products by participant, product and bodypart PartID

P01 P02 P03 P04 P05 A P01 P02 P03 P04 P05 B P01 P02 P03 P04 P05 C P01 P02 P04 P05 D P01 P02 P04 P05 E

ProdID

A A A A A AM SD B B B B B AM SD C C C C C AM SD D D D D AM SD E E E E AM SD

BCload mg/cm2 4.4 4.4 3.7 2.2 2.2 3.4 1.1 4.2 2.5 2.6 3.2 5.5 3.6 1.3 3.7 3.1 1.8 4.0 2.8 3.1 0.8 3.3 2.9 1.7 5.8 2.9 1.9 2.9 5.3 1.2 2.4 2.7 1.6

Protection (%) right left palm dorsal 98.0 91.6 73.1 53.2 73.5 72.4 90.2 74.7 99.8 94.6 86.9 77.3 12.9 16.7 60.4 55.6 56.4 48.6 61.3 60.3 77.7 71.5 70.2 61.1 65.2 59.4 8.6 8.4 78.4 70.8 54.6 49.2 66.5 61.8 90.7 76.3 72.1 65.9 72.5 64.8 13.5 10.3 65.5 58.6 53.1 48.4 69.6 65.8 60.4 61.5 52.4 48.9 22.6 22.5 59.1 58.8 56.2 50.5 67.0 67.4 73.3 66.5 55.6 53.2 19.6 18.4

right palm 100.7 51.5 70.5 74.6 96.9 78.8 20.3 53.5 50.4 57.9 74.2 62.9 59.8 9.3 68.8 47.8 67.2 77.7 63.5 65.0 10.9 58.5 48.0 70.2 59.4 49.4 22.9 52.7 49.7 64.8 66.7 51.4 17.6

left dorsal 98.5 70.2 80.2 93.4 99.8 88.4 12.8 60.2 54.2 65.1 77.0 65.4 64.4 8.4 . 58.7 82.4 93.2 77.0 77.8 14.4 66.8 51.7 70.2 62.9 53.2 22.8 61.8 55.2 67.8 73.4 56.2 19.9

PF (%) 97.2 62.0 74.2 83.2 97.8 82.9 15.3 57.5 52.4 61.2 75.1 64.9 62.2 8.6 72.7* 52.6 69.5 84.5 69.6 69.8 11.4 62.4 50.3 68.9 61.1 60.7 23.0 58.1 52.9 66.8 70.0 61.9 18.7

PartID – Participant ID; ProdID – ProductID; BCload – Barrier cream load; PF – Protection factor (%) ; AM – Arithmetic mean; SD – Standard deviation; RP – Right palmar region; RB – Right dorsal region; LP – Left palmar region; LB – Left dorsal region; Note: Product A – E45; Product C – ‘Hands first barrier cream’ *Value based on average of change in Fluorescence of 3 dermal regions.

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100 90 Protection (%)

80 70 60 50 40 30 20 10 0 A

A

A

A

A

B

B

B

B

B

C

C

C

C

C

D

D

D

D

E

E

E

E

P01 P02 P03 P04 P05 P01 P02 P03 P04 P05 P01 P02 P03 P04 P05 P01 P02 P04 P05 P01 P02 P04 P05 Product ID / Participant codes

Note: Product A – E45; Product C – ‘Hands first barrier cream’ Figure 2: Protection (%) for each product /participant pair and showing the hand load concentration of the barrier cream.

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A correlation analysis was performed to determine if the dermal hand cream load influenced the effectiveness of the respective creams. No relationship was found and with s0 few data there was no statistical significance (r = -0.133; p = 0.556). 4.6

RELATIVE PERFORMANCE OF HANDS FIRST BARRIER CREAM

The highest protection factor was seen for the emollient hand cream E45, which was the control cream. The relative effectiveness of all the products represented as protection factors (%) relative to the control is shown in Figure 3. In Figure 3, Protection Factors for each product is represented in boxplots with the upper and lower horizontal lines of the box indicating the 75th and 25th percentiles, respectively and the horizontal line within the box showing the 50th percentile (median value). The overall protection factor for the control is indicated at 83% and it is clear that all products had lower barrier protection compared with the control.

Figure 3: Overall protection factor (%) of each of the products tested. The average protection factor for the control cream, E45 is indicated

Hands First Barrier Cream was found to be 16 % less efficient than E45 but was observed to be between 9 to 11% more efficient that the other three barrier creams tested.

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5 CONCLUSION AND DISCUSSION A small laboratory-based study was undertaken to determine the effectiveness of ‘Hands First, invisible gloves dry feel barrier cream’ in preventing the skin of the hands from becoming contaminated during a simulated exposure scenario, and to compare the product’s effectiveness with other barrier cream products readily available on the market and one emollient hand cream. Our findings suggest that Hands First Barrier Cream was the most protective among the barrier cream products tested in this study using these methods. However, while it appeared to be more effective than the other barrier creams, the control emollient cream seemed to perform better than all the creams tested with Hands First Barrier Cream being 16 % less effective than the control but between 9 to 11 % more effective than the other barrier creams. Given the small difference in protective ratings between the Hands First Cream and the other barrier creams and the small sample size of this study there is some degree of uncertainty and the results should be interpreted with care. A much larger laboratory study would be needed to establish whether the differences observed are statistically significant With respect to participants’ subjective rating of the different products on ease of application, and influences on skin quality, products D and E scored highest with respect to positive statements about the products (easily absorbed, felt pleasant/comfortable) while E45 scored the highest with respect to the negative quality of ‘left hands feeling wet and sticky’. Participants found it difficult to assess the influence on skin quality of the products. Some felt that skin improvement was something that needed repeat applications over a period of time to determine. Consequently this question was often answered as ‘neutral’ relatively more than any of the other statements put to the participants. With respect to whether or not any of the creams irritated their skin, the answer was always negative. Generally the subjective assessment of Hands First Barrier Cream tended towards the positive for most of the statements put to the participants. Two out of the five participants who rated Hands First found that it was ‘easily absorbed’, four out of five found that it ‘felt pleasant/comfortable’, while only one out of five felt that it left his hands feeling wet/sticky. With respect to influence on the skin four out of five said it did not irritate the skin with the other participant returning an answer of ‘neutral’. Also, three agreed that it improved the skin and two returned an answer of ‘neutral’ with respect to the question of whether of not it improved the skin. The main limitation of this study was the small sample size. Consequently, the reported differences between the products are suggestive only. Another possible limitation was the overrepresentation of male participants. Given that the target market for Hands First Barrier Cream is within the hairdressing sector, it would have been better to have more female participants. Unfortunately, it was not possible to recruit additional female participants. However, given the similarity of participants’ hands using both objective and subjective measures this may not be an issue and the hand conditions observed may well be representative of the target group for this product. Efficacy of BCs is influenced by application methods (Zhai and Maibach, 2002). The ease of application is likely to be influenced by how easily the cream spreads on the skin. Using the methods described here it was not possible to determine the precise distribution of hand cream on the skin. However, based on the hand loading data it was observed that the control, which had the most frequent rating of leaving the hands ‘wet/sticky’ had the highest number of hand loading values above the average of 3.3 mg/cm2 while the creams D and E both of which had the most frequent rating of being ‘easily absorbed’ had the highest number of hand loading values below the average. This may suggest that certain aspects of the cream can influence how efficiently the cream is applied and consequently its protective efficacy. It is possible that the

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differences in loadings observed here may be related to the density of the cream since there was nothing to influence the participants from applying a larger amount of cream from one session to the next. Also there was no correlation between the level of hand loading and the efficacy of the creams. If one accepts the hypothesis that barrier creams provide protection by physically blocking agents from coming into contact with the skin’s surface then a physical property such as the density of the cream would be expected to have an influence on the protection afforded by these products. This was not tested. Also the greasiness or oiliness of the product does have an influence on the efficacy of BCs depending on the nature of the solution that contacts the treated skin. The general rule is that water in oil (W/O) emulsions are more effective against aqueous solutions of irritants and oil in water (O/W) emulsions are more effective against lipophilic materials (Zhai and Maibach 2002). Rieger et al., (2007) investigated three different methods to test the efficacy of three different BCs against the penetration of a hydrophilic dye solution. Among the BCs tested was the highly greasy Vaseline and all three methods showed that the Vaseline had the most protective effect conferring 100% protection against penetration by a fluorescent solution. Our findings that the ‘wet/sticky’ control appeared to be the most protective of the creams against the aqueous fluorescent dye solution is comparable with the results of Reiger et al., 2007. It is however important to consider the cosmetic qualities of the creams since the feel of the product on the skin may be an important factor in compliance issues. According to Perrenoud et al., 2001, who conducted a study to investigate the efficacy of a barrier cream in the hairdressing industry, participants seemed to find that the cosmetic qualities of the creams to be as important as their real protective and hydrating properties. However, the importance of such properties will differ for workers in different types of industries since as noted by Perrenoud et al., as a group, hairdressers have a heightened sensitivity to aesthetic issues. In addition there is the increased risk of losing hold of tools when using very greasy substances (Wigger-Alberti et al., 1998). The importance of the physical qualities of cosmetic acceptance and non-greasiness should not be under estimated since as indicated by Lushniak et al., (2003), among the nine important qualities of BCs were ‘ease of application’, ‘cosmetic acceptability’ and ‘noninterference with grip, especially in occupational settings’. Although the small sample size puts limitations on the confidence with which these products can be rated against each other, the results suggest that overall Hands First Barrier Cream scored better than the other products tested when one considers both protectiveness and desirable properties to users. However, it should be noted that the products in this study were tested against one aqueous solution only and BCs vary considerably in their ability to protect against a range of different types of substances (Lushniak et al., 2003). Consequently, the relative protective ratings are specific for protection against an aqueous solution and subsequent tests with different types of solutions could give different results. The efficacy of the cream will depend on the specific exposure(s), the hygiene and work practices of the individual, and the interval of re-application of the barrier creams (Lushniak et al., 2003).

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6 GLOSSARY Pixels – A pixel (short for picture element, using the common abbreviation "pix" for "pictures") is a single point in a graphic image. It is generally thought of as the smallest single component of an image. Threshold — In the Corel software the threshold allows user to specify a brightness value as a threshold. Pixels with a brightness value higher or lower than the threshold will display in white or black, depending on the threshold option you specify.

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7 ACKNOWLEDGEMENTS This work was funded by Personal Brands Ltd and we would like to thank Mike Corzberg and Amanda Miles for all their support and assistance during the study. The authors would like to thank Mike Beveridge for assisting with the construction of the sampling box. Thanks also to Dr. Sean Semple and Dr. John Cherrie for their helpful comments when preparing this report. Finally, we would like to thank all the participants in this study for their time and collaboration with the study.

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8 REFERENCES Frisch PJ, Schultze-Dirks A, Hoffmann M et al (1993). Efficacy of skin barrier creams. (1) The repetitive irritation test (RIT) in the guinea pig. Contact Dermatitis; 28: 94-100. Goh CL, Gan Sl. (1994). Efficacies of a barrier cream and an after work emollient cream against cutting fluid dermatitis in metal workers: a prospective study. Contact Dermatitis; 31: 176-180. HSE (2008). Dermatitis and other skin disorders. Available from URL: http://www.hse.gov.uk/statistics/causdis/dermatitis/index.htm. Last accessed 1st June 2008. HSE (2006). Hairdressing. SR11 COSHH Essentials for service and retail. Available from URL: http://www.hse.gov.uk/pubns/guidance/sr11.pdf. Last accessed 1st June 2008. HSE (2001). Assessing and managing risks at work from skin exposure to chemical

agents”. U.K.Health and Safety Executive, ISBN 0-7176-1826-9 Lushniak B, Mathias CGT, Taylor JS (2003). Barrier Creams: Fact or Fiction. Dermatitis; 14(2): 97-98. Parkinson MT (2000). A new method to measure the effectiveness of barrier creams. Master of Science thesis; University of Aberdeen. Parkinson M, Cherrie JW (2001). The effectiveness of barrier creams in protecting against dermatitis: a pilot study. Available from URL: http://www.abdn.ac.uk/~oem148/Parkinson%20and%20Cherrie%202001.hti. Last accessed 28th November 2007. Perrenoud D, Gallezoti D, Van Melle G (2001). The efficacy of a protective cream in a realworld apprentice hairdresser environment. Contact Dermatitis; 45: 134-138. Rieger T, Teichmann A, Richter H et al (2007). Evaluation of barrier creams – Introduction and comparison of 3 in vivo methods. Contact Dermatitis; 56: 347-354 Teichmann A, Jacobi U, Waibler E, et al (2006). An in vivo model to evaluate the efficacy of barrier creams on the level of skin penetration of chemicals. Contact Dermatitis; 54: 5-13. Turner S, Carder M, Van Tongeren M, et al. (2007). The incidence of occupational skin disease as reported to the Health and Occupation Reporting (THOR) network between 2002 and 2005. British Journal of Dermatology; 157(4); 713-722. Wigger-Alberti W, Rougier A, Richard A et al (1998). Efficacy of Protective Creams in a Modified Repeated Irritation Test. Methodological Aspects. Acta Derm Venereol (Stockh); 78: 270–273 Zhai H, Maibach HI. (2002). Barrier creams – skin protectants: can you protect skin? Journal of Casmetic Dermatology; 1: 20-23.

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APPENDIX I – LABORATORY STUDY RECORD SHEETS Date:

Time:

Product identifier:

Participant ID number:

Gender:

Male

Female

Age (years):

Skin colour:

White skin, does not easily tan White skin that tans easily Brown skin Black skin

Work before test:

Use of hand / barrier cream before test? If yes:

Product:

Time last applied:

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Assessment of participants skin condition prior to test: TEWL reading Skin hydration Humidity Temperature

g/m3/hr % C

0

Does the participant’s hands show any of the following symptoms? Yes

No

Redness & swelling of hands or fingers Cracking of skin on hands or finger Blisters on hands or fingers Flaking or scaling of skin on hands/fingers Itching of fingers/hands, with cracks or splits

Digital images: File number Start of test

Right palm Right back Left palm Left back

End of test

Right palm Right back Left palm Left back

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Subjective assessment of skin product: Please state how strongly you agree / disagree with the following statements. ‘The cream I used today……’ Strongly agree

Agree

Neutral

Disagree

Strongly disagree

was easily absorbed / rubbed into my hands left my hands feeling wet and sticky felt pleasant / comfortable on my skin irritated my skin

improved the condition of my skin after use

Do you have any other comments about this product that you would like to make?

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APPENDIX II – DETAILED RESULTS OF PARTICIPANTS’ ASSESSMENT OF PRODUCTS Product

A B C D E Product

A B C D E Product

A B C D E

The cream I used today was easily absorbed strongly agree 0 0 0 1 1

Product

A B C D E

neutral 0 0 0 0 0

disagree 1 1 2 0 0

strongly disagree 2 1 1 0 0

missing 0 0 0 1 1

The cream I used today left my hands feeling wet/sticky strongly agree 2 1 0 0 0

agree 2 2 1 2 0

neutral 0 0 0 0 1

disagree 1 2 2 1 1

strongly disagree 0 0 2 1 2

missing 0 0 0 1 1

The cream I used today felt pleasant/ comfortable on my skin strongly agree 0 1 2 0 3

Product

A B C D E

agree 2 3 2 3 3

agree 3 3 2 3 1

neutral 1 0 0 0 0

disagree 0 1 1 1 0

strongly disagree 1 0 0 0 0

missing 0 0 0 1 1

The cream I used today irritated my skin strongly agree 0 0 0 0 0

agree 0 0 0 0 0

neutral 0 1 1 0 0

disagree 3 1 0 0 0

strongly disagree 2 3 4 4 4

missing 0 0 0 1 1

The cream I used today improved the condition of my skin strongly agree 0 0 1 1 0

agree 2 3 2 1 1

neutral 3 2 2 2 3

disagree 0 0 0 0 0

strongly disagree 0 0 0 0 0

missing 0 0 0 1 1

Note: Product A – E45; Product C – ‘Hands first barrier cream’

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APPENDIX III – FIGURES SHOWING PRE- AND POST- TEST FLUORESCENCE OF THE DIFFERENT AREAS OF THE HANDS OF THE 5 PARTICIPANTS

A4.2

post - Fluorescence (%)

pre - Fluorescence (%)

A4.1 Pre - Fluorescence

60

right palm

50

right back hand

40

left palm

30

left back hand

20 10 0 A

A

A

A

A

B

B

B

B

B

C

C

C

C

C

D

D

D

D

E

E

E

E

P01

P02

P03

P04

P05

P01

P02

P03

P04

P05

P01

P02

P03

P04

P05

P01

P02

P04

P05

P01

P02

P04

P05

Post- Fluorescence 60 50 40 30 20 10 0 A

A

A

A

A

B

B

B

B

B

C

C

C

C

C

D

D

D

D

E

E

E

E

P01

P02

P03

P04

P05

P01

P02

P03

P04

P05

P01

P02

P03

P04

P05

P01

P02

P04

P05

P01

P02

P04

P05

Product ID / Participant Code

Figure A4 Pre- and Post-fluorescence for each hand region by Product ID, Participant code for all the products tested.

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right palm 120

right back

Protection by dermal area (%)

left palm 100

left back

80

60

40

20

0 A

A

A

A

A

B

B

B

B

B

C

C

C

C

C

D

D

D

D

E

E

E

E

P01 P02 P03 P04 P05 P01 P02 P03 P04 P05 P01 P02 P03 P04 P05 P01 P02 P04 P05 P01 P02 P04 P05 Product ID / Participant code

Figure A4.3 Percentage protection for each hand region by Product ID, Participant code for all the products tested.

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3/15/06

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