New Evidence Suggests Possible Alternative To Steriods For Children With ATOPIC ECZEMA

DermaSilk reaches the bottom of the world

When arctic explorer and eczema sufferer Helen was planning her recent Antarctic trek she turned to DermaSilk Therapeutic Clothing as her base layer of choice. Previous experience with modern artificial fibre garments with wicking ability caused her, already damaged skin to dry even more and, as she explained, there is nothing worse than stripping down to next to nothing to apply moisturisers when the temperature is 30 degrees below zero and there is a 40 mph wind outside your tent! Happily for Helen the DermaSilk performed as expected and we are assured that they are in the picture – even though they are several layers down!

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DermaTherapy Bedding launched for Atopic Eczema & Night Sweats

Espère Healthcare Ltd has introduced DermaTherapy Therapeutic Bedding into the UK. Whilst it may appear unusual for a Healthcare company to become involved in bedding it should be remembered that we spend approximately 1/3rd of our lives in bed and our bed clothes can affect our skin condition almost as much as our normal clothes. This bedding has unique moisture wicking and antimicrobial properties, making it ideally suited for eczema sufferers. Find out more on www.dermatherapybedding.co.uk .

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DermaSilk Presented at Nursing Meeting

DermaSilk was the subject of a talk held at the Nursing in Practice Meeting in Birmingham. Under the title "What not to wear in eczema" Dr Rupert Mason presented an insight into what to look out for when choosing the best base layer for eczema. His 30 minute presentation can be viewed by clicking here.

The long-term weather forecast from the Met Office for winter predicts cold rainfall and above average wind and gale conditions. Research has shown that winter is a really miserable time for eczema sufferers, particularly children, where 1 in 3 is affected by this condition. The ‘winter itch season’ is particularly bad when temperatures fall and conditions become windier. The key cause of increased ‘itch’ is predominately:

• changes in the interior and exterior climate.
• central heating dries out the air in the home
• cold wet conditions penetrate the skin
• the body’s temperature mechanism is difficult to balance
• the ‘itch-scratch’ cycle in eczema flare ups.

Choice of clothing is an important element in controlling eczema. Whilst cotton has in the past been the fabric of choice, a recent breakthrough in the manufacture of knitted silk underwear impregnated with an antibacterial Microbial Shield, has shown in published clinical trials to be much more effective than cotton in breaking the ‘itch-scratch’ cycle.

This specially treated fabric, developed in Italy, clearly shows that silk has a much better moisture absorbency factor than cotton and it also retains better temperature controlling capabilities than other fabrics. A new range of eczema underwear, worn close to the skin has been launched in the UK. This range is designed for infants, children and adults by DermaSilk and further information on use of these garments as part of an overall eczema treatment programme can be found on www.dermasilk.co.uk.

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Note to Editors:

BODY TEMPERATURE CONTROL

Excessive moisture loss is a common feature of all eczema patients. Unlike cotton, DermaSilk absorbs excessive moisture without the fabric feeling damp and therefore allows better control of body temperature, keeping it cool when it is warm and warm when it is cool. This is important for maintaining the moisture balance of the skin. It is this balance that dominates skin reactions and the importance of moisturising the skin frequently and following a prescribed treatment programme is therefore essential.

Whilst everyone appreciates the value of central heating, it can be a major skin irritant. It is better to keep a home slightly cooler, to use humidifiers to counter-balance dry air conditions and to bathe or shower less frequently. The use of DermaSilk, as part of an overall treatment programme, will then reduce the itching and scratching. A recent small clinical trial from Switzerland even suggested that there was no significant difference between the therapeutic effect of using DermaSilk alone and using a topical corticosteroid with cotton clothing. The implications of this finding are interesting because parents continue to have great concerns about using steroids on children.

Full details on the whole range of DermaSilk Therapeutic Clothing can be found on www.dermasilk.co.uk or can be purchased direct from Espère Healthcare Ltd Suite G8 Bedford i-Lab, Priory Business Park. Bedford MK44 3RZ. Telephone: 08700 42 42 32

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A study published in the October edition of “Dermatology” by Senti et al has generated significant interest in the field of Atopic eczema management. Whilst it is accepted that topical corticosteroid treatment is highly effective in reducing inflammation and itch associated with Eczema there is a general concern that these products are often not used as prescribed due to fears of side effects by parents.

This trial was designed to compare the effectiveness of DermaSilk with that of a topical corticosteroid in the treatment of atopic dermatitis. Whilst the trial had been planned to feature 30 children with moderate atopic eczema, only fifteen children were eventually enrolled in the study. This was due to concerns from parents relating to the use of topical corticosteroids in the trial which they perceived as being undesirable despite constant education by healthcare professionals.

After the ‘wash out’ phases, to ensure that the effects of previous medications had gone, the patients received specially designed garments with the left arms and legs made of DermaSilk and the corresponding right limbs and whole trunk made of cotton. The cotton covered limbs were treated with topical mometasone 0.1% cream, a modern, topical corticosteroid, once a day for the first 7 days. Both left and right limbs were given identical topical non-medicated emollients and no other treatments were applied.

Results were measured by 4 means:
1. Modified EASI score (Eczema Area Severity Index)
2. Patient/Parent assessment of itch measured on visible analogue scale
3. Patient/Parent assessment of overall improvement
4. Physicians’ global assessment

Results were taken at day 0, 7, and 21.

RESULTS
The authors reported surprise at the outcome of the study. During the entire study period there was:
• No difference on the EASI scores were noted between the left and right side of individual patients at any time in the study
• No difference in the patient/parent assessment of efficacy
• Physician global assessment showed no difference in treatment groups over the identified milestones

Compliance was excellent on both treatment regimes with only one patient withdrawn due to widespread flare up of their condition.

CONCLUSIONS

This study showed that there was no significant difference between the therapeutic effect of DermaSilk alone and topical corticosteroid plus cotton. This confirms the findings reported by the Ricci et al study undertaken in 2004 which clearly proved that DermaSilk underwear was superior to cotton in reducing the itch and enhancing healing. Importantly, this new evidence suggests that DermaSilk provides a beneficial effect comparable to a a modern, high efficacy corticosteroid,

The authors suggest that DermaSilk has the potential to become a well accepted therapeutic alternative to the treatment with corticosteroids, especially for children whose parents are reluctant to apply topical corticosteroids.

NB This paper appeared in the October issue of Dermatology. The full citation reference is Senti. G, et al. Dermatology 2006 213: 228 - 233.

DermaSilk is a range of therapeutic underwear suitable for use by adults and children.
The DermaSilk range starts at £15.00 for specially designed gloves, baby-suits, pants, vests and leggings. The whole range can be viewed and purchased on the DermaSilk web site www.dermasilk.co.uk or via a dedicated order and information line on 08700 42 42 32.

The DermaSilk range is unique and is the only collection of underwear designed to be used in a treatment programme for eczema. It is made from pure, medical grade silk which has been impregnated with an antibacterial Microbe Shield. This range is classified as a Medical Device in the EU and is supported by clinical trial data.

CLINICAL DATA

dated: September 2006

Efficacy

The Italian manufacturers of DermaSilk, ALPRETEC, have undertaken both laboratory and human volunteer studies to demonstrate the safety and efficacy of the DermaSilk product. Formal medical studies have been undertaken in a number of medical conditions to demonstrate the efficacy of the fabric in conditions such as atopic dermatitis, diabetic ulcers and female fungal infections. Many of these have been presented as poster presentations at medical congresses and a number of the studies have either been published in medical journals or accepted for publication. Al.Pre.Tec will continue to expand this research into the future.

Details of the key study by Ricci et al 1were published in the British Journal of Dermatology in 2004. The purpose of this study was to evaluate the effectiveness of DermaSilk in the treatment of young children affected by atopic dermatitis with disease flare at the time of examination.

Forty six children with atopic dermatitis were recruited and randomised to DermaSilk (n=31) or cotton clothing (n=15) to be worn for a week. The only other agents prescribed were topical moisturisers. Severity of the condition was measured by the SCORAD index, an internationally recognised method of measuring disease severity and the effect of atopic dermatitis on subjective events such as itching and sleeplessness.

At the end of the study the SCORAD index of the DermaSilk group had significantly decreased from 47 to 30 (p=0.003) whilst the cotton wearing group had moved from 47 to 46. Eighty three percent of children using the DermaSilk had shown an improvement in their overall condition, whereas none of the cotton wearing children had shown any improvement. Measurement of the DermaSilk covered areas alone showed a significant decrease from 32 to18.6 (p=0.001). In addition the parents also reported an improvement in the areas of skin covered by the silk plus a decrease in the itching and scratching.

Areas of eczema which had not been covered by DermaSilk or cotton were also examined as a control. They also did not show a significant improvement over the week.

The authors concluded that DermaSilk appeared to alleviate the symptoms of atopic dermatitis in children and may represent a useful tool in the management of the disease.

Supportive data include a study conducted by Fischer 2 and his colleagues in Zurich and reported in a poster at the Annual meeting of the Swiss Society of Allergology and Immunology in Berne in 2005. Fifteen children were enrolled in an open, non-randomised study with left right intra patient comparison conducted over 4 weeks. The left limbs of each subject were covered in DermaSilk clothing for the duration of the study whilst the right hand limbs were clothed in cotton. Mometasone, a potent topical steroid, was applied to the cotton covered limbs once daily for the first 7 days and an identical base emollient was applied to both sides for the full duration of the study. The results were studied using a modified EASI score and a VAS score was adopted for measuring pruritus. Results measured at day 7 and day 21 showed no significant difference between the two sides in either the EASI score or the patient evaluations of the symptoms.

Arcangeli et al 3 reported a pilot study at the 7 th Congress European Society for Paediatric Dermatology held in Barcelona in 2002. Fifty children with atopic dermatitis were divided into 2 groups. Both groups wore a DermaSilk tubular dressing on their right leg and a cotton dressing on their left leg for 24 hours each day for 7 days. In one group topical mometasone was applied once daily to both limbs whilst in the second group no steroid was used. Erythema, exudation and itching were measured on a 3 point scale. In all cases the limbs covered in the DermaSilk tubes performed better than those clothed in cotton and the steroid plus DermaSilk had better treatment outcomes than the steroid plus cotton limbs.

Additional studies have been carried out in the treatment of itching caused by external thrush infections and the treatment of diabetic leg ulcers, both showing promising results.

References

1. Ricci, G. et al. Clinical effectiveness of a silk fabric in the treatment of atopic dermatitis. Brit. J. Derm. 2004; 150; 127-131
2. Fischer, B et al. Treatment with specially manufactured silk clothes (DermaSilk® in children with atopic dermatitis. Annual meeting of the Swiss Society of Allergology and Immunology. 2005. Manuscript accepted for publication.
3. Arcangeli, F. et al. Silk tubular clothes in paediatric atopic dermatitis. Poster presentation 7th Congress ESPD. Madrid. November 2002

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WHAT YOU WEAR CAN ALTER THE EFFECT OF YOUR ECZEMA TREATMENT:

ACCORDING TO CLINICAL TRIAL

Dated: September 2006

Scientists involved in treating skin conditions such as eczema have turned their attention to the type of clothing worn by patients and come up with an innovative fabric which has been shown in clinical trials to offer significant advantages over commonly used cotton underclothes.

The development of this fabric, which is impregnated with an antibacterial Microbial Shield, has resulted in the design of a range of underwear for use as part of the eczema treatment programme and helps control the terrible ‘itch-scratch’ cycle. Called DermaSilk, this new innovative product range is being launched in the UK in time for National Eczema Week by Espère Healthcare Ltd.

1 IN 3 PEOPLE IN THE UK SUFFER FROM ECZEMA

Eczema is one of the most difficult and unpleasant conditions that children suffer from. The recent ‘Department of Health Review of Services for Allergy’ published in July this year states that 1 in 3 people in England have Eczema during their life and mostly in childhood with this figure increasing every year.

Treatment for eczema varies, depending on the level of the condition, but for children with severe symptoms the whole treatment process needs to be all embracing and can severely restrict their lives and have a major impact on family life.

There is no one treatment that can clear eczema, it usually requires combined action. The worst and most difficult element to control is the itching and scratching which leads to weeping and bleeding skin. Until now there have been few dressing options that can alleviate this condition.

DERMASILK UNDERWEAR A BREAKTHROUGH IN ECZEMA TREATMENT

DermaSilk Therapeutic Underwear is being launched in the UK for the first time by Espère Healthcare Ltd during National Eczema Week (16th September 2006). The range offers a clinically proven collection of children’s underclothes which, as part of a treatment programme, can bring fast relief to the itching and scratching and can help promote the active healing of the affected areas.

The range includes vests, pants, baby suits, gloves and leggings.

The concept for this highly specialised collection of underwear was developed by Espère Healthcare’s partners in Italy who have combined the known traditional healing properties of silk with today’s state-of-the-art anti-microbial technology.

DermaSilk Therapeutic Underwear is made from pure, medical grade silk which has been impregnated with an antibacterial Microbe Shield. This range is classified as a Medical Device in the EU and is supported by clinical trial data.

CLINICAL TRIAL

A clinical trial, published in the British Journal of Dermatology in 2004 compared the effects of cotton and silk clothing on children with acutely inflamed atopic eczema. The children were divided in to two groups:

Group A was instructed to use DermaSilk and group B used cotton clothing. Both groups also used moisturising cream. After one week the state of the children’s eczema was evaluated using a validated scoring system (the SCORAD index). In addition, the local score of an area covered by DermaSilk was compared with the local score of an uncovered area in the same child. The results showed a significantly greater improvement in DermaSilk children compared to the cotton group, and in the local area covered by DermaSilk compared to the corresponding area left uncovered.

Further trials are currently awaiting publication and are expected to reinforce these conclusions.

Dr Rupert Mason, the medical advisor to the company said: “Eczema can be one of the most distressing conditions that children can suffer and it torments them in many ways. The introduction of the DermaSilk underwear range has many benefits not only for its therapeutic value but also in its design and construction, as the range looks very normal, reducing the self-conscious element children feel in front of their peer group.”

CONTROLS BODY TEMPERATURES

Excessive moisture loss is a common feature of all eczema patients. Unlike cotton garments, DermaSilk absorbs excessive moisture without feeling damp and therefore allows better control of body temperature, staying cool when it is warm and warm when it is cool. This is important in maintaining the water balance of the skin.

Importantly for mothers these are easy-to-care garments which when washed by hand with a non-biological detergent retain their antimicrobial efficacy for over 50 washes.

DERMASILK ON LINE

The DermaSilk range starts at £15.25 for specially designed gloves and includes baby-suits, pants, vests and leggings.

These can be ordered direct from Espère Healthcare Ltd either via their web site www.dermasilk.co.uk or from their brochure which can be obtained from Suite G8 Bedford i-Lab, Priory Business Park. Bedford MK44 3RZ Telephone: 08700 42 42 32

Note to Editors:

For further information about managing and treating eczema contact the National Eczema Society: 0870 241 3604 or via their web site: www.eczema.org Espère Healthcare is a Corporate member of the National Eczema Society.

BACKGROUND INFORMATION ON THE COMPANY

dated: September 2006

DermaSilk was developed by an Italian company, ALPRETEC, in 2001. The company, founded by Dino Montagner in 1997, initially manufactured allergy protection covers for mattresses and pillow cases. Historically they worked with the Italian fashion industry in the production of silk fabrics and were therefore, well aware of the capability of this raw material.

DermaSilk was created by combining a smooth, knitted silk fabric with an everlasting antimicrobial which has been used in operating theatre material for many years. This is permanently bonded to the silk by a patented process and will not leech onto the skin. DermaSilk is therefore unique in that it can control both the heat and moisture levels of the skin whilst also helping to protect the garments from bacterial and fungal growth.

DermaSilk has been through a series of clinical trials in Austria, Italy and Switzerland to ascertain efficacy across a range of dermatological conditions including eczema, contact dermatitis and thrush.

ALPRETEC has now appointed Espère Healthcare Ltd, a specialist healthcare marketing and distribution company headed by Chris Steeples and David Battershill, to manage exclusively the sales of DermaSilk in both the UK and Ireland.

World silk production has approximately doubled during the last 30 years in spite of the development of man-made fibres. China and Japan have traditionally been the two main producers and together manufactured more than 50% of the world production each year. During the late 1970's however, China, the country that first developed sericulture thousands years ago, dramatically increased its silk production and has again become the world's leading producer of silk.

Silk is a natural protein fibre containing about 70-75% of actual fibroin and about 25-30% sericin. Silk filaments are very fine and long - as much as 300 to 900 metres in length. Silk has a high natural lustre and sheen and is one of the strongest fibres at 2.6 to 4.8 grams per denier. When it is dry the elongation (elastic recovery) varies from 10-25% and when wet it will elongate as much as 33-35%. Silk has a relatively high standard moisture regain of 11%. When saturated the regain is 25-35%.

AVAILABILITY

The DermaSilk range is now being introduced into the UK and Ireland and is also available in Holland, Hungary, Slovenia, Switzerland, Germany, Austria Denmark, Sweden, Russia, Belgium, Spain and Portugal.

In the UK it will be available through a dedicated web site www.dermasilk.co.uk and the range includes body suits for babies through to vests, leggings, pants, socks and gloves for adults. The price range starts at £15.00 (EU 22.00).