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“He has been wearing them for 24 hours now and all I can say is WOW! His skin is already so much clearer, he has had a full night’s sleep, and very little scratching this morning. I honestly didn't think I would see the effects so quickly.”
SG Sandhurst
Clinical Trials
   


The therapeutic effects of DermaSilk have been extensively studied by clinicians throughout Europe and their findings published in "peer reviewed" academic medical journals. This means that the results demonstrated in the trials have been independently assessed as accurate by other doctors. The sections below give a brief description of the studies undertaken and the results obtained. No other product of this type has gone through such exhaustive tests to validate its effectiveness. DermaSilk continues to be researched in a wide range of medical conditions and future publications will be added when appropriate.

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2 Year study showing reduction in Steroid Usage

3 Month "long term" Study

Effect comparable to topical Steroid Usage

Use in Adults as well as Children


Clinical Effectiveness of a Silk Fabric in the Treatment of Atopic Dermatitis.
Ricci, G and colleagues from Bologna University Hospital, Italy.


Published in British Journal of Dermatology. 2004. Issue 150. Pages 127 - 131

The purpose of this study was to evaluate the effectiveness of DermaSilk in the treatment of young children affected by atopic dermatitis at the time of examination.

Method

Forty six children, aged between 4 months and 10 years old with atopic dermatitis were recruited and randomised to DermaSilk (31 patients) or cotton clothing (15 patients) to be worn continuously for a week. The only other medicines prescribed were topical moisturisers. No steroid creams or topical antibiotics were prescribed.

The severity of the eczema was measured by the SCORAD index, a scientific way of measuring a mixture of physical and social effects that atopic dermatitis has on patients. The doctors measuring these scores were not aware which garments the patients were using.

Results

At the end of the study the SCORAD index of the DermaSilk group had significantly decreased from 47 to 30 whilst the cotton wearing group had moved from 47 to 46.

83% of children using the DermaSilk had shown an improvement in their overall condition, whereas none of the cotton wearing children had shown any improvement.

Areas of eczema which were present on the DermaSilk clothed children but which had not been covered by DermaSilk were also examined as a control. They did not show any significant improvement over the week suggesting that it was, indeed the covering of the eczema with DermaSilk that was having the beneficial effect.

Conclusion

The authors concluded that DermaSilk appeared to significantly improve the condition of eczema lesions and that the parents of these children also reported a reduction in itching and scratching.

DermaSilk appears to have a rapid effect on the symptoms of atopic dermatitis in children, showing a positive effect in only 7 days in over 80% of children and may represent a useful tool in the management of the disease.                                                                                               

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Antimicrobial Silk Clothing in the Treatment of Atopic Dermatitis Proves Comparable to Topical Corticosteroid Treatment.


Senti. G. and Colleagues. Department of Dermatology. Zurich Switzerland.
Published in "Dermatology" 2006. 213:228 - 233

Method
Fifteen children were enrolled in an open study comparing different treatments on different arms and legs of the same patients conducted over 3 weeks.

The right limbs of each childt were covered in DermaSilk clothing for the duration of the study whilst the left hand limbs were clothed in cotton.

Mometasone, a potent topical corticosteroid was applied to the cotton covered limbs once daily for the first 7 days and an identical base emollient with no active steroid component was applied to both sides for the full duration of the study.

The results were studied using a modified eczema severity (EASI) score and a Visual Analogue Score (VAS) was adopted for measuring pruritus.

Results
Readings were measured at day 7 and day 21.

They showed no significant difference between the two sides in either EASI or the patient evaluation of the symptoms. This is surprising since the DermaSilk performed as well as an actively used potent steroid cream over the first 7 days of the study and remained as effective during the following 14 days when no steroid was applied. There was no evidence that the cream applied to the cotton covered limbs had any effect on the DermaSilk limbs via the bloodstream.

Conclusion
The authors concluded that the efficacy of DermaSilk was comparable in efficacy to a group III topical steroid and was as good as the current standard care in atopic dermatitis. They considered the use of DermaSilk to be a therapeutic approach in atopic dermatitis and suggested that it might become a well accepted therapeutic alternative to treatment with corticosteroids, especially for those children whose parents are reluctant to apply topical corticosteroids.

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A Randomised Double Blind Study to Investigate the Clinical Efficacy of Adding a Non-Migrating Antimicrobial to a Special Silk Fabric in the Treatment of Atopic Dermatitis.


Stinco, G and Colleagues. Institute of Dermatology. Udine. Italy. Published in "Dermatology" 2008. 217;191-195


Method
This was the first "Randomised double blind trial" (RCT) conducted with DermaSilk.RCTs are considered by doctors to be the gold standard in clinical trial design as they provide the least possible opportunity for bias in a trial. in this case the trial compared the DermaSilk fabric with the antimicrobial to the DermaSilk fabric without the antimicrobial finish..

Thirty patients aged between 3 and 31 years {mean 14.2 + 7.7}  were enrolled. The inclusion criterion was that the patients presented with active AD with eczematous lesions located on the arms without any sign of infection.

Each participant was given a set of 4 pairs of knitted silk tubular sleeves marked with seams of different colours. Only one colour was treated with AEM 5772/5. This information was unknown to the clinicians and the patient’s /parents. At baseline T0) and after 7 {T7}, 14 {T1 4},21 {T21) and 28 {T28} days, the patients were evaluated using the following methods: photographic assessment, local modified SCORAD index adapted for only the arm, and parent/patient assessment of pruritus measured with a visual analogue scale.

Results
The mean local SCORAD index of both the DermaSilk- and the unmodified-silk-covered arms decreased significantly between baseline {T0) and the end of study {T28}" However, while the Derma Silk group showed a constant decrease each week, the unmodified-silk group showed a significant decrease only in the first 2 weeks of the study. Also the decrease in pruritus values between T0 and T28 was greater for the DermaSilk group.

Conclusion
This study demonstrates the importance of including the AEM 5772/5 finish to the specially knitted silk for a long-term improvement of atopic eczema symptoms. The study also confirms the usefulness of DermaSilk in older patients.

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Action of a Silk Fabric Treated with AEGIS in Children with Atopic Dermatitis:

A 3-Month Trial

Koller DY, Halmerbauer G, Bock A, Engstler G.
Published in Pediatric Allergy & Immunology 2007.

Method
The aim of the study was to evaluate the clinical effect of Dermasilk in children with atopic dermatitis.

A total of 22 children with mild-to-moderate atopic dermatitis were recruited for a study period of 3 months. All of them received three different tube-fabrics

  • Dermasilk,
  • A sericin-free silk fabric without the antimicrobial  AEM 5772/5
  • and cotton.

These tubes were placed on the bend of each arm over the elbow. Patients were advised to wear the Dermasilk fabric all day long during the whole study period on one arm. On the other arm the sericin-free Antimicrobial-free silk tube had to be used during the first 2 weeks of the study and replaced with the cotton tube for the rest of the study period.

Evaluation of the local SCORAD score was carried out at the beginning of the study, after 2, 4, 8 and 12 weeks.

Results
A significant reduction of the local SCORAD index of the Dermasilk covered arm was observed after 4, 8 and 12 weeks in comparison with the cotton-covered arm score.

No adverse effects were observed by the doctors or reported by the parents. It was also demonstrated that the effectiveness of Dermasilk was not reduced by laundering, although the tubes were washed daily.

Conclusion
Dermasilk is useful in the treatment of mild-to-moderate atopic dermatitis in children This effectiveness continued over the whole 12 week trial indicating that usage over a long period will continue to help. The effectiveness is because of the characteristics of the fabric.

Silk enhances collagen synthesis and reduces inflammatory processes. The authors comment that "Normal" silk fabrics used for clothes are not recommended for dressing of subjects with atopic dermatitis, as these fabrics reduce transpiration and therefore may cause worsening of disease activity.

This statement highlights the need for knitted Sericin-free silk - DermaSilk.

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DermaSilk in long-term control of infantile atopic dermatitis: a double blind randomized controlled trial.

Fontanini, C et al. G Ital. Dermatol. Venereol. 2013;148:293-297

Fontanini et al carried out a randomised double-blind controlled trial comparing the longterm effects of DermaSilk versus identically styled cotton underclothes in 22 patients over 2 years.


Method

22 Children aged under 18 months of age were enrolled into this long term study. Half were given 3 sets of unmarked DermaSilk underclothes and half, identically styled pure cotton clothes. Both groups were told to wear the clothing exclusively during the
study with the exception of the time of the hot Italian summer where cotton clothing was unable to be worn. A diary of steroid usage was kept and parents were asked to request replacement garments as and when they were needed.

Results:

20 patients completed the study,
wearing the garments for an average of 17 of the 24 months. Steroid used was 60% less in the DermaSilk group compared with the
cotton group. Replacement garments were only needed once during the study period. 100% of the DermaSilk group were satisfied

with their treatment

Conclusion

This study is highly unusual in that it attempted to measure the long term seefect of DermaSilk over a full two year period. What is exciting is that the vast majority of participants continued with the study to the end and this is testament to the wearability of the DermaSilk. Children enjoy wearing it. The results also highlight the long term benefits of using DermaSilk - particularly the effect of reducing flares and minimising the use of topical steroids.

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