Clinical Trials
Since its inception over 15 years ago, DermaSilk has always been supported by good quality clinical trials to justify the claims that we make about its performance. We have also had feedback from our customers treating a range of conditions. To read some of our customer testimonials please
Over the years some of our customers have kept us informed on the use of DermaSilk in helping to manage their conditions, some of this detailed feedback has been featured in the press and as case studies when medical professionals ask for real life representation of the products. Please
to view our case studies.Clinical Trials
As a Class I Medical Device it is possible to create small scale studies which clearly demonstrate efficacy. In some cases, clinicians have adopted studies which can show the benefit of using DermaSilk versus not using it – on the same patient as the effect is purely local and only affects the quality of the skin which is covered by it.
Other studies are of the more conventional “Randomised, placebo controlled“ type, involving relatively large numbers of patients. All have been peer reviewed and published in highly respected Medical Journals, including the Journal of the British Association of Dermatologists.
One thing is common to all the studies – compared with either cotton control products or Standard treatment regimes, the addition of DermaSilk Therapeutic clothing had the ability to improve the parameters measured in symptom levels irrespective of the disease area being studied.
These papers and clinical abstracts form the majority of the clinical evidence supporting the use of silk clothing as a whole and justifying the place of DermaSilk in a number of European disease management guidelines.
Stinco Paper Dermatology 2008
A Randomized Double-Blind Study to lnvestigate the Clinical Efficacy of Adding a Non-Migrating Antimicrobial to a Special Silk Fabric in the Treatment of Atopic Dermatitis
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.
Senti Paper Dermatology 2006
Antimicrobial Silk Clothing in the Treatment of Atopic Dermatitis Proves Comparable to Topical Corticosteroid Treatment
Result: After 7 days of active treatment and a further 14 days of non-active treatment there were no differences between the use of Mometasone with cotton and DermaSilk
Ricci Paper Dermatology 2006
Evaluation of the Antibacterial Activity of a Special Silk Textile in the Treatment of Atopic Dermatitis
Ricci Paper Brit J Dermatology 2004
Clinical effectiveness of a silk fabric in the treatment of atopic dermatitis
Result: Significant reduction in SCORAD in DermaSilk group compared to zero improvement in cotton group.
Promotive effects of a silk film SUGIHARA et al 2000
Promotive Effects of a Silk Film on Epidermal Recovery from Full-Thickness Skin Wounds
Koller Paper Paed Allergy & Immunol 2007
Action of a silk fabric treated with AEGIS(TM) in children with atopic dermatitis: A 3-month trial
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
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.
DermaSilk in long-term treatment of infantile atopic dermatitis
DermaSilk in long-term control of infantile atopic dermatitis: a double blind randomized controlled trial
Case study Dr. Clemente
Use of Dermasilk® knitted silk in children with dermatitis and mothers with nipple’s rhagades.
BELTRANI
Dermatology Online Journal Volume 9 Number 2