A randomized 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

Background: A randomized, double-blind study designed to compare the efficacy of DermaSilk versus a sleeve of similar structure but minus the AEM 5772/5 antimicrobial finish in the treatment of atopic dermatitis (AD).

Objective: To evaluate the clinical effect of adding an antimicrobial finish to knitted silk garments on eczema severity and on pruritus in patients with AD.

Methods: 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 AEGIS AEM 5772/5. This information was unknown to both the clinicians and the patients/parents. At baseline (T0) and after 7 (T7), 14 (T14), 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.

Conclusions: 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.