Dermatol. praxi. 2018;12(4):199-203 | DOI: 10.36290/der.2018.032
The authors present the results of a prospective, multicenter, controlled clinical trial that looked at the effect of ENTEROSGEL,the hydrogel of methyl silicic acid available as a medical device, in patients with moderate to severe atopic eczema. The authorsfollowed the symptom score in patients 15 days before dosing and 30 days of enterosorbent administration and within six monthsafter the end of dosing. At the same time, they evaluated the basic biochemical values of blood serum, tolerability and subjectiveevaluation of the effect of the studied product on individual patients. The primary endpoint of the study was confirmed in the19 subjects evaluated – there was a statistically significant reduction in the overall symptom score (by 1.7 points at p = 0.005)over a 30-day period. Monitoring of secondary endpoints (individual clinical and laboratory parameters monitored) confirmeda statistically significant improvement in the parameter – range of eczema deposits (P = 0.005). In laboratory findings, only aparameter-specific IgE-mite (p = 0.03) was statistically significant improvement. Other observed laboratory parameters were notstatistically significantly altered. In the analysis of the monitored parameters during the whole monitored period (ie, in days: -14,0, 30, 90, 180) there was a statistically significant change (improvement) in parameters – total symptom score (p < 0.001) both bystudy subjects (drop by 7.1 points) and by doctors (drop by 7 points). In similar analysis of the monitored parameters statisticallysignificant (p < 0.001) parameters – extent of disability, intensity of disability, feeling of itching, feeling of fatigue and lower levelof significance, digestive problems, local treatment and headache were statistically significant.
Published: December 1, 2018 Show citation