Efficacy and Safety of Polisorb® MP in the Complex Therapy of Patients With Atopic Dermatitis - NCT07929181

This multicenter, open-label, randomized Phase III clinical trial evaluated the efficacy and safety of adding Polisorb® MP, an oral colloidal silicon dioxide adsorbent, to basic therapy in adults with mild to moderate atopic dermatitis. The study included 161 patients in the efficacy analysis. Participants were randomly assigned to receive either basic therapy alone (81 patients) or basic therapy in combination with Polisorb® MP (80 patients). Basic therapy included skin care with emollients and pharmacological treatment, including cetirizine and topical pimecrolimus. The treatment period lasted 14 days, followed by an observation period. The primary endpoint was the change in the SCORAD index from baseline to Day 14. Itch intensity, dermatology-related quality of life, EASI and IGA scores were also assessed. Both groups showed improvement in disease severity during treatment. The mean SCORAD score decreased by 21.5 points in patients receiving Polisorb® MP in addition to basic therapy, compared with 17.7 points in patients receiving basic therapy alone. The difference between the groups was statistically significant (p = 0.0028), favoring the addition of Polisorb® MP. Improvements in itch intensity and IGA scores also favored combination therapy, while differences between groups in EASI changes and changes in dermatology-related quality of life were not statistically significant. A total of 34 adverse events were reported in 26 patients. No serious adverse events or deaths were reported. Gastrointestinal events, particularly constipation, were more frequent in the Polisorb® MP group. Other reported events included difficulty with defecation, abdominal discomfort, bloating, dry mouth and nausea. No new or unexpected safety concerns specific to Polisorb® MP were identified during the study. The findings indicate that adding Polisorb® MP to basic therapy was associated with a greater reduction in SCORAD scores over 14 days than basic therapy alone. The results should be interpreted in the context of the open-label design and the short treatment period.