A Phase 3 interventional study of Colloidal Silicon Dioxide and Basic Therapy for Atopic Dermatitis in Atopic Dermatitis, sponsored by Polisorb Joint Stock Company. Completed at 7 sites in Russia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Polisorb Joint Stock Company · Phase 3, Interventional, and Treatment
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.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's enrollment of 161 is above the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →This is the only study on the registry with Polisorb Joint Stock Company as lead sponsor.
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Participants received basic therapy for atopic dermatitis, including emollient skin care and pharmacological treatment with cetirizine and topical pimecrolimus. The treatment period lasted 14 days, followed by an observation period.
Drug: Basic Therapy for Atopic Dermatitis
Participants received Polisorb® MP in combination with basic therapy for atopic dermatitis, including emollient skin care and pharmacological treatment with cetirizine and topical pimecrolimus. The treatment period lasted 14 days, followed by an observation period.
Drug: Colloidal Silicon Dioxide · Drug: Basic Therapy for Atopic Dermatitis
Polisorb® MP, an oral colloidal silicon dioxide adsorbent, was administered in addition to basic therapy for atopic dermatitis during the 14-day treatment period. The study evaluated the efficacy and safety of this combination compared with basic therapy alone.
Also known as: Basic Therapy for Atopic Dermatitis, Polisorb® MP
Basic therapy for atopic dermatitis consisted of emollient skin care and pharmacological treatment, including cetirizine and topical pimecrolimus. It was administered for 14 days in accordance with the study protocol.
Change in Scoring Atopic Dermatitis (SCORAD) Index from Baseline to Day 14
Change in the Scoring Atopic Dermatitis (SCORAD) Index from baseline to Day 14. The SCORAD Index ranges from 0 to 103, with higher scores indicating more severe atopic dermatitis and lower scores indicating less severe disease. Changes were evaluated in patients receiving basic therapy alone and in patients receiving basic therapy in combination with Polisorb® MP.
Time frame: Baseline to Day 14
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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