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

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Phase 3

Age range

18 years - 65 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

161 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

• Adults aged 18 to 65 years.
• Diagnosis of mild to moderate atopic dermatitis.
• Compliance with the study protocol requirements.
• Provision of written informed consent.

Exclusion Criteria:

• Failure to meet the inclusion criteria.
• Contraindications to the study treatment or concomitant therapy, as specified in the study protocol.
• Other conditions or circumstances that, according to the study protocol, could interfere with participation or the assessment of treatment efficacy and safety.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Research locations (7)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

7 locations

Study team and timeline

Lead sponsor

Polisorb Joint Stock Company

Study start

Apr 10, 2024 Actual

Primary completion

Nov 28, 2024 Actual

Study completion

Nov 28, 2024 Actual

First posted

Nov 10, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.