Efficacy and Safety of Polisorb® MP in the Complex Therapy of Patients With Atopic Dermatitis
Atopic Dermatitis
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- Fase 3
- Rango de edad
- 18 años - 65 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 161 Real
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Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
¿Quién podría participar?
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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.
Tratamiento, grupos y participación
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- Asignación
- Asignación al azar
- Enmascaramiento
- Sin enmascaramiento
Basic Therapy Alone
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
Basic Therapy in Combination with Polisorb® MP
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
Colloidal Silicon Dioxide DRUG
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.
Basic Therapy for Atopic Dermatitis DRUG
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.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Change in Scoring Atopic Dermatitis (SCORAD) Index from Baseline to Day 14
Plazo: 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.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (7)
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7 centros
Chelyabinsk Regional Clinical Skin and Venereological DispensaryChelyabinsk, RussiaEstado desconocido
Clinical Skin and Venereological DispensaryKrasnodar, RussiaEstado desconocido
Ryazan Regional Clinical Skin and Venereological DispensaryRyazan, RussiaEstado desconocido
Saint Petersburg State Medical Institution 'Skin and venereological dispensary No. 10'Saint Petersburg, RussiaEstado desconocido
Reavita Med SPB LLCSaint Petersburg, RussiaEstado desconocido
Skin and venereological dispensary No. 8Saint Petersburg, RussiaEstado desconocido
City polyclinic No. 4Saint Petersburg, RussiaEstado desconocido
Equipo y fechas
- Patrocinador principal
- Polisorb Joint Stock Company
- Inicio del estudio
- 10 abr 2024 Real
- Finalización primaria
- 28 nov 2024 Real
- Finalización del estudio
- 28 nov 2024 Real
- Primera publicación
- 10 nov 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
Multicenter Open-label Randomized Trial With an Active Control Group to Evaluate the Efficacy and Safety of Polisorb® MP in the Complex Therapy of Patients With Atopic Dermatitis
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026