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| Name | Class |
|---|---|
| Moscow State University of Medicine and Dentistry | OTHER |
| Moscow Dermatovenerologic Clinical Dispensary № 1 | UNKNOWN |
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The purpose is to study efficacy of Lactofiltrum in adult patients with atopic dermatitis. Lactofiltrum consists of 85% of hidrolytic lignin and 15% of lactulose and acts as an enterosorbent, which enables to enhance metabolism and elimination of endotoxins and to normalize metabolic and immune processes. Additionally, lactulose stimulates Bifidobacterium flora and in aggregate it could improve skin condition afflicted by atopic dermatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactofiltrum | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactofiltrum | Drug | Lactofiltrum (hydrolytic lignin 0.355, lactulose 0.12) 2 tablets three times a day before meals during 21 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| SCORAD Index | The Scoring of Atopic Dermatitis (SCORAD) index is a composite index (0-100 scores) measured by blinded physician assessing three main clinical features of the disease (separate scales), namely area of lesion, clinical severity, subjective symptoms. | Day 21 after start of the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| SCORAD Index | The Scoring of Atopic Dermatitis (SCORAD) index is a composite index (0-100 scores) measured by blinded physician assessing three main clinical features of the disease (separate scales), namely area of lesion, clinical severity, subjective symptoms. | Day 30 after end of the intervention |
| SCORAD Index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuriy Perlamutrov, MD, DrSc | Moscow State University of Medicine and Dentistry | Principal Investigator |
| Nickolay A. Kryuchkov, MD, PhD, MPH | Avva Rus, JSC | Study Director |
| Lyudmila Kobeleva, MD, PhD | Avva Rus, JSC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moscow Dermatovenerologic Clinical Dispensary № 1 | Moscow | Moscow | 119071 | Russia | ||
| Moscow State University of Medicine and Dentistry |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| D007792 | Lactulose |
| D008031 | Lignin |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Placebo | Drug | Placebo 2 tablets 3 times a day before meals during 21 days |
|
The Scoring of Atopic Dermatitis (SCORAD) index is a composite index (0-100 scores) measured by blinded physician assessing three main clinical features of the disease (separate scales), namely area of lesion, clinical severity, subjective symptoms. |
| Day 10 after start of the intervention |
| Dermatological Index of Life Quality | The Dermatological Index of Life Quality is a index (0-30 scores) representing patient's life quality deteriorations related to a skin disease (self-reported questionnaire). | Day 10 after start of the intervention |
| Dermatological Index of Life Quality | The Dermatological Index of Life Quality is a index (0-30 scores) representing patient's life quality deteriorations related to a skin disease (self-reported questionnaire). | Day 21 after start of the intervention |
| Dermatological Index of Life Quality | The Dermatological Index of Life Quality is a index (0-30 scores) representing patient's life quality deteriorations related to a skin disease (self-reported questionnaire). | Day 30 after end of the intervention |
| BRS Index | Behavioral rating scores (BRS) measures severity of itching. | Day 10 after start of the intervention |
| BRS Index | Behavioral rating scores (BRS) measures severity of itching. | Day 21 after start of the intervention |
| BRS Index | Behavioral rating scores (BRS) measures severity of itching. | Day 30 after end of the intervention |
| Blood test | It includes routine blood cells' counting and measurement of erythrocyte sedimentation rate and serum concentration of hemoglobin. | Day 21 after start of the intervention |
| Biochemical blood analysis | It includes routine measurements of serum concentrations of biochemical compounds including proteins, glucose, enzymes, creatinine, urea, potassium, sodium, bilirubin. | Day 21 after start of the intervention |
| Urine analysis | It includes routine measurements of urine concentrations of biochemical compounds including proteins and glucose, counting of cells, detection of bacteria and urinometry. | Day 21 after start of the intervention |
| Moscow |
| Moscow |
| 127473 |
| Russia |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000073893 |
| Sugars |
| D002482 | Cellulose |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D045424 | Complex Mixtures |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |