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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
Lactofiltrum (hydrolytic lignin 0.355, lactulose 0.12) 2 tablets three times a day before meals during 21 days
Placebo 2 tablets 3 times a day before meals during 21 days
Moscow Dermatovenerologic Clinical Dispensary № 1
Moscow, Moscow, Russia
Moscow State University of Medicine and Dentistry
Moscow, Moscow, Russia
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.
Time frame: Day 21 after start of the intervention
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.
Time frame: Day 30 after end of the intervention
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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
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Time frame: Day 30 after end of the intervention
BRS Index
Behavioral rating scores (BRS) measures severity of itching.
Time frame: Day 10 after start of the intervention
BRS Index
Behavioral rating scores (BRS) measures severity of itching.
Time frame: Day 21 after start of the intervention
BRS Index
Behavioral rating scores (BRS) measures severity of itching.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 21 after start of the intervention