Atopic Dermatitis
Conditions
Keywords
Lactofiltrum, atopic dermatitis, itching, Dermatological Index of Life Quality, SCORAD, Behavioral Rating Scores
Brief summary
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.
Interventions
DRUGLactofiltrum
Lactofiltrum (hydrolytic lignin 0.355, lactulose 0.12) 2 tablets three times a day before meals during 21 days
DRUGPlacebo
Placebo 2 tablets 3 times a day before meals during 21 days
Sponsors
Moscow State University of Medicine and Dentistry
Moscow Dermatovenerologic Clinical Dispensary № 1
Avva Rus, JSC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* patients aged 18-60 y.o. diagnosed with atopic dermatitis according to the UK refinement of the Hanifin-Rajka diagnostic criteria; * SCORAD Index more than 25.
Exclusion criteria
* pregnancy and breast-feeding; * severe diseases; * concomitant infection diseases (including parasitic ones); * diffusive connective-tissue (autoimmune) diseases; * renal and hepatic failure; * systemic or topical treatment with antibiotics, steroids, immunosuppressive, cytostatic or antimetabolite agents by the time of inclusion into the study; * concomitant skin diseases: skin lymphoma, scab, lichen ruber planus, psoriasis; * professional activity involving skin injury, exposure to cold, insolation, ultraviolet radiation; * psychoses; * application of pre-, probiotics, antibiotics, neuroleptics or tranquilizers 2 weeks before inclusion or during participation in the study; * participation in other clinical study 1 month before inclusion or during participation in the proposed study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SCORAD Index | Day 21 after start of the intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dermatological Index of Life Quality | Day 10 after start of the intervention | 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). |
| BRS Index | Day 10 after start of the intervention | Behavioral rating scores (BRS) measures severity of itching. |
| SCORAD Index | Day 30 after end of the intervention | 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. |
| Biochemical blood analysis | Day 21 after start of the intervention | It includes routine measurements of serum concentrations of biochemical compounds including proteins, glucose, enzymes, creatinine, urea, potassium, sodium, bilirubin. |
| Urine analysis | Day 21 after start of the intervention | It includes routine measurements of urine concentrations of biochemical compounds including proteins and glucose, counting of cells, detection of bacteria and urinometry. |
| Blood test | Day 21 after start of the intervention | It includes routine blood cells' counting and measurement of erythrocyte sedimentation rate and serum concentration of hemoglobin. |
Countries
Russia
Outcome results
None listed