A Pilot Study of Lactofiltrum to Treat Atopic Dermatitis in Adults
- Conditions
- Atopic Dermatitis
- Interventions
- Drug: LactofiltrumDrug: Placebo
- Registration Number
- NCT01124318
- Lead Sponsor
- Avva Rus, JSC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lactofiltrum Lactofiltrum - Placebo Placebo -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method SCORAD Index Day 10 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.
Dermatological Index of Life Quality Day 30 after end 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 30 after end of the intervention Behavioral rating scores (BRS) measures severity of itching.
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.
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.
Trial Locations
- Locations (2)
Moscow Dermatovenerologic Clinical Dispensary â„– 1
🇷🇺Moscow, Russian Federation
Moscow State University of Medicine and Dentistry
🇷🇺Moscow, Russian Federation