A Pilot Study of Lactofiltrum to Treat Atopic Dermatitis in Adults

Study Overview
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Brief Summary
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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.

Official Title
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Phase II Double Blind Placebo-controled Randomized Comparative Multicentered Study of Efficacy and Safety of Lactofiltrum, Orally Administered Tablets (Produced by AVVA RUS, JSC) to Treat Atopic Dermatitis in Adults

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: Lactofiltrum
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lactofiltrum<br> | Drug: Lactofiltrum<br>* Lactofiltrum (hydrolytic lignin 0.355, lactulose 0.12) 2 tablets three times a day before meals during 21 days<br>* Other names: Lignin;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo 2 tablets 3 times a day before meals during 21 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lactofiltrum, atopic dermatitis, itching, Dermatological Index of Life Quality, SCORAD, Behavioral Rating Scores