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Completed

NCT Number: NCT01124318

A Pilot Study of Lactofiltrum to Treat Atopic Dermatitis in Adults

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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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Moscow Dermatovenerologic Clinical Dispensary № 1, Moscow, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lactofiltrum

Drug

Lactofiltrum (hydrolytic lignin 0.355, lactulose 0.12) 2 tablets three times a day before meals during 21 days

Other names: Lactulose, Lignin

Placebo

Drug

Placebo 2 tablets 3 times a day before meals during 21 days

Primary outcomes

  1. SCORAD Index

    Time frame: 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 outcomes

  1. SCORAD Index

    Time frame: 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.

  2. SCORAD Index

    Time frame: 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.

  3. Dermatological Index of Life Quality

    Time frame: 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).

  4. Dermatological Index of Life Quality

    Time frame: Day 21 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).

  5. Dermatological Index of Life Quality

    Time frame: 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).

  6. BRS Index

    Time frame: Day 10 after start of the intervention

    Behavioral rating scores (BRS) measures severity of itching.

  7. BRS Index

    Time frame: Day 21 after start of the intervention

    Behavioral rating scores (BRS) measures severity of itching.

  8. BRS Index

    Time frame: Day 30 after end of the intervention

    Behavioral rating scores (BRS) measures severity of itching.

  9. Blood test

    Time frame: Day 21 after start of the intervention

    It includes routine blood cells' counting and measurement of erythrocyte sedimentation rate and serum concentration of hemoglobin.

  10. Biochemical blood analysis

    Time frame: 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.

  11. Urine analysis

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Avva Rus, JSC

Industry

Collaborators

  • Moscow Dermatovenerologic Clinical Dispensary № 1
  • Moscow State University of Medicine and Dentistry

Registry information

Official study title

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

Acronym: LF-AD-09

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 17, 2010
Registry last updated
Sep 14, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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