A Pilot Study of Lactofiltrum to Treat Atopic Dermatitis in Adults (LF-AD-09)

This study has been completed.
Sponsor:
Collaborators:
Moscow State University of Medicine and Dentistry
Moscow Dermatovenerologic Clinical Dispensary № 1
Information provided by:
Avva Rus, JSC
ClinicalTrials.gov Identifier:
NCT01124318
First received: April 28, 2010
Last updated: September 13, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Atopic Dermatitis
Drug: Lactofiltrum
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Avva Rus, JSC:

Primary Outcome Measures:
  • SCORAD Index [ Time Frame: Day 21 after start of the intervention ] [ Designated as safety issue: No ]
    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:
  • SCORAD Index [ Time Frame: Day 30 after end of the intervention ] [ Designated as safety issue: No ]
    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.

  • SCORAD Index [ Time Frame: Day 10 after start of the intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 10 after start of the intervention ] [ Designated as safety issue: No ]
    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).

  • Dermatological Index of Life Quality [ Time Frame: Day 21 after start of the intervention ] [ Designated as safety issue: No ]
    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).

  • Dermatological Index of Life Quality [ Time Frame: Day 30 after end of the intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 10 after start of the intervention ] [ Designated as safety issue: No ]
    Behavioral rating scores (BRS) measures severity of itching.

  • BRS Index [ Time Frame: Day 21 after start of the intervention ] [ Designated as safety issue: No ]
    Behavioral rating scores (BRS) measures severity of itching.

  • BRS Index [ Time Frame: Day 30 after end of the intervention ] [ Designated as safety issue: No ]
    Behavioral rating scores (BRS) measures severity of itching.

  • Blood test [ Time Frame: Day 21 after start of the intervention ] [ Designated as safety issue: Yes ]
    It includes routine blood cells' counting and measurement of erythrocyte sedimentation rate and serum concentration of hemoglobin.

  • Biochemical blood analysis [ Time Frame: Day 21 after start of the intervention ] [ Designated as safety issue: Yes ]
    It includes routine measurements of serum concentrations of biochemical compounds including proteins, glucose, enzymes, creatinine, urea, potassium, sodium, bilirubin.

  • Urine analysis [ Time Frame: Day 21 after start of the intervention ] [ Designated as safety issue: Yes ]
    It includes routine measurements of urine concentrations of biochemical compounds including proteins and glucose, counting of cells, detection of bacteria and urinometry.


Estimated Enrollment: 90
Study Start Date: May 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lactofiltrum Drug: Lactofiltrum
Lactofiltrum (hydrolytic lignin 0.355, lactulose 0.12) 2 tablets three times a day before meals during 21 days
Other Names:
  • Lactulose
  • Lignin
Placebo Comparator: Placebo Drug: Placebo
Placebo 2 tablets 3 times a day before meals during 21 days

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01124318

Locations
Russian Federation
Moscow State University of Medicine and Dentistry
Moscow, Russian Federation, 127473
Moscow Dermatovenerologic Clinical Dispensary № 1
Moscow, Russian Federation, 119071
Sponsors and Collaborators
Avva Rus, JSC
Moscow State University of Medicine and Dentistry
Moscow Dermatovenerologic Clinical Dispensary № 1
Investigators
Principal Investigator: Yuriy Perlamutrov, MD, DrSc Moscow State University of Medicine and Dentistry
Study Director: Nickolay A. Kryuchkov, MD, PhD, MPH Avva Rus, JSC
Study Director: Lyudmila Kobeleva, MD, PhD Avva Rus, JSC
  More Information

No publications provided

Responsible Party: Prof. Yuriy Perlamutrov, Head of dermatovenerologic diseases department, Moscow State University of Medicine and Dentistry
ClinicalTrials.gov Identifier: NCT01124318     History of Changes
Other Study ID Numbers: 04/09-AVVA RUS
Study First Received: April 28, 2010
Last Updated: September 13, 2010
Health Authority: Russia: Ethics Committee
Russia: FSI Scientific Center of Expertise of Medical Application
Russia: Federal Service on surveillance in Healthcare and Social development (Roszdravnadzor)

Keywords provided by Avva Rus, JSC:
Lactofiltrum
atopic dermatitis
itching
Dermatological Index of Life Quality
SCORAD
Behavioral Rating Scores

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Lactulose
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014