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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
History of Changes

April 28, 2010
September 13, 2010
May 2010
September 2010   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01124318 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
A Pilot Study of Lactofiltrum to Treat Atopic Dermatitis in Adults
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

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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Atopic Dermatitis
  • 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
  • Drug: Placebo
    Placebo 2 tablets 3 times a day before meals during 21 days
  • Active Comparator: Lactofiltrum
    Intervention: Drug: Lactofiltrum
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
September 2010
September 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT01124318
04/09-AVVA RUS
Yes
Prof. Yuriy Perlamutrov, Head of dermatovenerologic diseases department, Moscow State University of Medicine and Dentistry
Avva Rus, JSC
  • Moscow State University of Medicine and Dentistry
  • Moscow Dermatovenerologic Clinical Dispensary № 1
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
Avva Rus, JSC
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP