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

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Lactofiltrum
Placebo
Sponsored by
Avva Rus, JSC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Lactofiltrum, atopic dermatitis, itching, Dermatological Index of Life Quality, SCORAD, Behavioral Rating Scores

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Lactofiltrum

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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).
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).
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).
BRS Index
Behavioral rating scores (BRS) measures severity of itching.
BRS Index
Behavioral rating scores (BRS) measures severity of itching.
BRS Index
Behavioral rating scores (BRS) measures severity of itching.
Blood test
It includes routine blood cells' counting and measurement of erythrocyte sedimentation rate and serum concentration of hemoglobin.
Biochemical blood analysis
It includes routine measurements of serum concentrations of biochemical compounds including proteins, glucose, enzymes, creatinine, urea, potassium, sodium, bilirubin.
Urine analysis
It includes routine measurements of urine concentrations of biochemical compounds including proteins and glucose, counting of cells, detection of bacteria and urinometry.

Full Information

First Posted
April 28, 2010
Last Updated
September 13, 2010
Sponsor
Avva Rus, JSC
Collaborators
Moscow State University of Medicine and Dentistry, Moscow Dermatovenerologic Clinical Dispensary № 1
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1. Study Identification

Unique Protocol Identification Number
NCT01124318
Brief Title
A Pilot Study of Lactofiltrum to Treat Atopic Dermatitis in Adults
Acronym
LF-AD-09
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Avva Rus, JSC
Collaborators
Moscow State University of Medicine and Dentistry, Moscow Dermatovenerologic Clinical Dispensary № 1

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Lactofiltrum, atopic dermatitis, itching, Dermatological Index of Life Quality, SCORAD, Behavioral Rating Scores

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lactofiltrum
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lactofiltrum
Other Intervention Name(s)
Lactulose, Lignin
Intervention Description
Lactofiltrum (hydrolytic lignin 0.355, lactulose 0.12) 2 tablets three times a day before meals during 21 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 2 tablets 3 times a day before meals during 21 days
Primary Outcome Measure Information:
Title
SCORAD Index
Description
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.
Time Frame
Day 21 after start of the intervention
Secondary Outcome Measure Information:
Title
SCORAD Index
Description
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.
Time Frame
Day 30 after end of the intervention
Title
SCORAD Index
Description
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.
Time Frame
Day 10 after start of the intervention
Title
Dermatological Index of Life Quality
Description
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).
Time Frame
Day 10 after start of the intervention
Title
Dermatological Index of Life Quality
Description
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).
Time Frame
Day 21 after start of the intervention
Title
Dermatological Index of Life Quality
Description
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).
Time Frame
Day 30 after end of the intervention
Title
BRS Index
Description
Behavioral rating scores (BRS) measures severity of itching.
Time Frame
Day 10 after start of the intervention
Title
BRS Index
Description
Behavioral rating scores (BRS) measures severity of itching.
Time Frame
Day 21 after start of the intervention
Title
BRS Index
Description
Behavioral rating scores (BRS) measures severity of itching.
Time Frame
Day 30 after end of the intervention
Title
Blood test
Description
It includes routine blood cells' counting and measurement of erythrocyte sedimentation rate and serum concentration of hemoglobin.
Time Frame
Day 21 after start of the intervention
Title
Biochemical blood analysis
Description
It includes routine measurements of serum concentrations of biochemical compounds including proteins, glucose, enzymes, creatinine, urea, potassium, sodium, bilirubin.
Time Frame
Day 21 after start of the intervention
Title
Urine analysis
Description
It includes routine measurements of urine concentrations of biochemical compounds including proteins and glucose, counting of cells, detection of bacteria and urinometry.
Time Frame
Day 21 after start of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuriy Perlamutrov, MD, DrSc
Organizational Affiliation
Moscow State University of Medicine and Dentistry
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nickolay A. Kryuchkov, MD, PhD, MPH
Organizational Affiliation
Avva Rus, JSC
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lyudmila Kobeleva, MD, PhD
Organizational Affiliation
Avva Rus, JSC
Official's Role
Study Director
Facility Information:
Facility Name
Moscow Dermatovenerologic Clinical Dispensary № 1
City
Moscow
ZIP/Postal Code
119071
Country
Russian Federation
Facility Name
Moscow State University of Medicine and Dentistry
City
Moscow
ZIP/Postal Code
127473
Country
Russian Federation

12. IPD Sharing Statement

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A Pilot Study of Lactofiltrum to Treat Atopic Dermatitis in Adults

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