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

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Lactofiltrum; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 127473
    • Moscow State University of Medicine and Dentistry
  • Moscow, Russian Federation, 119071
    • Moscow Dermatovenerologic Clinical Dispensary № 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo 2 tablets 3 times a day before meals during 21 days
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Avva Rus, JSC
• Collaborators: 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 record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: April 28, 2010
• First Submitted That Met QC Criteria: May 13, 2010
• First Posted (Estimate): May 17, 2010

Study Record Updates

• Last Update Posted (Estimate): September 14, 2010
• Last Update Submitted That Met QC Criteria: September 13, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: atopic dermatitis; SCORAD; itching; Lactofiltrum; Dermatological Index of Life Quality; Behavioral Rating Scores
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Gastrointestinal Agents; Lactulose
• Other Study ID Numbers: 04/09-AVVA RUS