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A Pilot Study of Lactofiltrum to Treat Atopic Dermatitis in Adults

NCT ID: NCT01124318

Last Updated: 2010-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lactofiltrum

Group Type ACTIVE_COMPARATOR

Lactofiltrum

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Lactofiltrum

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Lactulose Lignin

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Moscow State University of Medicine and Dentistry

OTHER

Sponsor Role collaborator

Moscow Dermatovenerologic Clinical Dispensary № 1

UNKNOWN

Sponsor Role collaborator

Avva Rus, JSC

INDUSTRY

Sponsor Role lead

Responsible Party

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Moscow State University of Medicine and Dentistry

Principal Investigators

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Yuriy Perlamutrov, MD, DrSc

Role: PRINCIPAL_INVESTIGATOR

Moscow State University of Medicine and Dentistry

Nickolay A. Kryuchkov, MD, PhD, MPH

Role: STUDY_DIRECTOR

Avva Rus, JSC

Lyudmila Kobeleva, MD, PhD

Role: STUDY_DIRECTOR

Avva Rus, JSC

Locations

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Moscow Dermatovenerologic Clinical Dispensary № 1

Moscow, Moscow, Russia

Site Status

Moscow State University of Medicine and Dentistry

Moscow, Moscow, Russia

Site Status

Countries

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Russia

Other Identifiers

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04/09-AVVA RUS

Identifier Type: -

Identifier Source: org_study_id