NCT01124318

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2010

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 17, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

September 14, 2010

Status Verified

September 1, 2010

Enrollment Period

4 months

First QC Date

April 28, 2010

Last Update Submit

September 13, 2010

Conditions

Atopic Dermatitis

Keywords

Lactofiltrumatopic dermatitisitchingDermatological Index of Life QualitySCORADBehavioral Rating Scores

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • SCORAD Index

    Day 30 after end of the intervention

  • SCORAD Index

    Day 10 after start of the intervention

  • Dermatological Index of Life Quality

    Day 10 after start of the intervention

  • Dermatological Index of Life Quality

    Day 21 after start of the intervention

  • Dermatological Index of Life Quality

    Day 30 after end of the intervention

  • +6 more secondary outcomes

Study Arms (2)

Lactofiltrum

ACTIVE COMPARATOR
Drug: Lactofiltrum

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

LactofiltrumDRUG

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

Also known as: Lactulose, Lignin
Lactofiltrum
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • pregnancy and breast-feeding;
  • severe diseases;
  • concomitant infection diseases (including parasitic ones);
  • diffusive connective-tissue (autoimmune) diseases;
  • renal and hepatic failure;
  • concomitant skin diseases: skin lymphoma, scab, lichen ruber planus, psoriasis;
  • professional activity involving skin injury, exposure to cold, insolation, ultraviolet radiation;
  • psychoses;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Moscow Dermatovenerologic Clinical Dispensary № 1

Moscow, Moscow, 119071, Russia

Location

Moscow State University of Medicine and Dentistry

Moscow, Moscow, 127473, Russia

Location

MeSH Terms

Conditions

Dermatitis, AtopicPruritus

Interventions

LactuloseLignin

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugarsCelluloseGlucansBiopolymersPolymersMacromolecular SubstancesComplex MixturesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Yuriy Perlamutrov, MD, DrSc

    Moscow State University of Medicine and Dentistry

    PRINCIPAL INVESTIGATOR

  • Nickolay A. Kryuchkov, MD, PhD, MPH

    Avva Rus, JSC

    STUDY DIRECTOR

  • Lyudmila Kobeleva, MD, PhD

    Avva Rus, JSC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 28, 2010

First Posted

May 17, 2010

Study Start

May 1, 2010

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

September 14, 2010

Record last verified: 2010-09

Locations

RU(2)