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A Pilot Study of Lactofiltrum to Treat Atopic Dermatitis in Adults

NCT01124318 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2010-09-14

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Lactofiltrum

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Moscow State University of Medicine and Dentistry

    collaborator OTHER

  • Moscow Dermatovenerologic Clinical Dispensary № 1

    collaborator UNKNOWN

  • Avva Rus, JSC

    lead INDUSTRY

Principal Investigators

  • Yuriy Perlamutrov, MD, DrSc · Moscow State University of Medicine and Dentistry

  • Nickolay A. Kryuchkov, MD, PhD, MPH · Avva Rus, JSC

  • Lyudmila Kobeleva, MD, PhD · Avva Rus, JSC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • Russia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01124318 on ClinicalTrials.gov