A Pilot Study of Lactofiltrum to Treat Atopic Dermatitis in Adults

Last updated: September 13, 2010
Sponsor: Avva Rus, JSC
Overall Status: Completed

Phase

2/3

Condition

Dermatitis, Atopic

Allergy

Hives (Urticaria)

Treatment

N/A

Clinical Study ID

NCT01124318
04/09-AVVA RUS
  • Ages 18-60
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • patients aged 18-60 y.o. diagnosed with atopic dermatitis according to the UKrefinement of the Hanifin-Rajka diagnostic criteria;

  • SCORAD Index more than 25.

Exclusion

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, ultravioletradiation;

  • psychoses;

  • application of pre-, probiotics, antibiotics, neuroleptics or tranquilizers 2 weeksbefore inclusion or during participation in the study;

  • participation in other clinical study 1 month before inclusion or during participationin the proposed study.

Study Design

Total Participants: 90
Study Start date:
May 01, 2010
Estimated Completion Date:
September 30, 2010

Connect with a study center

  • Moscow Dermatovenerologic Clinical Dispensary № 1

    Moscow, 119071
    Russian Federation

    Site Not Available

  • Moscow State University of Medicine and Dentistry

    Moscow, 127473
    Russian Federation

    Site Not Available

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