Trial | NCT01124318  Report issue

Title

A Pilot Study of Lactofiltrum to Treat Atopic Dermatitis in Adults
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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    lactulose ...

  • Study Participants

    90
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 Started
May 31
2010
Primary Completion
Sep 30
2010
Study Completion
Sep 30
2010
Last Update
Sep 14
2010
Estimate

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

Drug Placebo

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

Lactofiltrum Active Comparator

Placebo Placebo Comparator

Criteria 

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.
No Results Posted