A Pilot Study of Lactofiltrum to Treat Atopic Dermatitis in Adults (LF-AD-09)

AVVA Pharmaceuticals

Status and phase

Completed

Phase 3

Phase 2

Conditions

Atopic Dermatitis

Treatments

Drug: Placebo

Drug: Lactofiltrum

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01124318

04/09-AVVA RUS

Details and patient eligibility

About

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.

Enrollment

90 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.